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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00412854
First received: December 18, 2006
Last updated: November 2, 2016
Last verified: November 2016
  Purpose
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.

Condition Intervention Phase
Tetanus
Diphtheria
Acellular Pertussis
Biological: Infanrix™/Hib
Biological: Infanrix
Biological: Hiberix
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase IIIb, Multicentre Study to Assess Safety & Immunogenicity of GSK Biologicals' Combined DTPa/Hib (Infanrix/Hib) Vaccine vs Separate Administration of DTPa (Infanrix) & Hib (Hiberix) Vaccines in Healthy Infants 3,4,&5 Months of Age as Compared With the Separate Administration of DTPa and Hib Vaccines at Different Injection Sites.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-diphtheria, anti-tetanus, anti-PT, anti-PRN, anti-FHA & anti-PRP antibody concentration. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Solicited symptoms (Day 0-3), unsolicited adverse events (Day 0-30) & serious adverse events [ Designated as safety issue: No ]

Enrollment: 660
Study Start Date: January 2007
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   90 Days to 120 Days   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412854

Locations
China
GSK Investigational Site
Mengshan, China
GSK Investigational Site
Wuzhou, China
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
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

Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 104567
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 104567
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 104567
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 104567
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 104567
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 104567
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 104567
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00412854     History of Changes
Other Study ID Numbers: 104567 
Study First Received: December 18, 2006
Last Updated: November 2, 2016
Health Authority: China: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Additional relevant MeSH terms:
Diphtheria
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on December 07, 2016