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

• ClinicalTrials.gov Identifier: NCT01105559
• Recruitment Status: Completed
• First Posted: April 16, 2010
• Last Update Posted: December 13, 2011
• Sponsor: Sanofi
• 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
• 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

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

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