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

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

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

Condition Phase
Whooping Cough
Hepatitis B
Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Enrollment: 455
Study Start Date: April 2010
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
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.

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.


Ages Eligible for Study:   41 Months to 43 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01105559

South Africa
Bertsham, South Africa, 2013
Johannesburg, South Africa
Sponsors and Collaborators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
Responsible Party: Sanofi Identifier: NCT01105559     History of Changes
Other Study ID Numbers: A3L26  UTN: U1111-1111-5789 
Study First Received: April 15, 2010
Last Updated: December 12, 2011
Health Authority: South Africa: Department of Health

Keywords provided by Sanofi:
Whooping cough
Hepatitis B
Diphtheria-Tetanus-acellular Pertussis Vaccines

Additional relevant MeSH terms:
Hepatitis B
Whooping Cough
Actinomycetales Infections
Bacterial Infections
Bordetella Infections
Central Nervous System Diseases
Central Nervous System Infections
Corynebacterium Infections
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Nervous System Diseases
Neuromuscular Diseases
Picornaviridae Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Spinal Cord Diseases
Virus Diseases
Vaccines processed this record on May 25, 2016