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A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Subjects

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NCT01531322

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Huaian, Jiangsu, 223300 China
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.
Pneumococcal Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
42-55 days
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Age at the time of enrollment is:

- 18 through 55 years (before the fifty sixth birthday) for Group 1.

- 3 through 5 years (before the sixth birthday) for Group 2.

- 42 to 98 days for Group 3.

2. Healthy subject 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 vaccine.

- Previous anaphylactic reaction to any vaccine or vaccine-related component.

- Contraindication to vaccination with pneumococcal vaccine.

NCT01531322
Pfizer
Completed
A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Subjects

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A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Subjects
A Phase 1 Open-label Study to Assess the Safety and Tolerability of a Single Dose of 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Adults, Children and Infants
This study will assess the safety and tolerability of a single dose of 13-valent Pneumococcal Conjugate Vaccine for approximately 1 month after vaccination sequentially in healthy Chinese adults aged 18 through 55 years, followed by children aged 3 through 5 years, and then infants aged approximately 2 months.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Pneumococcal Infection
Biological: 13-valent Pneumococcal Conjugate Vaccine
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
  • Experimental: Group 1
    Adults aged 18 through 55 years (before the fifty sixth birthday)
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Experimental: Group 2
    Children aged 3 through 5 years (before the sixth birthday)
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Experimental: Group 3
    Infants aged approximately 2 months (42 to 98 days)
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
January 2012
January 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age at the time of enrollment is:

    • 18 through 55 years (before the fifty sixth birthday) for Group 1.
    • 3 through 5 years (before the sixth birthday) for Group 2.
    • 42 to 98 days for Group 3.
  2. Healthy subject as determined by medical history, physical examination, and judgment of the investigator.

Exclusion Criteria:

  • Previous vaccination with licensed or investigational pneumococcal vaccine.
  • Previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Contraindication to vaccination with pneumococcal vaccine.
Sexes Eligible for Study: All
42 Days to 55 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01531322
B1851046
6096A1-1000
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2012

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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