Last updated: 07/18/2020 12:13:58
Study on the immunogenicity and tolerability of Influsplit SSW® 2005/2006 in children aged 6 - 13 years
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An open, phase IV study on the immunogenicity and tolerability of Influsplit SSW® 2005/2006 in children aged 6 – 13 years
Trial description: The study will evaluate the immune response and the tolerability of the influenza vaccine administered in children aged 6-13 years old.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Titers for serum Hemagglutination Inhibition (HI) antibodies against 3 strains of influenza disease in children aged between 6 and 9 years
Timeframe: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)
Seroconversion factor (SCF) for HI antibodies against 3 strains of influenza disease in children aged between 6 and 9 years
Timeframe: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)
Number of seroconverted subjects against 3 strains of influenza disease in children aged between 6 and 9 years
Timeframe: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)
Secondary outcomes:
Titers for serum HI antibodies against 3 strains of influenza disease in children aged between 10 and 13 years
Timeframe: 21 days post-vaccination (Day 21)
SCF for HI antibodies against 3 strains of influenza disease in children aged between 10 and 13 years
Timeframe: 21 days post-vaccination (Day 21)
Number of seroconverted subjects against 3 strains of influenza disease in children aged between 10 and 13 years
Timeframe: 21 days post-vaccination (Day 21)
Number of seroprotected subjects who were unprotected at pre-vaccination against 3 influenza strains in children aged between 10 and 13 years
Timeframe: 21 days post-vaccination (Day 21)
Number of seroprotected subjects against 3 strains of influenza disease in children aged between 10 and 13 years
Timeframe: 21 days post-vaccination (Day 21)
Number of subjects with solicited local symptoms
Timeframe: During the 4-day (Day 0–3) post-vaccination period following each dose and across doses
Number of subjects with solicited general symptoms
Timeframe: During the 4-day (Day 0–3) post-vaccination period following each dose and across doses
Number of subjects with unsolicited adverse events.
Timeframe: During 31 days after the study vaccine dose (Day 0-30)
Number of subjects with serious adverse events (SAEs)
Timeframe: During the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group
Interventions:
Biological/vaccine: Influsplit SSW® 2005/2006
Enrollment:
240
Observational study model:
Not applicable
Primary completion date:
2006-28-03
Time perspective:
Not applicable
Clinical publications:
Schmidt-Ott R et al. (2007) Immunogenicity and reactogenicity of a trivalent influenza split vaccine in previously unvaccinated children aged 6-9 and 10-13 years. Vaccine. 26(1):32-40.
Medical condition
Influenza
Product
SB218352
Collaborators
Not applicable
Study date(s)
November 2005 to March 2006
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
6 - 13 years
Accepts healthy volunteers
Yes
- Healthy children or children with an increased health risk due to an underlying chronic disease—such as chronic airways diseases (including asthma), chronic cardiovascular, hepatic and renal diseases as well as diabetes and other metabolic diseases—aged between 6 and 13 years.
- All subjects must not have received a prior influenza vaccination.
- Use of any study or unlicensed medications/ vaccine other than the study vaccine within 30 days of the vaccination and/or during the study period.
- Acute illness at the start of the study.
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy children or children with an increased health risk due to an underlying chronic disease—such as chronic airways diseases (including asthma), chronic cardiovascular, hepatic and renal diseases as well as diabetes and other metabolic diseases—aged between 6 and 13 years.
- All subjects must not have received a prior influenza vaccination.
- All subjects must not have had a prior influenza disease.
Exclusion criteria:
- Use of any study or unlicensed medications/ vaccine other than the study vaccine within 30 days of the vaccination and/or during the study period.
- Acute illness at the start of the study.
- Acute, clinically significant pulmonary, cardiovascular abnormalities or abnormalities of the hepatic or renal function.
- Known allergic reactions which might be caused by the ingredients of the vaccine.
- Girls post-menarche: pregnancy or positive pregnancy-test
- Multiple sclerosis or congenital or acquired immunodeficiencies.
Trial location(s)
Location
GSK Investigational Site
Bischofswerda, Sachsen, Germany, 01877
Status
Study Complete
Location
GSK Investigational Site
Bredstedt, Schleswig-Holstein, Germany, 25821
Status
Study Complete
Location
GSK Investigational Site
Buetzow, Mecklenburg-Vorpommern, Germany, 18246
Status
Study Complete
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
Status
Study Complete
Location
GSK Investigational Site
Husum, Schleswig-Holstein, Germany, 25813
Status
Study Complete
Location
GSK Investigational Site
Niebuell, Schleswig-Holstein, Germany, 25899
Status
Study Complete
Location
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18106
Status
Study Complete
Location
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18109
Status
Study Complete
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
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2006-28-03
Actual study completion date
2006-28-03
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.
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