Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine (REPLAY)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00853749
First received: February 19, 2009
Last updated: December 16, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Invasive Pneumococcal Disease
Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
Procedure: Blood draw
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Revaccination With Pneumococcal Conjugate Vaccine - Characterization Of The Immune Response After Polysaccharide

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Antibody Response Measured 1 Month After Vaccination (Avidity Assay) [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 89
Study Start Date: May 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single
All subjects will receive a single dose of 13vPnC
Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
0.5 mL intramuscular injection
Procedure: Blood draw
Collection of 10 mL of blood

Detailed Description:

Follow-up measure for the EMEA supporting a Type II variation for Prevenar (PCV7) label

  Eligibility

Ages Eligible for Study:   5 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00853749

Locations
Iceland
Pfizer Investigational Site
Reykjavik, Iceland, 101
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Wyeth
ClinicalTrials.gov Identifier: NCT00853749     History of Changes
Other Study ID Numbers: 6096A1-3013, B1851012
Study First Received: February 19, 2009
Results First Received: December 16, 2010
Last Updated: December 16, 2010
Health Authority: Iceland: Ministry of Health and Social Security

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Immune response
pneumococcal conjugate vaccine
polysaccharide

ClinicalTrials.gov processed this record on April 16, 2014