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

NCT ID: NCT00474539

Last Updated: 2013-03-05

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

449 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-03-31

Brief Summary

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The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in Spain.

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Detailed Description

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Conditions

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Vaccines, Pneumococcal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

13-valent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

1 dose at 2,4,6 and 15 months of age

2

Group Type ACTIVE_COMPARATOR

7-valent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

1 dose at 2,4,6 and 15 months of age

Interventions

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13-valent pneumococcal conjugate vaccine

1 dose at 2,4,6 and 15 months of age

Intervention Type BIOLOGICAL

7-valent pneumococcal conjugate vaccine

1 dose at 2,4,6 and 15 months of age

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy 2-month-old infants
* Available for the entire study period

Exclusion Criteria

* Previous vaccination with any vaccine before the start of the study
* Known contraindication to vaccination
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

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Spain: [email protected]

Locations

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A Coruña, , Spain

Site Status

A Coruña, , Spain

Site Status

Almería, , Spain

Site Status

Almería, , Spain

Site Status

Almería, , Spain

Site Status

Barcelona, , Spain

Site Status

Barcelona, , Spain

Site Status

Madrid, , Spain

Site Status

Madrid, , Spain

Site Status

Madrid, , Spain

Site Status

Madrid, , Spain

Site Status

Málaga, , Spain

Site Status

Málaga, , Spain

Site Status

Ourense, , Spain

Site Status

Pamplona, , Spain

Site Status

Santiago de Compostela, , Spain

Site Status

Seville, , Spain

Site Status

Valencia, , Spain

Site Status

Valencia, , Spain

Site Status

Valencia, , Spain

Site Status

Valencia, , Spain

Site Status

Valencia, , Spain

Site Status

Valencia, , Spain

Site Status

Valencia, , Spain

Site Status

Valencia, , Spain

Site Status

Valencia, , Spain

Site Status

Vigo, , Spain

Site Status

Countries

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Spain

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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6096A1-3007

Identifier Type: -

Identifier Source: org_study_id

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