Extension Study to Evaluate the Safety and Immunogenicity of a Revaccination Dose of the RSVPreF3 OA Investigational Vaccine in Adults 60 Years and Older Who Participated in the RSV OA=ADJ-002 Study

Recruiting in Palo Alto (17 mi)

+9 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: GlaxoSmithKline

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new vaccine to protect against RSV. The vaccine works by helping the body build defenses against RSV. New vaccines for RSV are in progress with promising results, although their efficacy in the presence of maternal antibodies, and their tolerance in very young babies, remain to be demonstrated.

Eligibility Criteria

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Group Medium Dose_AdjuvantedExperimental Treatment1 Intervention

Participants in one of the medium dose adjuvanted groups in part B of the parent study RSV OA=ADJ-002: Group Medium Dose Adjuvanted will receive one revaccination dose of the RSVPreF3 OA investigational vaccine in the current study by IM injection in the non-dominant arm.

Group II: Group Low Dose_AdjuvantedExperimental Treatment1 Intervention

Participants in one of the low dose adjuvanted groups in part B of the parent study RSV OA=ADJ-002: Group Low Dose Adjuvanted will receive one revaccination dose of the RSVPreF3 OA investigational vaccine in the current study by IM injection in the non-dominant arm.

Group III: Group High Dose_AdjuvantedExperimental Treatment1 Intervention

Participants in one of the high dose adjuvanted groups in part B of the parent study RSV OA=ADJ-002: Group High Dose Adjuvanted will receive one revaccination dose of the RSVPreF3 OA investigational vaccine in the current study by intramuscular (IM) injection in the non-dominant arm.