Comparison of DTaP-IPV-Hep B-PRP~T Combined Vaccine to CombAct-HIB® Concomitantly Given With Engerix B® Paediatric and OPV
NCT ID: NCT00362336
Last Updated: 2014-05-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
622 participants
INTERVENTIONAL
2006-08-31
2009-08-31
Brief Summary
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The primary objective is to demonstrate that the hexavalent DTaP-IPV-HB-PRP\~T combined vaccine does not induce lower immune responses than CombAct-HIB® with Engerix B® Paediatric and OPV in terms of seroprotection rates to Diphtheria (D), Tetanus (T), polio, Hepatitis B (HB), and Polyribosyl ribitol phosphate (PRP), one month after a 3-dose primary series (6, 10, and 14 weeks) with no HB vaccination at birth.
The secondary Objectives are:
To describe the safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial.
To describe Immunogenicity after the primary series and prior to and after a booster vaccination.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group 1: DTaP-IPV-Hep B-PRP-T
DTaP-IPV-HB-PRP~T
0.5 mL, Intramuscular (IM)
Group 2: CombAct-HIB™ + OPV
CombAct-HIB®
0.5 mL, IM
Group 3: DTaP-IPV-Hep B-PRP-T (ENGERIX B™ at birth)
Engerix B® Pediatric
0.5 mL, IM
Interventions
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DTaP-IPV-HB-PRP~T
0.5 mL, Intramuscular (IM)
CombAct-HIB®
0.5 mL, IM
Engerix B® Pediatric
0.5 mL, IM
Eligibility Criteria
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Inclusion Criteria
* Mother seronegative for Human Immunodeficiency Virus (HIV)
* Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
* Apgar score \>7 at 5 or 10 minutes of life
* Informed consent form signed by a parent or other legal guardian and by an independent witness if the parent or other legal guardian is illiterate
* Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion Criteria
* Suspected congenital or acquired immunodeficiency
* Suspected maternal acute seroconversion syndrome to HIV after 24 weeks gestation based on clinical history
* Chronic illness at a stage that could interfere with trial conduct or completion
* Blood or blood-derived products received since birth
* Any planned vaccination (except Bacille Calmette Guérin and trial vaccinations) from birth to 18 weeks of age
* Oral Poliovirus Vaccine (OPV) administration at birth
* Known maternal history of HIV, Hepatitis B (HB) (HbsAg carrier) or Hepatitis C seropositivity
* Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination
* History of seizures
* Febrile or acute illness on the day of inclusion.
3 Days
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Soweto, Johannesburg, South Africa
Bertsham, , South Africa
Countries
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References
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Madhi SA, Mitha I, Cutland C, Groome M, Santos-Lima E. Immunogenicity and safety of an investigational fully liquid hexavalent combination vaccine versus licensed combination vaccines at 6, 10, and 14 weeks of age in healthy South African infants. Pediatr Infect Dis J. 2011 Apr;30(4):e68-74. doi: 10.1097/INF.0b013e31820b93d2.
Related Links
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Related Info
Other Identifiers
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A3L15
Identifier Type: -
Identifier Source: org_study_id
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