NCT05886777 is a Phase 2 clinical trial of Combination [RSVpreF+BNTb162b2] in Healthy Participants, sponsored by Pfizer.

Who is sponsoring NCT05886777?

NCT05886777 is sponsored by Pfizer.

What drugs are being tested in NCT05886777?

Interventions in NCT05886777: Combination [RSVpreF+BNTb162b2], Bivalent BNT162b2 (original/Omi BA.4/BA.5), RSVpreF, QIV, Normal Saline Placebo.

What condition does NCT05886777 study?

NCT05886777 studies Healthy Participants.

Is NCT05886777 still recruiting?

NCT05886777 is currently completed. Last updated 18 December 2024.

Are results published for NCT05886777?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-12-18 · How we verify

NCT05886777

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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).

Completed Phase 2 Results posted Last updated 18 December 2024

What this trial tests

Phase 2 trial testing Combination [RSVpreF+BNTb162b2] in Healthy Participants in 1,142 participants. Completed in 1 January 2024.

Timeline

5 June 2023

Primary endpoint
1 January 2024

1 January 2024

Quick facts

Lead sponsor	Pfizer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	1,142
Start date	5 June 2023
Primary completion	1 January 2024
Estimated completion	1 January 2024
Sites	37 locations across United States

Drugs / interventions tested

Combination [RSVpreF+BNTb162b2] (combination-rsvpref-bntb162b2) — full drug profile →
Bivalent BNT162b2 (original/Omi BA.4/BA.5) (bivalent-bnt162b2-original-omi-ba-4-ba-5) — full drug profile →
RSVpreF (rsvpref) — full drug profile →
QIV (qiv) — full drug profile →
Normal Saline Placebo

Conditions studied

Healthy Participants — all drugs for Healthy Participants →

Sponsor

Pfizer — full company profile →

Who can join

65 and older, any sex, with Healthy Participants. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

The respiratory syncytial virus vaccine and monoclonal antibody landscape: the road to global access.
Terstappen J, Hak SF, Bhan A, Bogaert D, et al · · 2024 · cited 54× · PMID 39326422 · DOI 10.1016/s1473-3099(24)00455-9
Vaccine and therapeutic agents against the respiratory syncytial virus: resolved and unresolved issue.
Li Q, Li H, Li Z, Wang Y. · · 2024 · cited 16× · PMID 39575302 · DOI 10.1002/mco2.70016
Advancing mRNA vaccines for infectious diseases: key components, innovations, and clinical progress.
Li S, Zheng L, Zhong J, Gao X. · · 2025 · cited 8× · PMID 40321006 · DOI 10.1042/ebc20253009
Respiratory Syncytial Virus Vaccines: Analysis of Pre-Marketing Clinical Trials for Immunogenicity in the Population over 50 Years of Age.
Papazisis G, Topalidou X, Gioula G, González PA, et al · · 2024 · cited 8× · PMID 38675736 · DOI 10.3390/vaccines12040353
Unlocking the potential of RNA-based therapeutics in the lung: current status and future directions.
Man HSJ, Moosa VA, Singh A, Wu L, et al · · 2023 · cited 7× · PMID 38075698 · DOI 10.3389/fgene.2023.1281538
Nanotechnology Platform for Advancing Vaccine Development against the COVID-19 Virus.
Chowdhury N, Kundu A. · · 2023 · cited 3× · PMID 38131983 · DOI 10.3390/diseases11040177
Safety and Immunogenicity of Concomitant Administration and Combined Administration of Bivalent BNT162b2 COVID-19 Vaccine and Bivalent RSVpreF Respiratory Syncytial Virus Vaccine with or Without Quadrivalent Influenza Vaccine in Adults ≥ 65 Years of Age.
Neutel JM, Erdem R, Jiang Q, Cannon K, et al · · 2025 · cited 1× · PMID 40006705 · DOI 10.3390/vaccines13020158
SARS-CoV-2 and Influenza Co-Circulation and Co-Vaccination: A Narrative Review.
Kamransarkandi M, Varyushina EA, Gorshkov AN, Stukova MA. · · 2026 · PMID 41893818 · DOI 10.3390/vaccines14030283

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05886777 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 18 December 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05886777.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing