A Study of DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Act-HIB Monovalent Vaccine in Healthy Infants
NCT ID: NCT01062477
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
PHASE3
1056 participants
INTERVENTIONAL
2010-01-31
2011-12-31
Brief Summary
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Primary Objectives:
* To demonstrate that ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age is not inferior, in terms of seroprotection, to Wuhan's Diphtheria, Tetanus, acellular Pertussis (DTaP) and Haemophilus influenzae type b (Act-HIB) vaccine given concomitantly, for diphtheria, tetanus, and Polyribosyl Ribitol Phosphate (PRP) antigens, one month after the three-dose primary vaccination.
* To demonstrate the superiority, in terms of seroconversion, of ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age for Pertussis Toxoid (PT), Fimbriae types 2 and 3 (FIM2) and (FIM3) pertussis antigens, compared with Wuhan's DTaP and Act-HIB vaccines given concomitantly, one month after the three-dose primary vaccination.
Secondary Objectives:
* To describe the safety after administration of the study vaccines.
* To describe in each group the immunogenicity of the study vaccines one month after the primary vaccination and before and one month after the booster vaccination.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Study Group 1
Participants will receive ACTACEL vaccine at 2, 3, and 4 months of age.
DTaP//PRP-T Combined Vaccine
0.5 mL, Intramuscular
Study Group 2
Participants will receive ACTACEL vaccine at 3, 4, and 5 months of age.
DTaP//PRP-T Combined Vaccine
0.5 mL, Intramuscular
Study Group 3
Participants will receive Wuhan DTaP and Act-HIB vaccines concomitantly at 3, 4 and 5 months of age.
DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine
0.5 mL, Intramuscular (each vaccine)
Interventions
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DTaP//PRP-T Combined Vaccine
0.5 mL, Intramuscular
DTaP//PRP-T Combined Vaccine
0.5 mL, Intramuscular
DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine
0.5 mL, Intramuscular (each vaccine)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Born at full term pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg
* Informed consent form signed by the parent(s) or legal representative
* Participant and parent/legal representative able to attend all scheduled visits and to comply with all trial procedures
Exclusion Criteria
* Planned participation in another clinical trial during the present trial period
* Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth, or long-term systemic corticosteroids therapy
* Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
* Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
* Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response
* Receipt or planned receipt of any vaccine in the 4 weeks preceding or following any trial vaccination (except oral poliovirus (OPV), bacillus Calmette-Guérin (BCG), and Hepatitis B vaccines which cannot be given within 8 days before or after any study vaccination)
* History of seizures
* Known personal or maternal Human Immunodeficiency Virus (HIV), Hepatitis B (HB) surface antigen or Hepatitis C seropositivity
* History of diphtheria, tetanus, pertussis or Haemophilus influenzae type b infection (confirmed either clinically, serologically or microbiologically)
* Previous vaccination against diphtheria, tetanus, pertussis or Haemophilus influenzae type b disease with either the trial vaccine or another vaccine
* Participant at high risk for diphtheria, tetanus, pertussis or Haemophilus influenzae type b infection during the trial
* Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination
* History of contraindication to vaccination with pertussis-containing vaccine
* Febrile illness (axillary temperature ≥37.1°C) or moderate or severe acute illness/infection on the day of inclusion, according to Investigator judgment
Temporary contraindications that must be resolved before vaccination:
* Acute febrile illness within the 72 hours preceding the vaccination, or temperature ≥37.1°C present at this visit
* Any vaccination in the 4 weeks preceding the vaccination (except OPV, BCG, and hepatitis B vaccines which cannot be given within 8 days before or after any study vaccination)
* Systemic corticosteroids therapy (prednisone or equivalent) for more than 2 consecutive weeks within the past 3 months
60 Days
89 Days
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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LingChuan County, Guilin City, Guangxi, China
Lipu County, Guilin City, Guangxi, China
Countries
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Related Links
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Related Info
Other Identifiers
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UTN: U1111-1112-2509
Identifier Type: OTHER
Identifier Source: secondary_id
C5A06
Identifier Type: -
Identifier Source: org_study_id