Group B streptococcus (GBS) disease
Conditions
Brief summary
Prespecified local reactions (redness, swelling, and pain at the injection site)., Prespecified systemic events (fever, nausea, vomiting, diarrhea, headache, fatigue, muscle pain, and joint pain)., Adverse events (AEs)., Serious adverse events (SAEs)., Medically attended adverse events (MAAEs)., GBS serotype specific anti-CPS IgG antibody concentrations measured at birth in infant participants
Detailed description
GBS serotype-specific anti-CPS IgG antibody concentrations in infant participants, GBS serotype-specific OPA antibody titers in infant participants, GBS serotype-specific anti-CPS IgG antibody concentrations measured at birth in infant participants, GBS serotype-specific anti-CPS IgG antibody concentrations in maternal participants, Serum IgG concentration to diphtheria toxoid in a subset of infant participants. Serum IgG concentration to PCV serotypes in a subset of infant participants
Interventions
DRUGPlacebo to Group B Streptococcus 6-Valent Polysaccharide Conjugate Vaccine (GBS6)
DRUGGroup B Streptococcus 6-Valent Polysaccharide Conjugate Vaccine (GBS6)
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prespecified local reactions (redness, swelling, and pain at the injection site)., Prespecified systemic events (fever, nausea, vomiting, diarrhea, headache, fatigue, muscle pain, and joint pain)., Adverse events (AEs)., Serious adverse events (SAEs)., Medically attended adverse events (MAAEs)., GBS serotype specific anti-CPS IgG antibody concentrations measured at birth in infant participants | — |
Secondary
| Measure | Time frame |
|---|---|
| GBS serotype-specific anti-CPS IgG antibody concentrations in infant participants, GBS serotype-specific OPA antibody titers in infant participants, GBS serotype-specific anti-CPS IgG antibody concentrations measured at birth in infant participants, GBS serotype-specific anti-CPS IgG antibody concentrations in maternal participants, Serum IgG concentration to diphtheria toxoid in a subset of infant participants. Serum IgG concentration to PCV serotypes in a subset of infant participants | — |
Countries
Finland, Netherlands, Spain
Outcome results
None listed