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A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.

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NCT01250756

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Sotobo Children's Clinic
Isumi-city, Chiba, Japan
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Subjects
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
3-6 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01250756
Pfizer
Completed
A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.

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A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.
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.
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Healthy Subjects
  • Biological: 7-pneumococcal conjugate vaccine (7vPnC)
    0.5 mL per dose, 4 doses
  • Biological: diphtheria, tetanus, and acellular pertussis vaccine (DTaP)
    0.5 mL per dose, 4 doses
  • Biological: DTaP
    0.5 mL per dose, 4 doses
  • Experimental: 1
    Experimental
    Interventions:
    • Biological: 7-pneumococcal conjugate vaccine (7vPnC)
    • Biological: diphtheria, tetanus, and acellular pertussis vaccine (DTaP)
  • Experimental: 2
    Active comparator
    Intervention: Biological: DTaP
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
321
March 2012
March 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Sexes Eligible for Study: All
3 Months to 6 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01250756
B1841007
B1841007, 6107A1-4000
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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