Safety and Immunogenicity of RSVpreF Coadministered With SIIV in Adults ≥65 Years of Age

NCT05301322 | Completed Phase 3 Results FDA Drug

• 1 other identifier: C3671006
• Study Type: interventional
• Target: 1,471
• Locations: 1 country
• Sites: 33

Brief Summary

The purpose of this study is to assess the safety and immunogenicity of RSVpreF when coadministered with SIIV compared to sequential administration of the vaccines when given 1 month apart (SIIV followed by RSVpreF). Additionally, the study will contribute data supporting the development of RSVpreF as a prophylactic vaccine against RSV disease in infants through maternal immunization and in older adults through active vaccination.

Conditions

Respiratory Syncytial Virus

Keywords

Respiratory tract infection; RSV; vaccine; older adults

Outcome Measures

Primary Outcomes (8)

• Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination With RSVpreF or Placebo

  Local reactions were collected at the RSVpreF or placebo injection site after Vaccination 1 and Vaccination 2 and were recorded by participants using electronic diary (e-diary). Local reactions included redness, swelling and pain at injection site. Redness and swelling were measured and recorded in measuring device units where, 1 measuring device unit =0.5 centimeter (cm) and were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm), and severe (\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Percentage of participants reporting local reactions at injection site in Coadministration Group, and Sequential-Administration Group and associated 2-sided 95% confidence interval (CI) based on Clopper and Pearson method was presented in this outcome measure (OM). Safety population=all enrolled participants who received study intervention (RSVpreF, placebo).

  Within 7 days after Vaccination 1 or Vaccination 2

• Percentage of Participants Reporting Systemic Events Within 7 Days After Vaccination With RSVpreF or Placebo

  Systemic events included fever, fatigue, headache, nausea, vomiting, diarrhea, muscle pain and joint pain and were recorded by participants using an e-diary. Fever was defined as an oral temperature \>=38.0 degree Celsius (deg C) and categorized as \>=38.0 to 38.4 deg C (mild), \>38.4 to 38.9 deg C (moderate), \>38.9 to 40.0 deg C (severe) and \>40.0 deg C (grade 4). 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 mild: 1 to 2 times in 24 hours (h), moderate: \>2 times in 24h, and severe: required intravenous hydration. Diarrhea was graded 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. Percentage of participants with systemic events within 7 days after each vaccination and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented.

  Within 7 days after Vaccination 1 or Vaccination 2

• Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 1

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs within 1 month after Vaccination 1 were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure.

  Within 1 month after Vaccination 1

• Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 2

  An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs within 1 month after Vaccination 2 were reported in this outcome measure. Exact 2-sided CI was calculated using the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.

  Within 1 month after Vaccination 2

• Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 1 Month After Vaccination 1

  An SAE was defined as an AE that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic or that was considered to be an important medical event. Percentage of participants with SAEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. Percentage of participants reporting SAEs within 1 month after Vaccination 1 were reported in this outcome measure.

  Within 1 month after Vaccination 1

• Percentage of Participants Reporting Serious Adverse Events (SAEs) Within 1 Month After Vaccination 2

  An SAE was defined as an AE that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic or that was considered to be an important medical event. Percentage of participants with SAEs and the associated 2-sided 95% CI based on the Clopper and Pearson method was presented. Percentage of participants reporting SAEs within 1 month after Vaccination 2 were reported in this outcome measure.

  Within 1 month after Vaccination 2

• Geometric Mean Ratio (GMR) of Neutralizing Titer (NTs) at 1 Month After Vaccination With RSVpreF for RSV Subfamily A and B in RSVpreF + SIIV Compared to RSVpreF Alone

  Geometric mean titer (GMT) of RSV A and RSV B neutralizing titers for the Coadministration Group and Sequential-Administration Group were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CI were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the lower limit of quantification (LLOQ) were set to 0.5\*LLOQ. Geometric mean ratio (GMR) was reported in the statistical analysis section and was calculated as ratio of GMTs in the Coadministration Group to the Sequential-Administration Group.

  1 month after Vaccination 1 for Coadministration Group and 1 month after Vaccination 2 for Sequential-Administration Group

• GMR of the Strain-Specific Hemagglutination Inhibition (HAI) Titers 1 Month After Vaccination With SIIV in the Coadministration Group to the Corresponding HAI Titers in the Sequential-Administration Group

  GMTs of strain-specific HAI titers for the Coadministration Group and Sequential-Administration Group were reported in this outcome measure in descriptive data section. GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5\*LLOQ. GMR was reported in the statistical analysis section and was calculated as ratio of GMT in the Coadministration Group to the Sequential-Administration Group.

  1 month after Vaccination 1

Secondary Outcomes (4)

• Geometric Mean of the Neutralizing Titers for RSV A and RSV B Before Vaccination and at 1 Month and 2 Months After Vaccination With RSVpreF

  Coadministration Group: before RSVpreF vaccination, and 1 and 2 months after RSVpreF vaccination; Sequential-Administration Group: before RSVpreF vaccination (most recent serology results before RSVpreF) and 1 month after RSVpreF vaccination

• Geometric Mean Fold Rise (GMFR) of the NTs for RSV A and RSV B Before Vaccination and at 1 Month and 2 Months After Vaccination With RSVpreF

  Coadministration Group: before RSVpreF vaccination, and 1 and 2 months after vaccination; Sequential-Administration Group: before RSVpreF vaccination (most recent serology results before RSVpreF) and 1 month after vaccination

• HAI Geometric Mean Titer (GMT) Before Vaccination and 1 Month After Vaccination With SIIV

  Before SIIV vaccination, and 1 month after vaccination

• GMFR of Strain-Specific HAI Titers Before Vaccination and 1 Month After Vaccination With SIIV

  Before SIIV vaccination, and 1 month after vaccination

Study Arms (2)

Coadministration Group

EXPERIMENTAL

RSVpreF and SIIV followed by placebo a month later

Biological: RSVpreF Vaccine; Other: Placebo; Biological: Seasonal Inactivated Influenza Vaccine

Sequential Administration Group

EXPERIMENTAL

Placebo and SIIV followed by RSVpreF a month later

Biological: RSVpreF Vaccine; Other: Placebo; Biological: Seasonal Inactivated Influenza Vaccine

Interventions

RSVpreF Vaccine BIOLOGICAL

RSV Vaccine

Coadministration Group; Sequential Administration Group

Placebo OTHER

Placebo

Coadministration Group; Sequential Administration Group

Seasonal Inactivated Influenza Vaccine BIOLOGICAL

SIIV

Coadministration Group; Sequential Administration Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Male and female participants ≥65 years of age at the time of consent.
• Participants who are willing and able to comply with scheduled visits, laboratory tests, lifestyle considerations, and other study procedures, including daily completion of the e diary for 7 days after each study vaccination.
• Capable of giving signed informed consent

You may not qualify if:

• Bleeding diathesis or condition associated with prolonged bleeding time that may contraindicate IM injection.
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention or any related vaccine.
• Allergy to egg proteins (egg or egg products) or chicken proteins.
• History of Guillain-Barré syndrome.
• 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.
• Previous vaccination with any licensed or investigational RSV vaccine at any time prior to enrollment, or planned receipt throughout the study of nonstudy RSV vaccine.
• Previous vaccination with any influenza vaccine within 6 months before study intervention administration, or planned receipt of any nonstudy licensed or investigational influenza vaccine during study participation.
• Receipt of any blood/plasma products or immunoglobulin, from 60 days before study intervention administration, or planned receipt throughout the study.
• Individuals who receive chronic 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 (\<20 mg/day of prednisone or equivalent) 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) corticosteroid use is permitted.
• Current alcohol abuse or illicit drug use.
• Current use of any prohibited concomitant medication(s) or those unwilling/unable to use a permitted concomitant medication(s)
• Participation in other studies involving investigational product(s) within 28 days prior to consent and/or 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (33)

Paratus Clinical Research Canberra

Bruce, Australian Capital Territory, 2617, Australia

Location

Paratus Clinical Research Western Sydney

Blacktown, New South Wales, 2148, Australia

Location

Emeritus Research

Botany, New South Wales, 2019, Australia

Location

Genesis Research Services

Broadmeadow, New South Wales, 2292, Australia

Location

Northern Beaches Clinical Research

Brookvale, New South Wales, 2100, Australia

Location

Northside Health

Coffs Harbour, New South Wales, 2450, Australia

Location

Holdsworth House Medical Practice

Darlinghurst, New South Wales, 2010, Australia

Location

Paratus Clinical Research Central Coast

Kanwal, New South Wales, 2259, Australia

Location

The AIM Centre / Hunter Diabetes Centre

Merewether, New South Wales, 2291, Australia

Location

John Hunter Hospital

New Lambton Heights, New South Wales, 2305, Australia

Location

Scientia Clinical Research

Randwick, New South Wales, 2031, Australia

Location

Australian Clinical Research Network

Sydney, New South Wales, NSW 2035, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Paratus Clinical Research Brisbane

Albion, Queensland, 4010, Australia

Location

Core Research Group

Brisbane, Queensland, 4064, Australia

Location

Griffith University

Gold Coast Campus, Queensland, 4222, Australia

Location

Nucleus Network Brisbane

Herston, Queensland, 4006, Australia

Location

Mackay Hospital and Health Service

Mackay, Queensland, 4740, Australia

Location

USC Clinical Trials Moreton Bay

Morayfield, Queensland, 4506, Australia

Location

USC Clinical Trials Centre

Sippy Downs, Queensland, 4556, Australia

Location

AusTrials - Taringa

Taringa, Queensland, 4068, Australia

Location

Core Research Group

Taringa, Queensland, 4068, Australia

Location

AusTrials Wellers Hill

Tarragindi, Queensland, 4121, Australia

Location

CMAX Clinical Research Pty Ltd

Adelaide, South Australia, 5000, Australia

Location

University of Tasmania

Hobart, Tasmania, 7000, Australia

Location

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

Emeritus Research

Camberwell, Victoria, 3124, Australia

Location

Barwon Health

Geelong, Victoria, 3220, Australia

Location

Doctors of Ivanhoe

Ivanhoe, Victoria, 3079, Australia

Location

Nucleus Network Brisbane

Melbourne, Victoria, 3004, Australia

Location

Nucleus Network Melbourne

Melbourne, Victoria, 3004, Australia

Location

Institute for Respiratory Health

Nedlands, Western Australia, 6009, Australia

Location

Latitude Clinical Research

Spearwood, Western Australia, 6163, Australia

Location

Related Publications (1)

• Athan E, Baber J, Quan K, Scott RJ, Jaques A, Jiang Q, Li W, Cooper D, Cutler MW, Kalinina EV, Anderson AS, Swanson KA, Gruber WC, Gurtman A, Schmoele-Thoma B; Study C3671006 Investigator Group. Safety and Immunogenicity of Bivalent RSVpreF Vaccine Coadministered With Seasonal Inactivated Influenza Vaccine in Older Adults. Clin Infect Dis. 2024 May 15;78(5):1360-1368. doi: 10.1093/cid/ciad707.

  PMID: 37992000 DERIVED

Related Links

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

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study is double-blinded. The participant, study coordinator, and all site staff will be blinded. The majority of sponsor staff will be blinded to study intervention allocation. All laboratory testing personnel performing serological assays or diagnostic assays will remain blinded to the study intervention assigned/received throughout the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 29, 2022
• Study Start: April 13, 2022
• Primary Completion: October 12, 2022
• Study Completion: October 12, 2022
• Last Updated: October 27, 2023
• Results First Posted: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

AU (33)