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

Phase 2

Completed

Conditions: Group B Streptococcus Infections

Interventions: Biological: Placebo
Biological: Multivalent Group B streptococcus vaccine

Registration Number: NCT03765073

Lead Sponsor: Pfizer

Brief Summary: Phase 1/2, randomized, placebo-controlled, observer-blinded study will evaluate the safety, tolerability and immunogenicity of the investigational multivalent group B streptococcus vaccine administered at one dose level (various formulations) in healthy nonpregnant women (various formulations at one dose level), and then in healthy pregnant women (various formulations at three dose levels), and finally in healthy pregnant women at a selected dose level/formulation.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1208

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Stage 1 Placebo	Placebo	Saline control
Stage 1 - Highest dose formulation b	Multivalent Group B streptococcus vaccine	Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women
Stage 2 - Middle dose formulation a	Multivalent Group B streptococcus vaccine	Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Stage 3 - Selected dose and formulation	Multivalent Group B streptococcus vaccine	Multivalent group B streptococcus vaccine - Stage 3 Pregnant women
Stage 1 - Highest dose formulation a	Multivalent Group B streptococcus vaccine	Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women
Stage 2 - Lowest dose formulation a	Multivalent Group B streptococcus vaccine	Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Stage 2 - Middle dose formulation b	Multivalent Group B streptococcus vaccine	Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Stage 2 - Lowest dose formulation b	Multivalent Group B streptococcus vaccine	Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Stage 3 Placebo	Placebo	Saline control
Stage 2 - Highest dose formulation a	Multivalent Group B streptococcus vaccine	Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Stage 2 - Highest dose formulation b	Multivalent Group B streptococcus vaccine	Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
Stage 2 Placebo	Placebo	Saline control

Primary Outcome Measures

Secondary Outcome Measures

Name	Time	Method
Group B streptococcus (GBS) serotype-specific IgG geometric mean concentrations (GMCs) 1 month after vaccination in nonpregnant women.	1 month after vaccination	Describe GBS serotype-specific IgG geometric mean concentrations (GMCs) 1 month after vaccination in nonpregnant women.
GBS serotype-specific IgG GMCs measured at 2 weeks after vaccination in maternal participants.	2 weeks after vaccination	Describe GBS serotype-specific IgG GMCs measured at 2 weeks after vaccination in maternal participants.
GBS serotype-specific OPA GMTs measured at 1 month after vaccination in maternal participants.	1 month after vaccination	Describe GBS serotype-specific OPA GMTs measured at 1 month after vaccination in maternal participants.
GBS serotype-specific IgG geometric mean concentrations (GMCs) measured before a booster vaccination in nonpregnant women	Before booster vaccination	Describe GBS serotype-specific IgG GMCs measured before a booster vaccination in nonpregnant women
GBS serotype-specific IgG GMCs in infant participants measured at birth.	Birth	Describe GBS serotype-specific IgG GMCs in infant participants measured at birth.
GBS serotype-specific OPA GMTs in infant participants measured at birth.	Birth	Describe GBS serotype-specific OPA GMTs in infant participants measured at birth.
GBS serotype-specific IgG GMCs measured at 1 month after vaccination in maternal participants.	1 month after vaccination	Describe GBS serotype-specific IgG GMCs measured at 1 month after vaccination in maternal participants.
GBS serotype-specific IgG GMCs measured at delivery in maternal participants.	Delivery	Describe GBS serotype-specific IgG GMCs measured at delivery in maternal participants.
GBS serotype-specific IgG geometric mean concentrations (GMCs) measured 6 months after a booster vaccination in nonpregnant women	6 months after booster vaccination	Describe GBS serotype-specific IgG GMCs measured 6 months after a booster vaccination in nonpregnant women
GBS serotype-specific OPA GMTs measured at delivery in maternal participants.	Delivery	Describe GBS serotype-specific OPA GMTs measured at delivery in maternal participants.
GBS serotype-specific IgG geometric mean concentrations (GMCs) measured 1 month after a booster vaccination in nonpregnant women	1 month after booster vaccination	Describe GBS serotype-specific IgG GMCs measured 1 month after a booster vaccination in nonpregnant women
GBS serotype-specific IgG geometric mean concentrations (GMCs) measured 3 months after a booster vaccination in nonpregnant women	3 months after booster vaccination	Describe GBS serotype-specific IgG GMCs measured 3 months after a booster vaccination in nonpregnant women

Trial Locations

Locations (41): Clinical Research Prime
🇺🇸
Idaho Falls, Idaho, United States
Velocity Clinical Research
🇺🇸
Cincinnati, Ohio, United States
MedPharmics, LLC
🇺🇸
Albuquerque, New Mexico, United States
Velocity Clinical Research, Covington
🇺🇸
Covington, Louisiana, United States
Velocity Clinical Research, Phoenix
🇺🇸
Phoenix, Arizona, United States
Chemidox Clinical Trials Inc.
🇺🇸
Lancaster, California, United States
Chemidox Clinical Trials Inc
🇺🇸
Lancaster, California, United States
Emerson Clinical Research Institute
🇺🇸
Washington, District of Columbia, United States
Lakeview Regional Medical Center
🇺🇸
Covington, Louisiana, United States
MedPharmics
🇺🇸
Covington, Louisiana, United States
Clinical Research Prime Rexburg
🇺🇸
Rexburg, Idaho, United States
St. Tammany Parish Hospital
🇺🇸
Covington, Louisiana, United States
North Oaks Medical Center
🇺🇸
Hammond, Louisiana, United States
North Oaks Obstetrics & Gynecology
🇺🇸
Hammond, Louisiana, United States
MedPharmics, LLC (Recruitment Call Center)
🇺🇸
Lafayette, Louisiana, United States
Velocity Clinical Research, Slidell
🇺🇸
Slidell, Louisiana, United States
Boeson Research
🇺🇸
Missoula, Montana, United States
Community Hospital
🇺🇸
Missoula, Montana, United States
The Birth Center
🇺🇸
Missoula, Montana, United States
Meridian Clinical Research
🇺🇸
Hastings, Nebraska, United States
Frontier Pediatric Care (Follow-Up Visits for Infant Participants)
🇺🇸
Lincoln, Nebraska, United States
Bryan Women's Care Physicians (Maternal Visits & Obstetric Exams)
🇺🇸
Lincoln, Nebraska, United States
Be Well Clinical Studies
🇺🇸
Lincoln, Nebraska, United States
Lowcountry Women's Specialists
🇺🇸
Summerville, South Carolina, United States
Coastal Pediatric Research
🇺🇸
Summerville, South Carolina, United States
Meridian Clinical Research, LLC
🇺🇸
Norfolk, Nebraska, United States
St. Davids Medical Center
🇺🇸
Austin, Texas, United States
Summerville Medical Center
🇺🇸
Summerville, South Carolina, United States
Tekton Research, Inc
🇺🇸
Austin, Texas, United States
Sentara Leigh Hospital
🇺🇸
Norfolk, Virginia, United States
The Group for Women
🇺🇸
Norfolk, Virginia, United States
Wits Reproductive Health and HIV Institute
🇿🇦
Johannesburg, Gauteng, South Africa
Tidewater Physicians for Women
🇺🇸
Norfolk, Virginia, United States
Respiratory and Meningeal Pathogens Research Unit (RMPRU)
🇿🇦
Soweto, Gauteng, South Africa
Charlotte Maxeke Johannesburg Academic Hospital
🇿🇦
Parktown, Johannesburg, South Africa
Empilweni Services and Research Unit (ESRU)
🇿🇦
Coronationville, Johannesburg, South Africa
Site B
🇿🇦
Khayelitsha, Western CAPE, South Africa
Michael Mapongwana Community Health Centre
🇿🇦
Khayelitsha, Western CAPE, South Africa
St George's University Hospitals NHS Foundation Trust
🇬🇧
London, Tooting, United Kingdom
Khayelitsha Hospital
🇿🇦
Khayelitsha, Western CAPE, South Africa
FAMCRU
🇿🇦
Parow Valley, Western CAPE, South Africa

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

Recruitment & Eligibility

Study & Design

Trial Locations

Instant Trial Alerts

Instant Trial Alerts

Name	Time	Method
Percentages of nonpregnant women reporting prompted systemic events within 7 days following primary and booster doses of investigational product (fever, nausea/vomiting, diarrhea, headache, fatigue/tiredness, muscle pain, and joint pain).	Day 7	Describe prompted systemic events for nonpregnant women following investigational product administration.
Percentages of nonpregnant women reporting SAEs through 6 months following administration of the primary dose of investigational product.	6 months following administration of investigational product	Describe SAEs for nonpregnant women through 6 months following administration of investigational product.
Percentages of sentinel-cohort maternal participants (Stage 2 only) with clinical laboratory abnormalities following administration of investigational product at the 2-week follow-up visit.	2 weeks following administration of investigational product	Describe clinical laboratory abnormalities for maternal participants (Stage 2 only) following administration of investigational product at 2-week follow-up visit.
Percentages of maternal participants reporting AEs through 1 month after administration of investigational product.	1 month after administration of investigational product	Describe AEs through 1 month after administration of investigational product.
Percentages of maternal participants with each delivery outcome (live birth, delivery mode).	Delivery	Describe delivery outcomes (live birth, delivery mode) for maternal participants.
Percentages of infant participants with SAEs, AEs of special interest (major congenital anomalies, developmental delay, and suspected or confirmed GBS infection), and MAEs through 12 months of age.	12 months of age	Describe SAEs, AEs of special interest (major congenital anomalies, developmental delay, and suspected or confirmed GBS infection), and MAEs for infant participants through 12 months of age.
Percentages of nonpregnant women reporting SAEs approximately 7 to 12 months following the booster doses of investigational product.	7 to 12 months following administration of investigational product	Describe SAEs for nonpregnant women 7 to 12 months following administration of investigational product.
Percentages of nonpregnant women reporting medically attended adverse events (MAEs) approximately 7 to 12 months following the booster doses of investigational product.	7 to 12 months following administration of investigational product	Describe MAEs for nonpregnant women 7 to 12 months following administration of investigational product.
Percentages of infant participants with specific birth outcomes.	Birth	Describe specific birth outcomes for infant participants.
Percentages of infant participants with AEs from birth to 6 weeks of age.	6 weeks of age	Describe AEs for infant participants from birth to 6 weeks of age.
Percentages of nonpregnant women reporting medically attended adverse events (MAEs) through 6 months following administration of the primary dose of investigational product.	6 months following administration of investigational product	Describe MAEs for nonpregnant women through 6 months following administration of investigational product.
Percentages of nonpregnant women reporting prompted local reactions within 7 days following primary and booster doses of investigational product (pain at the injection site, redness, and swelling).	Day 7	Describe prompted local reactions for nonpregnant women following investigational product administration.
Percentages of nonpregnant women reporting adverse events (AEs) through 1 month following administration of the primary and booster doses of investigational product.	1 month following administration of investigational product	Describe AEs for nonpregnant women occurring through 1 month following administration of investigational product.
Percentages of maternal participants reporting prompted local reactions within 7 days following administration of investigational product (pain at the injection site, redness, and swelling).	Day 7	Describe prompted local reactions for maternal participants within 7 days following administration of investigational product (pain at the injection site, redness, and swelling).
Percentages of maternal participants reporting prompted systemic events within 7 days following administration of investigational product (fever, nausea/vomiting, diarrhea, headache, fatigue/tiredness, muscle pain, and joint pain).	Day 7	Describe prompted systemic events for maternal participants within 7 days following administration of investigational product (fever, nausea/vomiting, diarrhea, headache, fatigue/tiredness, muscle pain, and joint pain).
Percentages of maternal participants with SAEs, MAEs, and obstetric complications (prepartum, intrapartum, and postpartum) throughout the study (Visit 1 through the 12-month postdelivery study visit).	12 months after delivery	Describe SAEs, MAEs, and obstetric complications (prepartum, intrapartum, and postpartum) for maternal participants throughout the study (Visit 1 through the 12-month postdelivery study visit).