A Study to Describe the Safety and Immunogenicity of a RSV Vaccine in Healthy Adults

NCT03529773 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: C3671001RSV FIH
• Study Type: interventional
• Target: 1,235
• Locations: 1 country
• Sites: 40

Brief Summary

The study will describe the safety, tolerability, and immunogenicity of up to 6 RSV vaccine formulations when administered alone or concomitantly with seasonal inactivated influenza vaccine (SIIV).

Conditions

Respiratory Tract Infections

Keywords

Respiratory tract infections, RSV, vaccine

Outcome Measures

Primary Outcomes (18)

• Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination

  Local reactions included pain at injection site, redness and swelling recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: 2.5 to 5.0 cm, moderate: greater than (\>) 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 14 days after vaccination

• Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Local Reactions Within 14 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: interfered with daily activity and severe: prevented daily activity.

  Within 14 days after vaccination

• Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Local Reactions Within 14 Days After Vaccination 1

  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 14 days after vaccination 1 on Day 1

• Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Local Reactions Within 14 Days After Vaccination 1

  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: interfered with daily activity and severe: prevented daily activity.

  Within 14 days after vaccination 1 on Day 1

• Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 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 14 days after vaccination

• Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With Systemic Reactions Within 14 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: \>= 38.0 deg 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 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 14 days after vaccination

• Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With Systemic Reactions Within 14 Days After Vaccination 1

  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: \>= 38.0 deg 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 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 14 days after vaccination 1 on Day 1

• Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With Systemic Reactions Within 14 Days After Vaccination 1

  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: \>= 38.0 deg 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 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 14 days after vaccination 1 on Day 1

• Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Adverse Events (AEs) 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. Serious adverse event (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.

  Within 1 month after vaccination (up to 35 days)

• Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With AEs 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. 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.

  Within 1 month after vaccination (up to 35 days)

• Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AE Within 1 Month After Vaccination 1

  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. 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.

  Within 1 month after vaccination 1 (up to 35 days)

• Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With 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. 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.

  Within 1 month after vaccination 1 (up to 35 days)

• Sentinel Cohort: Percentage of Participants (Aged 18 to 49 Years) With Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Upto 12 Months After Vaccination

  MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. 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.

  Upto 12 months after vaccination (up to 378 days)

• Sentinel Cohort: Percentage of Participants (Aged 50 to 85 Years) With MAEs and SAEs Upto 12 Months After Vaccination

  MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. 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.

  Upto 12 months after vaccination (upto 378 days)

• Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With MAEs and SAEs Upto 12 Months After Vaccination 1

  MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. 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.

  Upto 12 months after vaccination 1 (upto 378 days)

• Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With MAEs and SAEs 12 Months After Vaccination 1

  MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. 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.

  Upto 12 months after vaccination 1 (upto 378 days)

• Expanded Cohort: Percentage of Participants (Aged 18 to 49 Years) With AEs Within 1 Month After Vaccination 2

  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 2 (upto Day 70)

• Expanded Cohort: Percentage of Participants (Aged 65 to 85 Years) With AEs Within 1 Month After Vaccination 2

  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 2 (upto Day 70)

Secondary Outcomes (6)

• Sentinel Cohort: Geometric Mean Titers (GMTs) of Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years)

  Before vaccination, and 2 weeks and 1, 2, 3, 6 and 12 months after vaccination

• Sentinel Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 50 to 85 Years)

  Before vaccination, and 2 weeks and 1, 2, 3, 6 and 12 months after vaccination

• Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 18 to 49 Years)

  Before vaccination, 1, 2, 3, 6 and 12 months after vaccination

• Expanded Cohort: GMTs of RSV A and RSV B Antigens Following Vaccination in Participants (Aged 65 to 85 Years)

  Before vaccination, 1, 2, 3, 6 and 12 months after vaccination

• Expanded Cohort: Hemagglutination Inhibition Assay (HAI) Titers for All Strains Following Vaccination With Seasonal Inactivated Influenza (SIIV) Vaccine in Participants (Aged 18 to 49 Years)

  Before vaccination and 1 Month after SIIV vaccination

Study Arms (20)

Sentinel Arm 1

EXPERIMENTAL

Low dose formulation A

Biological: Formulation A

Sentinel Arm 2

EXPERIMENTAL

Mid dose formulation A

Biological: Formulation A

Sentinel Arm 3

EXPERIMENTAL

High dose formulation A

Biological: Formulation A

Sentinel Arm 4

EXPERIMENTAL

Low dose formulation B

Biological: Formulation B

Sentinel Arm 5

EXPERIMENTAL

Mid dose formulation B

Biological: Formulation B

Sentinel Arm 6

EXPERIMENTAL

High dose formulation B

Biological: Formulation B

Sentinel Arm 7

PLACEBO COMPARATOR

Placebo

Biological: Placebo

Expanded Arm 8

EXPERIMENTAL

Low dose formulation A and SIIV

Biological: Formulation A

Expanded Arm 9

EXPERIMENTAL

Mid dose formulation A and SIIV

Biological: Formulation A

Expanded Arm 10

EXPERIMENTAL

High dose formulation A and SIIV

Biological: Formulation A

Expanded Arm 11

EXPERIMENTAL

Low dose formulation B and SIIV

Biological: Formulation B

Expanded Arm 12

EXPERIMENTAL

Mid dose formulation B and SIIV

Biological: Formulation B

Expanded Arm 13

EXPERIMENTAL

High dose formulation B and SIIV

Biological: Formulation B

Expanded Arm 14

EXPERIMENTAL

Low dose formulation A and placebo

Biological: Formulation A

Expanded Arm 15

EXPERIMENTAL

Mid dose formulation A and placebo

Biological: Formulation A

Expanded Arm 16

EXPERIMENTAL

High dose formulation A and placebo

Biological: Formulation A

Expanded Arm 17

EXPERIMENTAL

Low dose formulation B and placebo

Biological: Formulation B

Expanded Arm 18

EXPERIMENTAL

Mid dose formulation B and placebo

Biological: Formulation B

Expanded Arm 19

EXPERIMENTAL

High dose formulation B and placebo

Biological: Formulation B

Expanded Arm 20

PLACEBO COMPARATOR

placebo and placebo

Biological: Placebo

Interventions

Formulation A BIOLOGICAL

RSV vaccine

Expanded Arm 10; Expanded Arm 14; Expanded Arm 15; Expanded Arm 16; Expanded Arm 8; Expanded Arm 9; Sentinel Arm 1; Sentinel Arm 2; Sentinel Arm 3

Formulation B BIOLOGICAL

RSV vaccine

Expanded Arm 11; Expanded Arm 12; Expanded Arm 13; Expanded Arm 17; Expanded Arm 18; Expanded Arm 19; Sentinel Arm 4; Sentinel Arm 5; Sentinel Arm 6

Placebo BIOLOGICAL

Placebo

Expanded Arm 20; Sentinel Arm 7

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study.
• Willing and able to comply with scheduled visits, vaccination plan, laboratory tests, and other study procedures.
• Male subject who is able to father children and willing to use a highly effective method of contraception as outlined in this protocol until at least 28 days after the last dose of investigational product; female subject who is of childbearing potential and at risk for pregnancy and who is willing to use a highly effective method of contraception as outlined in this protocol until at least 28 days after the last dose of investigational product; male subject not able to father children; female subject not of childbearing potential.
• Sentinel-cohort subjects only: Male and female adults aged 18 to 85 years at the time of enrollment (signing of the ICD).
• Expanded-cohort subjects only: Male and female adults aged 18 to 49 years of age or 65 to 85 years at the time of enrollment (signing of the ICD).

You may not qualify if:

• Sentinel-cohort subjects only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality.
• Sentinel-cohort subjects only: Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (HBc Abs), or hepatitis C virus antibodies (HCV Abs) at the screening visit.
• Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees, including their family members, directly involved in the conduct of the study.
• Participation in other studies involving investigational product within 28 days prior to study entry and/or during study participation.
• Known infection with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV).
• Previous vaccination with any licensed or investigational RSV vaccine, or planned receipt throughout the study of nonstudy RSV vaccine.
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product(s).
• Immunocompromised subjects with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
• Subjects who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. If systemic corticosteroids have been administered short term (\<14 days) for treatment of an acute illness, subjects should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before investigational product administration. Intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
• Subject with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention including but not limited to: systemic or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain-Barré syndrome, multiple sclerosis, Sjögren's syndrome, idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), psoriasis, and insulin-dependent diabetes mellitus (type 1).
• Receipt of blood/plasma products or immunoglobulin, from 60 days before investigational product administration or planned receipt throughout the study.
• Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
• Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
• Women who are pregnant or breastfeeding.
• Expanded-cohort subjects only: Vaccination with any influenza vaccine within 6 months (182 days) before investigational product administration.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (40)

Coastal Clinical Research, Inc.

Mobile, Alabama, 36608, United States

Location

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

Paradigm Clinical Research Centers, Inc.

La Mesa, California, 91942, United States

Location

Paradigm Clinical Research Center

Redding, California, 96001, United States

Location

Clinical Research of South Florida

Coral Gables, Florida, 33134, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32801, United States

Location

Meridian Clinical Research

Savannah, Georgia, 31406, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

Meridian Clinical Research Dakota Dunes

Sioux City, Iowa, 51106, United States

Location

Augusta Family Practice

Augusta, Kansas, 67010, United States

Location

Heartland Research Associates, LLC

Augusta, Kansas, 67010, United States

Location

Axtell Clinic, P.A.

Newton, Kansas, 67114, United States

Location

Heartland Research Associates, LLC

Newton, Kansas, 67114, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

Location

Sundance Clinical Research, LLC

St Louis, Missouri, 63141, United States

Location

Meridian Clinical Research, LLC

Norfolk, Nebraska, 68701, United States

Location

Quality Clinical Research, Inc.

Omaha, Nebraska, 68114, United States

Location

United Medical Associates

Binghamton, New York, 13901, United States

Location

Regional Clinical Research, Inc.

Endwell, New York, 13760, United States

Location

Rochester Regional Health/Rochester General Hospital

Rochester, New York, 14621, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

PMG Research of Charlotte, LLC

Charlotte, North Carolina, 28209, United States

Location

PMG Research of Raleigh

Raleigh, North Carolina, 27609, United States

Location

PMG Research of Wilmington, LLC

Wilmington, North Carolina, 28401, United States

Location

PMG Research of Winston-Salem, LLC

Winston-Salem, North Carolina, 27103, United States

Location

Sterling Research Group, Ltd.

Cincinnati, Ohio, 45219, United States

Location

Aventiv Research Inc.

Columbus, Ohio, 43213, United States

Location

PriMed Clinical Research

Dayton, Ohio, 45419, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Benchmark Research

Austin, Texas, 78705, United States

Location

Texas Health Care, PLLC

Fort Worth, Texas, 76104, United States

Location

Ventavia Research Group, LLC

Fort Worth, Texas, 76104, United States

Location

Benchmark Research

Fort Worth, Texas, 76135, United States

Location

HealthFirst Medical Group

Fort Worth, Texas, 76135, United States

Location

Clinical Trials of Texas, LLC

San Antonio, Texas, 78229, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, 84109, United States

Location

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

Salt Lake City, Utah, 84121, United States

Location

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

South Jordan, Utah, 84095, United States

Location

Advanced Clinical Research

West Jordan, Utah, 84088, United States

Location

Related Publications (3)

• Walsh EE, Falsey AR, Zareba AM, Jiang Q, Gurtman A, Radley D, Gomme E, Cooper D, Jansen KU, Gruber WC, Swanson KA, Schmoele-Thoma B. Respiratory Syncytial Virus Prefusion F Vaccination: Antibody Persistence and Revaccination. J Infect Dis. 2024 Oct 16;230(4):e905-e916. doi: 10.1093/infdis/jiae185.

  PMID: 38606958 DERIVED

• Walsh EE, Falsey AR, Scott DA, Gurtman A, Zareba AM, Jansen KU, Gruber WC, Dormitzer PR, Swanson KA, Radley D, Gomme E, Cooper D, Schmoele-Thoma B. A Randomized Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine. J Infect Dis. 2022 Apr 19;225(8):1357-1366. doi: 10.1093/infdis/jiab612.

  PMID: 34932102 DERIVED

• Falsey AR, Walsh EE, Scott DA, Gurtman A, Zareba A, Jansen KU, Gruber WC, Dormitzer PR, Swanson KA, Jiang Q, Gomme E, Cooper D, Schmoele-Thoma B. Phase 1/2 Randomized Study of the Immunogenicity, Safety, and Tolerability of a Respiratory Syncytial Virus Prefusion F Vaccine in Adults With Concomitant Inactivated Influenza Vaccine. J Infect Dis. 2022 Jun 15;225(12):2056-2066. doi: 10.1093/infdis/jiab611.

  PMID: 34931667 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 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Observer blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: May 18, 2018
• Study Start: April 18, 2018
• Primary Completion: November 20, 2019
• Study Completion: December 28, 2020
• Last Updated: March 3, 2022
• Results First Posted: March 4, 2021

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Starting 24 months after study completion.

Locations

US (40)