Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
All participants must have received the primary series of vaccinations and a booster vaccination in Study A3L15 (NCT 00362336).
Participants will receive no vaccination in this study but will undergo immunologic assessments at 3.5 and 4.5 years of age.
Age
3–3
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Aged 3 years and a half on the day of inclusion (42 months ± 60 days)
Informed consent form signed by a parent or other legally acceptable representative and by an independent witness if the parent or other legal guardian is illiterate.
Subject and parent/ legally acceptable representative able to attend the scheduled visits and to comply with all trial procedures.
Receipt of primary vaccination with 3 doses of either DTaP-IPV-Hep B-PRP-T or CombAct-Hib™ + Oral poliovirus vaccine (OPV) + Engerix™ B and a booster dose of either DTaP-IPV-Hep B-PRP-T or CombAct-Hib™+ OPV.
You may not be if
Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the inclusion in the trial.
Incomplete primary and booster immunization at trial A3L15.
Previous confirmed clinical, serological, or microbiological diagnosis of diphtheria, tetanus, whooping cough, poliomyelitis, Haemophilus influenza b or hepatitis B after completion of A3L15 Study.
Subjects known to have received diphtheria, tetanus, pertussis, Haemophilus influenza b and hepatitis B vaccination after completion of A3L15 Study.
Any vaccination within 30 days preceding inclusion, except for measles or poliovirus (monovalent) containing vaccines and pandemic influenza vaccines including pandemic H1N1-2009 strain, which may be received at least two weeks before the subject's blood sample collection
Blood or blood-derived products received at the latest 3 months before inclusion, receipts of immunosuppressant drugs within the previous 3 months.
Known or suspected congenital or acquired immunodeficiency since completion of A3L15 Study.
Serious chronic illness occurring after receipt of the primary and booster series (e.g. leukemia, lymphoma \[Tor B cells\], Crohn's disease).
Known or suspected subject seroconversion for human immunodeficiency virus (HIV) or hepatitis C seropositivity since completion of A3L15 Study.
Febrile (temperature ≥ 38.0°C) or acute, moderate or severe systemic illness on the day of inclusion.
Clareo Health | Antibody Persistence in Healthy Children After Primary and Booster DTaP-IPV-Hep B-PRP-T Vaccine or Control Vaccine
