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A Study to Learn About Two or More Vaccines That Are Put Together as One Shot Against Infectious Lung Illnesses, Including COVID-19 and Respiratory Syncytial Virus (RSV).

NCT05886777 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1142

Last updated 2024-12-18

Study results available
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Summary

The purpose of the study is to learn about the safety and effects of a combined vaccine for RSV and COVID-19 when given with a seasonal flu vaccine or when given alone. A combined vaccine will help to reduce the number of vaccinations given when trying to prevent respiratory infections.

This study is seeking participants who:

* are 65 years of age or older.
* are healthy or have well-controlled chronic conditions.
* in the past have received at least 3 US-authorized mRNA COVID 19 vaccines, with the most recent vaccine being an updated booster vaccine given at least more than or equal to 150 days before Visit A101 (Day 1).
* have not had a flu shot in the last 120 days.
* agree to be present for all study visits, procedures, and blood draws.

Participants will be involved in this study for 6 months. During this time, participants will have 2 study visits at the study clinic and a 6-month telephone contact.

Conditions

  • Healthy Participants

Interventions

BIOLOGICAL

Combination [RSVpreF+BNTb162b2]

Combination of RSVpreF and Bivalent BNT162b2 given as a single intramuscular injection

BIOLOGICAL

Bivalent BNT162b2 (original/Omi BA.4/BA.5)

Bivalent BNT162b2 given as an intramuscular injection

BIOLOGICAL

RSVpreF

RSVpreF given as an intramuscular injection

BIOLOGICAL

QIV

Licensed QIV given as an intramuscular injection

BIOLOGICAL

Normal Saline Placebo

Normal saline (0.9% sodium chloride solution for injection)

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-05
Primary Completion
2024-01-01
Completion
2024-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT05886777 on ClinicalTrials.gov