Condition: Healthy · Sponsor: Pfizer
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) …
This description comes directly from the study's public registry record.
Pfizer CT.gov Call Center · 1-800-718-1021 · ClinicalTrials.gov_Inquiries@pfizer.com
Always discuss trial participation with your own doctor first.
| Center for Research in Women's Health | Birmingham, Alabama, United States | Recruiting |
| Children's of Alabama | Birmingham, Alabama, United States | Recruiting |
| University of Alabama at Birmingham - School of Medicine | Birmingham, Alabama, United States | Recruiting |
| University of Alabama at Birmingham Women & Infants Center | Birmingham, Alabama, United States | Recruiting |
| SEC Clinical Research | Dothan, Alabama, United States | Recruiting |
| USA Health Allen Cox Building | Mobile, Alabama, United States | Recruiting |
| USA Health Children's and Women's Hospital | Mobile, Alabama, United States | Recruiting |
| USA Health Mitchell Cancer Institute | Mobile, Alabama, United States | Recruiting |
| USA Health Strada Patient Care Center | Mobile, Alabama, United States | Recruiting |
| ClinMed | Phoenix, Arizona, United States | Recruiting |
| Valleywise Comprehensive Health Center Women's Clinic | Phoenix, Arizona, United States | Recruiting |
| Valleywise Health Medical Center | Phoenix, Arizona, United States | Recruiting |
+ 195 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07160244