Study Evaluating the Impact of a 13-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1866 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2011-08-31

Brief Summary

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This study is designed to assess the impact of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) on nasopharyngeal colonization with Streptococcus pneumoniae in healthy infants.

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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

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

13 valent pneumococcal conjugate vaccine

Group Type EXPERIMENTAL

13-valent Pneumococcal Conjugate Vaccine

Intervention Type BIOLOGICAL

1 dose at 2, 4, 6 and 12 months of age

2

7 valent pneumococcal conjugate vaccine

Group Type ACTIVE_COMPARATOR

7 valent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

1 dose at 2, 4, 6 and 12 months of age

Interventions

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13-valent Pneumococcal Conjugate Vaccine

1 dose at 2, 4, 6 and 12 months of age

Intervention Type BIOLOGICAL

7 valent pneumococcal conjugate vaccine

1 dose at 2, 4, 6 and 12 months of age

Intervention Type BIOLOGICAL

Other Intervention Names

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13vPnC 7vPnC

Eligibility Criteria

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Inclusion Criteria

* Healthy infants aged 2 months (42-98 days) at time of enrolment.
* Available for the entire study period and whose parent/legal guardian can be reached by telephone.

Exclusion Criteria

* Previous vaccination with licensed or investigational pneumococcal vaccine.
* A previous anaphylactic reaction to any vaccine or vaccine-related component.
* Contraindication to vaccination with a pneumococcal conjugate vaccine.

Minimum Eligible Age

42 Days

Maximum Eligible Age

98 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes