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

NCT ID: NCT04300192

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 273 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-27
• Study Completion Date: 2023-01-11

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

Detailed Description

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.

Conditions

Pertussis Immunisation; Diphtheria Immunisation; Tetanus Immunisation; Poliomyelitis Vaccine

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1: Adacel Quadra vaccine

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Pharmaceutical form:Suspension for injection Route of administration: Intramuscular

Group 2: Adacel Quadra vaccine

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Pharmaceutical form:Suspension for injection Route of administration: Intramuscular

Group 3: Adacel Quadra vaccine

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Pharmaceutical form:Suspension for injection Route of administration: Intramuscular

Group 4: Adacel Quadra vaccine

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Pharmaceutical form:Suspension for injection Route of administration: Intramuscular

Group 5: Adacel Quadra vaccine

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Pharmaceutical form:Suspension for injection Route of administration: Intramuscular

Group 6: Adacel Quadra vaccine (HIV positive)

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Pharmaceutical form:Suspension for injection Route of administration: Intramuscular

Group 7: Adacel Quadra vaccine (HIV positive)

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

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

Pharmaceutical form:Suspension for injection Route of administration: Intramuscular

Interventions

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

Pharmaceutical form:Suspension for injection Route of administration: Intramuscular

Intervention Type: BIOLOGICAL

Other Intervention Names

Adacel®-Polio, Adacel Quadra®

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
• 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi Pasteur, a Sanofi Company

Locations

Investigational Site Number : 7100001

Cape Town, , South Africa

Investigational Site Number : 7100003

Johannesburg, , South Africa

Investigational Site Number : 7100002

Middelburg, , South Africa

Countries

South Africa

Related Links

https://www.trialsummaries.com/Study/StudyDetails?id=25353&tenant=MT_SNY_9011

TD500056 Plain Language Results Summary

Other Identifiers

U1111-1223-5186

Identifier Type: REGISTRY

Identifier Source: secondary_id

TD500056

Identifier Type: OTHER

Identifier Source: secondary_id

2022-002452-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TD500056

Identifier Type: -

Identifier Source: org_study_id