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AzTrials

Pertussis ImmunisationPhase 4NCT04300192

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

A Phase 4 study testing Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine in people with Pertussis Immunisation and Diphtheria Immunisation, run by Sanofi Pasteur, a Sanofi Company at 3 sites in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 8 to 14 yearsHealthy volunteers can take part
What is being tested?
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
273 participants
Where
3 sitesSouth Africa
Study dates
27 Jan 2021to 11 Jan 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

South Africa3 sites

  • Investigational Site Number : 7100001

    Cape Town, 7925

  • Investigational Site Number : 7100003

    Johannesburg, 1619

  • Investigational Site Number : 7100002

    Middelburg, 1055

Other trials in South Africa

About this study

Official title: Immune Response to Pertussis After Vaccination With a Tdap-IPV Booster Vaccine in Children in the Republic of South Africa: Effect of Homologous and Heterologous Pertussis Vaccination Priming Background

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

Read the 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.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Adacel®-Polio, Adacel Quadra®

    Pharmaceutical form:Suspension for injection Route of administration: Intramuscular

Study groups in NCT04300192
Study groupRoleWhat they receive
Group 1: Adacel Quadra vaccineExperimentalAdacel 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
Receives: Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine
Group 2: Adacel Quadra vaccineExperimentalAdacel 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
Receives: Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine
Group 3: Adacel Quadra vaccineExperimentalAdacel 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
Receives: Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine
Group 4: Adacel Quadra vaccineExperimentalAdacel 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
Receives: Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine
Group 5: Adacel Quadra vaccineExperimentalAdacel Quadra single injection at Day 0 in participants who received 4 doses of aP vaccine during the first 2 years of life
Receives: Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine
Group 6: Adacel Quadra vaccine (HIV positive)ExperimentalAdacel Quadra single injection at Day 0 in HIV + participants who received 4 doses of wP vaccine during the first 2 years of life
Receives: Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine
Group 7: Adacel Quadra vaccine (HIV positive)ExperimentalAdacel Quadra single injection at Day 0 in HIV + participants who received 4 doses of aP vaccine during the first 2 years of life
Receives: Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

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

  2. GMCs of anti-diphtheria IgG

    Total IgG anti-diphtheria antibody concentrations

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

  3. GMCs of anti-tetanus toxoid IgG

    Total IgG anti-tetanus antibody concentrations

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

  4. 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)

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

  5. 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

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

  6. 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

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

Secondary outcomes (4)

  1. Number of participants reporting immediate adverse events (AEs)

    Medically relevant unsolicited systemic AEs, including those related to the product administered

    Measured: Within 30 minutes post-vaccination

  2. 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

    Measured: Within 7 days post-vaccination

  3. Number of participants reporting unsolicited AEs

    AEs other than solicited reactions

    Measured: Within 30 days post-vaccination

  4. Number of participants reporting serious adverse events (SAEs)

    SAEs, including adverse event of special interest (AESIs)

    Measured: Up to 37 days post-vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2020
  2. Study start27 Jan 2021
  3. Primary completion11 Jan 2023
  4. Study completion11 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
273 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04300192
Sponsor's protocol ID
TD500056
Other IDs
U1111-1223-5186, TD500056, 2022-002452-40
Status last verified
Sep 2025
First submitted
5 Mar 2020
Last updated
12 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine in people with Pertussis Immunisation and Diphtheria Immunisation, run by Sanofi Pasteur, a Sanofi Company at 3 sites in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Concentrations (GMCs) of anti-pertussis total immunoglobulin G (IgG) (time frame: Day 0 (pre-vaccination) and Day 30 (post-vaccination)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04300192.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.

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