Study to Evaluate the Immune Response After Booster Vaccination With Tdap-IPV Vaccine (Against Tetanus, Diphtheria, Pertussis and Poliomyelitis) in Children Who Received Different Pertussis Primary Vaccine Regimens in Republic of South Africa

NCT04300192 | Completed Phase 4

• 3 other identifiers: TD500056U1111-1223-51862022-002452-40
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Pertussis Immunisation; Diphtheria Immunisation; Tetanus Immunisation; Poliomyelitis Vaccine

Outcome Measures

Primary Outcomes (6)

• 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)

  Day 0 (pre-vaccination) and Day 30 (post-vaccination)

• GMCs of anti-diphtheria IgG

  Total IgG anti-diphtheria antibody concentrations

  Day 0 (pre-vaccination) and Day 30 (post-vaccination)

• GMCs of anti-tetanus toxoid IgG

  Total IgG anti-tetanus antibody concentrations

  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)

  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

  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

  Day 0 (pre-vaccination) and Day 30 (post-vaccination)

Secondary Outcomes (4)

• Number of participants reporting immediate adverse events (AEs)

  Within 30 minutes post-vaccination

• Number of participants reporting solicited injection site reactions and systemic reactions

  Within 7 days post-vaccination

• Number of participants reporting unsolicited AEs

  Within 30 days post-vaccination

• Number of participants reporting serious adverse events (SAEs)

  Up to 37 days post-vaccination

Study Arms (7)

Group 1: Adacel Quadra vaccine

EXPERIMENTAL

Adacel Quadra single injection at Day 0 in participants who received 4 doses of whole-cell pertussis (wP) vaccine during the first 2 years of life

Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine

Group 2: Adacel Quadra vaccine

EXPERIMENTAL

Adacel Quadra single injection at Day 0 in participants who received 3 doses of wP followed by 1 dose of acellular pertussis (aP) vaccine during the first 2 years of life

Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine

Group 3: Adacel Quadra vaccine

EXPERIMENTAL

Adacel Quadra single injection at Day 0 in participants who received 2 doses of wP vaccine followed by 2 doses of aP vaccine during the first 2 years of life

Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine

Group 4: Adacel Quadra vaccine

EXPERIMENTAL

Adacel Quadra single injection at Day 0 in participants who received 1 dose of wP vaccine followed by 3 doses of aP vaccine during the first 2 years of life

Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine

Group 5: Adacel Quadra vaccine

EXPERIMENTAL

Adacel Quadra single injection at Day 0 in participants who received 4 doses of aP vaccine during the first 2 years of life

Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine

Group 6: Adacel Quadra vaccine (HIV positive)

EXPERIMENTAL

Adacel Quadra single injection at Day 0 in HIV + participants who received 4 doses of wP vaccine during the first 2 years of life

Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine

Group 7: Adacel Quadra vaccine (HIV positive)

EXPERIMENTAL

Adacel Quadra single injection at Day 0 in HIV + participants who received 4 doses of aP vaccine during the first 2 years of life

Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine

Interventions

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine BIOLOGICAL

Pharmaceutical form:Suspension for injection Route of administration: Intramuscular

Also known as: Adacel®-Polio, Adacel Quadra®

Group 1: Adacel Quadra vaccine; Group 2: Adacel Quadra vaccine; Group 3: Adacel Quadra vaccine; Group 4: Adacel Quadra vaccine; Group 5: Adacel Quadra vaccine; Group 6: Adacel Quadra vaccine (HIV positive); Group 7: Adacel Quadra vaccine (HIV positive)

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Born in 2007 to 2011 in the RSA
• Received primary pertussis vaccination and the toddler booster in the RSA
• Assent form has been signed and dated by the participant, and informed consent form (ICF) has been signed and dated by the parent(s) or another legal guardian and by an independent witness, if required by local regulations
• Participants and parent/legal guardian are able to attend all scheduled visits and to comply with all trial procedures
• Valid clinical record of primary vaccination with DTaP/DTwP vaccines immunization history from 2007 through 2011, either by hand-held (Road-to-Health Card) or immunization clinical records
• For Groups 6 and 7: children infected with perinatally acquired HIV infection currently under care who received either an all wP or all aP priming regimen
• For Groups 6 and 7: be on highly active antiretroviral therapy (HAART) therapy and have known CD4 cell counts \> 200 cells/µL

You may not qualify if:

• Participation in the 4 weeks preceding the vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
• Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination except for influenza
• Receipt of additional pertussis vaccination doses inconsistent with pertussis vaccination schedule in the RSA
• Previous confirmed diagnosis of pertussis disease
• Receipt of immune globulins, blood or blood-derived products in the past 3 months
• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
• For Groups 1 to 5: known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
• Known thrombocytopenia, as reported by the parent/ legal guardian or suspected thrombocytopenia contraindicating intramuscular vaccination in the Investigator's opinion
• Participants with progressive neurological disorder, uncontrolled epilepsy, or progressive encephalopathy except if a treatment regimen has been established and the condition has stabilized
• Encephalopathy within 7 days of a previous dose of pertussis-containing vaccine
• Had contraindication to receipt of Adacel Quadra vaccine at the time of vaccination as defined in the Adacel Quadra vaccine Republic of South Africa (RSA) label
• Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]). A prospective participants should not be included in the study until the condition has resolved or the febrile event has subsided (temporary contraindication)
• Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw Note: Potential participants receiving standard HIV treatments such as antiretrovirals and/or antibiotic prophylaxis can be enrolled in the study. Their routine medications should be documented in the CRB.
• Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (3)

Investigational Site Number : 7100001

Cape Town, 7925, South Africa

Location

Investigational Site Number : 7100003

Johannesburg, 1619, South Africa

Location

Investigational Site Number : 7100002

Middelburg, 1055, South Africa

Location

Related Links

• TD500056 Plain Language Results Summary

MeSH Terms

Interventions

Tetanus Toxoid; Poliovirus Vaccine, Inactivated

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures; Vaccines, Inactivated; Poliovirus Vaccines; Viral Vaccines

Study Officials

• Clinical Sciences & Operations

  Sanofi Pasteur, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 9, 2020
• Study Start: January 27, 2021
• Primary Completion: January 11, 2023
• Study Completion: January 11, 2023
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

ZA (3)