Health Trials

BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies

ConditionHealthy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-49
SponsorPfizer

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy pregnant women ≤49 years of age who are between 24 0/7 and 36 0/7 weeks of gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, and who have no known increased risk of complications.

Had a fetal anomaly ultrasound examination with no significant fetal abnormalities observed.

Documented negative human immunodeficiency virus (HIV) antibody test, syphilis test, and hepatitis B virus (HBV) surface antigen test during this pregnancy and prior to randomization.

Capable of giving personal signed informed consent.

Disqualifiers

Prepregnancy body mass index (BMI) of >40 kg/m2.

Current pregnancy complications or abnormalities that may increase the risk associated with the participation in and completion of the study.

Prior pregnancy complications or abnormalities that, based on the investigator's judgment, may increase the risk associated with the participation in and completion of the study.

History of microbiologically proven invasive disease caused by GBS in the current pregnancy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multivalent Group B streptococcus vaccine

    Biological/Vaccine

    Multivalent Group B streptococcus vaccine

  • Placebo

    Biological/Vaccine

    Saline Control

  • Infanrix hexa

    Biological/Vaccine

    Vaccine administered in a subset of infant participants as per the national immunization schedule

  • Prevenar 20

    Biological/Vaccine

    Vaccine administered in a subset of infant participants as per the national immunization schedule

  • Pediarix

    Biological/Vaccine

    Vaccine administered in a subset of infant participants as per the national immunization schedule

  • Prevnar 20

    Biological/Vaccine

    Vaccine administered in a subset of infant participants as per the national immunization schedule

  • Infanrix

    Biological/Vaccine

    Vaccine administered in a subset of infant participants as per the national immunization schedule

Treatment groups

6,000 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: GBS6Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Group C: Infanrix hexaExperimental treatment 1 intervention
Group D: Prevenar 20Experimental treatment 1 intervention
Group E: PediarixExperimental treatment 1 intervention
Group F: Prevnar 20Experimental treatment 1 intervention
Group G: InfanrixExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The proportion of maternal participants reporting prespecified local reactions within 7 days following study intervention

Time frame
Within 7 days
2

The proportion of maternal participants reporting prespecified systemic events within 7 days following study intervention

Time frame
Within 7 days
3

The proportion of maternal participants reporting adverse events (AEs) through 1 month following study intervention

Time frame
1 month
4

The proportion of maternal participants reporting serious adverse events (SAEs) through 6 months after delivery

Time frame
6 months after delivery

Secondary outcomes

1

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

Time frame
Birth
2

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.

Time frame
Birth
3

To describe anti-CPS IgG antibody levels in infant participants born to maternal participants vaccinated with GBS6.

Time frame
Birth
4

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.

Time frame
Birth

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pfizer

Lead sponsor

Source ClinicalTrials.gov
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