Study Evaluating Prevenar Vaccine in Healthy Infants

NCT00276107

Last updated date
Contact
1-800-718-1021

FOR MORE INFORMATION

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

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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
42-100 days
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male and female children 2 months of age (42 to 100 days) in good health.

- An informed consent must be signed by a parent or legal guardian following a detailed explanation of participation in the study.

- Infants whose parent(s)/guardian(s) will be available for the entire study period.

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


- Hypersensitivity to any component of the vaccine, including diphtheria toxoid


- Infants with thrombocytopenia or any coagulation disorder that would contraindicate
intramuscular injection


- Infants with known or suspected impairment of immunologic functions including HIV or
those receiving immunosuppressive therapy.


Other exclusions apply.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Pneumococcal InfectionsEarly Versus Delayed Pneumococcal Vaccination in HIV
NCT00137605
  1. Kelowna, British Columbia
  2. Vancouver, British Columbia
  3. Vancouver, British Columbia
  4. Winnipeg, Manitoba
  5. Windsor, New Brunswick
  6. Halifax, Nova Scotia
  7. Hamilton, Ontario
  8. London, Ontario
  9. Toronto, Ontario
  10. Toronto, Ontario
  11. Windsor, Ontario
  12. Montreal, Quebec
  13. Sherbrooke, Quebec
  14. Ste-Foy, Quebec
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Pneumococcal InfectionsAn Incitative Multifaceted PROcedure for Pneumococcal Vaccination at the Emergency Department
NCT01899365
  1. Clermont-ferrand,
  2. Issoire,
  3. Marseille,
  4. Marseille,
  5. Marseille,
  6. Menton,
  7. Nice,
  8. Orange,
  9. Paris,
  10. Paris,
  11. Paris,
  12. Paris,
  13. Paris,
  14. Saint-denis,
  15. Vaison-la-romaine,
  16. Valreas,
  17. Vichy,
  18. Monaco,
ALL GENDERS
65 Years+
years
MULTIPLE SITES
Pneumococcal InfectionsStudy Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India
NCT00452790
  1. Sector-12, Chandigarh
  2. Sector-32 B, Chandigarh
  3. Bangalore, Karnataka
  4. Bangalore, Karnataka
  5. Mumbai, Maharashtra
  6. Pune, Maharashtra
  7. Pune, Maharashtra
  8. Pune, Maharashtra
  9. Rajinder Nagar, New Delhi
  10. Ludhiana, Punjab
  11. Chennai, Tamil Nadu
  12. Vellore, Tamil Nadu
ALL GENDERS
42 Days+
years
MULTIPLE SITES
Pneumococcal InfectionsStudy Investigating Administration of Prevenar for Post-Marketing Surveillance
NCT00195390
  1. Seoul,
ALL GENDERS
6 Weeks+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Prevenar Vaccine in Healthy Infants
Official Title  ICMJE An Open-Label Trial of the Immunogenicity and Safety of Prevenar (Pneumococcal 7-Valent Conjugate Vaccine [Diphteria CRM197 Protein Conjugate]) in Healthy Infants at 2, 4 and 6 Months of Age
Brief Summary To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age. To determine the antibody responses to the seven pneumococcal vaccine serotypes one month after second dose and determine the safety of Prevenar in infants immunized at 2,4 and 6 months of age.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Infections
Intervention  ICMJE Biological: Prevenar
Study Arms  ICMJE Not Provided
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
Enrollment  ICMJE
 (submitted: January 11, 2006)
200
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE December 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and female children 2 months of age (42 to 100 days) in good health.
  • An informed consent must be signed by a parent or legal guardian following a detailed explanation of participation in the study.
  • Infants whose parent(s)/guardian(s) will be available for the entire study period.

Exclusion Criteria:

  • Hypersensitivity to any component of the vaccine, including diphtheria toxoid
  • Infants with thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
  • Infants with known or suspected impairment of immunologic functions including HIV or those receiving immunosuppressive therapy.

Other exclusions apply.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 42 Days to 100 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00276107
Other Study ID Numbers  ICMJE 0887X-101446
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
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 2009

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