Secondary endpoints: details revised at 1 of 6 entries
MinorTrial sites reduced: 212 → 206 locations
Trial sites expanded: 207 → 212 locations
v21
MinorStudy sites: 207 to 212v20
MinorTrial sites expanded: 202 → 207 locationsv19
MinorTrial sites expanded: 198 → 202 locationsv18
MinorTrial sites expanded: 179 → 198 locationsv17
NotablePrimary endpoint(s) modified
Study sites: 178 to 179
Secondary endpoints revised (6)
v16
MinorStudy sites: 177 to 178v15
MinorTrial sites expanded: 165 → 177 locationsv14
MinorTrial sites expanded: 162 → 165 locationsv13
MinorTrial sites expanded: 158 → 162 locationsv12
MinorTrial sites expanded: 105 → 158 locationsv11
MinorSite details revised at 1 of 105 sitesv10
MinorStudy sites: 81 to 105v9
MinorStudy sites: 71 to 81v8
MinorStudy sites: 42 to 71v7
MinorStudy sites: 23 to 42v6
MinorStudy sites: 19 to 23v5
MinorStudy sites: 12 to 19v4
MinorStudy sites: 14 to 12v3
MinorStudy sites: 10 to 14v2
MinorStudy First Submitted
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.