Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine

NCT00853749

Last updated date
Study Location
Pfizer Investigational Site
Reykjavik, , 101, Iceland
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Invasive Pneumococcal Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
5-8 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
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 CenterPfizer
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