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Safety and Immunogenicity of RSVpreF Coadministered With SIIV in Adults ≥65 Years of Age

NCT05301322 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1471

Last updated 2023-10-27

Study results available
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Summary

The purpose of this study is to assess the safety and immunogenicity of RSVpreF when coadministered with SIIV compared to sequential administration of the vaccines when given 1 month apart (SIIV followed by RSVpreF). Additionally, the study will contribute data supporting the development of RSVpreF as a prophylactic vaccine against RSV disease in infants through maternal immunization and in older adults through active vaccination.

Conditions

Interventions

BIOLOGICAL

RSVpreF Vaccine

RSV Vaccine

OTHER

Placebo

Placebo

BIOLOGICAL

Seasonal Inactivated Influenza Vaccine

SIIV

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
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-13
Primary Completion
2022-10-12
Completion
2022-10-12
FDA Drug
Yes

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases
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 NCT05301322 on ClinicalTrials.gov