Last updated: 11/07/2018 01:13:59
Multicentre booster & immune memory study of a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine or a single dose of 23-valent plain polysaccharide vaccine in healthy children aged 11-18 mths, previously vaccinated in study 103488
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A phase II, multicentre booster study to evaluate booster vaccination with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine or to evaluate the immune memory following the administration of a single dose of 23-valent plain polysaccharide vaccine in healthy children, previously vaccinated in infancy in the primary study 11PN-PD-DIT-002 (103488)
Trial description: Booster and immune memory study
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
689
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Silfverdal SA et al. (2016) Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Expert Rev Vaccines. [Epub ahead of print]
Medical condition
acellular pertussis, Tetanus, Hepatitis B, Diphtheria, Haemophilus influenzae type b, Poliomyelitis
Product
GSK1024850A
Collaborators
Not applicable
Study date(s)
November 2005 to March 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
11 - 18 months
Accepts healthy volunteers
Yes
- Inclusion criteria: Male or female between, and including, 11-18 months of age at the time of vaccination and who previously participated in the study 11PN-PD-DIT-002 and received at least one dose of pneumococcal conjugate vaccine during the primary study, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject. Exclusion criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first 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 one month before the first dose of vaccine(s) and during the entire study period. Administration of any additional pneumococcal vaccine or DTPa combined vaccine since study end of 11PN-PD-DIT-002 study
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria: Male or female between, and including, 11-18 months of age at the time of vaccination and who previously participated in the study 11PN-PD-DIT-002 and received at least one dose of pneumococcal conjugate vaccine during the primary study, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject. Exclusion criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first 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 one month before the first dose of vaccine(s) and during the entire study period. Administration of any additional pneumococcal vaccine or DTPa combined vaccine since study end of 11PN-PD-DIT-002 study
Trial location(s)
Location
GSK Investigational Site
Bredstedt, Schleswig-Holstein, Germany, 25821
Status
Study Complete
Location
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48159
Status
Study Complete
Location
GSK Investigational Site
Lobenstein, Thueringen, Germany, 07356
Status
Study Complete
Showing 1 - 6 of 51 Results
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
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2006-13-03
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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