InfluenzaPhase 3NCT00731029
Reacto & Immunogenicity of TF Formulation of Influsplit SSW® 2002/03 v/s Std Formulation of Influsplit SSW® 2002/03
A Phase 3 study testing Thiomersal free trivalent influenza split vaccine 2002/2003 and GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003 in people with Influenza, run by GlaxoSmithKline at 1 site in Germany.
Trial summary
This is a comparative vaccination study of the reactogenicity and immunogenicity of a thiomersal-free formulation of Influsplit SSW® 2002/2003 versus the standard formulation of Influsplit SSW® 2002/2003 in individuals over 18 years. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Thiomersal free trivalent influenza split vaccine 2002/2003 and GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2002to Apr 2003
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects who are capable of being vaccinated and subjects with primary diseases (cardiovascular conditions, metabolic conditions such as diabetes mellitus, respiratory diseases) who are capable of being vaccinated and aged over 18 years who want to be vaccinated against influenza or for whom the doctor considers prophylactic influenza immunisation to be indicated.
- The inclusion of individuals who had not been immunised in the 2001/2002 season is preferred.
- Written consent to vaccination must be available after the subjects have been briefed on the study in 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
- 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
- Pregnancy
- Women who would like to fall pregnant during the period from the day of vaccination to 1 month thereafter
- Known allergic reactions that might have been caused by one or more ingredients of the vaccine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Vaccination Study of the Reactogenicity and Immunogenicity of a Thiomersal-Free Formulation of Influsplit SSW® 2002/2003 Versus the Standard Formulation of Influsplit SSW® 2002/2003 in Individuals Over 18 Years
This is a comparative vaccination study of the reactogenicity and immunogenicity of a thiomersal-free formulation of Influsplit SSW® 2002/2003 versus the standard formulation of Influsplit SSW® 2002/2003 in individuals over 18 years.
- Conditions
- Influenza
- Being tested
- Thiomersal free trivalent influenza split vaccine 2002/2003, GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003
- Keywords
- Influenza, Thiomersal-free influenza split vaccine 2002/2003, Influsplit SSW®/Fluarix™ 2002/2003
- 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 2002/2003Biological
Single dose, intramuscular injection
GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003Biological
Single dose, intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | The subjects in this group will be 18-60 years. Receives: Biological: Thiomersal free trivalent influenza split vaccine 2002/2003 |
| Group B | Experimental | The subjects in this group will be > 60 years. Receives: Biological: Thiomersal free trivalent influenza split vaccine 2002/2003 |
| Group C | Active comparator | The subjects in this group will be 18-60 years. Receives: Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003 |
| Group D | Active comparator | The subjects in this group will be > 60 years. Receives: Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMT of the haemagglutination-inhibiting antibodies (HIA) and calculation of seroconversion factor, seroconversion rate and seroprotection rate checked against the CHMP criteria. The seroprotection power will be calculated as well.
Measured: On Day 21 (± 2) after vaccination
Descriptive comparison of the occurrence, severity and causal relationship to vaccination of solicited local and general symptoms
Measured: Within 4 days after vaccination
Secondary outcomes (3)
Descriptive comparison of the occurrence and causal relationship to vaccination of unsolicited signs and symptoms
Measured: Within 30 days after vaccination
Descriptive comparison of the occurrence, severity and causal relationship to vaccination of any serious adverse events (SAEs)
Measured: During the entire study period.
Investigation of antibody persistence assessed by the criteria of the CHMP.
Measured: 11, 19, 27 weeks after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startSep 2002
- Primary completionApr 2003
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
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731029
- Sponsor's protocol ID
- 218352/053
- Status last verified
- Aug 2008
- First submitted
- 7 Aug 2008
- Last updated
- 8 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Vaccination Study of the Reactogenicity and Immunogenicity of a Thiomersal-Free Formulation of Influsplit SSW® 2002/2003 Versus the Standard Formulation of Influsplit SSW® 2002/2003 in Individuals Over 18 Years
- ClinicalTrials.gov ID
- NCT00731029
- Acronym / sponsor ID
- 218352/053
- Conditions
- Influenza
- Keywords
- Influenza, Thiomersal-free influenza split vaccine 2002/2003, Influsplit SSW®/Fluarix™ 2002/2003
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Primary completion
- Apr 2003 (actual)
- First posted
- 8 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.
This is a comparative vaccination study of the reactogenicity and immunogenicity of a thiomersal-free formulation of Influsplit SSW® 2002/2003 versus the standard formulation of Influsplit SSW® 2002/2003 in individuals over 18 years.
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 2002/2003The subjects in this group will be 18-60 years. |
| Group B | Experimental | Biological: Thiomersal free trivalent influenza split vaccine 2002/2003The subjects in this group will be > 60 years. |
| Group C | Active comparator | Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003The subjects in this group will be 18-60 years. |
| Group D | Active comparator | Biological: GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003The subjects in this group will be > 60 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy subjects who are capable of being vaccinated and subjects with primary diseases (cardiovascular conditions, metabolic conditions such as diabetes mellitus, respiratory diseases) who are capable of being vaccinated and aged over 18 years who want to be vaccinated against influenza or for whom the doctor considers prophylactic influenza immunisation to be indicated.
- The inclusion of individuals who had not been immunised in the 2001/2002 season is preferred.
- Written consent to vaccination must be available after the subjects have been briefed on the study in understandable language.
Key exclusion criteria (6 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
- 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
- Pregnancy
- Women who would like to fall pregnant during the period from the day of vaccination to 1 month thereafter
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 2002/2003Single dose, intramuscular injection | Biological | Group A, Group B |
| GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003Single dose, intramuscular injection | Biological | Group C, Group D |
Primary outcome
GMT of the haemagglutination-inhibiting antibodies (HIA) and calculation of seroconversion factor, seroconversion rate and seroprotection rate checked against the CHMP criteria. The seroprotection power will be calculated as well.
Time frame: On Day 21 (± 2) after vaccination
Descriptive comparison of the occurrence, severity and causal relationship to vaccination of solicited local and general symptoms
Time frame: Within 4 days after vaccination
3 secondary outcomes
Descriptive comparison of the occurrence and causal relationship to vaccination of unsolicited signs and symptoms
Time frame: Within 30 days after vaccination
Descriptive comparison of the occurrence, severity and causal relationship to vaccination of any serious adverse events (SAEs)
Time frame: During the entire study period.
Investigation of antibody persistence assessed by the criteria of the CHMP.
Time frame: 11, 19, 27 weeks after 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 8 Aug 2008.
Related trials for Influenza
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
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.
Clinical Trials study director
GlaxoSmithKline
1 site 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 2002/2003 and GlaxoSmithKline Biologicals' Influsplit SSW®/Fluarix™ 2002/2003 in people with Influenza, run by GlaxoSmithKline at 1 site 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 3 inclusion and 6 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 8 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 antibodies (HIA) and calculation of seroconversion factor, seroconversion rate and seroprotection rate checked against the CHMP criteria. The seroprotection power will be calculated as well. (time frame: On Day 21 (± 2) after vaccination). The study lists 2 primary outcomes in all. 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 8 Aug 2008.