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

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NCT01531322

Last updated on November 10, 2019
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Study Location
Pfizer Investigational Site
Huaian, Jiangsu, 223300 China
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Contact
1-800-718-1021
[email protected]
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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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Descriptive Information
Brief Title  ICMJE A Study Assessing 13-valent Pneumococcal Conjugate Vaccine in Healthy Chinese Subjects
Official Title  ICMJE 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
Brief SummaryThis 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Pneumococcal Infection
Intervention  ICMJE Biological: 13-valent Pneumococcal Conjugate Vaccine
suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
Study Arms  ICMJE
  • 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
Publications *Zhu F, Hu Y, Liang Q, Young M Jr, Zhou X, Chen Z, Liang JZ, Gruber WC, Scott DA. Safety and tolerability of 13-valent pneumococcal conjugate vaccine in healthy Chinese adults, children and infants. Ther Adv Drug Saf. 2015 Dec;6(6):206-11. doi: 10.1177/2042098615613985.


*   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: February 8, 2012)		72
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion DateJanuary 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 42 Days to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01531322
Other Study ID Numbers  ICMJE B1851046
6096A1-1000
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 DateSeptember 2018

ICMJE     Data element required by the

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

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