Study Evaluating Prevenar Vaccine in Healthy Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2005-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pneumococcal Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Prevenar

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

42 Days

Maximum Eligible Age

100 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes