Status:
COMPLETED
Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants
Lead Sponsor:
Pfizer
Conditions:
Healthy Subjects
Eligibility:
All Genders
3-6 years
Phase:
PHASE3
Brief Summary
Subjects will be randomly assigned to 1 of 3 groups to receive the following vaccines: Group 1: 13-valent pneumococcal conjugate vaccine (13vPnC) and diphtheria, tetanus, and acellular pertussis vacci...
Eligibility Criteria
Inclusion
- Male or female subjects between 3 to 6 months of age at the enrollment.
- Available for the entire study period and whose parent/legal guardian can be reached by telephone.
- Healthy infant as determined by medical history, physical examination, and judgement of the investigator.
Exclusion
- Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, or pertussis vaccines.
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
- History of culture-proven invasive disease caused by S pneumoniae (eg, meningitis, bacteremia, osteomyelitis, arthritis).
- Infant who is a direct descendant (child, grandchild) of the study site personnel.
Key Trial Info
Start Date :
September 24 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2011
Estimated Enrollment :
551 Patients enrolled
Trial Details
Trial ID
NCT01200368
Start Date
September 24 2010
End Date
November 30 2011
Last Update
December 19 2018
Active Locations (32)
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1
Sunrise Children's Clinic
Funabashi, Chiba, Japan, 273-0035
2
Sotobo Children's Clinic
Isumi, Chiba, Japan, 299-4503
3
Matsuyama Red Cross Hospital
Matsuyama, Ehime, Japan, 790-8524
4
Fukazawa Pediatric Clinic
Higashi-ku, Fukuoka-city, Fukuoka, Japan, 813-0036