Last updated: 11/02/2018 23:36:12
Immune memory foll pry vaccination with DTPw-HBV/Hib vaccine formulation; immuno & reacto of booster dose at 15-18 mths
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Assess the immunogenicity &d reactogenicity of a booster dose of a formulation of GSK Biologicals’ DTPw-HBV/Hib vaccine at 15-18 mths of age in infants previously primed with the same vaccine
Trial description: To assess the anti-PRP antibody response one month after vaccination in the groups receiving a fourth consecutive dose of two formulations of DTPw-HBV/Hib vaccine
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
175
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hib Disease, Hepatitis B, Pertussis, Prophylaxis of Diphtheria, Tetanus
Product
GSK357939A
Collaborators
Not applicable
Study date(s)
January 2005 to April 2005
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
15+ years
Accepts healthy volunteers
Yes
- Inclusion criteria
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria -Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. -A male or female of at least 15 months of age at the time of the booster vaccination, who had previously received 3-dose primary vaccination and, if applicable, plain-PRP vaccination. -Free of obvious health problems as established by medical history and clinical examination before entering the study. Exclusion criteria for enrolment -Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period. -Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after administration of study vaccines with the exception of oral polio vaccine (OPV). -Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose. -Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B or Hib with the exception of plain PRP challenge. -Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
Trial location(s)
Study documents
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
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2005-08-04
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
Additional information
Not applicable
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