Safety and Dose Ranging Study of Acellular Pertussis and Acellular Pertussis -Tetanus-Diphtheria … (NCT01529645) | Clinical Trial Compass
CompletedPhase 1
Safety and Dose Ranging Study of Acellular Pertussis and Acellular Pertussis -Tetanus-Diphtheria Booster Vaccines in Healthy Adults Ages 18 to 40 Years
Belgium420 participantsStarted 2012-03
Plain-language summary
This study will evaluate the safety and efficacy of 9 different vaccines containing aP (acellular pertussis) and TdaP (acellular pertussis, tetanus and diphtheria) in healthy subjects 18 to 40 years of age.
Who can participate
Age range18 Years – 40 Years
SexALL
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Inclusion criteria
✓. Healthy male and female individuals between 18 and 40 years of age (inclusive) who had provided informed consent.
✓. Individuals who were able to be contacted for the duration of the study.
Exclusion criteria
✕. Individuals who had received vaccines containing T, D, or pertussis (aP or whole cell), been diagnosed with pertussis disease, or who have had a household exposure to pertussis within the past 8 years.
✕. If female, "of childbearing potential", sexually active, and had not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry:
✕. Of childbearing potential was defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy.
✕. Acceptable birth control methods were defined as one or more of the following:
✕. If female of childbearing potential and sexually active, refusal to use an "acceptable contraceptive method" through to 3 weeks after last study vaccination.
✕. Any positive or indeterminate pregnancy test.
✕. Female individuals who were pregnant or breastfeeding.
✕. Individuals with contraindications, warnings and/or precautions to vaccination with Boostrix or Td-pur as specified within the summary of product characteristics.
What they're measuring
1
The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
Timeframe: Day 1 through 7 after vaccination
2
The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine
Timeframe: From day 1 to day 365
3
Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination
Timeframe: Day 1 (baseline) and Day 30 post vaccination
4
GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination
Timeframe: Day 1 (baseline) and Day 30 post vaccination
5
GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination
Timeframe: Day 1 (baseline) and Day 30 post vaccination
6
Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens
Timeframe: Day 30 post vaccination/baseline (Day 1)
7
GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens