Study Evaluating Pneumococcal Vaccine in Healthy Infants

NCT00205803

Last updated date
Study Location
New York, New York, 10045, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Subjects, Pneumococcal Infections
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 6 weeks to 14 weeks (42-98 days of age) at time of enrollment,

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

3. Subject must have been born ≥36 weeks of gestational age,

4. Subject must be available for entire study period and whose parent/legal guardian can be reached by telephone,

5. Parent/legal guardian must be able to understand and sign an informed consent form prior to participation and complete a parent worksheet 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, DTaP or IPV vaccines,


3. Contraindication to immunization with HepB, Hib conjugate, DTaP or IPV vaccines,


4. 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,


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


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


7. Previous anaphylactic reaction to any vaccine or vaccine components,


8. Major known congenital malformation or serious chronic disorders,


9. Participation in another investigational study (however, observation-only trials are
permitted),


10. Known or suspected immune deficiency/suppression,


11. Receipt of blood products or gamma globulin (including Hepatitis B immunoglobulin and
monoclonal antibody; eg, Synagis®).

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Healthy Subjects, Pneumococcal InfectionsStudy Evaluating Pneumococcal Vaccine in Healthy Infants
NCT00205803
  1. New York, New York
ALL GENDERS
42 Days+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Pneumococcal Vaccine in Healthy Infants
Official Title  ICMJE A Phase I/II, 2-stage, Randomized, Double-Blind Trial of the Safety, Tolerability and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine (Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in Healthy Infants
Brief Summary The purpose of this study is to evaluate the safety and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in healthy infants. This is the first study with this vaccine in infants.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE
  • Healthy Subjects
  • Pneumococcal Infections
Intervention  ICMJE
  • Biological: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
  • Biological: 7-Valent Pneumococcal Conjugate Vaccine (7vPnC)
Study Arms  ICMJE
  • Experimental: 13vPnC
    Intervention: Biological: 13-Valent Pneumococcal Conjugate Vaccine (13vPnC)
  • Active Comparator: 7vPnC
    Intervention: Biological: 7-Valent Pneumococcal Conjugate Vaccine (7vPnC)
Publications * Bryant KA, Block SL, Baker SA, Gruber WC, Scott DA; PCV13 Infant Study Group. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine. Pediatrics. 2010 May;125(5):866-75. doi: 10.1542/peds.2009-1405.

*   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)
249
Original Enrollment  ICMJE
 (submitted: September 19, 2005)
240
Actual Study Completion Date  ICMJE May 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Aged 6 weeks to 14 weeks (42-98 days of age) at time of enrollment,
  2. In good health as determined by medical history, physical examination and judgment of the investigator,
  3. Subject must have been born ?36 weeks of gestational age,
  4. Subject must be available for entire study period and whose parent/legal guardian can be reached by telephone,
  5. Parent/legal guardian must be able to understand and sign an informed consent form prior to participation and complete a parent worksheet during study participation.

Exclusion Criteria:

  1. Previous vaccination with licensed or investigational pneumococcal vaccine,
  2. Previous vaccination with Hib conjugate, DTaP or IPV vaccines,
  3. Contraindication to immunization with HepB, Hib conjugate, DTaP or IPV vaccines,
  4. 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,
  5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection,
  6. History of culture-proven invasive disease caused by S. pneumoniae,
  7. Previous anaphylactic reaction to any vaccine or vaccine components,
  8. Major known congenital malformation or serious chronic disorders,
  9. Participation in another investigational study (however, observation-only trials are permitted),
  10. Known or suspected immune deficiency/suppression,
  11. Receipt of blood products or gamma globulin (including Hepatitis B immunoglobulin and monoclonal antibody; 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00205803
Other Study ID Numbers  ICMJE 6096A1-003
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
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