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).

Conditions

• Healthy Participants

Eligibility Criteria

Sex

ALL

Age

65 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Combination [RSVpreF+BNTb162b2] — BIOLOGICAL
  Combination of RSVpreF and Bivalent BNT162b2 given as a single intramuscular injection
• Bivalent BNT162b2 (original/Omi BA.4/BA.5) — BIOLOGICAL
  Bivalent BNT162b2 given as an intramuscular injection
• RSVpreF — BIOLOGICAL
  RSVpreF given as an intramuscular injection
• QIV — BIOLOGICAL
  Licensed QIV given as an intramuscular injection
• Normal Saline Placebo — BIOLOGICAL
  Normal saline (0.9% sodium chloride solution for injection)

Study Details

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.

Key Dates

First listed

Jun 2, 2023

Start date

Jun 5, 2023

Status verified

Nov 2024

Primary completion

Jan 1, 2024

Completion

Jan 1, 2024

Study Design

Enrollment

1,142 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Group 1
  Combination \[RSVpreF+BNT162b2\] + Quadrivalent influenza vaccine (QIV)
• Experimental: Group 2
  Combination \[RSVpreF+BNT162b2\] + placebo
• Active Comparator: Group 3
  BNT162b2 + placebo
• Active Comparator: Group 4
  RSVpreF + placebo
• Active Comparator: Group 5
  QIV + placebo
• Experimental: Group 6
  Coadministration RSVpreF + bivalent BNT162b2 + placebo
• Experimental: Group 7
  Coadministration RSVpreF + bivalent BNT162b2 + QIV

Primary Outcome Measure

Percentage of Participants With Local Reactions Within 7 Days After Vaccination [ Time Frame: Day 1 to Day 7 after Vaccination on Day 1 ]

Locations (37)

Find similar trials in Dublin, CA

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