Vaccines - Group B Streptococcus
Conditions
Interventions
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. Willing to give informed consent for her infant to participate in the study
Exclusion criteria
Exclusion criteria: Key Exclusion criteria- Maternal: 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. A known or suspected infection during the current pregnancy that may increase the risk of complications in pregnancy (eg, active tuberculosis, syphilis, primary genital herpes simplex, malaria). Key Inclusion criteria- Infant Participants - Evidence of a signed and dated ICD signed by the parent(s)/legally authorized representative or legal guardian Key Exclusion Criteria - Infant Participants: - Children or grandchildren who are direct descendants of investigator site staff or sponsor and sponsor delegate employees directly involved in the conduct of the study. Key Exclusion Criteria - Infant immunogenicity subset Participants: - Children with a known or suspected contraindication to any vaccine administered in the infant vaccine immunogenicity subset.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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.;The proportion of maternal participants reporting medically attended adverse events (MAAEs) through 6 months after delivery;1. Primary safety 2. Primary immunogenicity ;The proportion of maternal participants reporting prespecified local reactions within 7 days following study intervention;The proportion of maternal participants reporting prespecified systemic events within 7 days following study intervention;The proportion of maternal participants reporting adverse events (AEs) through 1 month following study intervention;The proportion of maternal participants reporting serious adverse events (SAEs) through 6 months after delivery;The proportion of maternal participants reporting medically attended adverse events (MAAEs) through 6 months after delivery;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;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;The proportion of infant participants born to pregnant women who were vaccinated w | — |
Secondary
| Measure | Time frame |
|---|---|
| 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;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;To describe anti-CPS IgG antibody levels in infant participants born to maternal participants vaccinated with GBS6;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;To measure GBS serotype-specific IgG by geometric mean concentration in maternal participants at 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. | — |
Countries
Kenya
Contacts
Public ContactOkubukola;Kwaku Poku Idoko;Asante
Associate Professor Clinical Vaccinology London School of Hygiene and Tropical Medicine;Director
Outcome results
None listed