RSVpreF

Phase 3Biologic

Pfizer

RSVpreF is one of 46 biologic programs targeting Respiratory Syncytial Virus (RSV). It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Respiratory Syncytial Virus (RSV)Completed

RSV ImmunizationNot yet recruiting

ImmunogenicityCompleted

Respiratory Syncytial Virus (RSV)Phase 3

Completed

RSV ImmunizationPhase 3

Not yet recruiting

ImmunogenicityPhase 3

Completed

Competition

Competitive Landscape

87 competitors in Immunogenicity

#DrugCompanyPhaseTrials

Perjeta

Roche

Phase 3

2 2

Rabies Vaccine

Novartis

Phase 3

12 3

Prolia

OOrganon and Co

Phase 3

2 4

HPV Vaccine

SShanghai Zerun Biotechnology Co.,Ltd

Phase 3

3 5

Gardasil-9

BBeijing Health Guard Biotechnology, Inc

Phase 3

2 6

Bexsero

GSK

Phase 3

8 7

Gardasil

Merck & Co.

Phase 3

7 8

PCV21

Sanofi

Phase 3

1 9

Opfolda

Johnson & Johnson

Phase 3

1 10

RSVpreF

Pfizer

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 3Active, not recruiting

Immunogenicity

NCT05035212

Phase 3Recruiting

Respiratory Syncytial Virus (RSV)

NCT07653100

Q2 2027

Phase 3Recruiting

Study completion

NCT07819097

Q4 2027

Active, not recruiting

Respiratory Syncytial Virus Infection

NCT06546800

Q1 2028

Phase 3Recruiting

RSV Infection

NCT06866405

ApprovedNot yet recruiting

RSV Immunization

NCT07693166

Clinical

Trials by Indication[1]

Immunogenicity5 trials

A Study to Assess the Safety, Tolerability, and Immunogenicity of RSVpreF in Older Adults in Korea

Completed· Pfizer logo

Pfizer·Phase 3·NCT06593587·378 enrolled

A Study to Assess the Safety, Tolerability, and Immunogenicity of RSVpreF in Adults at High Risk of Severe RSV Disease

Completed· Pfizer logo

Pfizer·Phase 3·NCT05842967·885 enrolled

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

Active, not recruiting· Pfizer logo

Pfizer·Phase 3·NCT05035212·38,861 enrolled

Show 2 more trials

A Study to Assess Safety, Tolerability and Immunogenicity of RSVpreF From Multidose Vials in Healthy Female Adults.

Completed· Pfizer logo

Pfizer·Phase 3·NCT06473519·453 enrolled

Safety and Immunogenicity of RSVpreF Coadministered With SIIV in Adults ≥65 Years of Age

Completed· Pfizer logo

Pfizer·Phase 3·NCT05301322·1,471 enrolled

Respiratory Syncytial Virus (RSV)5 trials

A Study to Examine Respiratory Combination Vaccines Against Respiratory Syncytial Virus (RSV) and Flu in Older Adults

Completed· Pfizer logo

Pfizer·Phase 1·NCT05788237·508 enrolled

A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF A SECOND DOSE OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE GIVEN 5 YEARS AFTER THE INITIAL DOSE IN OLDER ADULTS

Not yet recruiting· Pfizer logo

Pfizer·Phase 3·NCT07885956·750 enrolled

A PHASE 3, MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS CONSIDERED AT HIGH RISK OF SEVERE RSV DISEASE IN JAPAN

Completed· Pfizer logo

Pfizer·Phase 3·NCT07543380·130 enrolled

Show 2 more trials

A PHASE 3 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS VACCINE IN CHILDREN AT HIGH RISK OF RSV DISEASE

Not yet recruiting· Pfizer logo

Pfizer·Phase 3·NCT07839871·920 enrolled

A PHASE 3 STUDY IN INDIA TO DESCRIBE THE SAFETY AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS

Recruiting· Pfizer logo

Pfizer·Phase 3·NCT07653100·540 enrolled

Pregnancy1 trial

A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.

Completed· Pfizer logo

Pfizer·Phase 3·NCT04424316·14,727 enrolled

Vaccination1 trial

Study of RSVpreF Vaccination and RSV Challenge in Healthy Adults

Completed·HHvivo·Phase 2·NCT04785612·70 enrolled

COVID-191 trial

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· Pfizer logo

Pfizer·Phase 2·NCT05886777·1,142 enrolled

8 more indications

Adult1 trial

Clinical Lot Consistency for RSVpreF in a Population of Healthy Adults 18 to ≤49 Years of Age

Completed· Pfizer logo

Pfizer·Phase 3·NCT05096208·1,028 enrolled

Children1 trial

A Study to Learn About the Safety and Immune Activity of RSVpreF in Children 2 to <18 Years of Age

Completed· Pfizer logo

Pfizer·Phase 1·NCT05900154·128 enrolled

Pregnant Women1 trial

SPECIAL INVESTIGATION FOR ABRYSVO IN PREGNANT WOMEN AND INFANTS

Active, not recruiting· Pfizer logo

Pfizer··NCT06482099·497 enrolled

Respiratory Syncytial Virus Infection1 trial

SPECIAL INVESTIGATION FOR ABRYSVO INTRAMUSCULAR INJECTION -INVESTIGATION IN INDIVIDUALS AGED 60 YEARS OR OLDER-

Active, not recruiting· Pfizer logo

Pfizer··NCT06546800·1,100 enrolled

RSV Infection1 trial

A Phase 3 Study to Investigate the Safety, Tolerability, and Immunogenicity of Revaccinating Pregnant Participants During Subsequent Pregnancies and Persistence of Immunity of a Single Dose of a Bivalent Respiratory Syncytial Virus (RSV) Vaccine.

Recruiting· Pfizer logo

Pfizer·Phase 3·NCT06866405·550 enrolled

RSV Immunization1 trial

Study of HIV-Exposed Pregnancies and Transplacental Antibody Delivery Following RSVpreF (SHIELD-RSV)

Not yet recruiting·UUniversity of British Columbia·Approved·NCT07693166·20 enrolled

Respiratory Syncytial Virus1 trial

A PHASE 3, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN PREGNANT PARTICIPANTS LIVING WITH HIV AND THEIR INFANTS

Completed· Pfizer logo

Pfizer·Phase 3·NCT06325657·681 enrolled

Unspecified1 trial

AN INTERVENTIONAL PHASE 3 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN PARTICIPANTS 60 YEARS OF AGE AND OLDER

Recruiting· Pfizer logo

Pfizer·Phase 3·NCT07819097·600 enrolled

Sources

References

[1]
ClinicalTrials.gov — 21 trial records for RSVpreF. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — RSVpreF compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for RSVpreF. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Biologic[2]
Highest Phase: Phase 3[1]
Company: Pfizer

RSVpreF

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q2 2027

Q4 2027

Q1 2028

Trials by Indication[1]

Immunogenicity5 trials

Respiratory Syncytial Virus (RSV)5 trials

Pregnancy1 trial

Vaccination1 trial

COVID-191 trial

Adult1 trial

Children1 trial

Pregnant Women1 trial

Respiratory Syncytial Virus Infection1 trial

RSV Infection1 trial

RSV Immunization1 trial

Respiratory Syncytial Virus1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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