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Antibody Persistence in Healthy Children After Primary and Booster DTaP-IPV-Hep B-PRP-T Vaccine or Control Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01105559
First received: April 15, 2010
Last updated: December 12, 2011
Last verified: December 2011

April 15, 2010
December 12, 2011
April 2010
November 2011   (final data collection date for primary outcome measure)
The antibody titers for each valence of DTaP-IPV-Hep B-PRP-T vaccine (except poliovirus) post-primary and booster vaccination. [ Time Frame: Age 3.5 and 4.5 years after infant and booster vaccination ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01105559 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Antibody Persistence in Healthy Children After Primary and Booster DTaP-IPV-Hep B-PRP-T Vaccine or Control Vaccine
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

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Participants aged 3 years and a half on the day of inclusion and must have received the primary series of vaccinations and a booster vaccination in Study A3L15 (NCT 00362336). No vaccination will be provided or administered in this study.

  • Diphtheria
  • Tetanus
  • Whooping Cough
  • Hepatitis B
  • Poliomyelitis
Not Provided
  • Group 1
    Participants previously received 3 doses and a booster dose of the investigational vaccine DTaP IPV Hep B PRP-T.
  • Group 2
    Participants previously received 3 doses CombAct-Hib™ + Engerix™ B + OPV and a booster dose of CombAct-Hib™ + Oral poliovirus vaccine (OPV) vaccine.
  • Group 3
    Participants previously received 3 doses DTaP IPV Hep B PRP-T; a dose of Engerix™ B at birth, and a booster dose of DTaP IPV Hep B PRP-T vaccine.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
455
December 2011
November 2011   (final data collection date for primary outcome measure)

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.
Both
41 Months to 43 Months
Yes
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT01105559
A3L26, UTN: U1111-1111-5789
No
Sanofi
Sanofi
Not Provided
Study Director: Medical Director Sanofi Pasteur Inc.
Sanofi
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP