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NCT05886777 · ClinicalTrials.gov registry record · Phase 2

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).

A Phase 2 study, sponsored by Pfizer.

Completed
Registry status
Phase 2
Development phase
1,142
Enrollment target

NCT05886777: Completed Phase 2 study, sponsored by Pfizer.

NCT05886777 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 1,142 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (759% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05886777, a Phase 2 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 2
Development phase
1,142 participants
Enrollment target

Study 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.

Primary Outcome

Local reactions included pain, redness and swelling at the injection site, recorded by participants in an electronic diary (e-diary). Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity and severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 centimeter (cm) and graded as mild: 2.5 cm to 5.0 cm; moderate: greater than (\>) 5.0 cm to 10.0 cm; severe:

Interventions

  • BIOLOGICAL RSVpreF
  • BIOLOGICAL QIV
  • BIOLOGICAL Normal Saline Placebo
  • BIOLOGICAL Combination [RSVpreF+BNTb162b2]
  • BIOLOGICAL Bivalent BNT162b2 (original/Omi BA.4/BA.5)

Trial Details

FieldValue
Enrollment Target 1,142 participants
Start Date 2023-06-05
Est. Completion 2024-01-01
Phase Phase 2
Pfizer

1,845 total trials

What the finished NCT05886777 record still lists

NCT05886777 is an interventional study that assigns participants to a tested intervention. Its 1,142 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (759% higher).

The record links to 0 conditions, and to 5 interventions - of which RSVpreF is the first listed.

NCT05886777 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05886777 about?

NCT05886777 is a clinical study titled "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).". 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 ...

What is the current status of trial NCT05886777?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,142 participants. The study started on 2023-06-05. Estimated completion is 2024-01-01.

What interventions are being tested in trial NCT05886777?

The interventions under investigation include: RSVpreF (BIOLOGICAL), QIV (BIOLOGICAL), Normal Saline Placebo (BIOLOGICAL), Combination [RSVpreF+BNTb162b2] (BIOLOGICAL), Bivalent BNT162b2 (original/Omi BA.4/BA.5) (BIOLOGICAL).

Who is sponsoring clinical trial NCT05886777?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05886777's enrollment target sits among peer trials

1,142 20th of 2000 higher than 1,981 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05886777, the US trial registry maintained by the National Library of Medicine. NCT05886777 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.