Last updated: 11/03/2018 08:47:14
Study to assess the safety & reactogenicity of GSK Biologicals’ DTPa/Hib vaccine when given at 3, 4 and 5 months of age
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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.
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: diphtheria, tetanus, pertussis & Hib vaccine
Enrollment:
30
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Tetanus, Haemophilus influenzae type b, acellular pertussis, Diphtheria
Product
SB208355
Collaborators
Not applicable
Study date(s)
September 2006 to December 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
90 - 120 days
Accepts healthy volunteers
Yes
- 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
- 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.
Inclusion and exclusion 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 (Hib) diseases can not participate.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-25-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
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