Status:

COMPLETED

Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants in Mexico

Lead Sponsor:

Wyeth is now a wholly owned subsidiary of Pfizer

Conditions:

Vaccines, Pneumococcal

Eligibility:

All Genders

42-98 years

Phase:

PHASE3

Brief Summary

The purpose of this study will be to evaluate safety, tolerability and immunogenicity of 13-valent pneumococcal vaccine in healthy infants given with routine pediatric vaccinations in Mexico.

Eligibility Criteria

Inclusion

  • Healthy 2 month infants, available for entire study period and parent/legal guardian reachable by telephone
  • Able to complete three blood draws during study
  • At least 3.5 kg at enrollment

Exclusion

  • Previous vaccination (except Hepatitis, BCG), contraindication or allergic reaction to vaccines
  • Immune deficiency, bleeding disorder or significant chronic medical condition

Key Trial Info

Start Date :

July 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2010

Estimated Enrollment :

225 Patients enrolled

Trial Details

Trial ID

NCT00708682

Start Date

July 1 2008

End Date

May 1 2010

Last Update

October 25 2011

Active Locations (9)

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Page 1 of 3 (9 locations)

1

Guadalajara, Jalisco, Mexico, 44080

2

Distrio Federal, Mexico, Mexico, 14080

3

Distrio Federal, Mexico, Mexico, 4530

4

Morelia, Michoacán, Mexico, 58070