AzTrials
AzTrials

RSVPhase 3NCT05096208

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

A Phase 3 study testing RSVpreF (Group 1), RSVpreF (Group 2) and RSVpreF (Group 3) in people with RSV, run by Pfizer at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for
RSV
What is being tested?
RSVpreF (Group 1), RSVpreF (Group 2) and RSVpreF (Group 3)
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,028 participants
Where
18 sitesUnited States
Study dates
21 Oct 2021to 4 Apr 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
  • Healthy participants as determined by medical history, physical examination (if required), and the clinical judgment of the investigator to be eligible for inclusion in the study. Participants with preexisting chronic medical conditions determined to be stable in the clinical judgment of the investigator may be included.
  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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 alcohol abuse or illicit drug use. Note: Marijuana use is not considered an exclusion criterion for the study when elicited in participant screening, though it may be considered illicit in some locales.
  • 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.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • Benchmark Research

    Austin, Texas, 78705

  • Kentucky Pediatric/ Adult Research

    Bardstown, Kentucky, 40004

  • Aventiv Research Inc

    Columbus, Ohio, 43213

  • Velocity Clinical Research, Providence

    East Greenwich, Rhode Island, 02818

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814

  • Texas Center for Drug Development, Inc.

    Houston, Texas, 77081

  • Clinical Research Prime

    Idaho Falls, Idaho, 83404

  • Global Health Research Center, Inc.

    Miami Lakes, Florida, 33016

  • Meridian Clinical Research, LLC

    Omaha, Nebraska, 68134

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

    Salt Lake City, Utah, 84109

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

    Salt Lake City, Utah, 84121

  • Sundance Clinical Research

    St Louis, Missouri, 63141

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • Precision Clinical Research

    Sunrise, Florida, 33351

  • DM Clinical Research

    Tomball, Texas, 77375

  • Accellacare - Wilmington

    Wilmington, North Carolina, 28401

  • Clinical Site Partners, Inc

    Winter Park, Florida, 32789

  • Clinical Site Partners

    Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF 3 LOTS OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN HEALTHY ADULTS

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.

Read the detailed description

This randomized, double-blinded, placebo-controlled Phase 3 study will examine the immune response and the safety and tolerability profiles across 3 manufactured lots of RSVpreF when administered as a single 120 µg dose to healthy adults to demonstrate lot equivalence in manufacturing of RSVpreF.

Conditions
RSV
Being tested
RSVpreF (Group 1), RSVpreF (Group 2), RSVpreF (Group 3), Placebo
Keywords
RSV, Vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RSVpreF (Group 1)Biological

    RSV vaccine (RSVpreF)

  • RSVpreF (Group 2)Biological

    RSV vaccine (RSVpreF)

  • RSVpreF (Group 3)Biological

    RSV vaccine (RSVpreF)

  • PlaceboBiological

    Placebo

Study groups in NCT05096208
Study groupRoleWhat they receive
RSVpreF vaccine Group 1ExperimentalRSVpreF
Receives: Biological: RSVpreF (Group 1)
RSVpreF vaccine Group 2ExperimentalRSVpreF
Receives: Biological: RSVpreF (Group 2)
RSVpreF vaccine Group 3ExperimentalRSVpreF
Receives: Biological: RSVpreF (Group 3)
Placebo dosePlacebo comparatorPlacebo
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

    Measured: Within 7 days after vaccination on Day 1

  3. 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.

    Measured: Within 7 days after vaccination on Day 1

  4. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2021
  2. Study start21 Oct 2021
  3. Primary completion4 Apr 2022
  4. Study completion4 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,028 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05096208
Sponsor's protocol ID
C3671014
Status last verified
Mar 2023
First submitted
14 Oct 2021
Last updated
12 Apr 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • 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.

    PubMed 38616438

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RSVpreF (Group 1), RSVpreF (Group 2) and RSVpreF (Group 3) in people with RSV, run by Pfizer at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 1 month (27 to 42 days window) after vaccination on Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05096208, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in