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
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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 or disease |
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Diphtheria Tetanus Whooping Cough Hepatitis B Poliomyelitis |
Study Type : | Observational |
Actual Enrollment : | 455 participants |
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 |
Study Start Date : | April 2010 |
Actual Primary Completion Date : | November 2011 |
Actual Study Completion Date : | December 2011 |

Group/Cohort |
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Group 1
Participants previously received 3 doses and a booster dose of the investigational vaccine DTaP IPV Hep B PRP-T.
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Group 2
Participants previously received 3 doses CombAct-Hib™ + Engerix™ B + OPV and a booster dose of CombAct-Hib™ + Oral poliovirus vaccine (OPV) vaccine.
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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.
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- 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 ]

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Ages Eligible for Study: | 41 Months to 43 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01105559
South Africa | |
Bertsham, South Africa, 2013 | |
Johannesburg, South Africa |
Study Director: | Medical Director | Sanofi Pasteur Inc. |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT01105559 |
Other Study ID Numbers: |
A3L26 UTN: U1111-1111-5789 ( Other Identifier: WHO ) |
First Posted: | April 16, 2010 Key Record Dates |
Last Update Posted: | December 13, 2011 |
Last Verified: | December 2011 |
Diphtheria Tetanus Whooping cough |
Hepatitis B Poliomyelitis Diphtheria-Tetanus-acellular Pertussis Vaccines |
Hepatitis B Tetanus Diphtheria Poliomyelitis Whooping Cough Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections |
Communicable Diseases Hepadnaviridae Infections DNA Virus Infections Respiratory Tract Diseases Clostridium Infections Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Nervous System Diseases Corynebacterium Infections Actinomycetales Infections Myelitis Central Nervous System Infections Central Nervous System Diseases Spinal Cord Diseases |