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).
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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