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

NCT03572062 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 317

Last updated 2021-08-26

Study results available
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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.

Conditions

  • Respiratory Tract Infection

Interventions

BIOLOGICAL

Formulation A

RSV vaccine

BIOLOGICAL

Formulation B

Adjuvanted RSV vaccine

BIOLOGICAL

Formulation C

RSV vaccine

BIOLOGICAL

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-05
Primary Completion
2020-06-23
Completion
2020-08-19
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03572062 on ClinicalTrials.gov