Last updated: 11/02/2018 22:54:08
Immuno & reacto of TF trivalent influenza split vaccine 2003/04 or of std formulation Influsplit SSW®/Fluarix™ 2003/04
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: To determine the immunogenicity and reactogenicity of a thiomersal free trivalent influenza split vaccine 2003/2004 or of GSK Biologicals’ standard formulation Influsplit SSW®/Fluarix™ 2003/2004 in children aged from 6 months until 6 years
Trial description: The aim of the present study is to assess the reactogenicity and immunogenicity of a thiomersal-free influenza vaccine. For comparison, a group of subjects is administered the standard formulation of Influsplit SSW® 2003/2004.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
GMT of the haemagglutination-inhibiting (HI) antibodies and calculation of seroconversion factor, seroconversion rate & seroprotection rate, checked against CHMP criteria (for 18 – 60 years old); seroprotection power is also calculated.
Timeframe: On Day 21 (+- 2) after the second vaccination
Secondary outcomes:
Descriptive comparison of the occurrence and severity of solicited local and general symptoms
Timeframe: Within 4 days after each vaccination
Descriptive comparison of the occurrence, severity and relationship to vaccination of unsolicited signs and symptoms
Timeframe: Within 30 days after each vaccination
Descriptive comparison of the occurrence, severity and relationship to vaccination of serious adverse events (SAEs).
Timeframe: Throughout the study
GMT of the HI antibodies in each case against the 3 influenza virus strains of the vaccine separately for both age groups.
Timeframe: On Day 21 (+- 2), Month 3 and Month 6 after the second vaccination
Interventions:
Biological/vaccine: Thiomersal free trivalent influenza split vaccine 2003/2004
Biological/vaccine: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004
Enrollment:
157
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
SB218352
Collaborators
Not applicable
Study date(s)
October 2003 to August 2004
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
6 months - 6 years
Accepts healthy volunteers
Yes
- Subjects whose parents/guardians the investigator believes can and will comply with the requirements of the protocol
- Male or female children over 6 months of age at the time of vaccination, but who are not yet 6 years old.
- Use of study or unlicensed medication or administration of a vaccine other than the study vaccine within 30 days preceding vaccination and/or during the study period until 30 days after administration of the second vaccine dose.
- Acute disease at the beginning of the study
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects whose parents/guardians the investigator believes can and will comply with the requirements of the protocol
- Male or female children over 6 months of age at the time of vaccination, but who are not yet 6 years old.
- All children included in the study must never have been given a prophylactic influenza inoculation.
- Written consent to vaccination must be available from both parents or only the single parent after the parents/guardians have been briefed on the study in an understandable language.
Exclusion criteria:
- Use of study or unlicensed medication or administration of a vaccine other than the study vaccine within 30 days preceding vaccination and/or during the study period until 30 days after administration of the second vaccine dose.
- Acute disease at the beginning of the study
- Acute clinically significant changes in the lungs, cardiovascular system, liver or kidney function, identified by physical examination or laboratory tests.
- Known allergic reactions that might have been caused by one or more components of the vaccine.
- Administration of immunoglobulins and/or other blood products within 3 months before the beginning of the study or planned administration during the study period.
Trial location(s)
Location
GSK Investigational Site
Buetzow, Mecklenburg-Vorpommern, Germany, 18246
Status
Study Complete
Location
GSK Investigational Site
Husum, Schleswig-Holstein, Germany, 25813
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bischofswerda, Sachsen, Germany, 01877
Status
Study Complete
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
Status
Study Complete
Location
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, Germany, 23795
Status
Study Complete
Location
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18106
Status
Terminated/Withdrawn
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
2004-27-08
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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