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
  Purpose

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
Diphtheria
Tetanus
Whooping Cough
Hepatitis B
Poliomyelitis
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)
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.

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.

  Eligibility

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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01105559

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

Additional Information:
No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov 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:
Diphtheria
Tetanus
Whooping cough
Hepatitis B
Poliomyelitis
Diphtheria-Tetanus-acellular Pertussis Vaccines

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Diphtheria
Poliomyelitis
Whooping Cough
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Myelitis
Central Nervous System Viral Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014