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Study Evaluating 13-valent Pneumococcal Conjugate Vaccine Catch-Up Regimens in Older Infants and Children

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Bydgoszcz, , 85-168 Poland
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
7+ months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Aged from 7 months to

2. Available for entire study period and whose parent/legal guardian could be reached by
telephone.

3. Healthy as determined by medical history, physical examination, and judgment of the
investigator.

4. Parent/legal guardian had to be able to complete all relevant study procedures during
subject participation.

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

1. Previous vaccination with licensed or investigational pneumococcal vaccine.

2. A previous anaphylactic reaction to any vaccine or vaccine-related component.

3. Contraindication to vaccination with pneumococcal vaccine.

4. Bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate intramuscular injection.

5. Known or suspected immune deficiency or suppression.

6. History of culture-proven invasive disease caused by S pneumoniae.

7. Major known congenital malformation or serious chronic disorders.

8. Significant neurological disorder or history of seizure including febrile seizure, or
significant stable or evolving disorders such as cerebral palsy, encephalopathy,
hydrocephalus, or other significant disorders. Does not include resolving syndromes
due to birth trauma such as Erb palsy.

9. Receipt of blood products or gamma-globulin (including monoclonal antibodies) in the
last 3 months.

10. Participation in another investigational or interventional trial. Participation in
purely observational studies is acceptable.

11. Child is a direct descendant (child or grandchild) of a member of the study site
personnel.

NCT00452452
Pfizer
Completed
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine Catch-Up Regimens in Older Infants and Children

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Similar Trials

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine Catch-Up Regimens in Older Infants and Children
A Phase 3 Open-label Trial Evaluating the Safety, Tolerability and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Older Infants and Children Who Are Naive to Previous Vaccination With Pneumococcal Conjugate Vaccine.
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent Pneumococcal conjugate vaccine (13vPnC) in older infants and children who have not previously been immunized with Pneumococcal vaccine.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Pneumococcal Infections
Biological: 13-valent Pneumococcal Conjugate Vaccine
Experimental: A
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
355
March 2008
March 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Aged from 7 months to <72 months at time of enrollment.
  2. Available for entire study period and whose parent/legal guardian could be reached by telephone.
  3. Healthy as determined by medical history, physical examination, and judgment of the investigator.
  4. Parent/legal guardian had to be able to complete all relevant study procedures during subject participation.

Exclusion Criteria:

  1. Previous vaccination with licensed or investigational pneumococcal vaccine.
  2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
  3. Contraindication to vaccination with pneumococcal vaccine.
  4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  5. Known or suspected immune deficiency or suppression.
  6. History of culture-proven invasive disease caused by S pneumoniae.
  7. Major known congenital malformation or serious chronic disorders.
  8. Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma such as Erb palsy.
  9. Receipt of blood products or gamma-globulin (including monoclonal antibodies) in the last 3 months.
  10. Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
  11. Child is a direct descendant (child or grandchild) of a member of the study site personnel.
Sexes Eligible for Study: All
7 Months to 5 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Poland
 
 
NCT00452452
6096A1-3002
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Poland: [email protected]
Wyeth is now a wholly owned subsidiary of Pfizer
July 2012

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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