Healthy pregnant women and their infants
Conditions
Interventions
*Biological: Multivalent Group B streptococcus vaccine
-Multivalent Group B streptococcus vaccine
-Other Names:
#GBS6
*Biological: Placebo
-Saline Control
*Biological: Infanrix hexa
-Vaccine administe
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key Inclusion criteria- Maternal: *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. Key Inclusion criteria- Infant Participants - Evidence of a signed and dated ICD signed by the parent(s)/legally authorized representative or legal guardian
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 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. Refer to the study contact for further eligibility details
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *The proportion of maternal participants reporting prespecified local reactions within 7 days following study intervention [Time Frame: Within 7 days] *The proportion of maternal participants reporting prespecified systemic events within 7 days following study intervention [Time Frame: Within 7 days] *The proportion of maternal participants reporting adverse events (AEs) through 1 month following study intervention [Time Frame: 1 month] *The proportion of maternal participants reporting serious adverse events (SAEs) through 6 months after delivery [Time Frame: 6 months after delivery] *The proportion of maternal participants reporting medically attended adverse events (MAAEs) through 6 months after delivery [Time Frame: 6 months after delivery] *The proportion of maternal participants reporting adverse events of special interest (AESIs) through 6 months after delivery [Time Frame: 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 [Time Frame: 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 [Time Frame: 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 adverse events (MAAEs) from birth through 6 months of age [Time Frame: Birth to 6 months of age] *The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting adverse events of special interest (AESIs) from birth through end of study [Time Frame: Through study completion, at least 1 year] *To measure the relative risk reduction in the proportion of infant participants at birth with GBS serotype-specific IgG antibody concentration | — |
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 [Time Frame: 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. [Time Frame: Birth] *To describe anti-CPS IgG antibody levels in infant participants born to maternal participants vaccinated with GBS6. [Time Frame: 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. [Time Frame: Birth] *To measure GBS serotype-specific IgG by geometric mean concentration in maternal participants at 1 month after vaccination and at delivery. [Time Frame: 1 month after vaccination and at delivery] *Compare the proportion of infants with anti-diphtheria toxoid and/or pneumococcal IgG responses at 1 month post-primary and toddler doses between GBS6 and placebo groups, including predefined IgG levels and geometric mean ratios. [Time Frame: 1 month after the primary vaccination series and 1 month after the toddler dose] | — |
Countries
Argentina, Brazil, Canada, Finland, Japan, Mexico, Netherlands, South Africa, South Korea, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed