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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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RSV

Intervention / Treatment
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* Biological: RSVpreF (Group 1)
* Biological: RSVpreF (Group 2)
* Biological: RSVpreF (Group 3)
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RSVpreF vaccine Group 1<br>RSVpreF | Biological: RSVpreF (Group 1)<br>* RSV vaccine (RSVpreF)<br>|
| Experimental: RSVpreF vaccine Group 2<br>RSVpreF | Biological: RSVpreF (Group 2)<br>* RSV vaccine (RSVpreF)<br>|
| Experimental: RSVpreF vaccine Group 3<br>RSVpreF | Biological: RSVpreF (Group 3)<br>* RSV vaccine (RSVpreF)<br>|
| Placebo Comparator: Placebo dose<br>Placebo | Biological: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RSV, Vaccine