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Trial record 1 of 1 for:    A3L26
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Antibody Persistence in Healthy Children After Primary and Booster DTaP-IPV-Hep B-PRP-T Vaccine or Control Vaccine

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ClinicalTrials.gov Identifier: NCT01105559
Recruitment Status : Completed
First Posted : April 16, 2010
Last Update Posted : December 13, 2011
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date April 15, 2010
First Posted Date April 16, 2010
Last Update Posted Date December 13, 2011
Study Start Date April 2010
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 15, 2010)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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.
Condition
  • Diphtheria
  • Tetanus
  • Whooping Cough
  • Hepatitis B
  • Poliomyelitis
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 4, 2011)
455
Original Estimated Enrollment
 (submitted: April 15, 2010)
567
Actual Study Completion Date December 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 41 Months to 43 Months   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries South Africa
Removed Location Countries  
 
Administrative Information
NCT Number NCT01105559
Other Study ID Numbers A3L26
UTN: U1111-1111-5789 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Sanofi
Original Responsible Party Medical Director, Sanofi Pasteur Inc.
Current Study Sponsor Sanofi
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date December 2011