Status:
COMPLETED
A Trial Evaluating a 7-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:
PHASE4
Brief Summary
Subjects will be randomly assigned to 1 of 2 groups to receive the following vaccines: Group 1: 7-valent pneumococcal conjugate vaccine (7vPnC) and diphtheria, tetanus, and accelular pertussis vaccine...
Eligibility Criteria
Inclusion
- Aged 3 to 6 months (defined as the first day the subject is 3 months of age to the last day the subject is 6 months of age) at time of enrollment.
- Available for entire study period and whose parent/legal guardian can be reached by telephone.
- Healthy infant as determined by medical history, physical examination, and judgment 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).
- Subjects who are direct descendants (child, grandchild) of investigational site staff members or subjects who are direct descendants (child, grandchild) of Pfizer employees directly involved in the conduct of the trial.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT01250756
Start Date
November 1 2010
End Date
March 1 2012
Last Update
February 26 2013
Active Locations (18)
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1
Tsubaki Children's Clinic
Chiba, Chiba, Japan
2
Sotobo Children's Clinic
Isumi, Chiba, Japan
3
Matsuyama Red Cross Hospital
Matsuyama, Ehime, Japan
4
Kiyomatsu Childrens Clinic
Fukuoka, Fukuoka, Japan