Clinical Lot Consistency for RSVpreF in a Population of Healthy Adults 18 to ≤49 Years of Age

NCT05096208 | Completed Phase 3 Results FDA Drug

• 1 other identifier: C3671014
• Study Type: interventional
• Target: 1,028
• Locations: 1 country
• Sites: 18

Brief Summary

This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the safety, tolerability, and immunogenicity of 3 lots of RSVpreF in healthy adults.

Conditions

RSV

Keywords

RSV; Vaccine

Outcome Measures

Primary Outcomes (4)

• Geometric Mean Ratios (GMRs) of Respiratory Syncytial Virus Subgroup A (RSV A) and B (RSV B) Neutralizing Antibodies at 1 Month After Vaccination for Every Pair of RSVpreF Lots

  Geometric mean titer (GMT) of RSV A and RSV B neutralizing antibodies were calculated by exponentiating the mean logarithm of the titers and the corresponding 95% confidence interval (CI) was based on the Student t distribution. GMTs were reported in the descriptive section. Geometric mean ratios (GMRs) for each RSV vaccine lot comparison (Group 1/Group 2, Group 1/Group 3, and Group 2/Group 3) for RSV A and RSV B neutralizing antibody titers was calculated and reported in statistical analysis.

  1 month (27 to 42 days window) after vaccination on Day 1

• Percentage of Participants With Local Reactions Within 7 Days After Vaccination

  Local reactions included pain at injection site, redness and swelling and were 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: 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. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

  Within 7 days after vaccination on Day 1

• Percentage of Participants With Systemic Events Within 7 Days After Vaccination

  Systemic events included fever, fatigue, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and were recorded by participants in an e-diary. Fever was defined as temperature greater than or equal to (\>=)38.0 degrees Celsius (C) and categorized as mild (\>=38.0 to 38.4 degrees C), moderate (\>38.4 to 38.9 degrees C) and severe (\>38.9 to 40.0 degrees 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: required 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. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

  Within 7 days after vaccination on Day 1

• Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious adverse events excluding local reactions and systemic events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; required inpatient hospitalization or prolongation of existing hospitalization; life-threatening ; persistent or significant disability/incapacity; congenital anomaly/birth defect and suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI was based on the Clopper and Pearson method.

  Day of consent (Day 1) through study completion (approximately 1 Month)

Study Arms (4)

RSVpreF vaccine Group 1

EXPERIMENTAL

RSVpreF

Biological: RSVpreF (Group 1)

RSVpreF vaccine Group 2

EXPERIMENTAL

RSVpreF

Biological: RSVpreF (Group 2)

RSVpreF vaccine Group 3

EXPERIMENTAL

RSVpreF

Biological: RSVpreF (Group 3)

Placebo dose

PLACEBO COMPARATOR

Placebo

Biological: Placebo

Interventions

RSVpreF (Group 1) BIOLOGICAL

RSV vaccine (RSVpreF)

RSVpreF vaccine Group 1

RSVpreF (Group 2) BIOLOGICAL

RSV vaccine (RSVpreF)

RSVpreF vaccine Group 2

RSVpreF (Group 3) BIOLOGICAL

RSV vaccine (RSVpreF)

RSVpreF vaccine Group 3

Placebo BIOLOGICAL

Placebo

Placebo dose

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males or nonpregnant, nonbreastfeeding females between the ages of 18 and ≤49 years, inclusive, at Visit 1 (Day 1).
• 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 study vaccination.
• 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 the protocol.

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.
• Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization for worsening disease within 3 months before receipt of study intervention.
• Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
• Known infection with HIV, HCV, or HBV.
• 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.
• Receipt of any blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.
• Receipt of monoclonal antibodies from 60 days before study intervention administration or planned receipt throughout the study.
• Receipt of systemic treatment with known immunosuppressant medications within 60 days before study intervention administration or the use of systemic corticosteroids (≥20 mg/day of prednisone or equivalent) for ≥14 days within 28 days prior to study enrollment. Prednisone use of \<20 mg/day for \<14 days is permitted. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin, eyes, ears) corticosteroids are permitted.
• 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 drug(s) or investigational vaccines within 28 days prior to consent and/or during study participation.
• Pregnant females; breastfeeding females; and women of child bearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in the protocol for the duration of the study.
• Men who are unwilling to comply with contraception methods as outlined in the protocol for the duration of the study.
• 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 (18)

Global Health Research Center, Inc.

Miami Lakes, Florida, 33016, United States

Location

Precision Clinical Research

Sunrise, Florida, 33351, United States

Location

Clinical Site Partners, Inc

Winter Park, Florida, 32789, United States

Location

Clinical Site Partners

Winter Park, Florida, 32789, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

East-West Medical Research Institute

Honolulu, Hawaii, 96814, United States

Location

Clinical Research Prime

Idaho Falls, Idaho, 83404, United States

Location

Kentucky Pediatric/ Adult Research

Bardstown, Kentucky, 40004, United States

Location

Sundance Clinical Research

St Louis, Missouri, 63141, United States

Location

Meridian Clinical Research, LLC

Omaha, Nebraska, 68134, United States

Location

Accellacare - Wilmington

Wilmington, North Carolina, 28401, United States

Location

Aventiv Research Inc

Columbus, Ohio, 43213, United States

Location

Velocity Clinical Research, Providence

East Greenwich, Rhode Island, 02818, United States

Location

Benchmark Research

Austin, Texas, 78705, United States

Location

Texas Center for Drug Development, Inc.

Houston, Texas, 77081, United States

Location

DM Clinical Research

Tomball, Texas, 77375, 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

Related Publications (1)

• Baker J, Aliabadi N, Munjal I, Jiang Q, Feng Y, Brock LG, Cooper D, Anderson AS, Swanson KA, Gruber WC, Gurtman A. Equivalent immunogenicity across three RSVpreF vaccine lots in healthy adults 18-49 years of age: Results of a randomized phase 3 study. Vaccine. 2024 May 10;42(13):3172-3179. doi: 10.1016/j.vaccine.2024.03.070. Epub 2024 Apr 16.

  PMID: 38616438 DERIVED

Related Links

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

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: DOUBLE
• Who Masked: PARTICIPANT, 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: October 14, 2021
• First Posted: October 27, 2021
• Study Start: October 21, 2021
• Primary Completion: April 4, 2022
• Study Completion: April 4, 2022
• Last Updated: April 12, 2023
• Results First Posted: April 12, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

US (18)