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Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine

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NCT00853749

Last updated on November 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Reykjavik, , 101 Iceland
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.

NCT00853749
Pfizer
Completed
Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine

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Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine
Revaccination With Pneumococcal Conjugate Vaccine - Characterization Of The Immune Response After Polysaccharide
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.
Follow-up measure for the EMEA supporting a Type II variation for Prevenar (PCV7) label
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Invasive Pneumococcal Disease
  • Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
    0.5 mL intramuscular injection
  • Procedure: Blood draw
    Collection of 10 mL of blood
Single
All subjects will receive a single dose of 13vPnC
Interventions:
  • Biological: 13-valent pneumococcal conjugate vaccine (13vPnC)
  • Procedure: Blood draw
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
August 2010
August 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
5 Years to 8 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Iceland
 
 
NCT00853749
6096A1-3013
B1851012
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
December 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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