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Study Evaluating Antibody Response Of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) 24 Months After Toddler Dose.

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NCT01026038

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Ancenis, , 44150 France
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.
13-valent Pneumococcal Vaccine, Immunization, Safety, Antibody Response
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
3+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy subjects at least 3 years of age, who received all 4 assigned doses of
pneumococcal conjugate vaccine and completed Study 6096A1-008-EU (NCT00366678) for at
least 24 months

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

- Vaccination with any licensed or investigational pneumococcal vaccine since completion
of Study 6096A1-008-EU(NCT00366678).

- History of culture-proven invasive disease caused by S pneumoniae since the completion
of Study 6096A1-008-EU (NCT00366678).

- Previous anaphylactic reaction to any vaccine or vaccine-related component.

- Contraindication to vaccination

NCT01026038
Pfizer
Completed
Study Evaluating Antibody Response Of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) 24 Months After Toddler Dose.

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Study Evaluating Antibody Response Of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) 24 Months After Toddler Dose.
A Phase 3, Open-label Study to Evaluate Persistence of the Antibody Response Elicited by Pneumococcal Conjugate Vaccine in Healthy Children Who Have Been Previously Immunized With a 4-Dose Series of a Pneumococcal Conjugate Vaccine During Infancy in Study 6096A1-008-EU and the Safety and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Administered at Least 24 Months After the Last Toddler Dose of Pneumococcal Conjugate Vaccine
This is an open-label study (a study in which the doctors and participants know which drug or vaccine is being administered) in children who previously received a 4-dose series of a pneumococcal conjugate vaccine (PnC) during infancy in Study 6096A1-008-EU (NCT00366678). In this study, participants will receive an additional dose of 13-valent pneumococcal conjugate vaccine. The purpose of this study is to evaluate persistence, if any, of the antibody response by measuring any remaining pneumococcal antibodies since the previous study. This study will also evaluate the safety and immunogenicity of 13-valent pneumococcal conjugate vaccine when administered at least 24 months after the last dose of pneumococcal conjugate vaccine.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • 13-valent Pneumococcal Vaccine
  • Immunization
  • Safety
  • Antibody Response
Biological: 13-valent pneumococcal conjugate vaccine
All subjects will receive 1 dose (0.5 mL), IM of 13vPnC vaccine. (at least 24 months after toddler dose).
Experimental: 1
1 dose (0.5 mL), IM of 13vPnC vaccine.
Intervention: Biological: 13-valent pneumococcal conjugate vaccine
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
263
November 2010
November 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy subjects at least 3 years of age, who received all 4 assigned doses of pneumococcal conjugate vaccine and completed Study 6096A1-008-EU (NCT00366678) for at least 24 months

Exclusion Criteria:

  • Vaccination with any licensed or investigational pneumococcal vaccine since completion of Study 6096A1-008-EU(NCT00366678).
  • History of culture-proven invasive disease caused by S pneumoniae since the completion of Study 6096A1-008-EU (NCT00366678).
  • Previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Contraindication to vaccination
Sexes Eligible for Study: All
3 Years and older   (Child, Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01026038
6096A1-3021
B1851016
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2012

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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1-800-718-1021

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