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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT00619502
Eligibility Criteria:
Inclusion Criteria:
* Toddler previously included in Study A3L10 who completed the three-dose primary series vaccination of either DTaP-IPV-HB-PRP\~T or PENTAXIM™ and ENGERIX B® at 2, 3 and 4 months of age.
* Toddler of 15 to 18 months of age (range: 456 to 578 days of age inclusive).
* Informed Consent Form signed by the parent(s) or other legal representative(s) and an institution official other than an Investigator.
* 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 booster vaccination.
* Planned participation in another clinical trial during the present trial period.
* Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy.
* 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 booster vaccination.
* Any vaccination planned until second Visit.
* History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically).
* Previous booster vaccination against pertussis, tetanus, diphtheria, polio or Haemophilus influenzae type b, and hepatitis B infection(s).
* Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination.
* Any vaccine-related serious adverse event that occurred following the three-dose primary series administration of the investigational vaccine or of the reference vaccine in Study A3L10 (NCT00315055).
* Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion.
* Known contraindication to further vaccination with a pertussis vaccine, i.e.: Encephalopathy; temperature \> 40.0°C within 48 hours following a vaccine injection, not due to another identifiable cause during the primary series; Inconsolable crying that occurred for \> 3 hours within 48 hours following vaccine injection during the primary series; Hypotonic hyporesponsive episode within 48 hours following vaccine injection during the primary series; Seizures with or without fever within 3 days following vaccine injection.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
15 Months
Maximum Age:
18 Months
Study:
NCT00619502
Study Brief:
Protocol Section:
NCT00619502