EUCTR2005-002578-31-CZActive, not recruitingPhase 1
A controlled, double-blind and randomized study, to compare the immunogenicity and safety of HEXAVAC manufactured by an upgraded process to HEXAVAC manufactured by the current process when given to healthy infants at 2, 4 & 6 months of age followed by a booster dose at 12 months of age
Sanofi Pasteur MSD S.N.C.0 sites800 target enrollmentStarted: August 3, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 800
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Healthy infants of either gender,
- •2. 2 month-old infants (aged 57 to 90 days inclusive),
- •3. Infant born after 36 weeks of pregnancy and with a birth weight = 2.5 kg,
- •4. Consent form signed by parents or by the legal representative properly informed about the study,
- •5. Parents / legal representative able to understand the protocol requirements and to fill in the Diary Card.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. Severe febrile illness and/or rectal temperature ³ 38.0°C at the time of vaccination,
- •2. Known history of diphtheria, tetanus, pertussis, H. influenzae type b, poliomyelitis, hepatitis B,
- •3. Infant known to be already immunised with one or more doses of vaccine against pertussis, tetanus, diphtheria, H. influenzae type b, poliomyelitis or hepatitis B,
- •4. Infant born from known HBs-Ag positive mother,
- •5. Known allergy to at least one of the vaccine components,
- •6. Known immune dysfunction (including subjects with HIV infection, sickle cell disease, asplenia, and other acquired immunodeficiency),
- •7. Infant who received within the previous 30 days or who will receive during the course of the study, a treatment likely to alter the immune response (any long-term (³ 14 days) administration of systemic corticosteroid therapy given daily or on alternate days at high doses [³ 2mg/kg/day prednisone equivalent or ³ 20mg/day if weight more than 10kg]),
- •8. Infant who received within the previous 90 days or who will receive during the course of the study immunoglobulin or blood products
- •9. Infant with severe chronic disease,
- •10. Known history of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection,
- •11. BCG vaccination in the previous 30 days,
- •12. Infant who, in the investigator’s opinion, is likely to be lost to follow-up or to be poorly compliant with the study requirements,
- •13. Participation in another clinical study within 30 days before study inclusion and/or during the whole study period.
Investigators
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