Study to Evaluate the Efficacy, Immunogenicity, and Safety of RSVpreF in Adults.

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NCT05035212 · readout in 152 d

Sponsored by Pfizer (industry) · PFE — their whole pipeline →.

Phase

Phase 3

Status

Active, not recruiting

Study type

Interventional

Design

Randomized · Triple · Prevention

Enrollment

38,861actual

Sites

263

Countries

Argentina, Canada, Finland +4

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2021-08-31

actual

When the study began enrolling

Primary completion

2027-01-18

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2027-01-18

estimated

The whole study's end, after follow-up

First posted

2021-09-05

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-01-28

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Lower Respiratory Tract Illness

Interventions

Biological: RSVpreF
Biological: Placebo

Primary outcomes

what the primary-completion date above is the date OF

Efficacy Study: Number of first episode of RSV-associated lower respiratory tract illness (LRTI-RSV) in the first RSV season

measured From Day 15 after vaccination until the end of season 1 visit (an average of 6 months)

Efficacy Study: Proportion of participants reporting prompted local reactions within 7-days after vaccination

measured Within 7 days after vaccination

Efficacy Study: Proportion of participants reporting prompted systemic events within 7-days after vaccination

measured Within 7 days after vaccination

Efficacy Study: Proportion of participants reporting AE within 1-month after vaccination

measured Within 1 month after vaccination (up to 35 days)

Efficacy Study: Proportion of participants reporting SAE throughout the study

measured Throughout the study duration (an average of 30 months)

Efficacy Study: Proportion of participants reporting NDCMC throughout the study

measured Throughout the study duration (an average of 30 months)

SSA: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 2-dose of RSVpreF

measured Before revaccination and 1, 6, 12 and 18-months after revaccination with RSVpreF in SSA

SSA: Proportion of participants reporting prompted local reactions within 7-days after revaccination

measured Within 7 days after revaccination

SSA: Proportion of participants reporting prompted systemic events within 7-days after revaccination

measured Within 7 days after revaccination

SSA: Proportion of participants reporting AE within 1-month after revaccination

measured Within 1 month after revaccination (up to 35 days)

SSA: Proportion of participants reporting SAE throughout the study

measured Throughout the study duration (approximately 18 months)

SSA: Proportion of participants reporting NDCMC throughout the study

measured Throughout the study duration (approximately 18 months)

SSB: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 2-dose of RSVpreF

measured Before revaccination and 1, 6, 12 and 18-months after revaccination with RSVpreF in SSB

SSB: Proportion of participants reporting prompted local reactions within 7-days after revaccination

measured Within 7 days after revaccination

SSB: Proportion of participants reporting prompted systemic events within 7-days after revaccination

measured SSB: Proportion of participants reporting prompted systemic events within 7-days after revaccination

SSB: Proportion of participants reporting AE within 1-month after revaccination

measured Within 1 month after revaccination (up to 35 days)

SSB: Proportion of participants reporting SAE throughout the study

measured Throughout the study duration (approximately 18 months)

SSB: Proportion of participants reporting NDCMC throughout the study

measured Throughout the study duration (approximately 18 months)

SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received RSVpreF or placebo in SSC (Year 3)

measured 1 month after revaccination in SSC (Year 3)

SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 1 dose in the Main Efficacy Study (preS2) and revaccination in SSC (Year 3)

measured At preseason 2 (preS2) after receiving the initial vaccination in the efficacy study and 1 month after revaccination in SSC (Year 3)

SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 1 dose in the Main Efficacy Study and revaccination in SSC (Year 3)

measured 1 month after receiving the initial vaccination in the efficacy study and 1 month after revaccination in SSC (Year 3)

SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received RSVpreF or placebo in SSC (Year 4)

measured 1 month after revaccination in SSC (Year 4)

SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 1 dose in the Main Efficacy Study (preS2) and revaccination in SSC (Year 4)

measured At preseason 2 (preS2) after receiving the initial vaccination in the efficacy study and 1 month after revaccination in SSC (Year 4)

SSC: Respiratory Syncytial Virus Subgroup A (RSV A) and RSV B neutralizing titers from participants who received 1 dose in the Main Efficacy Study and revaccination in SSC (Year 4)

measured 1 month after receiving the initial vaccination in the efficacy study and 1 month after revaccination in SSC (Year 4)

SSC: Proportion of participants reporting prompted local reactions within 7-days after revaccination (Year 3)

measured Within 7 days after revaccination

SSC: Proportion of participants reporting prompted local reactions within 7-days after revaccination (Year 4)

measured Within 7 days after revaccination

SSC: Proportion of participants reporting prompted systemic events within 7-days after revaccination (Year 3)

measured Within 7 days after revaccination

SSC: Proportion of participants reporting prompted systemic events within 7-days after revaccination (Year 4)

measured Within 7 days after revaccination

SSC: Proportion of participants reporting AE within 1-month after revaccination (Year 3)

measured Within 1 month after revaccination (up to 35 days)

SSC: Proportion of participants reporting AE within 1-month after revaccination (Year 4)

measured Within 1 month after revaccination (up to 35 days)

SSC: Proportion of participants reporting SAE after revaccination (Year 3)

measured Following revaccination and throughout the study duration (approximately 24 months)

SSC: Proportion of participants reporting SAE after revaccination (Year 4)

measured Following revaccination and throughout the study duration (approximately 12 months)

SSC: Proportion of participants reporting NDCMC after revaccination (Year 3)

measured Following revaccination and throughout the study duration (approximately 24 months)

SSC: Proportion of participants reporting NDCMC after revaccination (Year 4)

measured Following revaccination and throughout the study duration (approximately 12 months)

Publications

PMID 39928572 — linked by the registry
PMID 37018468 — linked by the registry

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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