Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered To Infants In Korea

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NCT00689351

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Study Location
Pfizer Investigational Site
Incheon, Bupyeong-gu, 400-711, Korea, Republic of
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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 Vaccine
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
42-98 days
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy 2-month-old-infants (42 to 98 days)

- Available for the entire study period (14 months)

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


- Previous vaccine with pneumococcal, diptheria, tetanus, pertussis, polio or Hib
vaccine


- A previous severe reaction to any vaccine or vaccine-related component

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Pneumococcal VaccineStudy Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered To Infants In Korea
NCT00689351
  1. Incheon, Bupyeong-gu
  2. Seoul, Jongno-gu
  3. Incheon, Jung-gu
  4. Kyunggi, Koyang
  5. Seoul, Seodaemun-gu
  6. Seoul, Yeongdeungpo-gu
ALL GENDERS
42 Days+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered To Infants In Korea
Official Title  ICMJE Phase 2, Randomized, Active-Controlled, Double-Blind Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine In Healthy Infants Given With Routine Pediatric Vaccinations In Korea
Brief Summary The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Korea.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Vaccine
Intervention  ICMJE
  • Biological: 13-valent pneumococcal conjugate vaccine
    13vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.
  • Biological: 7-valent pneumococcal conjugate vaccine
    7vPnC is given via intramuscular injection at approximately 2, 4, 6 and 12 months of age.
Study Arms  ICMJE
  • Experimental: 1
    13vPnC
    Intervention: Biological: 13-valent pneumococcal conjugate vaccine
  • Active Comparator: 2
    7vPnC
    Intervention: Biological: 7-valent pneumococcal conjugate vaccine
Publications * Kim DS, Shin SH, Lee HJ, Hong YJ, Lee SY, Choi KM, Oh CE, Kim KH, Juergens C, Patterson S, Giardina PC, Gruber WC, Emini EA, Scott DA. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine given to korean children receiving routine pediatric vaccines. Pediatr Infect Dis J. 2013 Mar;32(3):266-73. doi: 10.1097/INF.0b013e3182748bb6.

*   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: June 2, 2008)		180
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy 2-month-old-infants (42 to 98 days)
  • Available for the entire study period (14 months)

Exclusion Criteria:

  • Previous vaccine with pneumococcal, diptheria, tetanus, pertussis, polio or Hib vaccine
  • A previous severe reaction to any vaccine or vaccine-related component
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 42 Days to 98 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00689351
Other Study ID Numbers  ICMJE 6096A1-010
B1851001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Wyeth, Inc
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP