Antibody Persistence in Healthy Children After Primary and Booster DTaP-IPV-Hep B-PRP-T Vaccine or Control Vaccine
NCT ID: NCT01105559
Last Updated: 2011-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
455 participants
OBSERVATIONAL
2010-04-30
2011-12-31
Brief Summary
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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
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Participants will receive no vaccination in this study but will undergo immunologic assessments at 3.5 and 4.5 years of age.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Group 2
Participants previously received 3 doses CombAct-Hib™ + Engerix™ B + OPV and a booster dose of CombAct-Hib™ + Oral poliovirus vaccine (OPV) vaccine.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
41 Months
43 Months
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Bertsham, , South Africa
Johannesburg, , South Africa
Countries
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Related Links
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Related Info
Other Identifiers
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UTN: U1111-1111-5789
Identifier Type: OTHER
Identifier Source: secondary_id
A3L26
Identifier Type: -
Identifier Source: org_study_id