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

NCT00452452

Last updated date
Study Location
Bydgoszcz, , 85-168, Poland
Contact
1-800-718-1021

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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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 <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
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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating 13-valent Pneumococcal Conjugate Vaccine Catch-Up Regimens in Older Infants and Children
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Infections
Intervention  ICMJE Biological: 13-valent Pneumococcal Conjugate Vaccine
Study Arms  ICMJE Experimental: A
Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
Publications * Not Provided

*   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: July 6, 2012)
355
Original Enrollment  ICMJE
 (submitted: March 26, 2007)
354
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 7 Months to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00452452
Other Study ID Numbers  ICMJE 6096A1-3002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Poland: [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP