Study Evaluating 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Children With Sickle Cell Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00918580
First received: June 9, 2009
Last updated: April 8, 2013
Last verified: April 2013
  Purpose

This study is to evaluate the safety, tolerability and immunogenicity of 13-valent pneumococcal Conjugate Vaccine in children with Sickle Cell Disease who have already been vaccinated with 23-valent polysaccharide vaccine. The study will measure the amount of antibodies (the proteins that fight off germs) produced by children with Sickle Cell Disease after they have been given the 13-valent pneumococcal vaccine between 6 and less than 18 years of age. They will be given the vaccination twice, each vaccination separated by approximately 6 months.


Condition Intervention Phase
Pneumococcal Conjugate Vaccine
Biological: 13-valent Pneumoccocal Conjugate Vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase 3, Open-Label, Single-Arm Trial Evaluating the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine in Children With Sickle Cell Disease Previously Immunized With 23vPS Vaccine

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The immune response as measured by fold rise in serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMC). [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The acceptability of the safety profile as measured by the incidence rates of injection site reactions, systemic events, and adverse events (AEs). [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 158
Study Start Date: November 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: 13-valent Pneumoccocal Conjugate Vaccine
2 doses of 13vPnC will be administered by intramuscular injection separated by approximately 6 months.
Other Name: 13vPnC

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subject between the ages of >=6 to <18 years.
  • Diagnosis of SCD
  • 23vPS vaccination at least 6 months prior to enrollment.

Exclusion Criteria:

  • Previous vaccination with pneumococcal conjugate vaccine.
  • Previous reaction to any vaccine or vaccine-related component or contraindication to vaccination with pneumococcal conjugate vaccine.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918580

Locations
United States, Alabama
Pfizer Investigational Site
Birmingham, Alabama, United States, 35233
United States, Kentucky
Pfizer Investigational Site
Louisville, Kentucky, United States, 40202
Pfizer Investigational Site
Louisville, Kentucky, United States, 40202-3830
United States, New York
Pfizer Investigational Site
Bronx, New York, United States, 10467
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37232
Egypt
Pfizer Investigational Site
Cairo, Egypt, 11361
Pfizer Investigational Site
Cairo, Egypt, 11511
France
Pfizer Investigational Site
Paris, France, 75015
Italy
Pfizer Investigational Site
Orbassano (TO), Italy, 10043
Pfizer Investigational Site
Roma, Italy, 00165
Lebanon
Pfizer Investigational Site
Beirut, Lebanon
Pfizer Investigational Site
Beirut, Lebanon, 2833-7401
Saudi Arabia
Pfizer Investigational Site
Riyadh, Saudi, Saudi Arabia
United Kingdom
Pfizer Investigational Site
Manchester, Cheshire, United Kingdom, M27 4HA
Pfizer Investigational Site
London, United Kingdom, SE5 9RS
Pfizer Investigational Site
London, United Kingdom, SE1 9RT
Pfizer Investigational Site
London, United Kingdom, SE1 7RH
Pfizer Investigational Site
London, United Kingdom, SW17 0RE
Pfizer Investigational Site
London, United Kingdom, E1 1BB
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00918580     History of Changes
Other Study ID Numbers: 6096A1-3014, B1851013
Study First Received: June 9, 2009
Last Updated: April 8, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on April 17, 2014