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Study Evaluating Prevenar Vaccine in Healthy Infants

Last updated on November 13, 2019

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Study Location
Contact
1-800-718-1021
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.
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- 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.

NCT00276107
Pfizer
Completed
Study Evaluating Prevenar Vaccine in Healthy Infants

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18+
Years
Multiple Sites
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 SummaryTo 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 DescriptionNot 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 DateNot 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 CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot 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 AccountWyeth is now a wholly owned subsidiary of Pfizer
Verification DateJuly 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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]

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