NCT03572062

A Study to Evaluate the Safety and Immunogenicity of an Adjuvanted RSV Vaccine in Healthy Older Adults

A PHASE 1/2, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND,DOSE-FINDING, FIRST-IN-HUMAN STUDY TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF AN ADJUVANTED RESPIRATORY SYNCYTIAL VIRUS (RSV) VACCINE IN HEALTHY OLDER ADULTS

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 317 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The study will evaluate the safety, tolerability, and immunogenicity of up to 7 different RSV vaccine candidates, some with adjuvant, when administered concomitantly with seasonal inactivated influenza vaccine (SIIV) and may evaluate a second dose of RSV vaccine administered12 months after the initial dose. In addition the study will evaluate a 2-dose regimen administered 2 months apart to 62 subjects.

Detailed description

The study will evaluate the safety, tolerability, and immunogenicity of up to 7 different RSV vaccine candidates, some with adjuvant, when administered concomitantly with SIIV. Healthy male and female subjects between 65 to 85 years of age will be enrolled. Subjects will receive 2 intramuscular injections to assess the concomitant administration of SIIV when given to subjects receiving one of the 3 RSV vaccine dose-level candidates formulated with or without an adjuvant. If interim support implementation of revaccination, invited, consenting subjects will be revaccinated with the same dose and formulation of the RSV vaccine or placebo received at Visit 1, concomitantly with SIIV. The safety, tolerability, and immunogenicity of the second dose will be evaluated through 12 months after revaccination. 62 subjects will be randomized 1:1 to receive a dose of high dose adjuvanted RSV vaccine or placebo followed by a second dose 2 months later. Safety, tolerability, and immunogenicity will be evaluated. The subjects will be enrolled before the influenza season. There will be no concomitant SIIV administration.

Conditions

• Respiratory Tract Infection

Interventions

Type	Name	Description
BIOLOGICAL	Formulation A	RSV vaccine
BIOLOGICAL	Formulation B	Adjuvanted RSV vaccine
BIOLOGICAL	Formulation C	RSV vaccine
BIOLOGICAL	Placebo	Placebo

Timeline

• Start date: 2018-06-05
• Primary completion: 2020-06-23
• Completion: 2020-08-19
• First posted: 2018-06-28
• Last updated: 2021-08-26
• Results posted: 2021-08-26

Locations

16 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study