Actively Recruiting

Phase 3
Age: 0Years +
All Genders
Healthy Volunteers
NCT06866405

A Phase 3 Study of Revaccination in Subsequent Pregnancies With Bivalent RSV Vaccine and Duration of Protection of a Single Dose

Led by Pfizer · Updated on 2026-05-05

550

Participants Needed

94

Research Sites

149 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study aims to check how safe and well-tolerated a second dose of RSVpreF is when given during later pregnancies, and to see how long the immunity lasts from a single dose given during a previous pregnancy by examining the blood of nonpregnant participants who had the vaccine before.

CONDITIONS

Official Title

A Phase 3 Study of Revaccination in Subsequent Pregnancies With Bivalent RSV Vaccine and Duration of Protection of a Single Dose

Who Can Participate

Age: 0Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 49 who are pregnant between 24 and 36 weeks expecting one baby without known risks
  • Received RSVpreF or Abrysvo vaccine during a previous pregnancy
  • Had an ultrasound at 18 weeks or later in the current pregnancy showing no major fetal problems
  • Medically suitable to join based on history, exam, and doctor judgment
  • Agree to let their baby participate and provide permission
  • Able to sign consent agreeing to study rules
  • Parent or guardian consent for infant participation
  • Parent or guardian agrees to attend visits and follow study plans including tests
  • Nonpregnant participants who had one dose of RSVpreF in a previous Pfizer trial with available results
  • Able to sign consent and follow study requirements
Not Eligible

You will not qualify if you...

  • Received any approved or experimental RSV vaccine since previous pregnancy
  • Pre-pregnancy BMI over 40 kg/m2
  • History of severe vaccine or allergic reactions to study vaccine or similar
  • Current pregnancy problems at consent time
  • Previous pregnancy problems at consent time
  • Breastfeeding at enrollment
  • Received any approved or experimental RSV vaccine after the Pfizer trial (nonpregnant cohort)
  • Participating in other drug studies within 28 days before consent or during study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 94 locations

1

Center for Research in Women's Health

Birmingham, Alabama, United States, 35233

Actively Recruiting

2

Children's of Alabama

Birmingham, Alabama, United States, 35233

Actively Recruiting

3

University of Alabama at Birmingham - School of Medicine

Birmingham, Alabama, United States, 35233

Actively Recruiting

4

University of Alabama at Birmingham Women & Infants Center

Birmingham, Alabama, United States, 35233

Actively Recruiting

5

USA Health Children's and Women's Hospital

Mobile, Alabama, United States, 36604

Actively Recruiting

6

USA Health Strada Patient Care Center

Mobile, Alabama, United States, 36604

Actively Recruiting

7

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States, 90024

Actively Recruiting

8

Ronald Reagan UCLA Medical Center (inpatient hospital)

Los Angeles, California, United States, 90095

Actively Recruiting

9

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States, 90095

Actively Recruiting

10

UCLA (outpatient clinic)

Los Angeles, California, United States, 90095

Actively Recruiting

11

UCLA Clinical and Translational Research Center (research clinic)

Los Angeles, California, United States, 90095

Actively Recruiting

12

UCLA

Los Angeles, California, United States, 90095

Actively Recruiting

13

Lucile Packard Children's Hospital-Labor and Delivery Unit

Palo Alto, California, United States, 94304

Actively Recruiting

14

Stanford Obstetrics Clinic

Palo Alto, California, United States, 94304

Actively Recruiting

15

Stanford University Medical Center

Palo Alto, California, United States, 94304

Actively Recruiting

16

Stanford University

Palo Alto, California, United States, 94304

Actively Recruiting

17

Anschutz Health Sciences Building (AHSB)

Aurora, Colorado, United States, 80045

Actively Recruiting

18

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

19

CU Research Pharmacy

Aurora, Colorado, United States, 80045

Actively Recruiting

20

University of Colorado AO1 UCH

Aurora, Colorado, United States, 80045

Actively Recruiting

21

University of Colorado Hospital Inpatient Pavilion

Aurora, Colorado, United States, 80045

Actively Recruiting

22

University of Colorado Hospital Outpatient Pavilion

Aurora, Colorado, United States, 80045

Actively Recruiting

23

University of Colorado Research II Building

Aurora, Colorado, United States, 80045

Actively Recruiting

24

Citadelle Clinical Research

North Miami Beach, Florida, United States, 33162

Actively Recruiting

25

Emerald Coast OBGYN Clinical Research

Panama City, Florida, United States, 32405

Actively Recruiting

26

Emerald Coast Pediatrics

Panama City, Florida, United States, 32405

Actively Recruiting

27

HCA Florida Gulf Coast Hospital

Panama City, Florida, United States, 32405

Actively Recruiting

28

Emerald Coast Pediatrics

Panama City Beach, Florida, United States, 32407

Actively Recruiting

29

Advanced Specialty Research

Boise, Idaho, United States, 83702

Actively Recruiting

30

Saint Alphonsus Regional Medical Center

Boise, Idaho, United States, 83706

Actively Recruiting

31

St. Luke's Boise Medical Center

Boise, Idaho, United States, 83712

Actively Recruiting

32

Clinical Research Prime

Idaho Falls, Idaho, United States, 83404

Actively Recruiting

33

Saint Alphonsus Medical Center

Nampa, Idaho, United States, 83687

Actively Recruiting

34

St. Luke's Nampa Medical Center

Nampa, Idaho, United States, 83687

Actively Recruiting

35

Accellacare - McFarland

Ames, Iowa, United States, 50010

Actively Recruiting

36

Mary Greeley Medical Center

Ames, Iowa, United States, 50010

Actively Recruiting

37

McFarland Clinic, PC

Ames, Iowa, United States, 50010

Actively Recruiting

38

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Actively Recruiting

39

Velocity Clinical Research, Lafayette

Lafayette, Louisiana, United States, 70508

Actively Recruiting

40

Velocity Clinical Research - New Orleans

New Orleans, Louisiana, United States, 70119

Actively Recruiting

41

Boston Medical Center

Boston, Massachusetts, United States, 02118

Actively Recruiting

42

Velocity Clinical Research, Gulfport

Gulfport, Mississippi, United States, 39503

Actively Recruiting

43

Boeson Research GTF

Great Falls, Montana, United States, 59405

Actively Recruiting

44

OBGYN Associates

Great Falls, Montana, United States, 59405

Actively Recruiting

45

Boeson Research KAL

Kalispell, Montana, United States, 59901

Actively Recruiting

46

Heart & Hands Midwifery

Kalispell, Montana, United States, 59901

Actively Recruiting

47

Boeson Research MSO

Missoula, Montana, United States, 59804

Actively Recruiting

48

Origin Health

Missoula, Montana, United States, 59804

Actively Recruiting

49

Velocity Clinical Research, Grand Island

Grand Island, Nebraska, United States, 68803

Actively Recruiting

50

Velocity Clinical Research, Norfolk

Norfolk, Nebraska, United States, 68701

Actively Recruiting

51

Presbyterian Hospital

Albuquerque, New Mexico, United States, 87107

Actively Recruiting

52

UNM Hospital

Albuquerque, New Mexico, United States, 87107

Actively Recruiting

53

Velocity Clinical Research, Albuquerque

Albuquerque, New Mexico, United States, 87107

Actively Recruiting

54

Lovelace Women's Hospital

Albuquerque, New Mexico, United States, 87109

Actively Recruiting

55

Duke University - Main Hospital and Clinics

Durham, North Carolina, United States, 27705

Actively Recruiting

56

Duke University - Main Hospital and Clinics

Durham, North Carolina, United States, 27710

Actively Recruiting

57

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

58

Prisma Health-Upstate

Greenville, South Carolina, United States, 29605

Actively Recruiting

59

Prisma Health

Greenville, South Carolina, United States, 29605

Actively Recruiting

60

Memorial Hermann Memorial City Hospital

Houston, Texas, United States, 77024

Actively Recruiting

61

The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77204

Actively Recruiting

62

Helios Clinical Research - WEA

Weatherford, Texas, United States, 76086

Actively Recruiting

63

Medical City Weatherford

Weatherford, Texas, United States, 76086

Actively Recruiting

64

Weatherford OB/GYN Associates

Weatherford, Texas, United States, 76086

Actively Recruiting

65

University of Utah

Salt Lake City, Utah, United States, 84112

Actively Recruiting

66

University of Utah Clinical Neuroscience Center

Salt Lake City, Utah, United States, 84132

Actively Recruiting

67

University of Utah Hospital

Salt Lake City, Utah, United States, 84132

Actively Recruiting

68

University of Utah

Salt Lake City, Utah, United States, 84132

Actively Recruiting

69

Sentara Leigh Hospital

Norfolk, Virginia, United States, 23502

Actively Recruiting

70

The Group For Women - Kempsville Office

Norfolk, Virginia, United States, 23502

Actively Recruiting

71

Tidewater Physicians for Women

Norfolk, Virginia, United States, 23502

Actively Recruiting

72

WomensCare Center

Norfolk, Virginia, United States, 23502

Actively Recruiting

73

Virginia Physicians For Women (VPFW)

North Chesterfield, Virginia, United States, 23235

Actively Recruiting

74

Clinical Research Partners, LLC

Richmond, Virginia, United States, 23226

Actively Recruiting

75

Infusion Solutions, LLC

Richmond, Virginia, United States, 23226

Actively Recruiting

76

Seattle Children's Research Institute

Seattle, Washington, United States, 98101

Actively Recruiting

77

Seattle Children's Hospital

Seattle, Washington, United States, 98105

Actively Recruiting

78

University of Washington - Northwest

Seattle, Washington, United States, 98133

Actively Recruiting

79

University of Washington Medical Center - Montlake

Seattle, Washington, United States, 98195

Actively Recruiting

80

Fundación Respirar

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ABP

Actively Recruiting

81

Clinica Del Niño Y La Madre

Mar del Plata, Buenos Aires, Argentina, 7600

Actively Recruiting

82

Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L

San Miguel de Tucumán, Tucumán Province, Argentina, 4000

Actively Recruiting

83

Instituto de Maternidad y Ginecología Nuestra Señora de las Mercedes

San Miguel de Tucumán, Tucumán Province, Argentina, 4000

Actively Recruiting

84

Centro de investigación Clínica OSECAC - Sede Jonas Salk

Buenos Aires, Argentina, 1044

Actively Recruiting

85

Equipo Ciencia

Buenos Aires, Argentina, C1428BNF

Actively Recruiting

86

Hospital Público Materno Infantil

Salta, Argentina, 4400

Actively Recruiting

87

Josha Research

Bloemfontein, Free State, South Africa, 9301

Actively Recruiting

88

University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA)

Johannesburg, Gauteng, South Africa, 1864

Actively Recruiting

89

Wits RHI

Johannesburg, Gauteng, South Africa, 2001

Actively Recruiting

90

Into Research

Pretoria, Gauteng, South Africa, 0181

Actively Recruiting

91

Family Clinical Research Unit (Fam-Cru)

Cape Town, Western Cape, South Africa, 7500

Actively Recruiting

92

MRC Unit on Child And Adolescent Health

Cape Town, Western Cape, South Africa, 7700

Actively Recruiting

93

University of Cape Town Lung Institute (Pty) Ltd

Cape Town, Western Cape, South Africa, 7700

Actively Recruiting

94

Medical Research Council Unit

Banjul, The Gambia, POBox 273

Actively Recruiting

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Research Team

P

Pfizer CT.gov Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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