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Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered to Infants in Taiwan

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ClinicalTrials.gov Identifier: NCT00688870
Recruitment Status : Completed
First Posted : June 3, 2008
Results First Posted : May 12, 2011
Last Update Posted : November 2, 2011
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

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 Taiwan.

Condition or disease Intervention/treatment Phase
Vaccines Pneumococcal Conjugate Vaccine Biological: 13-valent pneumococcal conjugate vaccine (13vPnC) Biological: 7-valent pneumococcal conjugate vaccine (7vPnC) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 3, 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 Taiwan
Study Start Date : June 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
13vPnC
Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
13vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.
Active Comparator: 2
7vPnC
Biological: 7-valent pneumococcal conjugate vaccine (7vPnC)
7vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.



Primary Outcome Measures :
  1. Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Micrograms (Mcg)/mL, 1 Month After the Infant Series. [ Time Frame: 1 month after the infant series (7 months of age) ]
    Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 95% confidence interval (CI) for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.


Secondary Outcome Measures :
  1. Percentage of Participants Achieving a Predefined Antibody Level of Greater Than or Equal to 0.35 Mcg/mL, 1 Month After the Toddler Dose [ Time Frame: 1 month after toddler dose (16 months of age) ]
    Percentage of participants achieving a predefined antibody level of greater than or equal to 0.35 mcg/mL along with the corresponding exact 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.



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Ages Eligible for Study:   42 Days to 98 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib vaccines
  • A previous anaphylactic reaction to any vaccine or vaccine-related component.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00688870


Locations
Taiwan
Pfizer Investigational Site
Taipei, Taiwan, 100
Pfizer Investigational Site
Taoyuan Hsien, Taiwan, 333
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00688870     History of Changes
Other Study ID Numbers: 6096A1-3004
B1851005
First Posted: June 3, 2008    Key Record Dates
Results First Posted: May 12, 2011
Last Update Posted: November 2, 2011
Last Verified: October 2011

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Prevention against pneumococcal disease

Additional relevant MeSH terms:
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs