Study to Assess the Safety & Reactogenicity of GSK Biologicals' DTPa/Hib Vaccine When Given at 3, 4 and 5 Months of Age

Tetanus Clinical Trial

Official title:

Open, Primary Vaccination Study to Assess Safety and Reactogenicity of GSK Biologicals' DTPa/Hib Vaccine When Administered to Healthy Chinese Infants at 3, 4 and 5 Months of Age.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00379977
• Other study ID #: 106345
• Status: Completed
• Phase: Phase 3
• First received: September 22, 2006
• Last updated: October 11, 2016
• Start date: September 2006
• Est. completion date: December 2006

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and reactogenicity of GSK Biologicals' Diphtheria Tetanus acellular Pertussis/Haemophilus influenzae type b vaccine given to Chinese infants at 3, 4 and 5 months of age.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 90 Days to 120 Days

Eligibility

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 (Hib) diseases can not participate.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acellular Pertussis
• Diphtheria
• Haemophilus Influenzae Type b
• Tetanus

Intervention

Biological:
• diphtheria, tetanus, pertussis & Hib vaccine

Locations

Country	Name	City	State
China	GSK Investigational Site	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of solicited symptoms during the 4 days following vaccination, unsolicited symptoms during the 31 days following vaccination and serious adverse events

External Links

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