A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.
NCT01250756
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Adult Trials: 18+ Years
- 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.
- 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.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants. | |||
| Official Title ICMJE | A Phase 4, Randomized, Open-label Trial Evaluating the Safety, Tolerability, and Immunogenicity of DTaP Vaccine in Healthy Infants Given With a 7-valent Pneumococcal Conjugate Vaccine in Japan. | |||
| 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 (DTaP), Group 2: DTaP alone. Group 2 subjects will also receive catch-up doses of 7vPnC. The study vaccines will be open-label. The main purpose of the study is to demonstrate that the immune responses as measured by serum antibody responses to diphtheria toxin, tetanus toxin, pertussis toxin (PT) and filamentous haemagglutinin (FHA) induced by DTaP given concomitantly with 7vPnC are comparable to the immune responses induced by DTaP given alone. In addition, the study aims to evaluate the side effects (safety profile) after vaccination of 7vPnC when given with DTaP in healthy Japanese infants. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 4 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention | |||
| Condition ICMJE | Healthy Subjects | |||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 321 | |||
| Original Estimated Enrollment ICMJE | 310 | |||
| Actual Study Completion Date ICMJE | March 2012 | |||
| Actual Primary Completion Date | March 2012 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
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| Ages ICMJE | 3 Months to 6 Months (Child) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Japan | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01250756 | |||
| Other Study ID Numbers ICMJE | B1841007 B1841007, 6107A1-4000 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | Pfizer | |||
| Verification Date | January 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||