Phase III, multi-center study in children fully vaccinated with a three-dose primary and the booster dose of the DTaP-IPV-Hep B-PRP-T combined vaccine or CombAct-Hib™ and OPV and Engerix™ B in Study A3L15.

Sanofi Pasteur SA0 sites567 target enrollmentApril 10, 2012

ConditionsPrevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus type 1, 2 and 3, prevention against invasive infections caused by Haemophilus influenzae type b and infections caused by hepatitis B virus MedDRA version: 14.1Level: PTClassification code 10021430Term: ImmunisationSystem Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1Level: LLTClassification code 10036897Term: Prophylactic vaccinationSystem Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1Level: HLTClassification code 10021431Term: ImmunisationsSystem Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.1Level: HLGTClassification code 10043413Term: Therapeutic procedures and supportive care NECSystem Organ Class: 10042613 - Surgical and medical procedures Therapeutic area: Diseases [C] - Virus Diseases [C02]

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus type 1, 2 and 3, prevention against invasive infections caused by Haemophilus influenzae type b and infections caused by hepatitis B virus
Sponsor: Sanofi Pasteur SA
Enrollment: 567
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 10, 2012

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Sanofi Pasteur SA

Eligibility Criteria

Inclusion Criteria

•1\) Aged 3 years and a half on the day of inclusion (42 months ± 60 days)
•2\) 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.
•3\) Subject and parent/ legally acceptable representative able to attend the scheduled visits and to comply with all trial procedures.
•4\) Receipt of primary vaccination with 3 doses of either DTaP\-IPV\-Hep B\-PRP\-T or CombAct\-Hib™ \+ OPV \+ Engerix™ B and a booster dose of either DTaP\-IPV\-Hep B\-PRP\-T or CombAct\-Hib™\+ OPV.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 567
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no

Exclusion Criteria

•1\) 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.
•2\) Incomplete primary and booster immunization at trial A3L15\.
•3\) Previous confirmed clinical, serological, or microbiological diagnosis of diphtheria, tetanus, whooping cough, poliomyelitis, Haemophilus influenza b or hepatitis B after completion of A3L15 Study.
•4\) Subjects known to have received diphtheria, tetanus, pertussis, Haemophilus influenza b and hepatitis B vaccination after completion of A3L15 Study.
•5\) 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
•6\) Blood or blood\-derived products received at the latest 3 months before inclusion, receipts of immunosuppressant drugs within the previous 3 months.
•7\) Known or suspected congenital or acquired immunodeficiency since completion of A3L15 Study.
•8\) Serious chronic illness occurring after receipt of the primary and booster series (e.g. leukemia, lymphoma \[Tor B cells], Crohn's disease).
•9\) Known or suspected subject seroconversion for HIV or hepatitis C seropositivity since completion of A3L15 Study.
•10\) Febrile (temperature \=38\.0°C) or acute, moderate or severe systemic illness on the day of inclusion.