Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi Pasteur, a Sanofi Company
Age
1–1
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Toddlers previously included in Study A3L11 (NCT00404651) who completed the three-dose primary series vaccination of either DTaP-IPV-HepB-PRP-T or Infanrix hexa™ at 2, 4 and 6 months of age
Toddlers of 15 to 18 months (456 to 578 days) of age, inclusive
Informed Consent Form signed by at least one parent or legal representative and two mandatory witnesses
Able to attend all scheduled visits and to comply with all trial procedures.
You may not be if
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 the next visit.
History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B (HB) infection(s) (confirmed either clinically, serologically or microbiologically).
Administration of a vaccine against pertussis, tetanus, diphtheria, polio, Hib, and/or hepatitis B infection(s) since the end of participation in Study A3L11.
Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination.
Known maternal history of human immunodeficiency virus (HIV), Hepatitis B surface antigen (HbsAg) or Hepatitis C seropositivity.
Subjects with any related serious adverse event that occurred following the three-dose primary series administration of the investigational vaccine or of the reference vaccine in Study A3L11.
History of seizures.
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.
