Clinical Lot Consistency for RSVpreF in a Population of Healthy Adults 18 to ≤49 Years of Age
Condition: RSV
Intervention: RSVpreF (Group 1); RSVpreF (Group 2); RSVpreF (Group 3); Placebo
Intervention description: RSV vaccine (RSVpreF); RSV vaccine (RSVpreF); RSV vaccine (RSVpreF); Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: This is a double-blinded, placebo controlled study
Enrollment: 1028.0
Sex: All
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: RSV; Vaccine

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy males or nonpregnant, nonbreastfeeding females between the ages of 18 and ≤49
             years, inclusive, at Visit 1 (Day 1).

          2. 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.

          3. 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.

          4. 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:

          1. Bleeding diathesis or condition associated with prolonged bleeding time that may
             contraindicate IM injection.

          2. 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.

          3. Unstable chronic medical condition or disease requiring significant change in therapy
             or hospitalization for worsening disease within 3 months before receipt of study
             intervention.

          4. Immunocompromised individuals with known or suspected immunodeficiency, as determined
             by history and/or laboratory/physical examination.

          5. Known infection with HIV, HCV, or HBV.

          6. 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.

          7. Previous vaccination with any licensed or investigational RSV vaccine at any time
             prior to enrollment or planned receipt throughout the study.

          8. Receipt of any blood/plasma products or immunoglobulin, from 60 days before study
             intervention administration or planned receipt throughout the study.

          9. Receipt of monoclonal antibodies from 60 days before study intervention administration
             or planned receipt throughout the study.

         10. 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.

         11. 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.

         12. Current use of any prohibited concomitant medication(s) or those unwilling/unable to
             use a permitted concomitant medication(s).

         13. Participation in other studies involving investigational drug(s) or investigational
             vaccines within 28 days prior to consent and/or during study participation.

         14. 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.

         15. Men who are unwilling to comply with contraception methods as outlined in the protocol
             for the duration of the study.

         16. 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.