InfluenzaPhase 3NCT00731393
Immuno & Reacto of TF Trivalent Influenza Split Vaccine 2003/04 or of Std Formulation Influsplit SSW®/Fluarix™ 2003/04
A Phase 3 study testing Thiomersal free trivalent influenza split vaccine 2003/2004 and GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004 in people with Influenza, run by GlaxoSmithKline at 13 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Thiomersal free trivalent influenza split vaccine 2003/2004 and GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 13 sitesGermany
- Study dates
- Oct 2003to Aug 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
13 sites in 1 country.
13 sites in 1 country
Germany13 sites
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, 23795
GSK Investigational Site
Berlin, State of Berlin, 10315
GSK Investigational Site
Berlin, State of Berlin, 12627
GSK Investigational Site
Berlin, State of Berlin, 13355
GSK Investigational Site
Bischofswerda, Saxony, 01877
GSK Investigational Site
Bützow, Mecklenburg-Vorpommern, 18246
GSK Investigational Site
Coswig, Saxony, 01640
GSK Investigational Site
Dresden, Saxony, 01169
GSK Investigational Site
Dresden, Saxony, 01307
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24937
GSK Investigational Site
Husum, Schleswig-Holstein, 25813
GSK Investigational Site
Leipzig, Saxony, 04209
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, 18106
About this study
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
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.
- Conditions
- Influenza
- Being tested
- Thiomersal free trivalent influenza split vaccine 2003/2004, GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004
- Keywords
- Thiomersal-free influenza split vaccine 2003/2004, Influsplit SSW®/Fluarix™ 2003/2004, Influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thiomersal free trivalent influenza split vaccine 2003/2004Biological
2 doses, intramuscular injection
GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004Biological
Also called Thiomersal free trivalent influenza split vaccine 2003/2004
2 doses, intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Subjects aged between 6 months and 3 years. Receives: Biological: Thiomersal free trivalent influenza split vaccine 2003/2004 |
| Group B | Experimental | Subjects aged 3 to 6 years. Receives: Biological: Thiomersal free trivalent influenza split vaccine 2003/2004 |
| Group C | Active comparator | Subjects aged between 6 months and 3 years. Receives: Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004 |
| Group D | Active comparator | Subjects aged 3 to 6 years. Receives: Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On Day 21 (+- 2) after the second vaccination
Secondary outcomes (4)
Descriptive comparison of the occurrence and severity of solicited local and general symptoms
Measured: Within 4 days after each vaccination
Descriptive comparison of the occurrence, severity and relationship to vaccination of unsolicited signs and symptoms
Measured: Within 30 days after each vaccination
Descriptive comparison of the occurrence, severity and relationship to vaccination of serious adverse events (SAEs).
Measured: 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.
Measured: On Day 21 (+- 2), Month 3 and Month 6 after the second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startOct 2003
- Primary completionAug 2004
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731393
- Sponsor's protocol ID
- 100351
- Status last verified
- Sep 2016
- First submitted
- 7 Aug 2008
- Last updated
- 15 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00731393
- Acronym / sponsor ID
- 100351
- Conditions
- Influenza
- Keywords
- Thiomersal-free influenza split vaccine 2003/2004, Influsplit SSW®/Fluarix™ 2003/2004, Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Primary completion
- Aug 2004 (actual)
- Study completion
- Aug 2004 (actual)
- First posted
- 11 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: Thiomersal free trivalent influenza split vaccine 2003/2004Subjects aged between 6 months and 3 years. |
| Group B | Experimental | Biological: Thiomersal free trivalent influenza split vaccine 2003/2004Subjects aged 3 to 6 years. |
| Group C | Active comparator | Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004Subjects aged between 6 months and 3 years. |
| Group D | Active comparator | Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004Subjects aged 3 to 6 years. |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thiomersal free trivalent influenza split vaccine 2003/20042 doses, intramuscular injection | Biological | Group A, Group B |
| GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004Also: Thiomersal free trivalent influenza split vaccine 2003/20042 doses, intramuscular injection | Biological | Group C, Group D |
Primary outcome
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.
Time frame: On Day 21 (+- 2) after the second vaccination
4 secondary outcomes
Descriptive comparison of the occurrence and severity of solicited local and general symptoms
Time frame: Within 4 days after each vaccination
Descriptive comparison of the occurrence, severity and relationship to vaccination of unsolicited signs and symptoms
Time frame: Within 30 days after each vaccination
Descriptive comparison of the occurrence, severity and relationship to vaccination of serious adverse events (SAEs).
Time frame: 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.
Time frame: On Day 21 (+- 2), Month 3 and Month 6 after the second vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2016.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thiomersal free trivalent influenza split vaccine 2003/2004 and GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2003/2004 in people with Influenza, run by GlaxoSmithKline at 13 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: On Day 21 (+- 2) after the second vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2016.