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

NCT ID: NCT00708682

Last Updated: 2011-10-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Vaccines, Pneumococcal

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

13-valent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

Interventions

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13-valent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

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

42 Days

Maximum Eligible Age

98 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Guadalajara, Jalisco, Mexico

Site Status

Distrio Federal, Mexico, Mexico

Site Status

Distrio Federal, Mexico, Mexico

Site Status

Morelia, Michoacán, Mexico

Site Status

Cuernavaca, Morelos, Mexico

Site Status

Monterrey, Nuevo León, Mexico

Site Status

Oaxaca City, Oaxaca, Mexico

Site Status

Puebla City, Puebla, Mexico

Site Status

Mérida, Yucatán, Mexico

Site Status

Countries

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Mexico

References

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Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinon-Torres F, Gruber WC, Patterson S, Thompson A, Gurtman A, Paradiso P, Scott DA. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-74. doi: 10.1016/j.vaccine.2013.08.009. Epub 2013 Aug 16.

Reference Type DERIVED
PMID: 23965217 (View on PubMed)

Other Identifiers

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6096A1-3009

Identifier Type: -

Identifier Source: org_study_id