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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.

Last updated on November 17, 2019

FOR MORE INFORMATION
Study Location
Sotobo Children's Clinic
Isumi-city, Chiba, Japan
Contact
1-800-718-1021
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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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 SummarySubjects 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 DescriptionNot 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
  • 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
Study Arms  ICMJE
  • 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
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
 (submitted: March 26, 2012)
321
Original Estimated Enrollment  ICMJE
 (submitted: November 29, 2010)
310
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion DateMarch 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateJanuary 2013

ICMJE     Data element required by the

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

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