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Trial record 1 of 1 for:    NCT00574795
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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants

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ClinicalTrials.gov Identifier: NCT00574795
Recruitment Status : Completed
First Posted : December 17, 2007
Results First Posted : August 8, 2012
Last Update Posted : August 8, 2012
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE December 13, 2007
First Posted Date  ICMJE December 17, 2007
Results First Submitted Date  ICMJE March 26, 2010
Results First Posted Date  ICMJE August 8, 2012
Last Update Posted Date August 8, 2012
Study Start Date  ICMJE September 2007
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2012)
Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series [ Time Frame: one month after 3-dose infant series (at 7 months of age) ]
Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 13, 2007)
Immunogenicity (serum IgG antibody levels) to the 13 pneumococcal conjugates induced by 13vPnC when measured 1 month after the infant series. [ Time Frame: 28 to 42 days after primary series (the 3rd vaccination) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2012)
  • Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series [ Time Frame: one mone month after 3-dose infant series (at 7 months of age) ]
    GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 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.
  • Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose [ Time Frame: one month after the toddler dose (at 12 - 15 months of age) ]
    Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/mL along with the corresponding 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.
  • Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose [ Time Frame: one month after the toddler dose (at 12-15 months of age) ]
    GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2007)
Safety and immunogenicity after toddler dose. [ Time Frame: 28 to 42 days after toddlar dose (the 4th vaccination) ]
Current Other Pre-specified Outcome Measures
 (submitted: June 28, 2012)
  • Percentage of Participants Reporting Pre-Specified Local Reactions [ Time Frame: Within 7 days after each dose ]
    Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category.
  • Percentage of Participants Reporting Pre-Specified Systemic Events [ Time Frame: Within 7 days after each dose ]
    Systemic events (fever ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants
Official Title  ICMJE A Phase 3, Open-Label Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Japan
Brief Summary The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in infants of Japanese descent.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Vaccines, Pneumococcal Conjugate Vaccine
Intervention  ICMJE Biological: 13vPnC
"First dose during 2 to 6 months of age Second dose at least 28 days after the first dose Third dose at least 28 days after the second dose Forth dose during 12 to 15 months of age"
Study Arms  ICMJE Not Provided
Publications * Togashi T, Yamaji M, Thompson A, Giardina PC, Aizawa M, Patterson S, Gruber WC, Scott DA; 3003 Study Group. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in healthy infants in Japan. Pediatr Infect Dis J. 2013 Sep;32(9):984-9. doi: 10.1097/INF.0b013e318293007e.

*   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 28, 2012)
193
Original Estimated Enrollment  ICMJE
 (submitted: December 13, 2007)
165
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy 2 to 6 month-old infant
  • Available for entire study period

Exclusion Criteria:

  • Previous vaccination with licensed or investigational pneumococcal vaccine.
  • Previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Contraindication to vaccination with a pneumococcal conjugate vaccine.
  • Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
  • Known or suspected immune deficiency or suppression.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Months to 6 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00574795
Other Study ID Numbers  ICMJE 6096A1-3003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date June 2012

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