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:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT00534833
Eligibility Criteria:
Inclusion Criteria:
* Toddler aged 15 to 18 months of age on the day of inclusion (range: 456 days to 578 days of age inclusive)
* Participated in the AL203 study and completed the three-dose primary series with either DTaP-HB-PRP\~T or Tritanrix-HepB/Hib™, and OPV, at 6, 10 and 14 weeks of age
* Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate)
* Able to attend all scheduled visits and to comply with all trial procedures
Exclusion Criteria:
* Participation in another clinical trial in the 4 weeks preceding the trial vaccination
* Planned participation in another clinical trial during the present trial period
* Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term (for more than 2 weeks) systemic corticosteroid therapy within the preceding 3 months
* Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances
* Chronic illness at a stage that could interfere with trial conduct or completion
* Blood or blood-derived products received in the last 3 months
* Any vaccination in the 4 weeks preceding the trial vaccination
* Vaccination planned in the 4 weeks following the trial vaccination
* Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion
* History of documented diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B or poliomyelitis infection(s) (confirmed either clinically, serologically, or microbiologically)
* Vaccination with a vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B, or poliovirus 3 types antigen since the end of the primary series
* Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination
* Serious adverse event related to any vaccination in the AL203 study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
15 Months
Maximum Age:
18 Months
Study:
NCT00534833
Study Brief:
Protocol Section:
NCT00534833