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Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Sunrise Children's Clinic
Funabashi, 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

- 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 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).

- Infant who is a direct descendant (child, grandchild) of the study site personnel.

NCT01200368
Pfizer
Completed
Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants

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Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants
A Phase 3, Randomized, Active-controlled, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine Given With DTaP Compared to Open-label DTaP in Healthy Japanese Infants
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 vaccine (DTaP), Group 2: 7-valent pneumococcal conjugate vaccine (7vPnC) and DTaP, Group 3: DTaP alone. Group 3 subjects will also receive catch-up doses of Prevenar (commercial product of Prevenar in Japan) 13vPnC and 7vPnC will be blinded, and DTaP will be open-label. The main purpose of the study is to determine if the immune responses to 13vPnC are comparable to the immune responses to 7vPnC and if the immune responses to 13vPnC given with DTaP are comparable to those induced by DTaP given alone. In addition, the study aims to evaluate the side effects (safety profile) after vaccination of 13vPnC and 7vPnC when given with DTaP in healthy Japanese infants.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Healthy Subjects
  • Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
    0.5 mL per dose, 4 doses
  • Biological: diphtheria, tetanus, and acellular pertussis vaccine (DTaP)
    0.5 mL per dose, 4 doses
  • Biological: 7-valent pneumococcal conjugate vaccine (7vPnC)
    0.5 mL per dose, 4 doses
  • Biological: DTaP
    0.5 mL per dose, 4 doses
  • Experimental: 1
    Experimental
    Interventions:
    • Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
    • Biological: diphtheria, tetanus, and acellular pertussis vaccine (DTaP)
  • Active Comparator: 2
    Active comparator
    Interventions:
    • Biological: 7-valent pneumococcal conjugate vaccine (7vPnC)
    • Biological: DTaP
  • Active Comparator: 3
    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
551
November 2011
November 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 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).
  • Infant who is a direct descendant (child, grandchild) of the study site personnel.
Sexes Eligible for Study: All
3 Months to 6 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01200368
B1851056
B1851056
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2014

ICMJE     Data element required by the

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

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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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