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Trial record 1 of 1 for:    NCT00853749
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Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine (REPLAY)

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ClinicalTrials.gov Identifier: NCT00853749
Recruitment Status : Completed
First Posted : March 2, 2009
Results First Posted : January 5, 2011
Last Update Posted : January 5, 2011
Sponsor:
Collaborator:
Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE February 19, 2009
First Posted Date  ICMJE March 2, 2009
Results First Submitted Date  ICMJE December 16, 2010
Results First Posted Date  ICMJE January 5, 2011
Last Update Posted Date January 5, 2011
Study Start Date  ICMJE May 2009
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2010)
  • Percentage of Participants Achieving a Predefined Serotype-specific Immunoglobulin G (IgG) Antibody Concentration Greater Than or Equal to ( ≥) 0.35 Micrograms Per Milliliter (Mcg/mL) Measured 1 Month After Vaccination [ Time Frame: Day 28 ]
    Percentage of participants achieving predefined antibody threshold ≥ 0.35 mcg/mL along with the corresponding 95 percent (%) 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. Exact 2-sided CI based on the observed proportion of participants.
  • Percentage of Participants Achieving Opsonophagocytic Assay (OPA) Titers ≥ 1:8 Measured 1 Month After Vaccination [ Time Frame: Day 28 ]
    Percentage of participants achieving OPA 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. Exact 2-sided CI based on the observed proportion of participants.
Original Primary Outcome Measures  ICMJE
 (submitted: February 27, 2009)
The coprimary endpoints are the proportions of subjects achieving a serotype-specific immunoglobulin G antibody concentration greater than or equal to 0.35µg/mL by enzyme-linked immunosorbent assay and a titre ≥1:8 by opsonophagocytic assay. [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT00853749 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2010)
  • Antibody Response Measured 1 Month After Vaccination (Avidity Assay) [ Time Frame: Day 28 ]
    Avidity assay had measurable range of 0.117 to 7.5. Results expressed as avidity index (AI). Geometric mean avidity presented for 3 common pneumococcal serotypes (serotype 6B, 19F, and 23F) and 2 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1 and 5).
  • Antibody Response Measured 1 Month After Vaccination (OPA) [ Time Frame: Day 28 ]
    Antibody response as measured by OPA, 1 month after vaccination. Geometric mean titers (GMTs) calculated using all participants with available data for the specified blood draw. CIs were back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2009)
Antibody response as measured by Avidity Assay. Safety as measured by the occurrence of serious adverse evens (SAEs), adverse events (AEs), and solicited local and systemic reactions in the two groups. [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine
Official Title  ICMJE Revaccination With Pneumococcal Conjugate Vaccine - Characterization Of The Immune Response After Polysaccharide
Brief Summary The primary purpose of this study is to evaluate the immune response to 13-valent pneumococcal conjugate vaccine (13vPnCV) in children who as infants received either a complete series of PnCV versus a combination of PnCV and pneumococcal polysaccharide vaccine (PSV). This study is also intended to evaluate the safety of the 13vPnC.
Detailed Description Follow-up measure for the EMEA supporting a Type II variation for Prevenar (PCV7) label
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Invasive Pneumococcal Disease
Intervention  ICMJE
  • Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
    0.5 mL intramuscular injection
  • Procedure: Blood draw
    Collection of 10 mL of blood
Study Arms  ICMJE Single
All subjects will receive a single dose of 13vPnC
Interventions:
  • Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
  • Procedure: Blood draw
Publications * Sigurdardottir ST, Center KJ, Davidsdottir K, Arason VA, Hjalmarsson B, Elisdottir R, Ingolfsdottir G, Northington R, Scott DA, Jonsdottir I. Decreased immune response to pneumococcal conjugate vaccine after 23-valent pneumococcal polysaccharide vaccine in children. Vaccine. 2014 Jan 9;32(3):417-24. doi: 10.1016/j.vaccine.2013.11.029. Epub 2013 Dec 2.

*   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: December 13, 2010)
89
Original Estimated Enrollment  ICMJE
 (submitted: February 27, 2009)
224
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Fully vaccinated children who participated in a previous Wyeth study (Study D139-P506) and received a booster dose of either 23-valent pneumococcal polysaccharide vaccine (PPV23) or pneumococcal conjugate vaccine (PnCV) per the original protocol for that study.
  • Subjects must be in good health as determined by medical history, physical examination and clinical judgment.

Exclusion Criteria:

  • Known allergy to any component of the 7-valent pneumococcal conjugate vaccine (7vPnC) or 13-valent pneumococcal conjugate vaccine (13vPnC).
  • History of documented invasive pneumococcal disease (defined as a positive culture of S. pneumoniae from a normally sterile body site).
  • Any known or suspected disease or dysfunction of the immune system, including: HIV infection, Malignancy, Receipt of immunosuppressive therapy, Sickle cell hemoglobinopathy.
  • Receipt of immune-globulin within the past 3 months.
  • Receipt of either PSV or 7vPnCV since the completion of Study D139-P506.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iceland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00853749
Other Study ID Numbers  ICMJE 6096A1-3013
B1851012
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
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2010

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