Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants

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Wyeth

Status and phase

Completed
Phase 3

Conditions

Vaccines, Pneumococcal Conjugate Vaccine

Treatments

Biological: 13vPnC

Study type

Interventional

Funder types

Industry

Identifiers

NCT00574795
6096A1-3003

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in infants of Japanese descent.

Enrollment

193 patients

Sex

All

Ages

2 to 6 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy 2 to 6 month-old infant
  • Available for entire study period

Exclusion criteria

  • Previous vaccination with licensed or investigational pneumococcal vaccine.
  • Previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Contraindication to vaccination with a pneumococcal conjugate vaccine.
  • Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate any type of injection.
  • Known or suspected immune deficiency or suppression.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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