Study Evaluating Prevenar Vaccine in Healthy Infants

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00276107
First received: January 11, 2006
Last updated: July 28, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Pneumococcal Infections
Biological: Prevenar
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age

Secondary Outcome Measures:
  • To determine the antibody responses to the seven pneumococcal vaccine serotypes after second dose and to determine the safety of Prevenar in infants immunized at 2, 4 and 6 months of age

Estimated Enrollment: 200
Study Start Date: December 2004
Estimated Study Completion Date: December 2005
  Eligibility

Ages Eligible for Study:   42 Days to 100 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276107

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00276107     History of Changes
Other Study ID Numbers: 0887X-101446
Study First Received: January 11, 2006
Last Updated: July 28, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Vaccine
Healthy Infants

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 14, 2014