Status:
COMPLETED
DTaP-IPV/Hib Vaccine Primary & Booster Vaccinations Versus Co-administration of DTaP-IPV and Hib Vaccine in Japanese Infants
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Tetanus
Diphtheria
Eligibility:
All Genders
2-68 years
Phase:
PHASE3
Brief Summary
Primary objective: * To demonstrate the non-inferiority in terms of seroprotection rates (Hib antigen (PRP), Diphtheria, Tetanus, and Pertussis antigens (PT and FHA), and polio types 1, 2 and 3 antig...
Detailed Description
Participants will be enrolled in two steps (Cohort 1 and Cohort 2). Step one will enroll Cohort 1 made of 40 participants randomized in two groups with a 1:1 ratio. After review of the local and syst...
Eligibility Criteria
Inclusion
- Aged 2 months to 68 months inclusive (recommended 3 to 8 months for Groups A and B; 2 months for Group C) on the day of inclusion
- Informed consent form signed by the parent(s) or other legal representative
- Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion
- Fever ≥ 37.5°C (axillary temperature) on the day of inclusion
- Any serious disease whether acute or chronic
- Past or current medical history of Guillain-Barre syndrome, acute thrombocytopenic purpura or encephalopathy
- History of diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b infections
- History of a life threatening reaction to a vaccine containing the same substances of the study vaccine
- History of anaphylaxis to any of the study vaccine components
- Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis or Haemophilus influenzae type b infections with a trial vaccine or another vaccine
- Congenital or current acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- Participation in another clinical trial preceding the trial inclusion
- Planned participation in another clinical trial during the present trial period
- Blood or blood-derived products received in the past or current or planned administration during the trial (including immunoglobulins)
- Any vaccination with live vaccines within the past 27 days preceding the first trial vaccination
- Any vaccination with inactivated vaccines within the past 6 days preceding the first trial vaccination
- Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or HIV infection
- Subject ineligible according to the Investigator's clinical judgment
- Identified as employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family member (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2016
Estimated Enrollment :
424 Patients enrolled
Trial Details
Trial ID
NCT02274285
Start Date
October 1 2014
End Date
May 28 2016
Last Update
April 25 2022
Active Locations (12)
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1
Aichi, Japan
2
Chiba, Japan
3
Fukui, Japan
4
Fukuoka, Japan