Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

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NCT00464945

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Study Location
Torun, Bydgoszcz, 87-100, Poland
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

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

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Vaccines
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
41-99 days
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Aged 2 months (42 to 98 days) at time of enrollment.

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

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

4. Parent/legal guardian must be able to complete all relevant study procedures during study 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, Hib conjugate,
diphtheria, tetanus, pertussis, or polio vaccines.


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


3. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis,
polio, hepatitis B, measles, mumps, rubella, or pneumococcal vaccines.


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 hepatitis B immunoglobulin and
monoclonal antibodies; eg, Synagis®).


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


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

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Pfizer Clinical Trials Contact Center

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Advanced Information
Descriptive Information
Brief Title  ICMJE Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
Official Title  ICMJE A Phase 3, Randomised,Active-Controlled ,Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of Manufacturing Scale 13-valent Pneumococcal Conjugate Vaccine
Brief Summary The purpose of this study is to assess the safety, tolerability and immunogenicity of manufacturing scale 13-valent pneumococcal conjugate (13vPnC) vaccine compared to pilot scale 13vPnC in healthy infants when given with routine pediatric vaccines.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Vaccines
Intervention  ICMJE Biological: 13-valent Pneumococcal Conjugate Vaccine
1 dose at 2,3,4 and 12 months of age
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
  • Active Comparator: 2
    Intervention: Biological: 13-valent Pneumococcal Conjugate Vaccine
Publications * Gadzinowski J, Albrecht P, Hasiec B, Konior R, Dziduch J, Witor A, Mellelieu T, Tansey SP, Jones T, Sarkozy D, Emini EA, Gruber WC, Scott DA. Phase 3 trial evaluating the immunogenicity, safety, and tolerability of manufacturing scale 13-valent pneumococcal conjugate vaccine. Vaccine. 2011 Apr 5;29(16):2947-55. doi: 10.1016/j.vaccine.2011.02.002. Epub 2011 Feb 16.

*   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)		269
Original Enrollment  ICMJE
 (submitted: April 23, 2007)		268
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Aged 2 months (42 to 98 days) at time of enrollment.
  2. Available for entire study period and whose parent/legal guardian can be reached by telephone.
  3. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
  4. Parent/legal guardian must be able to complete all relevant study procedures during study participation.

Exclusion criteria:

  1. Previous vaccination with licensed or investigational pneumococcal, Hib conjugate, diphtheria, tetanus, pertussis, or polio vaccines.
  2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
  3. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, measles, mumps, rubella, or pneumococcal vaccines.
  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 hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
  10. Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
  11. Infant who 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 41 Days to 99 Days   (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 NCT00464945
Other Study ID Numbers  ICMJE 6096A1-3000
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