Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered to Infants in Taiwan

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

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-05

Study Completion Date

2010-01-13

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 vaccine (13vPnC), relative to a 7-valent pneumococcal conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Taiwan.

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Detailed Description

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Conditions

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Vaccines Pneumococcal Conjugate Vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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1

13vPnC

Group Type EXPERIMENTAL

13-valent pneumococcal conjugate vaccine (13vPnC)

Intervention Type BIOLOGICAL

13vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.

2

7vPnC

Group Type ACTIVE_COMPARATOR

7-valent pneumococcal conjugate vaccine (7vPnC)

Intervention Type BIOLOGICAL

7vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.

Interventions

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13-valent pneumococcal conjugate vaccine (13vPnC)

13vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.

Intervention Type BIOLOGICAL

7-valent pneumococcal conjugate vaccine (7vPnC)

7vPnC is given via intramuscular injection at approximately 2, 4, 6, and 15 months of age.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy 2-month-old infants (42 to 98 days)
* Available for the entire study period (14 months)

Exclusion Criteria

* Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib vaccines
* A previous anaphylactic reaction to any vaccine or vaccine-related component.

Minimum Eligible Age

42 Days

Maximum Eligible Age

98 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No