Study to Assess Safety & Immunogenicity of GSK Biologicals' DTPa/Hib Vaccine vs Separate Administration of DTPa and Hib.

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

660 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-03

Study Completion Date

2007-06-25

Brief Summary

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This study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese infants 3, 4 \& 5 months of age, in terms of safety and immunogenicity.

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Detailed Description

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Conditions

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Tetanus Diphtheria Acellular Pertussis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Infanrix™/Hib

Intervention Type BIOLOGICAL

Infanrix

Intervention Type BIOLOGICAL

Hiberix

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* A male or female between, and including, 90 and 120 days of age at the time of the first vaccination,
* written informed consent obtained from the parent or guardian of the subject

Exclusion Criteria

* Subjects with known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenzae disease can not participate,
* Subjects who have received previous vaccination against diphtheria, tetanus, acellular pertussis and/or Haemophilus influenzae type b diseases can not participate.

Minimum Eligible Age

90 Days

Maximum Eligible Age

120 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Mengshan, , China

Site Status

GSK Investigational Site

Wuzhou, , China

Site Status

Countries

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China

References

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Yan-Ping Li, Shumin Zhang, Qiang Ye, Qiming Hou, Yanan Li, Hong Li, Yinghua Xu, Xiao Ma, Youping Liu, Xiaoling Chen, Lirong Huang, Gunasekaran Ramakrishnan, Richard Zhao, Haiwen Tang, Olivier Van Der Meeren, Hans L Bock.Combined diphtheria-tetanus-acellular pertussis vaccine mixed with Haemophilus influenzae type b conjugate vaccine is safe and immunogenic in two studies in Chinese infants.Chinese Journal of Vaccines - Zhongguo Yi Miao He Mian Yi (Zhongguo Ji Hua Mian Yi). Zhongguo Yi Miao He Mian Yi. 2010 Apr;16(2):97-104

Reference Type BACKGROUND

Study Documents

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