Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Nonpregnant Women And Pregnant Women And Their Infants

PHASE2CompletedINTERVENTIONAL
Enrollment

1,208

Participants

Timeline

Start Date

January 14, 2019

Primary Completion Date

March 4, 2024

Study Completion Date

March 4, 2024

Conditions
Group B Streptococcus Infections
Interventions
BIOLOGICAL

Multivalent Group B streptococcus vaccine

Various formulations at three dose levels

BIOLOGICAL

Placebo

Saline control

Trial Locations (35)

1862

Respiratory and Meningeal Pathogens Research Unit (RMPRU), Soweto

2001

Wits Reproductive Health and HIV Institute, Johannesburg

2093

Empilweni Services and Research Unit (ESRU), Coronationville

2196

Charlotte Maxeke Johannesburg Academic Hospital, Parktown

7505

FAMCRU, Parow Valley

7784

Khayelitsha District Hospital (KDH), Khayelitsha

Michael Mapongwana Community Health Centre, Khayelitsha

Site B, Khayelitsha

20009

Emerson Clinical Research Institute, Washington D.C.

23502

Sentara Leigh Hospital, Norfolk

The Group for Women, Norfolk

Tidewater Physicians for Women, Norfolk

29485

Lowcountry Women's Specialists, Summerville

Summerville Medical Center, Summerville

29486

Coastal Pediatric Research, Summerville

36608

Velocity Clinical Research, Mobile

59804

Boeson Research, Missoula

Community Hospital, Missoula

The Birth Center, Missoula

68506

Frontier Pediatric Care (Follow-Up Visits for Infant Participants), Lincoln

68510

Bryan Women's Care Physicians (Maternal Visits & Obstetric Exams), Lincoln

68516

Be Well Clinical Studies, Lincoln

68901

Meridian Clinical Research, Hastings

70403

North Oaks Medical Center, Hammond

North Oaks Obstetrics & Gynecology, Hammond

70433

Lakeview Regional Medical Center, Covington

MedPharmics, Covington

St. Tammany Parish Hospital, Covington

70458

Velocity Clinical Research, Slidell

83404

Clinical Research Prime, Idaho Falls

83440

Clinical Research Prime Rexburg, Rexburg

85006

Velocity Clinical Research, Phoenix, Phoenix

93534

Chemidox Clinical Trials Inc., Lancaster

Chemidox Clinical Trials Inc, Lancaster

SW17 0QT

St George's University Hospitals NHS Foundation Trust, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY