Study Evaluating Prevenar Vaccine in Healthy Infants

Pneumococcal Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00276107
• Other study ID #: 0887X-101446
• Status: Completed
• Phase: Phase 4
• First received: January 11, 2006
• Last updated: July 28, 2009
• Start date: December 2004
• Est. completion date: December 2005

Study information

• Verified date: July 2009
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 42 Days to 100 Days

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumococcal Infections

Intervention

Biological:
• Prevenar

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the immunogenicity of Prevenar in infants immunized at 2, 4 and 6 months of age
Secondary	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