Primary Objectives : * To describe the long-term humoral immune responses to pertussis, diphtheria, and tetanus after homologous and heterologous pertussis vaccine priming regimens * To determine the effects of the priming regimen on humoral responses to booster vaccination with Tdap-IPV vaccine * To describe the long-term cell-mediated immune responses to pertussis after homologous and heterologous pertussis vaccine priming regimens * To determine the effects of the priming regimen on cell-mediated immune response to booster vaccination with Tdap-IPV vaccine Secondary Objective: To describe the safety profile of Tdap-IPV vaccine in each group
Study duration per participant will be approximately 30 days including: 1 day of screening and vaccination, a phone call and a safety follow-up/end of study visit, at Day 8 and Day 30 after vaccine administration, respectively.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
273
Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Investigational Site Number : 7100001
Cape Town, South Africa
Investigational Site Number : 7100003
Johannesburg, South Africa
Investigational Site Number : 7100002
Middelburg, South Africa
Geometric Mean Concentrations (GMCs) of anti-pertussis total immunoglobulin G (IgG)
Total IgG anti-pertussis antibody concentrations against the following pertussis antigens: pertussis toxin (PT), filamentous hemagglutinin (FHA), pertactin (PRN), and fimbriae types 2 and 3 (FIM)
Time frame: Day 0 (pre-vaccination) and Day 30 (post-vaccination)
GMCs of anti-diphtheria IgG
Total IgG anti-diphtheria antibody concentrations
Time frame: Day 0 (pre-vaccination) and Day 30 (post-vaccination)
GMCs of anti-tetanus toxoid IgG
Total IgG anti-tetanus antibody concentrations
Time frame: Day 0 (pre-vaccination) and Day 30 (post-vaccination
GMCs of anti-pertussis total immunoglubulin A (IgA) and of anti-heat-killed B pertussis (HK Bp) IgA in cell-mediated immunity (CMI) subset only
Total IgA anti-pertussis antibody concentrations against the following pertussis antigens: PT, FHA, PRN, FIM types 2 and 3, and heat-killed B. pertussis (HK Bp)
Time frame: Day 0 (pre-vaccination) and Day 30 (post-vaccination)
Geometric Mean (GM) of anti-pertussis IgG subclasses and of anti-HK Bp IgG subclasses.
Anti-pertussis IgG subclasses (ie, IgG1, IgG2, IgG3, and IgG4) distribution against PT, FHA, PRN, FIM types 2 and 3, and HK Bp
Time frame: Day 0 (pre-vaccination) and Day 30 (post-vaccination)
GM of pertussis antigen-specific T cells
Absolute numbers (spot forming cells \[SFC\]/10e6 PBMCs) of pertussis antigen-specific (antigen pool and HK Bp) interferon (IFN)-ɣ, interleukin (IL)-17, IL-4 secreting cells
Time frame: Day 0 (pre-vaccination) and Day 30 (post-vaccination)
Number of participants reporting immediate adverse events (AEs)
Medically relevant unsolicited systemic AEs, including those related to the product administered
Time frame: Within 30 minutes post-vaccination
Number of participants reporting solicited injection site reactions and systemic reactions
Adverse reactions prelisted in the (electronic) case report book (CRB) Injection site reactions: pain, erythema, swelling Systemic reactions: fever, headache, malaise, myalgia
Time frame: Within 7 days post-vaccination
Number of participants reporting unsolicited AEs
AEs other than solicited reactions
Time frame: Within 30 days post-vaccination
Number of participants reporting serious adverse events (SAEs)
SAEs, including adverse event of special interest (AESIs)
Time frame: Up to 37 days post-vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.