Study to Evaluate the Immune Response After Booster Vaccination With Tdap-IPV Vaccine (Against Te… (NCT04300192) | Clinical Trial Compass
CompletedPhase 4
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
South Africa273 participantsStarted 2021-01-27
Plain-language 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
Who can participate
Age range
8 Years – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Geometric Mean Concentrations (GMCs) of anti-pertussis total immunoglobulin G (IgG)
Timeframe: Day 0 (pre-vaccination) and Day 30 (post-vaccination)
2
GMCs of anti-diphtheria IgG
Timeframe: Day 0 (pre-vaccination) and Day 30 (post-vaccination)
3
GMCs of anti-tetanus toxoid IgG
Timeframe: 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
Timeframe: 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.
Timeframe: Day 0 (pre-vaccination) and Day 30 (post-vaccination)
6
GM of pertussis antigen-specific T cells
Timeframe: Day 0 (pre-vaccination) and Day 30 (post-vaccination)