InfluenzaPhase 3Stop-Flu-2NCT00784784
Zanamivir Versus Trivalent Split Virus Influenza Vaccine
A Phase 3 study testing Fluviral and Zanamivir in people with Influenza, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
This unblinded pilot study is intended to assess the feasibility of a larger double-blind, randomized control trial. For the larger trial the investigators are interested in understanding the relative benefits of vaccine and antiviral prophylaxis, the risk factors for influenza infection in healthy adults, and in… Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Fluviral and Zanamivir
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2008to Jun 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-69 years old as of 01/Nov/2008
- have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry
- available for follow-up during the study period
- if a women of child-bearing years, must meet criteria to prevent pregnancy
Who cannot join
- allergy to any component of influenza vaccine or zanamivir
- previous serious adverse event associated with influenza vaccination
- receipt of influenza vaccine between 01/Mar/2008 and start of study
- previous adverse event associated with the use of antiviral medications
- expecting to be unable to take zanamivir for more than 72 hours during study period
- planning to spend more than 2 consecutive weeks outside Canada or more than 100 km from the study site during study period
Show all 14Show fewer
- pregnant, or planning to become pregnant, during study period
- breastfeeding, or planning to breastfeed, a child under 12 months of age during study period
- receipt of immunoglobulin within six months of study entry
- immunocompromising condition or therapy that would be expected to reduce the efficacy of vaccination
- plans to receive cytotoxic or radiation therapy during study period
- history of cardiovascular or pulmonary disease that has required hospital admission within the past year
- history of asthma or other chronic respiratory disease
- participating in a trial that will result in the receipt of an investigational medication during the period that zanamivir may be taken (15/Nov/2008 to 30/Apr/2009)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study for a Randomized Controlled Trial to Compare Trivalent Split Virus Influenza Vaccine to Seasonal Antiviral Prophylaxis in Healthcare and Other Healthy Adults: Assessment of Zanamivir Versus Vaccine (Stop-Flu-2)
This unblinded pilot study is intended to assess the feasibility of a larger double-blind, randomized control trial. For the larger trial the investigators are interested in understanding the relative benefits of vaccine and antiviral prophylaxis, the risk factors for influenza infection in healthy adults, and in assessing the safety and tolerability of seasonal antiviral prophylaxis in healthcare workers.
The pilot study will be assessing the rate of infection with influenza and the rate of adherence to long-term zanamivir in 60 healthy volunteers.
Read the detailed description
Several studies have demonstrated that zanamivir and oseltamivir are effective in preventing influenza infection and illness when used either as prophylaxis after exposure to a household contact with influenza or when taken for several weeks at the height of influenza activity in the general community. However, the longest duration of prophylaxis with neuraminidase inhibitors in two clinical trials, to date, has been six weeks.
Antiviral medication will likely have an important role in the response to the next influenza pandemic. Additionally, there may be indications for use during seasons when the major infecting strain of influenza in not one whose antigen is well covered by the vaccine.
- Conditions
- Influenza
- Being tested
- Fluviral, Zanamivir
- Keywords
- antiviral drugs, influenza vaccines
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluviralBiological
One dose
ZanamivirDrug
Also called Relenza
10 mg, OD, for duration of influenza season (10-23 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Influenza vaccine | Experimental | Influenza vaccine, using Fluviral trivalent split virus vaccine Receives: Biological: Fluviral |
| Antiviral prophylaxis | Experimental | Zanamivir antiviral prophylaxis Receives: Drug: Zanamivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Laboratory Confirmed Influenza Infections
Four-fold increase in antibody titer 2 weeks post injection and end of study or positive laboratory test for influenza during study (polymerase chain reaction [PCR] or culture)
Measured: 6 months
Secondary outcomes (1)
Number of Subjects Adhering to Long-term Zanamivir Prophylaxis
Number of subjects taking 80% or more doses per week of zanamivir (10 mg once daily), as influenza prophylaxis, for 13 weeks or longer (as measured by weekly diary and dose counts at study visits).
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionMay 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Allison McGeer, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00784784
- Sponsor's protocol ID
- 08-0189-A
- Other IDs
- CRT113936
- Acronym
- Stop-Flu-2
- Status last verified
- Nov 2014
- First submitted
- 3 Nov 2008
- Last updated
- 21 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for a Randomized Controlled Trial to Compare Trivalent Split Virus Influenza Vaccine to Seasonal Antiviral Prophylaxis in Healthcare and Other Healthy Adults: Assessment of Zanamivir Versus Vaccine (Stop-Flu-2)
- ClinicalTrials.gov ID
- NCT00784784
- Acronym / sponsor ID
- Stop-Flu-2 / 08-0189-A
- Conditions
- Influenza
- Keywords
- antiviral drugs, influenza vaccines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Nov 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 4 Nov 2008 (estimated)
- Results
- Posted 2 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This unblinded pilot study is intended to assess the feasibility of a larger double-blind, randomized control trial. For the larger trial the investigators are interested in understanding the relative benefits of vaccine and antiviral prophylaxis, the risk factors for influenza infection in healthy adults, and in assessing the safety and tolerability of seasonal antiviral prophylaxis in healthcare workers.
The pilot study will be assessing the rate of infection with influenza and the rate of adherence to long-term zanamivir in 60 healthy volunteers.
Detailed description
Several studies have demonstrated that zanamivir and oseltamivir are effective in preventing influenza infection and illness when used either as prophylaxis after exposure to a household contact with influenza or when taken for several weeks at the height of influenza activity in the general community. However, the longest duration of prophylaxis with neuraminidase inhibitors in two clinical trials, to date, has been six weeks.
Antiviral medication will likely have an important role in the response to the next influenza pandemic. Additionally, there may be indications for use during seasons when the major infecting strain of influenza in not one whose antigen is well covered by the vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Influenza vaccine | Experimental | Biological: FluviralInfluenza vaccine, using Fluviral trivalent split virus vaccine |
| Antiviral prophylaxis | Experimental | Drug: ZanamivirZanamivir antiviral prophylaxis |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-69 years old as of 01/Nov/2008
- have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry
- available for follow-up during the study period
- if a women of child-bearing years, must meet criteria to prevent pregnancy
Key exclusion criteria (14 listed)
- allergy to any component of influenza vaccine or zanamivir
- previous serious adverse event associated with influenza vaccination
- receipt of influenza vaccine between 01/Mar/2008 and start of study
- previous adverse event associated with the use of antiviral medications
- expecting to be unable to take zanamivir for more than 72 hours during 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 |
|---|---|---|
| FluviralOne dose | Biological | Influenza vaccine |
| ZanamivirAlso: Relenza10 mg, OD, for duration of influenza season (10-23 weeks) | Drug | Antiviral prophylaxis |
Primary outcome
Number of Laboratory Confirmed Influenza Infections
Time frame: 6 months
Four-fold increase in antibody titer 2 weeks post injection and end of study or positive laboratory test for influenza during study (polymerase chain reaction [PCR] or culture)
1 secondary outcome
Number of Subjects Adhering to Long-term Zanamivir Prophylaxis
Time frame: 5 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Allison McGeer, MD principal investigator
MOUNT SINAI HOSPITAL
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 Fluviral and Zanamivir in people with Influenza, run by Mount Sinai Hospital, Canada at 1 site in Canada.
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 14 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 21 Nov 2014. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 2 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Laboratory Confirmed Influenza Infections (time frame: 6 months). 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 21 Nov 2014.