At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 306 enrolled
Drug / intervention
Multivalent Group B streptococcus vaccine +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A PHASE 2B, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE WHEN ADMINISTERED CONCOMITANTLY WITH TETANUS, DIPHTHERIA, AND ACELLULAR PERTUSSIS VACCINE (TDAP) IN HEALTHY NONPREGNANT WOMEN 18 THROUGH 49 YEARS OF AGE
In Brief
A Phase 2 clinical trial evaluating Multivalent Group B streptococcus vaccine, Tetanus, diphtheria, and acellular pertussis vaccine, and 1 other intervention for Group B Streptococcus Infections. Completed, enrolled 306 participants across 12 sites.
Detailed Summary
This phase 2B, placebo-controlled, randomized, observer-blinded trial will evaluate the safety, tolerability, and immunogenicity of the investigational multivalent group B streptococcus vaccine administered concomitantly with Tdap in healthy nonpregnant women 18 through 49 years of age.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGroup B Streptococcus Infections
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedFeb 2021
Enrollment StartAug 2022
Primary CompletionApr 2023
TodayJul 2026
First PostedFeb 23, 2021
Enrollment StartAug 12, 2022
Primary CompletionApr 27, 2023
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.4 years ago
Interventions
Multivalent Group B streptococcus vaccinebiological
Multivalent Group B streptococcus vaccine
Tetanus, diphtheria, and acellular pertussis vaccinebiological
Tetanus, diphtheria, and acellular pertussis vaccine
Placebobiological
Saline control