The main objectives of the study are to demonstrate the non-inferiority of the immune response induced by co administered GBS-NN/NN2 and tetanus, diphtheria, and acellular pertussis (Tdap) compared to the separate administration of GBS-NN/NN2 and Tdap, to evaluate the reactogenicity of GBS NN/NN2 when administered alone or in combination with Tdap, and to evaluate the safety of GBS-NN/NN2 when administered alone or in combination with Tdap in terms of serious adverse events (SAEs) and unsolicited adverse events (AEs).
Age range
18 Years – 49 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of Participants Expressing Anti-tetanus Toxoid Antibody Concentration ≥0.1 IU/mL
Timeframe: Day 85
Number of Participants Expressing Anti-diphtheria Toxoid Antibody Concentrations ≥0.1 IU/mL
Timeframe: Day 85
Number of Participants Expressing Anti-pertussis Toxin Antibodies
Timeframe: Day 85
Number of Participants Expressing Anti-filamentous Hemagglutinin (FHA) Antibodies
Timeframe: Day 85
Number of Participants Expressing Anti-pertactin (PRN) Antibodies
Timeframe: Day 85
Number of Participants Expressing RibN Antibody
Timeframe: Day 85
Number of Participants Expressing Alp1N Antibody
Timeframe: Day 85
Number of Participants Expressing Alp2N Antibody
Timeframe: Day 85
Number of Participants Expressing AlpCN Antibody
Timeframe: Day 85
Number of Participants Experiencing Solicited Local Adverse Events (AEs)
Timeframe: Day 63
Number of Participants Experiencing Solicited Systemic AEs
Timeframe: Day 63
Number of Participants Experiencing Unsolicited AEs
Timeframe: Day 85
Number of Participants Experiencing SAEs
Timeframe: Day 85