InfluenzaPhase 2NCT00703651
Study of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route Versus Vaxigrip® in Adults
A Phase 2 study testing Inactivated, split-virion influenza vaccine in people with Influenza and Orthomyxoviridae Infection, run by Sanofi Pasteur, a Sanofi Company at 8 sites in 3 countries.
Trial summary
This is a follow-up of a previous dose-ranging study aimed at investigating 2 doses of the trivalent inactivated split virion influenza vaccine when administered by intradermal route with that of the current pharmaceutical presentation administered by intramuscular route. Read more about this study
- Who is it for?
- Ages 18 to 57 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Orthomyxoviridae Infection, Myxovirus Infection
- What is being tested?
- Inactivated, split-virion influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,150 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Sep 2003to Jul 2006
- Phase
- Phase 2
- 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 to 57 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject aged between 18 and 57 years (i.e., less than 60 at the last vaccination)
- For woman of child-bearing potential, negative urine pregnancy test at V#01
- Use of effective contraception prior to and during the trial
- Subject available during the trial period
- Subject able to read and understand the informed consent form
- Informed consent form signed and dated by the subject prior to any protocol-required intervention (and Visit 05 and Visit 07, respectively).
Who cannot join
- Self-reported allergy to egg proteins, chick proteins, or any of the constituents of the vaccine, in particular, neomycin, formaldehyde, and octoxinol 9
- Acute febrile disease within the 72 hours preceding V#01, or axillary temperature >37.5°C the day of inclusion, prior to vaccination (>37.0°C Czech Republic)
- Subject with an aggravation of existing chronic illness (heart disease, respiratory disease, etc.)
- Vaccination against influenza within the 6 months preceding V#01
- Any vaccination within the 28 days preceding V#01 or scheduled between V#01 and V#02
- Breast-feeding
Show all 11Show fewer
- Immunosuppressive therapy including long term systemic corticotherapy (20 mg/day of prednisolone or equivalent for >2 weeks) or cancer therapy within the month preceding V#01 or ongoing
- Immunoglobulin injection within the 3 months preceding V#01
- Subject taking part or planned to take part in another clinical trial (3 months before and through the trial duration)
- Subject having received extracted pituitary hormones
- Subjects who participated in the GID01 study (Lithuanian centers)
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Belgium5 sites
Study site
Gribomont
Study site
Kraainem
Study site
Linkebeek
Study site
Molenbeek
Study site
Thuin
About this study
Official title: Immunogenicity of Two Dosages of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Vaxigrip® in Adults
This is a follow-up of a previous dose-ranging study aimed at investigating 2 doses of the trivalent inactivated split virion influenza vaccine when administered by intradermal route with that of the current pharmaceutical presentation administered by intramuscular route.
Primary Objective:
To assess the immunogenicity of two pharmaceutical presentations of the trivalent inactivated split virion influenza vaccine 21 days after a single injection in subjects aged 18 to 57 years.
Secondary Objective:
To evaluate the safety profile during the 21-day period following each vaccination in each study group
Read the detailed description
This is an open (for the administration route) and double-blind (only for the two dosages administered at year 0 by using the investigational administration route) randomized trial conducted in subjects aged 18 to 60 years. The subjects will receive three vaccine injections at 1-year interval.
- Conditions
- Influenza, Orthomyxoviridae Infection, Myxovirus Infection
- Being tested
- Inactivated, split-virion influenza vaccine
- Keywords
- Influenza, Orthomyxoviridae Infection, Inactivated, Split-virion influenza vaccine, Intradermal injection, Adults.
- Medical subject headings
- Influenza, Human, Orthomyxoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated, split-virion influenza vaccineBiological
0.1 mL, ID. 1 injection/year for 3 years
Inactivated, split-virion influenza vaccineBiological
0.1 mL, ID. 1 injection/year for 3 years.
Inactivated, split-virion influenza vaccineBiological
Also called Vaxigrip®
0.5 mL, IM. 1 injection/year for 3 years
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: Inactivated, split-virion influenza vaccine |
| 2 | Experimental | Not described Receives: Biological: Inactivated, split-virion influenza vaccine |
| 3 | Active comparator | Not described Receives: Biological: Inactivated, split-virion influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide information concerning the immunogenicity of Inactivated, Split-Virion Influenza Vaccine.
Measured: 21days post-vaccination
To provide information concerning the safety of Inactivated, Split-Virion Influenza Vaccine
Measured: 21 days post-vaccination and entire study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2008 (estimated)
- Study startSep 2003
- Primary completionMay 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Sanofi Pasterur Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703651
- Sponsor's protocol ID
- GID02
- Status last verified
- Jan 2014
- First submitted
- 19 Jun 2008
- Last updated
- 13 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Beran J, Ambrozaitis A, Laiskonis A, Mickuviene N, Bacart P, Calozet Y, Demanet E, Heijmans S, Van Belle P, Weber F, Salamand C. Intradermal influenza vaccination of healthy adults using a new microinjection system: a 3-year randomised controlled safety and immunogenicity trial. BMC Med. 2009 Apr 2;7:13. doi: 10.1186/1741-7015-7-13.
PubMed 19341446
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of Two Dosages of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Vaxigrip® in Adults
- ClinicalTrials.gov ID
- NCT00703651
- Acronym / sponsor ID
- GID02
- Conditions
- Influenza, Orthomyxoviridae Infection, Myxovirus Infection
- Keywords
- Influenza, Orthomyxoviridae Infection, Inactivated, Split-virion influenza vaccine, Intradermal injection, Adults.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,150 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Primary completion
- May 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 23 Jun 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 follow-up of a previous dose-ranging study aimed at investigating 2 doses of the trivalent inactivated split virion influenza vaccine when administered by intradermal route with that of the current pharmaceutical presentation administered by intramuscular route.
Primary Objective:
To assess the immunogenicity of two pharmaceutical presentations of the trivalent inactivated split virion influenza vaccine 21 days after a single injection in subjects aged 18 to 57 years.
Secondary Objective:
To evaluate the safety profile during the 21-day period following each vaccination in each study group
Detailed description
This is an open (for the administration route) and double-blind (only for the two dosages administered at year 0 by using the investigational administration route) randomized trial conducted in subjects aged 18 to 60 years. The subjects will receive three vaccine injections at 1-year interval.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Inactivated, split-virion influenza vaccine |
| 2 | Experimental | Biological: Inactivated, split-virion influenza vaccine |
| 3 | Active comparator | Biological: Inactivated, split-virion influenza vaccine |
Who may qualify
- Ages
- 18 to 57 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subject aged between 18 and 57 years (i.e., less than 60 at the last vaccination)
- For woman of child-bearing potential, negative urine pregnancy test at V#01
- Use of effective contraception prior to and during the trial
- Subject available during the trial period
- Subject able to read and understand the informed consent form
Key exclusion criteria (11 listed)
- Self-reported allergy to egg proteins, chick proteins, or any of the constituents of the vaccine, in particular, neomycin, formaldehyde, and octoxinol 9
- Acute febrile disease within the 72 hours preceding V#01, or axillary temperature >37.5°C the day of inclusion, prior to vaccination (>37.0°C Czech Republic)
- Subject with an aggravation of existing chronic illness (heart disease, respiratory disease, etc.)
- Vaccination against influenza within the 6 months preceding V#01
- Any vaccination within the 28 days preceding V#01 or scheduled between V#01 and V#02
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 |
|---|---|---|
| Inactivated, split-virion influenza vaccine0.1 mL, ID. 1 injection/year for 3 years | Biological | 1 |
| Inactivated, split-virion influenza vaccine0.1 mL, ID. 1 injection/year for 3 years. | Biological | 2 |
| Inactivated, split-virion influenza vaccineAlso: Vaxigrip®0.5 mL, IM. 1 injection/year for 3 years | Biological | 3 |
Primary outcome
To provide information concerning the immunogenicity of Inactivated, Split-Virion Influenza Vaccine.
Time frame: 21days post-vaccination
To provide information concerning the safety of Inactivated, Split-Virion Influenza Vaccine
Time frame: 21 days post-vaccination and entire study duration
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 13 Jan 2014.
- Derived from this study: PubMed 19341446Beran J, Ambrozaitis A, Laiskonis A, Mickuviene N, Bacart P, Calozet Y, Demanet E, Heijmans S, Van Belle P, Weber F, Salamand C. Intradermal influenza vaccination of healthy adults using a new microinjection system: a 3-year randomised controlled safety and immunogenicity trial. BMC Med. 2009 Apr 2;7:13. doi: 10.1186/1741-7015-7-13.
- Related InfoLink provided by the sponsor.
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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.
Medical Monitor study director
Sanofi Pasterur Inc
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inactivated, split-virion influenza vaccine in people with Influenza and Orthomyxoviridae Infection, run by Sanofi Pasteur, a Sanofi Company at 8 sites in 3 countries.
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 6 inclusion and 11 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 13 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium, Lithuania, Czechia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To provide information concerning the immunogenicity of Inactivated, Split-Virion Influenza Vaccine. (time frame: 21days post-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?
On the ClinicalTrials.gov record for NCT00703651, which also lists 1 linked publication.
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 13 Jan 2014.