BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies
- Conditions
- Healthy
- Interventions
- Biological: Multivalent Group B streptococcus vaccineBiological: PlaceboBiological: Prevenar 20
- Registration Number
- NCT07160244
- Lead Sponsor
- Pfizer
- Brief Summary
BEATRIX (group B strEptococcus mATeRnal and Infant VaX study) The purpose of this study is to learn about the safety and how the group B streptococcus (GBS) vaccine works in pregnant women and their babies.
This study is seeking healthy pregnant participants:
* aged 49 or younger who can join.
* between 24 and 36 weeks of gestation ("Gestational age" is a medical term used to describe how far along your pregnancy is)
* had a fetal ultrasound examination performed with no major fetal abnormalities observed
* documented negative for HIV, syphilis and Hepatitis B All participants in this study will receive only 1 shot in an arm. This could either be a group B streptococcus 6-valent polysaccharide conjugate vaccine (GBS6) or placebo. Placebo is an inactive substance used in the study for comparison purposes; in this study, the placebo injection will be saline (saltwater). The pregnant participants may take part in this study for a maximum of 14 months (6 months after delivery) , and their babies for about 12 months after they are born. The pregnant participants will need to visit the research site at least 3 to 4 times with some visits permitted to occur over the telephone.
A subset of infants will be asked to take part in the study for up to 19 months. The subset will receive diphtheria toxoid-containing vaccine and/or pneumococcal vaccine following each country's standard immunization plan and have blood drawn 1 month after completion of the primary and/or toddler (booster) doses.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 6000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GBS6 Multivalent Group B streptococcus vaccine Multivalent group B streptococcus vaccine Placebo Placebo Placebo Infanrix hexa Infanrix hexa Commercially available combination vaccine containing diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio), and Haemophilus influenzae type b (Hib) Prevenar 20 Prevenar 20 Commercially available vaccine that protects against 20 strains of Streptococcus pneumoniae Pediarix Pediarix Commercially available combination vaccine containing diphtheria, tetanus, pertussis (whooping cough), hepatitis B, and polio Prevnar 20 Prevnar 20 Commercially available vaccine that protects against 20 strains of Streptococcus pneumoniae Infanrix Infanrix Commercially available combination vaccine containing diphtheria, tetanus, and pertussis
- Primary Outcome Measures
Name Time Method The proportion of maternal participants reporting prespecified local reactions within 7 days following study intervention Within 7 days The proportion of maternal participants reporting prespecified systemic events within 7 days following study intervention Within 7 days The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting adverse events (AEs) from birth through 1 month of age Birth to 1 month of age The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting serious adverse events (SAEs) from birth through end of the study Through study completion, at least 1 year The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting medically attended events (MAAEs) from birth through 6 months of age Birth to 6 months of age To measure the relative risk reduction in the proportion of infant participants at birth with GBS serotype-specific IgG antibody concentrations below predefined serotype-specific GBS late onset disease thresholds in the GBS6 group to the placebo group Birth The proportion of maternal participants reporting medically attended adverse events (MAAEs) through 6 months after delivery 6 months after delivery To evaluate the aggregate predicted VE combining all 6 serotypes in GBS6 to provide protection from invasive GBS early onset disease based on serotype specific anti-CPS IgG concentrations measured in infants at birth. Birth The proportion of maternal participants reporting adverse events (AEs) through 1 month following study intervention 1 month The proportion of maternal participants reporting serious adverse events (SAEs) through 6 months after delivery 6 months after delivery To measure the relative risk reduction in the proportion of infant participants at birth with GBS serotype-specific IgG antibody concentrations below predefined serotype-specific GBS early onset disease thresholds in the GBS6 group to the placebo group Birth To evaluate the aggregate predicted VE combining all 6 serotypes in GBS6 to provide protection from invasive GBS late onset disease based on serotype specific anti-CPS IgG concentrations measured in infants at birth. Birth
- Secondary Outcome Measures
Name Time Method To measure GBS serotype-specific opsonophagocytic titers in infant participants at birth by geometric mean ratio between GBS6 group versus placebo group and by the difference in seroresponse rates between GBS6 group and placebo group Birth To describe anti-CPS IgG antibody levels predicted to provide protection from invasive GBS disease (all disease) caused by the 6 individual vaccine serotypes in infants when GBS6 is administered to healthy pregnant women. Birth To describe anti-CPS IgG antibody levels in infant participants born to maternal participants vaccinated with GBS6. Birth To describe anti-CPS IgG antibody levels predicted to provide protection from invasive GBS LOD and EOD, separately, caused by the 6 individual vaccine serotypes (Ia, Ib, II, III, IV, and V) in infants when GBS6 is administered to healthy pregnant women. Birth To measure GBS serotype-specific IgG by geometric mean concentration in maternal participants at 1 month after vaccination and at delivery. 1 month after vaccination and at delivery Compare the proportion of infants with anti-diphtheria toxoid and pneumococcal IgG responses at 1 month post-primary and toddler doses between GBS6 and placebo groups, including predefined IgG levels and geometric mean ratios. 1 month after the primary vaccination series and 1 month after the toddler dose
Trial Locations
- Locations (14)
Velocity Clinical Research, Covington
🇺🇸Covington, Louisiana, United States
Virginia Physicians For Women (VPFW)
🇺🇸North Chesterfield, Virginia, United States
Clinical Research Partners, LLC
🇺🇸Richmond, Virginia, United States
Fukui Aiiku Hospital
🇯🇵Fukui, Japan
Clinical Research Prime
🇺🇸Idaho Falls, Idaho, United States
Eastern Idaho Regional Medical Center
🇺🇸Idaho Falls, Idaho, United States
Mountain View Hospital
🇺🇸Idaho Falls, Idaho, United States
Madison Memorial Hospital
🇺🇸Rexburg, Idaho, United States
Heart and Hands Midwifery and Family Practice
🇺🇸Kalispell, Montana, United States
POEM Healthcare
🇺🇸Kalispell, Montana, United States
Scroll for more (4 remaining)Velocity Clinical Research, Covington🇺🇸Covington, Louisiana, United States