Primary objective: * To determine the safety and immunogenicity of tetanus and diphtheria toxoids adsorbed combined with component pertussis and inactivated poliomyelitis vaccine grown on vero cells (TdcP-IPV) compared to tetanus and diphtheria toxoids adsorbed combined with component pertussis and inactivated poliomyelitis vaccine grown on vero cells (TdcP-IPV) and Hepatitis B vaccine administered concurrently in adolescents 11-14 years of age. Secondary objective: * To determine whether concurrent administration of TdcP-IPV and Hepatitis B vaccines at 11-14 years of age results in detectable immunologic interactions between components of the two vaccines.
Participants will be randomized into one of 2 groups to receive either a dose of the TdcP-IPV on Day 0 (visit 1) and Hepatitis B vaccine on subsequent visits 2, 3 and 4 (Group 1); or no vaccination on Day 0, concomitant administration of TdcP-IPV and Hepatitis B vaccine on Day 28 (Visit 2) and Hepatitis B vaccine on subsequent visits 3 and 4 (Group 2). All participants will be followed up for immunogenicity and safety
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
277
0.5 mL, Intramuscular
0.5 ml, Intramuscular
Unnamed facility
Winnipeg, Manitoba, Canada
Seroprotection against diphtheria and tetanus antigens after vaccination with either Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and Inactivated Poliomyelitis (Tdcp-IPV) or concurrent Tdcp-IPV and Hepatitis B vaccine
Seroprotection defined as: Diphtheria levels ≥ 0.01 IU/mL and ≥ 0.1 IU/mL; Tetanus levels ≥ 0.01 EU/mL and ≥ 0.1 EU/mL.
Time frame: Day 0 (pre-vaccination) and 1 month, 3, 5 and 10 years post-vaccination
Geometric Mean Titers for Diphtheria and Tetanus after vaccination with either Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine & Inactivated Poliomyelitis Vaccine (Tdcp-IPV) or concurrent Tdcp IPV and Hepatitis B vaccine
Diphtheria antibodies assayed using enzyme-linked immunoassay; Tetanus antibodies were assessed using microneutralization assay
Time frame: Day 0 (pre-vaccination) and 1 month, 3, 5 and 10 years post-vaccination
Number of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited adverse events, and serious adverse events occurring during trial
Solicited local injection site reactions: Redness, Swelling, and Tenderness. Solicited systemic reactions: Altered Appetite, Headache, General Malaise, Nausea, Vomiting and Muscle aches.
Time frame: Day 0 up to day 30 following each vaccination
Geometric Mean Titers for Pertussis antibodies after vaccination with either Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP IPV) or concurrent Tdcp IPV and Hepatitis B vaccine
Anti pertussis toxoid, anti filamentous hemagglutinin, anti fimbriae 2 + 3 and anti Pertactin antibodies were assayed by enzyme linked immunoassay; Polio types 1, 2, and 3 were assayed using neutralizing antibodies to poliovirus types1, 2 and 3.
Time frame: Day 0 (pre-vaccination) and 1 month, 3, 5 and 10 years post-vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.