Brief Title
Antibody Persistence in Healthy Children After Primary and Booster DTaP-IPV-Hep B-PRP-T Vaccine or Control Vaccine
Official Title
Antibody Persistence in Healthy South African Children After Primary Series and Booster Vaccination With an Investigational (DTaP-IPV-Hep B-PRP-T) or Control Vaccines
Brief Summary
The purpose of this study is to evaluate the long term immunogenicity produced in children by
the investigational hexavalent vaccine (DTaP-IPV-Hep B-PRP-T) given in Study A3L15 (NCT
00362336).
Primary Objective: To describe the antibody long term persistence at 3.5 and 4.5 years of age
following a 3 dose primary series vaccination of either DTaP-IPV-Hep B-PRP-T or CombAct-Hib™
+ Oral poliovirus vaccine (OPV) + Engerix™ B vaccination at 6, 10 and 14 weeks of age and a
booster vaccination of DTaP-IPV-Hep B-PRP-T or CombAct-Hib™ + OPV at 15-18 months
Detailed Description
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.
Study Type
Observational
Primary Outcome
The antibody titers for each valence of DTaP-IPV-Hep B-PRP-T vaccine (except poliovirus) post-primary and booster vaccination.
Condition
Diphtheria
Study Arms / Comparison Groups
Group 1
Description: Participants previously received 3 doses and a booster dose of the investigational vaccine DTaP IPV Hep B PRP-T.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
455
Start Date
April 2010
Completion Date
December 2011
Primary Completion Date
November 2011
Eligibility Criteria
Inclusion Criteria :
- 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.
Exclusion Criteria :
- 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.
Gender
All
Ages
41 Months - 43 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Medical Director, ,
Location Countries
South Africa
Location Countries
South Africa
Administrative Informations
NCT ID
NCT01105559
Organization ID
A3L26
Secondary IDs
UTN: U1111-1111-5789
Responsible Party
Sponsor
Study Sponsor
Sanofi
Study Sponsor
Medical Director, Study Director, Sanofi Pasteur Inc.
Verification Date
December 2011