Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

NCT00366548

Last updated date
Study Location
Bydgoszcz, , 85-168, Poland
Contact
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
42-98 days
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

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

3. In good health as determined by medical history, physical examination, and judgment of the investigator.

4. Parent(s)/legal guardian(s) were 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 vaccine.


2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, or polio
vaccines.


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


4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis,
polio, hepatitis B, or pneumococcal vaccines.


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


6. Known or suspected immune deficiency or suppression.


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


8. Major known congenital malformation or serious chronic disorder.


9. Significant neurological disorder or history of seizure (including febrile seizure),
or significant stable or evolving disorders (such as cerebral palsy, encephalopathy,
or hydrocephalus), or other significant disorders. This did not include resolving
syndromes because of birth trauma such as Erb palsy.


10. Receipt of blood products or γ-globulin (including hepatitis B immunoglobulin and
monoclonal antibodies [eg, Synagis]).

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
Official Title  ICMJE A Phase 3, Randomized, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine Manufactured With and Without Polysorbate 80 in Healthy Infants Given in a 2-, 3-, 4-, and 12-Month Schedule With Routine Pediatric Vaccinations
Brief Summary The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine manufactured with Polysorbate 80 compared to a 13-valent pneumococcal conjugate (13vPnC) manufactured without Polysorbate 80 when given concomitantly with routine paediatric vaccinations.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE Vaccines, Pneumococcal
Intervention  ICMJE
  • Biological: 13 valent pneumococcal conjugate vaccine with Polysorbate 80
  • Biological: 13 valent pneumococcal conjugate vaccine without Polysorbate 80
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Biological: 13 valent pneumococcal conjugate vaccine with Polysorbate 80
  • Active Comparator: 2
    Intervention: Biological: 13 valent pneumococcal conjugate vaccine without Polysorbate 80
Publications * Gadzinowski J, Tansey SP, Wysocki J, Kopi?ska E, Majda-Stanis?awska E, Czajka H, Korbal P, Pietrzyk JJ, Baker SA, Giardina PC, Gruber WC, Emini EA, Scott DA. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine manufactured with and without polysorbate 80 given to healthy infants at 2, 3, 4 and 12 months of age. Pediatr Infect Dis J. 2015 Feb;34(2):180-5. doi: 10.1097/INF.0000000000000511.

*   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: August 18, 2006)
500
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

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

Exclusion criteria:

  1. Previous vaccination with licensed or investigational pneumococcal vaccine.
  2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, or polio vaccines.
  3. A previous anaphylactic reaction to any vaccine or vaccine-related component.
  4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, or pneumococcal vaccines.
  5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  6. Known or suspected immune deficiency or suppression.
  7. History of culture-proven invasive disease caused by S pneumoniae.
  8. Major known congenital malformation or serious chronic disorder.
  9. Significant neurological disorder or history of seizure (including febrile seizure), or significant stable or evolving disorders (such as cerebral palsy, encephalopathy, or hydrocephalus), or other significant disorders. This did not include resolving syndromes because of birth trauma such as Erb palsy.
  10. Receipt of blood products or ?-globulin (including hepatitis B immunoglobulin and monoclonal antibodies [eg, Synagis]).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 42 Days to 98 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 NCT00366548
Other Study ID Numbers  ICMJE 6096A1-009
Has Data Monitoring Committee No
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