Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-24 @ 5:01 PM
NCT ID:
NCT00870350
Eligibility Criteria:
Inclusion Criteria:
* healthy subject
* 14-15 years old
* eligible for their school-leaving booster for DTP
* received a complete primary vaccination with a 5-component acellular pertussis vaccine (DT5aP-IPV-Hib) at 3, 5 and 12 months of age and vaccinated with a 5-component acellular pertussis vaccine (Td5aP-IPV or Td5aP + IPV) as a booster at 5½ years of age
* informed consent form signed by the subject and parent(s)/legal representative
* subject understand and comply with the study procedures (i.e. able to read and write Swedish)
* female must provide an agreement that they are either sexually continent or practice adequate contraceptive methods (intra-uterine contraceptive device (IUCD), hormonal contraceptives, condoms or other adequate barrier contraception).
Exclusion Criteria:
* acute febrile illness or axillary temperature ≥38.0°C at the time of vaccination
* receipt of immunoglobulin within the previous 3 months, immunosuppression (e g evidence of impaired cell mediated immunity, receipt of immunosuppressant drugs within the previous 3 months or receipt of systemic corticosteroids given daily or on alternate days at ≥20 mg/day prednisone equivalent during \>14 days within the past 30 days)
* receipt of a non-study vaccine in the past 30 days
* evolving encephalopathy not attributable to another identifiable cause within 7 days of administration of a previous dose of any vaccine
* booster vaccination with tetanus, low dose diphtheria and acellular pertussis vaccine since the booster vaccination at 5½ years of age
* previous clinical or bacteriological diagnosis of diphtheria, tetanus or pertussis
* hypersensitivity to any component of any of the study vaccines
* current participation in any other clinical trial or participation in any clinical trial in the previous month
* inability to adhere to the protocol, including plans to move from the area
* severe chronic disease
* family history of congenital or hereditary immunodeficiency
* any sever thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection
* any medical condition, which in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
15 Years
Study:
NCT00870350
Study Brief:
Protocol Section:
NCT00870350