Study to Evaluate the Efficacy, Immunogenicity, and Safety of RSVpreF in Adults.

NCT05035212 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: C36710132021-003693-31
• Study Type: interventional
• Target: 38,861
• Locations: 7 countries
• Sites: 263

Brief Summary

Efficacy Study: This randomized, double-blinded, placebo-controlled Phase 3 study is designed to assess the safety, immunogenicity, and efficacy of a single dose of RSVpreF in the prevention of LRTI-RSV in adults:

• At a dose of 120µg.
• In adults 60 years of age and older.
• The duration of the study for each participant will be up to approximately 24 months.
• The study will be conducted in the United States, Canada, Netherlands, Finland, Argentina, Japan and South Africa. Substudy A: This study is an extension of the efficacy study and was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 2 years:
• At a dose of 120µg (as studied in the Phase 3 Efficacy Study)
• Blood samples will be collected for antibody testing.
• The duration of the study for each participant will be up to approximately 18 months.
• The study will be conducted in the United States and Argentina. Substudy B: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of approximately 1 year:
• At a dose of 120µg (as studied in the Phase 3 Efficacy Study)
• Blood samples will be collected for antibody testing.
• The duration of the study for each participant will be up to approximately 18 months.
• The study will be conducted in Argentina. Substudy C: This study was designed to evaluate the safety and immunogenicity of a second dose of RSVpreF when administered after a dosing interval of either 3 or 4 years:
• At a dose of 120µg (as studied in the Phase 3 Efficacy Study)
• Participants will receive either placebo or a second dose of RSVpreF approximately 3 or 4 years after receiving the initial dose of RSVpreF in the main efficacy study.
• Blood samples will be collected for antibody testing.
• The duration of the study for each participant will be up to approximately 24 months.
• The study will be conducted in the United States and Canada.

Conditions

Lower Respiratory Tract Illness

Keywords

Lower Respiratory Tract Illness; RSV; Vaccine

Outcome Measures

Primary Outcomes (34)

• Efficacy Study: Number of first episode of RSV-associated lower respiratory tract illness (LRTI-RSV) in the first RSV season

  Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 2 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset. Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)-confirmed RSV A and/or RSV B- associated acute respiratory illness (ARI) is assessed. LRTI-RSV is defined as an ARI with 3 or more of the lower respiratory signs/symptoms lasting more than 1 day during the same illness, plus RT-PCR-confirmed RSV infection within 7 days of ARI symptom onset.

  From Day 15 after vaccination until the end of season 1 visit (an average of 6 months)

• Efficacy Study: Proportion of participants reporting prompted local reactions within 7-days after vaccination

  Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: \> 5.0 to 10.0 cm and severe: \>10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity

  Within 7 days after vaccination

• Efficacy Study: Proportion of participants reporting prompted systemic events within 7-days after vaccination

  Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (\>=)38.0 degrees (deg) Celsius (C), mild (\>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C), moderate (\>38.9 to 40.0 deg C and \>40.0 deg C), severe (\>38.9 deg C to 40.0 deg C) and grade 4 (\>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: \>2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.

  Within 7 days after vaccination

• Efficacy Study: Proportion of participants reporting AE within 1-month after vaccination

  An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.

  Within 1 month after vaccination (up to 35 days)

• Efficacy Study: Proportion of participants reporting SAE throughout the study

  SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  Throughout the study duration (an average of 30 months)

• Efficacy Study: Proportion of participants reporting NDCMC throughout the study

  An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma).

  Throughout the study duration (an average of 30 months)

• SSA: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 2-dose of RSVpreF

  RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs), and geometric mean fold rise (GMFR). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.

  Before revaccination and 1, 6, 12 and 18-months after revaccination with RSVpreF in SSA

• SSA: Proportion of participants reporting prompted local reactions within 7-days after revaccination

  Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: \> 5.0 to 10.0 cm and severe: \>10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity

  Within 7 days after revaccination

• SSA: Proportion of participants reporting prompted systemic events within 7-days after revaccination

  Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (\>=)38.0 degrees (deg) Celsius (C), mild (\>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C), moderate (\>38.9 to 40.0 deg C and \>40.0 deg C), severe (\>38.9 deg C to 40.0 deg C) and grade 4 (\>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: \>2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.

  Within 7 days after revaccination

• SSA: Proportion of participants reporting AE within 1-month after revaccination

  An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.

  Within 1 month after revaccination (up to 35 days)

• SSA: Proportion of participants reporting SAE throughout the study

  SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  Throughout the study duration (approximately 18 months)

• SSA: Proportion of participants reporting NDCMC throughout the study

  An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma).

  Throughout the study duration (approximately 18 months)

• SSB: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 2-dose of RSVpreF

  RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean Titers (GMTs), and geometric mean fold rise (GMFR). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.

  Before revaccination and 1, 6, 12 and 18-months after revaccination with RSVpreF in SSB

• SSB: Proportion of participants reporting prompted local reactions within 7-days after revaccination

  Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: \> 5.0 to 10.0 cm and severe: \>10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity.

  Within 7 days after revaccination

• SSB: Proportion of participants reporting prompted systemic events within 7-days after revaccination

  Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (\>=)38.0 degrees (deg) Celsius (C), mild (\>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C), moderate (\>38.9 to 40.0 deg C and \>40.0 deg C), severe (\>38.9 deg C to 40.0 deg C) and grade 4 (\>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: \>2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.

  SSB: Proportion of participants reporting prompted systemic events within 7-days after revaccination

• SSB: Proportion of participants reporting AE within 1-month after revaccination

  An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.

  Within 1 month after revaccination (up to 35 days)

• SSB: Proportion of participants reporting SAE throughout the study

  SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  Throughout the study duration (approximately 18 months)

• SSB: Proportion of participants reporting NDCMC throughout the study

  An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma).

  Throughout the study duration (approximately 18 months)

• SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received RSVpreF or placebo in SSC (Year 3)

  RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean NT ratios. The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.

  1 month after revaccination in SSC (Year 3)

• SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 1 dose in the Main Efficacy Study (preS2) and revaccination in SSC (Year 3)

  RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean NT ratios. The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.

  At preseason 2 (preS2) after receiving the initial vaccination in the efficacy study and 1 month after revaccination in SSC (Year 3)

• SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 1 dose in the Main Efficacy Study and revaccination in SSC (Year 3)

  RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean of individual NT ratios (GMIR). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.

  1 month after receiving the initial vaccination in the efficacy study and 1 month after revaccination in SSC (Year 3)

• SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received RSVpreF or placebo in SSC (Year 4)

  RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean NT ratios. The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.

  1 month after revaccination in SSC (Year 4)

• SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 1 dose in the Main Efficacy Study (preS2) and revaccination in SSC (Year 4)

  RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean NT ratios. The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.

  At preseason 2 (preS2) after receiving the initial vaccination in the efficacy study and 1 month after revaccination in SSC (Year 4)

• SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 1 dose in the Main Efficacy Study and revaccination in SSC (Year 4)

  RSV A and RSV B neutralizing titers (NT), expressed as Geometric Mean of individual NT ratios (GMIR). The NTs were calculated as the interpolated reciprocal of the serum dilution resulting in 50% reduction in the number of viral focus forming units when compared to the control without test serum.

  1 month after receiving the initial vaccination in the efficacy study and 1 month after revaccination in SSC (Year 4)

• SSC: Proportion of participants reporting prompted local reactions within 7-days after revaccination (Year 3)

  Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: \> 5.0 to 10.0 cm and severe: \>10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity.

  Within 7 days after revaccination

• SSC: Proportion of participants reporting prompted local reactions within 7-days after revaccination (Year 4)

  Local reactions included pain at injection site, redness and swelling recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: 2.5 to 5.0 cm, moderate: \> 5.0 to 10.0 cm and severe: \>10 cm. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfere with daily activity and severe: prevented daily activity.

  Within 7 days after revaccination

• SSC: Proportion of participants reporting prompted systemic events within 7-days after revaccination (Year 3)

  Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (\>=)38.0 degrees (deg) Celsius (C), mild (\>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C), moderate (\>38.9 to 40.0 deg C and \>40.0 deg C), severe (\>38.9 deg C to 40.0 deg C) and grade 4 (\>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: \>2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.

  Within 7 days after revaccination

• SSC: Proportion of participants reporting prompted systemic events within 7-days after revaccination (Year 4)

  Systemic reactions:fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever: greater than equal to (\>=)38.0 degrees (deg) Celsius (C), mild (\>=38.0 to 38.4 deg C, \>38.4 to 38.9 deg C), moderate (\>38.9 to 40.0 deg C and \>40.0 deg C), severe (\>38.9 deg C to 40.0 deg C) and grade 4 (\>40.0 deg C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: \>2 times in 24h and severe: requires intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h.

  Within 7 days after revaccination

• SSC: Proportion of participants reporting AE within 1-month after revaccination (Year 3)

  An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.

  Within 1 month after revaccination (up to 35 days)

• SSC: Proportion of participants reporting AE within 1-month after revaccination (Year 4)

  An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events.

  Within 1 month after revaccination (up to 35 days)

• SSC: Proportion of participants reporting SAE after revaccination (Year 3)

  SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  Following revaccination and throughout the study duration (approximately 24 months)

• SSC: Proportion of participants reporting SAE after revaccination (Year 4)

  SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  Following revaccination and throughout the study duration (approximately 12 months)

• SSC: Proportion of participants reporting NDCMC after revaccination (Year 3)

  An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma).

  Following revaccination and throughout the study duration (approximately 24 months)

• SSC: Proportion of participants reporting NDCMC after revaccination (Year 4)

  An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or otherwise long-lasting in its effects (eg, asthma).

  Following revaccination and throughout the study duration (approximately 12 months)

Secondary Outcomes (12)

• Efficacy Study: Number of first episode of RSV-associated severe LRTI (sLRTI-RSV) in the first RSV season

  From Day 15 after vaccination until the end of season 1 visit (an average of 6 months)

• Efficacy Study: Number of first episode of LRTI-RSV in the second RSV season

  During the second RSV season (an average of 6 months)

• Efficacy Study: Number of first episode of LRTI-RSV across 2 RSV seasons

  From Day 15 after vaccination until the end of season 2 visit (an average of 12 months of surveillance)

• Efficacy Study: Number of first episode of RSV-associated ARI (ARI-RSV) in the first RSV season

  From Day 15 after vaccination until the end of season 1 visit (an average of 6 months)

• Efficacy Study: Number of first episode of ARI-RSV in the second RSV season

  During the second RSV season (an average of 6 months)

Study Arms (9)

Efficacy Study: RSVpreF vaccine

EXPERIMENTAL

RSVpreF

Biological: RSVpreF

Efficacy Study: Placebo dose

PLACEBO COMPARATOR

Placebo

Biological: Placebo

SSA: Vaccination of RSVpreF recipients with RSVpreF (Year 2 revaccination)

EXPERIMENTAL

Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSA will receive RSVpreF in SSA.

Biological: RSVpreF

SSA: Vaccination of RSVpreF recipients with Placebo

PLACEBO COMPARATOR

Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSA will receive Placebo in SSA.

Biological: Placebo

SSB: Vaccination of RSVpreF recipients with RSVpreF (Year 1 revaccination)

EXPERIMENTAL

Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSB will receive RSVpreF in SSB.

Biological: RSVpreF

SSB: Vaccination of RSVpreF recipients with Placebo

PLACEBO COMPARATOR

Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSB will receive Placebo in SSB.

Biological: Placebo

SSC: Vaccination of RSVpreF recipients with RSVpreF (Year 3 revaccination)

EXPERIMENTAL

Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSC will receive RSVpreF at the Year 3 vaccination followed by placebo at the Year 4 vaccination in SSC.

Biological: RSVpreF

SSC: Vaccination of RSVpreF recipients with RSVpreF (Year 4 revaccination)

EXPERIMENTAL

Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSC will receive placebo at the Year 3 vaccination followed by RSVpreF at the Year 4 vaccination in SSC.

Biological: RSVpreF

SSC: Vaccination of RSVpreF recipients with Placebo

PLACEBO COMPARATOR

Participants who originally received RSVpreF in the Efficacy Study and are eligible for SSC will receive placebo at both the Year 3 and Year 4 vaccination in SSC.

Biological: Placebo

Interventions

RSVpreF BIOLOGICAL

RSV vaccine (RSVpreF)

Efficacy Study: RSVpreF vaccine; SSA: Vaccination of RSVpreF recipients with RSVpreF (Year 2 revaccination); SSB: Vaccination of RSVpreF recipients with RSVpreF (Year 1 revaccination); SSC: Vaccination of RSVpreF recipients with RSVpreF (Year 3 revaccination); SSC: Vaccination of RSVpreF recipients with RSVpreF (Year 4 revaccination)

Placebo BIOLOGICAL

Placebo

Efficacy Study: Placebo dose; SSA: Vaccination of RSVpreF recipients with Placebo; SSB: Vaccination of RSVpreF recipients with Placebo; SSC: Vaccination of RSVpreF recipients with Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, frequent symptom assessment by mobile device application, and other study procedures, including collection of nasal swabs by themselves and by study staff when indicated.
• Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. Specific criteria for participants with known stable infection with HIV, HCV, or HBV can be found in the protocol.
• Adults who are ambulatory and live in the community, or in assisted living or long-term care residential facilities that provide minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.
• Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
• Male or female participants ≥60 years of age.
• Male participants able to father children must agree to use a highly effective method of contraception from the time of informed consent through at least 28 days after study intervention administration.
• Female participants must not be of childbearing potential.

You may not qualify if:

• Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine.
• Serious chronic disorder including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
• Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
• Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• Participation in other studies involving an investigational product within 28 days prior to consent and/or through and including the 6-months follow-up visit (Visit 3).
• Note: This criterion does not apply to participants who are participating in a follow-up period for another study involving a study intervention that is an investigational drug or vaccine, if receipt of the last dose was at least 6 months prior to consenting for this study and there is no further dosing anticipated from the previous study during the participant's participation in this study - Individuals who receive chronic systemic treatment with immunosuppressive therapy, including cytotoxic agents, monoclonal antibodies, systemic corticosteroids, or radiotherapy, eg, for cancer or an autoimmune disease, from 60 days before study intervention administration or planned receipt throughout the study. If systemic corticosteroids have been administered short term (\<14 days) for treatment of an acute illness, participants should not be enrolled in the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
• Note: Participants with COPD or asthma can be enrolled if chronic corticosteroids do not exceed a dose equivalent to 10 mg/day of prednisone.
• Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration.
• Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during study participation.
• Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
• Substudy A
• Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, frequent symptom assessment by mobile device application, and other study procedures, including collection of nasal swabs by themselves and by study staff when indicated.
• Note: Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included. Specific criteria for participants with known stable infection with HIV, HCV, or HBV can be found in the protocol.
• Adults who are ambulatory and live in the community, or in assisted living or long-term care residential facilities that provide minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (263)

St. Vincent's Birmingham (Pharmacy)

Birmingham, Alabama, 35205, United States

Location

St. Vincent's Birmingham

Birmingham, Alabama, 35205, United States

Location

Medical Affiliated Research Center

Huntsville, Alabama, 35801, United States

Location

Lenzmeier Family Medicine / Avacare

Glendale, Arizona, 85308, United States

Location

Phoenix Clinical LLC

Phoenix, Arizona, 85014, United States

Location

HOPE Research Institute

Phoenix, Arizona, 85018, United States

Location

The Pain Center of Arizona

Phoenix, Arizona, 85018, United States

Location

HOPE Research Institute

Phoenix, Arizona, 85023, United States

Location

Cognitive Clinical Trials, LLC

Phoenix, Arizona, 85044, United States

Location

Headlands Research - Scottsdale

Scottsdale, Arizona, 85260, United States

Location

Alliance for Multispecialty Research, LLC

Tempe, Arizona, 85281, United States

Location

HOPE Research Institute

Tempe, Arizona, 85284, United States

Location

Noble Clinical Research

Tucson, Arizona, 85704, United States

Location

The Institute for Liver Health dba Arizona Clinical Trials

Tucson, Arizona, 85712, United States

Location

Hope Clinical Research

Canoga Park, California, 91303, United States

Location

eStudySite

Chula Vista, California, 91911, United States

Location

Benchmark Research

Colton, California, 92324, United States

Location

West Coast Research

Dublin, California, 94568, United States

Location

Marvel Clinical Research 002, LLC

Huntington Beach, California, 92647, United States

Location

Chemidox Clinical Trials

Lancaster, California, 93534, United States

Location

Ark Clinical Research

Long Beach, California, 90815, United States

Location

Downtown L.A. Research Center, Inc.

Los Angeles, California, 90017, United States

Location

Velocity Clinical Research, North Hollywood

North Hollywood, California, 91606, United States

Location

Clinica mi Salud by Focil Med

Oxnard, California, 93030, United States

Location

De Silva Medical Inc

Palmdale, California, 93551, United States

Location

Empire Clinical Research

Pomona, California, 91767, United States

Location

Paradigm Clinical Research Center

Redding, California, 96001, United States

Location

Artemis Institute for Clinical Research

Riverside, California, 92503, United States

Location

Benchmark Research

Sacramento, California, 95864, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92123, United States

Location

California Research Foundation

San Diego, California, 92123, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Lynn Institute of Denver

Aurora, Colorado, 80012, United States

Location

Tekton Research LLC

Longmont, Colorado, 80501, United States

Location

Clinical Research Consulting

Milford, Connecticut, 06460, United States

Location

Stamford Therapeutics Consortium

Stamford, Connecticut, 06905, United States

Location

JEM Research Institute

Atlantis, Florida, 33462, United States

Location

IDEAL Clinical Research

Aventura, Florida, 33180, United States

Location

Innovative Research of West Florida

Clearwater, Florida, 33756, United States

Location

Invictus Clinical Research Group, LLC

Coconut Creek, Florida, 33073, United States

Location

Nature Coast Clinical Research

Crystal River, Florida, 34429, United States

Location

Universal Axon Clinical Research, LLC (Administrative)

Doral, Florida, 33166, United States

Location

Indago Research & Health Center, Inc

Hialeah, Florida, 33012, United States

Location

Doral Medical Research, LLC

Hialeah, Florida, 33016, United States

Location

M3 Wake Research - Lake City

Lake City, Florida, 32055, United States

Location

Optimus U Corporation

Miami, Florida, 33125, United States

Location

Advance Medical Research Center

Miami, Florida, 33135, United States

Location

Flourish Research - Miami, LLC

Miami, Florida, 33135, United States

Location

Optimus U Corporation

Miami, Florida, 33135, United States

Location

Next Phase Research Alliance

Miami, Florida, 33144, United States

Location

New Horizon Research Center

Miami, Florida, 33165, United States

Location

De La Cruz Research Center, LLC

Miami, Florida, 33184, United States

Location

Global Health Research Center, Inc.

Miami Lakes, Florida, 33016, United States

Location

Headlands Research Orlando

Orlando, Florida, 32819, United States

Location

Pines Care Research Center, LLC

Pembroke Pines, Florida, 33024, United States

Location

IDEAL Clinical Research

Pembroke Pines, Florida, 33026, United States

Location

DBC Research USA

Pembroke Pines, Florida, 33029, United States

Location

Headlands Research Sarasota

Sarasota, Florida, 34243, United States

Location

Precision Clinical Research

Sunrise, Florida, 33351, United States

Location

Clinical Site Partners, LLC dba Flourish Research

Winter Park, Florida, 32789, United States

Location

Conquest Research

Winter Park, Florida, 32789, United States

Location

Javara - Privia Medical Group Georgia - Albany

Albany, Georgia, 31707, United States

Location

Coastal Heritage Clinical Research

Hinesville, Georgia, 31313, United States

Location

Javara - Privia Medical Group Georgia - Savannah

Savannah, Georgia, 31406, United States

Location

Velocity Clinical Research, Savannah

Savannah, Georgia, 31406, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Javara Inc.

Thomasville, Georgia, 31792, United States

Location

Snake River Research, PLLC

Idaho Falls, Idaho, 83404, United States

Location

Solaris Clinical Research

Meridian, Idaho, 83646, United States

Location

Great Lakes Clinical Trials, LLC dba Flourish Research

Chicago, Illinois, 60640, United States

Location

DM Clinical Research

Melrose Park, Illinois, 60160, United States

Location

Affinity Health Corp

Oak Brook, Illinois, 60523, United States

Location

Accellacare - DuPage

Oak Lawn, Illinois, 60453, United States

Location

MOC Research

Mishawaka, Indiana, 46544, United States

Location

Velocity Clinical Research Valparaiso

Valparaiso, Indiana, 46383, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Meridian Clinical Research, LLC

Sioux City, Iowa, 51106, United States

Location

AMR Clinical

Lexington, Kentucky, 40509, United States

Location

Ochsner Clinic Foundation

Kenner, Louisiana, 70065, United States

Location

Ochsner Medical Center - Kenner

Kenner, Louisiana, 70065, United States

Location

Velocity Clinical Research, Metairie

Metairie, Louisiana, 70006, United States

Location

Velocity Clinical Research, Rockville

Rockville, Maryland, 20854, United States

Location

ActivMed Practices & Research, LLC

Beverly, Massachusetts, 01915, United States

Location

ActivMed Practices & Research, LLC

Methuen, Massachusetts, 01844, United States

Location

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

Michigan Center of Medical Research (MICHMER)

Farmington Hills, Michigan, 48334, United States

Location

Ascension St. John Hospital Vaccine Research Unit

Grosse Pointe Woods, Michigan, 48236, United States

Location

Oakland Medical Research

Troy, Michigan, 48085, United States

Location

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

Troy, Michigan, 48098, United States

Location

Saint Louis University

St Louis, Missouri, 63104, United States

Location

Sundance Clinical Research

St Louis, Missouri, 63141, United States

Location

Skyline Medical Center, PC/CCT Research

Elkhorn, Nebraska, 68022, United States

Location

Quality Clinical Research

Omaha, Nebraska, 68114, United States

Location

Wr-Crcn, Llc.

Las Vegas, Nevada, 89106, United States

Location

Alliance for Multispecialty Research, LLC

Las Vegas, Nevada, 89119, United States

Location

Las Vegas Clinical Trials

North Las Vegas, Nevada, 89030, United States

Location

ActivMed Practices and Research, LLC.

Portsmouth, New Hampshire, 03801, United States

Location

South Jersey Infectious Disease

Somers Point, New Jersey, 08244, United States

Location

IMA Clinical Research Warren

Warren Township, New Jersey, 07059, United States

Location

Velocity Clinical Research, Binghamton

Binghamton, New York, 13905, United States

Location

Drug Trials America

Hartsdale, New York, 10530, United States

Location

Corning Center for Clinical Research

Horseheads, New York, 14845, United States

Location

Rochester Clinical Research, LLC

Rochester, New York, 14609, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

CHEAR Center LLC

The Bronx, New York, 10455, United States

Location

Velocity Clinical Research, Vestal

Vestal, New York, 13850, United States

Location

Atrium Health - Strive Vaccine Research Clinic

Charlotte, North Carolina, 28207, United States

Location

Tryon Medical Partners, PLLC

Charlotte, North Carolina, 28210, United States

Location

Accellacare - Charlotte

Charlotte, North Carolina, 28211, United States

Location

Sensenbrenner Primary Care Research Office

Charlotte, North Carolina, 28277, United States

Location

Accellacare - Wilmington - 1917 Tradd Court

Wilmington, North Carolina, 28401, United States

Location

Accellacare - Wilmington

Wilmington, North Carolina, 28401, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Velocity Clinical Research, Cincinnati, Mt. Auburn

Cincinnati, Ohio, 45219, United States

Location

Velocity Clinical Research - Cincinnati

Cincinnati, Ohio, 45242, United States

Location

Velocity Clinical Research, Springdale

Cincinnati, Ohio, 45246, United States

Location

Centricity Research Columbus Ohio Multispecialty

Columbus, Ohio, 43213, United States

Location

Tekton Research, LLC.

Edmond, Oklahoma, 73013, United States

Location

Tekton Research, Inc

Yukon, Oklahoma, 73099, United States

Location

The Corvallis Clinic, PC

Corvallis, Oregon, 97330, United States

Location

Velocity Clinical Research, Grants Pass

Grants Pass, Oregon, 97527, United States

Location

Velocity Clinical Research, Medford

Medford, Oregon, 97504, United States

Location

Summit Headlands, LLC

Portland, Oregon, 97210, United States

Location

Kaiser Permanente Northwest Center for Health Research

Portland, Oregon, 97227, United States

Location

Capital Area Research, LLC

Camp Hill, Pennsylvania, 17011, United States

Location

Central Erie Primary Care

Erie, Pennsylvania, 16508, United States

Location

Penn Prevention Unit

Philadelphia, Pennsylvania, 19104, United States

Location

Velocity Clinical Research, Providence

East Greenwich, Rhode Island, 02818, United States

Location

AMR Clinical

Knoxville, Tennessee, 37909, United States

Location

Accellacare US Inc., d/b/a Accellacare of Knoxville

Knoxville, Tennessee, 37912, United States

Location

Clinical Research Associates, Inc.

Nashville, Tennessee, 37203, United States

Location

Benchmark Research

Austin, Texas, 78705, United States

Location

Innovo Research - Austin Regional Clinic

Austin, Texas, 78726, United States

Location

Tekton Research, LLC.

Austin, Texas, 78745, United States

Location

Tekton Research, LLC.

Beaumont, Texas, 77706, United States

Location

Javara - Privia Medical Group Gulf Coast - The Woodlands HWH

Conroe, Texas, 77384, United States

Location

North Texas Infectious Diseases Consultants, P.A

Dallas, Texas, 75246, United States

Location

Benchmark Research

Fort Worth, Texas, 76135, United States

Location

Texas Health Family Care

Fort Worth, Texas, 76135, United States

Location

Allure Health at Mt. Olympus Medical Research

Friendswood, Texas, 77546, United States

Location

Hany H. Ahmed, MD

Houston, Texas, 77008, United States

Location

Helios Clinical Research - HOU

Houston, Texas, 77008, United States

Location

HG Pediatrics

Houston, Texas, 77008, United States

Location

Trio Clinical Trials, LLC

Houston, Texas, 77008, United States

Location

Van Tran Family Practice

Houston, Texas, 77008, United States

Location

Ventavia Research Group, LLC

Houston, Texas, 77008, United States

Location

Centex Studies

Houston, Texas, 77058, United States

Location

DM Clinical Research - Cy Fair

Houston, Texas, 77065, United States

Location

DM Clinical Research- Cyfair

Houston, Texas, 77065, United States

Location

DM Clinical Research - Bellaire

Houston, Texas, 77081, United States

Location

Centex Studies

Houston, Texas, 77090, United States

Location

DM Clinical Research - Humble

Humble, Texas, 77338, United States

Location

DM Clinical Research, Martin Diagnostic Clinic

Humble, Texas, 77338, United States

Location

Milton Haber, M.D.

Laredo, Texas, 78041, United States

Location

Milton Haber, MD

Laredo, Texas, 78041, United States

Location

SMS Clinical Research

Mesquite, Texas, 75149, United States

Location

Sun Research Institute

San Antonio, Texas, 78215, United States

Location

Clinical Trials of Texas, LLC dba Flourish Research

San Antonio, Texas, 78229, United States

Location

Clinical Trials of Texas, LLC

San Antonio, Texas, 78229, United States

Location

Dynamed Clinical Research, LP d/b/a DM Clinical Research

Sugar Land, Texas, 77478, United States

Location

Javara Inc.

Sugar Land, Texas, 77478, United States

Location

Mt Olympus Medical Research

Sugar Land, Texas, 77479, United States

Location

Dynamed Clinical Research, LP d/b/a DM Clinical Research

Tomball, Texas, 77375, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic Draper

Draper, Utah, 84020, United States

Location

Tanner Clinic

Layton, Utah, 84041, United States

Location

J. Lewis Research, Inc. / Jordan River Family Medicine

South Jordan, Utah, 84095, United States

Location

Velocity Clinical Research, Salt Lake City

West Jordan, Utah, 84088, United States

Location

Centricity Research Suffolk Primary Care

Suffolk, Virginia, 23435, United States

Location

Virginia Gastroenterology Clinical Research

Suffolk, Virginia, 23435, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

Sound Medical Research

Port Orchard, Washington, 98366, United States

Location

MultiCare Institute for Research & Innovation

Tacoma, Washington, 98405, United States

Location

MultiCare Medical Group

Tacoma, Washington, 98405, United States

Location

Central Washington Health Services Association d/b/a Confluence Health

Wenatchee, Washington, 98801, United States

Location

Research Building

Wenatchee, Washington, 98801, United States

Location

Allegiance Research Specialists, LLC

Wauwatosa, Wisconsin, 53226, United States

Location

Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

CABA, Buenos Aires, 1426, Argentina

Location

Fundación Respirar

CABA, Buenos Aires, C1426ABP, Argentina

Location

Clinica Privada Instituto Medico Platense S.A.

La Plata, Buenos Aires, B1900AVG, Argentina

Location

Instituto De Investigaciones Clínicas Mar Del Plata

Mar del Plata, Buenos Aires, B7600FZO, Argentina

Location

Clinica Mayo de Urgencias Medicas Cruz Blanca S.R.L

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Hospital de Clinicas Presidente Nicolas Avellaneda

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Clinica Privada del Sol S.A.

Córdoba, 5000, Argentina

Location

IMAC - Instituto Medico de Alta Complejidad

Salta, 4400, Argentina

Location

Kaye Edmonton Clinic

Edmonton, Alberta, T6G 1Z1, Canada

Location

University Of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Aggarwal and Associates Limited

Brampton, Ontario, L6T 0G1, Canada

Location

Dawson Clinical Research Inc

Guelph, Ontario, N1H 1B1, Canada

Location

Premier Clinical Trial Network

Hamilton, Ontario, L8L 5G4, Canada

Location

Centricity Research Toronto LMC Multispecialty

Toronto, Ontario, M4G 3E8, Canada

Location

Dr. Anil K. Gupta Medicine Professional Corporation

Toronto, Ontario, M9V 4B4, Canada

Location

Centricity Research Toronto Manna Multispecialty

Toronto, Ontario, M9W 4L6, Canada

Location

Centricity Research Mirabel Multispecialty

Mirabel, Quebec, J7J 2K8, Canada

Location

Clinique de Médecine Urbaine du Quartier Latin

Montreal, Quebec, H2L 4E9, Canada

Location

Alpha Recherche Clinique

Québec, Quebec, G2J 0C4, Canada

Location

Diex Recherche Sherbrooke

Sherbrooke, Quebec, J1L 0H8, Canada

Location

Diex Recherche Inc. Division Victoriaville

Victoriaville, Quebec, G6P 3Z8, Canada

Location

Diex Recherche Quebec

Québec, G1V 4T3, Canada

Location

Centre de Recherche Saint-Louis inc.

Québec, G1W 4R4, Canada

Location

Espoo Vaccine Research Clinic

Espoo, 02230, Finland

Location

FVR, Etelä-Helsingin rokotetutkimusklinikka

Helsinki, 00100, Finland

Location

Helsinki East Vaccine Research Clinic

Helsinki, 00930, Finland

Location

Järvenpää Vaccine Research Clinic

Jarvenpaa, 04400, Finland

Location

Terveystalo Jyväskylä

Jyväskylä, 40100, Finland

Location

Kokkola Vaccine Research Clinic

Kokkola, 67100, Finland

Location

Oulu Vaccine Research Clinic

Oulu, 90220, Finland

Location

Pori Vaccine Research Clinic

Pori, 28100, Finland

Location

Seinäjoki Vaccine Research Clinic

Seinäjoki, 60100, Finland

Location

Tampere Vaccine Research Clinic

Tampere, 33100, Finland

Location

Terveystalo Tampere

Tampere, 33100, Finland

Location

Terveystalo Turku Pulssi

Turku, 20100, Finland

Location

Turku Vaccine Research Clinic

Turku, 20520, Finland

Location

Tenjin General Clinic

Fukuoka, Fukuoka, 810-0021, Japan

Location

Seishinkai Inoue Hospital

Itoshima, Fukuoka, 819-1104, Japan

Location

Sasaki Clinic

Amagasaki, Hyōgo, 660-0827, Japan

Location

Motomachi Takatsuka Naika Clinic

Yokohama, Kanagawa, 231-0023, Japan

Location

Medical Corporation Heishinkai OPHAC Hospital

Osaka, Osaka, 532-0003, Japan

Location

Sugiura Clinic

Kawaguchi, Saitama, 332-0012, Japan

Location

Nihonbashi Sakura Clinic

Chuo-ku, Tokyo, 103-0025, Japan

Location

Tokyo Eki Center Building Clinic

Chuo-ku, Tokyo, 103-0027, Japan

Location

Fukuwa Clinic

Chuo-ku, Tokyo, 104-0031, Japan

Location

Tokyo Asbo Clinic

Chuo-ku, Tokyo, 104-0031, Japan

Location

Medical Corp. Seikoukai New Medical Research System Clinic

Hachioji-shi, Tokyo, 192-0046, Japan

Location

Hillside Clinic Jingumae

Shibuya-ku, Tokyo, 1500001, Japan

Location

Clinical Research Hospital Tokyo

Shinjuku-ku, Tokyo, 160-0004, Japan

Location

Clinical Research Hospital Tokyo

Shinjuku-ku, Tokyo, 162-0053, Japan

Location

Oda Clinic

Shinjuku-ku, Tokyo, 169-0072, Japan

Location

Souseikai Sumida Hospital

Sumida-ku, Tokyo, 130-0004, Japan

Location

Sekino Hospital

Toshima-ku, Tokyo, 171-0014, Japan

Location

SOUSEIKAI PS Clinic

Fukuoka, 812-0025, Japan

Location

AMC Nishiumeda Clinic

Osaka, 530-0001, Japan

Location

Meander Medisch Centrum

Amersfoort, 3813 TZ, Netherlands

Location

PoliDirect Amsterdam West

Amsterdam, 1064 BP, Netherlands

Location

Huisartsencentrum Parklaan

Eindhoven, 5613 BE, Netherlands

Location

Huisartsenpraktijk Radesingel

Groningen, 9718 TA, Netherlands

Location

Gezondheidscentrum Leonardus

Helmond, 5701 AH, Netherlands

Location

Spaarne Gasthuis

Hoofddorp, 2134 TM, Netherlands

Location

PoliDirect Nieuwegein

Nieuwegein, 3431 HR, Netherlands

Location

Franciscus Gasthuis & Vlietland, location Gasthuis

Rotterdam, 3045 PM, Netherlands

Location

Huisartsen Soest

Soest, 3762BN, Netherlands

Location

UMC Utrecht

Utrecht, 3584 CX, Netherlands

Location

Julius Clinical Breda

Zeist, 3703 CD, Netherlands

Location

Josha Research

Bloemfontein, Free State, 9301, South Africa

Location

Welkom Clinical Trial Centre (MERC WELKOM)

Welkom, Free State, 9460, South Africa

Location

Worthwhile Clinical Trials

Benoni, Gauteng, 1500, South Africa

Location

MERCLINCO (Pty) Ltd - Kempton

Kempton Park, Gauteng, 1619, South Africa

Location

Dr A Jacovides & Partners Inc.

Midrand, Gauteng, 1685, South Africa

Location

Newtown Clinical Research Centre (PTY) LTD

Newtown, Gauteng, 2001, South Africa

Location

Global Clinical Trials

Pretoria, Gauteng, 0083, South Africa

Location

About Allergy

Pretoria, Gauteng, 0181, South Africa

Location

Into Research

Pretoria, Gauteng, 0181, South Africa

Location

Jongaie Research

Pretoria, Gauteng, 0183, South Africa

Location

Synexus SA- Watermeyer Clinical Research Center

Pretoria, Gauteng, 0184, South Africa

Location

Setshaba Research Centre

Soshanguve, Gauteng, 0152, South Africa

Location

Wits Vaccines & Infectious Diseases Analytics

Soweto, Gauteng, 2195, South Africa

Location

FCRN Clinical Trial Centre

Vereeniging, Gauteng, 1935, South Africa

Location

MERC Research (Pty) Ltd - Middelburg

Middelburg, Mpumalanga, 1055, South Africa

Location

Synexus - Helderberg Clinical Research Centre - Somerset West

Cape Town, Western Cape, 7130, South Africa

Location

TREAD Research

Cape Town, Western Cape, 7500, South Africa

Location

Be Part Yoluntu Centre

Paarl, Western Cape, 7626, South Africa

Location

Helderberg Clinical Trials Centre

Somerset West, Western Cape, 7129, South Africa

Location

Emmed Research

Pretoria, 0002, South Africa

Location

Botho Ke Bontle Health Services

Pretoria, 0184, South Africa

Location

Related Publications (2)

• Walsh EE, Eiras D, Woodside J, Jiang Q, Patton M, Marc GP, Llapur C, Ramet M, Fukushima Y, Hussen N, Cardona J, Mikati T, Zareba A, Ilangovan K, Lino MM, Kalinina EV, Swanson KA, Gurtman A, Munjal I. Efficacy, Immunogenicity, and Safety of the Bivalent Respiratory Syncytial Virus (RSV) Prefusion F Vaccine in Older Adults Over 2 RSV Seasons. Clin Infect Dis. 2026 Feb 4;81(6):e680-e689. doi: 10.1093/cid/ciaf061.

  PMID: 39928572 DERIVED

• Walsh EE, Perez Marc G, Zareba AM, Falsey AR, Jiang Q, Patton M, Polack FP, Llapur C, Doreski PA, Ilangovan K, Ramet M, Fukushima Y, Hussen N, Bont LJ, Cardona J, DeHaan E, Castillo Villa G, Ingilizova M, Eiras D, Mikati T, Shah RN, Schneider K, Cooper D, Koury K, Lino MM, Anderson AS, Jansen KU, Swanson KA, Gurtman A, Gruber WC, Schmoele-Thoma B; RENOIR Clinical Trial Group. Efficacy and Safety of a Bivalent RSV Prefusion F Vaccine in Older Adults. N Engl J Med. 2023 Apr 20;388(16):1465-1477. doi: 10.1056/NEJMoa2213836. Epub 2023 Apr 5.

  PMID: 37018468 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This is a double-blinded, placebo-controlled study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: September 5, 2021
• Study Start: August 31, 2021
• Primary Completion (Estimated): January 18, 2027
• Study Completion (Estimated): January 18, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

FI (13); NL (11); ZA (21); CA (15); AR (8); JP (19); US (176)