Influenza VaccinePhase 4PCIRNRT09NCT01368796
Comparison of 4 Influenza Vaccines in Seniors
A Phase 4 study testing Agriflu, Fluad and Intanza in people with Influenza Vaccine, run by University of British Columbia at 8 sites in Canada.
Trial summary
Based on information from several years of looking at Influenza vaccination doctors know that: Older adults suffer the worst illness and most deaths caused by Influenza illness of all age groups. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza Vaccine
- What is being tested?
- Agriflu, Fluad and Intanza
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 953 participants
- Where
- 8 sitesCanada
- Study dates
- Jul 2011to May 2012
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Written informed consent provided by the subject, who can be male or female
- Subjects who the investigator believes can and will comply with the requirements of the protocol (i.e. return for follow-up visits, record safety observations and able to converse with study personnel including by personal telephone)
- Age 65 years or older at Visit 1
- Generally good health (stable chronic conditions acceptable), living independently or with minimal assistance (Clinical Frailty score 1-5) (33) and able to attend clinic appointments
- Receipt of at least one dose of TIV within the previous 2 influenza seasons, documented by written record or attested by a confident personal recollection. This refers to the trivalent seasonal vaccine, not the H1N12009 pandemic vaccine.
Who cannot join
- receipt of non-study influenza vaccine for 2011-12
- receipt of any live vaccine within 4 weeks or inactivated vaccine within one week of Visit 1 or planned administration of any non-study vaccines between Visits 1 and 2
- systemic hypersensitivity to influenza vaccine, hen's eggs or other vaccine constituent (eg neomycin sulphate, kanamycin, formalin)
- severe reaction to any previous influenza vaccine or vaccine component
- bleeding disorder, including anticoagulant therapy or thrombocytopenia, that contraindicates IM injection or blood collection (does not include daily low-dose ASA).
- incapacity to provide fully informed consent or be attentive to follow-up observations, resulting from cognitive impairment, abuse of alcohol, drug addiction
Show all 12Show fewer
- lack of telephone access, inadequate fluency in English (or French in applicable jurisdictions), uncertain availability during the 3 week study participation period or for the 6 month follow-up visit
- immune compromise resulting from disease or immunosuppressive systemic medication use within 3 months of V1
- receipt of blood or blood product within 3 months of V1
- unstable medical condition, as indicated by a requirement for hospitalization or a substantial medication change to stabilize said condition within previous 3 months
- Clinical Frailty score of 6-7 (moderately frail or severely frail)
- history of Guillain-Barré syndrome
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
Canadian Centre for Vaccinology Dalhousie University
Halifax, Nova Scotia
McMaster University
Hamilton, Ontario
McGill University Health Center - Vaccine Study Center
Montreal, Quebec
The Ottawa Hospital Research Institute, University of Ottawa
Ottawa, Ontario
Unité de Recherche en Santé Publique (CHUQ),
Québec, Quebec
University of Toronto, Mt Sinai Hospital
Toronto, Ontario
University of British Columbia, VITALiTY Research Center
Vancouver, British Columbia
University of Manitoba, Department of Medicine
Winnipeg, Manitoba
About this study
Official title: Controlled Comparison in Canadian Seniors of Seasonal Influenza Vaccines for 2011-2012
Based on information from several years of looking at Influenza vaccination doctors know that:
- Older adults suffer the worst illness and most deaths caused by Influenza illness of all age groups.
- Older adults do not seem to get as good a level of protection as younger adults after getting the usual seasonal Influenza vaccine.
Read more
Because of this information doctors wonder if one of the new seasonal Influenza vaccines is more effective or more acceptable.
This study has been designed to answer some of these questions. On this study doctors will compare 2 new vaccines against the usual seasonal influenza vaccine for protectiveness using several different testing methods (including the usual tests) and for acceptability.
Read the detailed description
This study is prospective, multicenter, randomized, evaluator-blinded, controlled, parallel group study of 3 licensed seasonal influenza vaccine products conducted in seniors, with a 4th vaccine included in a substudy of cellular immune responses.
Ambulatory adults 65+ years of age, in good health or with stable health conditions, given TIV within the past 2 years, will be recruited in multiple Canadian centres. Subjects can be dwelling in the community or in centers providing minimal assisted living support. A total of 930 subjects will be enrolled.
Subjects will be centrally (electronically) randomized to receive either TIV, IDV or AIV on Day 0. Three blood samples will be collected (1 pre and 2 post vaccination) to measure HAI antibody responses to each virus strain (H1N1, H3N2 and B) in each vaccine, using standardized assays. Randomly selected subsets of sera from each study group will also be tested for neutralizing antibody and for cross-protection against drift variants of H3N2, H1N1 and B viruses. In a subset of subjects in Vancouver, randomization assignments will include TIV2 and extra blood samples will be obtained 0, 21 and 72 days post vaccination for CMI testing. Safety assessments will be conducted on Day 7, Day 21 and Day 180 following vaccination. Acceptability of each product, reflecting the frequency, severity and tolerability of adverse effects, will be assessed.
- Conditions
- Influenza Vaccine
- Being tested
- Agriflu, Fluad, Intanza, Vaxigrip
- Keywords
- Vaccine, Influenza vaccine, Adjuvanted Influenza vaccine, Intradermal Influenza vaccine, Seniors, Acceptability of vaccines, 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.
AgrifluBiological
0.5mL dose IM vaccination
FluadBiological
0.5mL dose of vaccine given IM
IntanzaBiological
0.5mL dose vaccine given IM
VaxigripBiological
0.5mL dose vaccine given IM
| Study group | Role | What they receive |
|---|---|---|
| Trivalent Influenza vaccine subunit | Active comparator | The seasonal vaccine (Agriflu, Novartis) contains egg-derived, inactivated and detergent split versions of the 3 influenza strains (tri-valent). It is given into the muscle of the upper arm at a dose of 0.5 mL. Receives: Biological: Agriflu |
| Adjuvanted Tri-valent Influenza Vaccine | Active comparator | The adjuvanted vaccine (Fluad, Novartis) is made with an immune-stimulator (MF59) that contains squalene oil microdroplets and two surfactants, Tween 80 and Span 65. It is given into the muscle of the upper arm at a dose of 0.5 mL. Receives: Biological: Fluad |
| Intradermal Tri-valent Influenza vaccine | Active comparator | (Intanza 15ug, Sanofi Pasteur) is an inactivated, split-virion influenza vaccine. Strains are grown in fertilized hen's eggs, inactivated with formalin and split using Triton X-100 detergent, as for TIV. The syringe is attached to a micro-needle injection system (Beckton Dickinson) that limits the depth of injection to just under the skin. It is given into the skin over the upper arm at a dose of 0.1 mL. Receives: Biological: Intanza |
| Trivalent Split-virion Influenza vaccine | Active comparator | Vaxigrip, Sanofi Pasteur is an inactivated, split-virion Influenza vaccine. The 3 influenza strains are grown on fertilized eggs, concentrated, purified in a sugar-like solution, detergent split, and inactivated by formaldehyde, then diluted in phosphate buffered salt solution. A dose of 0.5 mL is given into the muscle of the arm. Receives: Biological: Vaxigrip |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAI response
The primary outcome measures will be the 3-week post-vaccination immune (HAI) responses to the 3 vaccine strains present in each product, assessed by the EMEA/CHMP criteria for evaluation of immune responses to influenza vaccines in persons >60 years of age.
Measured: Day 0; Day 21; Day 180
Secondary outcomes (2)
Seroprotection rates using microneutralization titres and cytokine testing
As secondary immunologic outcomes seroprotection rates will be compared between the products using a higher titer (≥160) as threshold. Microneutralization titers will be compared among products at the 3 sampling points, using sera from 100 subjects per group. Cross-protection afforded by each vaccine against drift variants of H3N2, H1N1 and B viruses will be assessed using serum panels selected from 50 subjects in each group. Cellular immune responses elicited will be compared in subgroups of 30 subjects per vaccine in the CMI subjset.
Measured: Day 0; Day 21; and Day 70
Safety and Acceptability
Safety and acceptability of the vaccines will also be examined and compared as the safety outcomes. The primary outcome measurements will be the rates of local adverse events (pain, redness, swelling, itchiness) as rates of general adverse events are not expected to differ substantially among the products.
Measured: Days 0-6; Day 21; Day 70; and Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2011
- Study completionMay 2012
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 Influenza VaccineStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 953 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- PHAC/CIHR Influenza Research Network
- Responsible party
- Sponsor
- Investigators
- David W Scheifele, MD, Principal investigator, University of Britich Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368796
- Sponsor's protocol ID
- H11-01457
- Acronym
- PCIRNRT09
- Status last verified
- Apr 2015
- First submitted
- 6 Jun 2011
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Skowronski DM, Janjua NZ, De Serres G, Purych D, Gilca V, Scheifele DW, Dionne M, Sabaiduc S, Gardy JL, Li G, Bastien N, Petric M, Boivin G, Li Y. Cross-reactive and vaccine-induced antibody to an emerging swine-origin variant of influenza A virus subtype H3N2 (H3N2v). J Infect Dis. 2012 Dec 15;206(12):1852-61. doi: 10.1093/infdis/jis500. Epub 2012 Aug 7.
PubMed 22872731
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Comparison in Canadian Seniors of Seasonal Influenza Vaccines for 2011-2012
- ClinicalTrials.gov ID
- NCT01368796
- Acronym / sponsor ID
- PCIRNRT09 / H11-01457
- Conditions
- Influenza Vaccine
- Keywords
- Vaccine, Influenza vaccine, Adjuvanted Influenza vaccine, Intradermal Influenza vaccine, Seniors, Acceptability of vaccines, Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 953 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- PHAC/CIHR Influenza Research Network
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 8 Jun 2011 (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.
Based on information from several years of looking at Influenza vaccination doctors know that:
- Older adults suffer the worst illness and most deaths caused by Influenza illness of all age groups.
- Older adults do not seem to get as good a level of protection as younger adults after getting the usual seasonal Influenza vaccine.
Because of this information doctors wonder if one of the new seasonal Influenza vaccines is more effective or more acceptable.
This study has been designed to answer some of these questions. On this study doctors will compare 2 new vaccines against the usual seasonal influenza vaccine for protectiveness using several different testing methods (including the usual tests) and for acceptability.
Detailed description
This study is prospective, multicenter, randomized, evaluator-blinded, controlled, parallel group study of 3 licensed seasonal influenza vaccine products conducted in seniors, with a 4th vaccine included in a substudy of cellular immune responses.
Ambulatory adults 65+ years of age, in good health or with stable health conditions, given TIV within the past 2 years, will be recruited in multiple Canadian centres. Subjects can be dwelling in the community or in centers providing minimal assisted living support. A total of 930 subjects will be enrolled.
Subjects will be centrally (electronically) randomized to receive either TIV, IDV or AIV on Day 0. Three blood samples will be collected (1 pre and 2 post vaccination) to measure HAI antibody responses to each virus strain (H1N1, H3N2 and B) in each vaccine, using standardized assays. Randomly selected subsets of sera from each study group will also be tested for neutralizing antibody and for cross-protection against drift variants of H3N2, H1N1 and B viruses. In a subset of subjects in Vancouver, randomization assignments will include TIV2 and extra blood samples will be obtained 0, 21 and 72 days post vaccination for CMI testing. Safety assessments will be conducted on Day 7, Day 21 and Day 180 following vaccination. Acceptability of each product, reflecting the frequency, severity and tolerability of adverse effects, will be assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Trivalent Influenza vaccine subunit | Active comparator | Biological: AgrifluThe seasonal vaccine (Agriflu, Novartis) contains egg-derived, inactivated and detergent split versions of the 3 influenza strains (tri-valent). It is given into the muscle of the upper arm at a dose of 0.5 mL. |
| Adjuvanted Tri-valent Influenza Vaccine | Active comparator | Biological: FluadThe adjuvanted vaccine (Fluad, Novartis) is made with an immune-stimulator (MF59) that contains squalene oil microdroplets and two surfactants, Tween 80 and Span 65. It is given into the muscle of the upper arm at a dose of 0.5 mL. |
| Intradermal Tri-valent Influenza vaccine | Active comparator | Biological: Intanza(Intanza 15ug, Sanofi Pasteur) is an inactivated, split-virion influenza vaccine. Strains are grown in fertilized hen's eggs, inactivated with formalin and split using Triton X-100 detergent, as for TIV. The syringe is attached to a micro-needle injection system (Beckton Dickinson) that limits the depth of injection to just under the skin. It is given into the skin over the upper arm at a dose of 0.1 mL. |
| Trivalent Split-virion Influenza vaccine | Active comparator | Biological: VaxigripVaxigrip, Sanofi Pasteur is an inactivated, split-virion Influenza vaccine. The 3 influenza strains are grown on fertilized eggs, concentrated, purified in a sugar-like solution, detergent split, and inactivated by formaldehyde, then diluted in phosphate buffered salt solution. A dose of 0.5 mL is given into the muscle of the arm. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Written informed consent provided by the subject, who can be male or female
- Subjects who the investigator believes can and will comply with the requirements of the protocol (i.e. return for follow-up visits, record safety observations and able to converse with study personnel including by personal telephone)
- Age 65 years or older at Visit 1
- Generally good health (stable chronic conditions acceptable), living independently or with minimal assistance (Clinical Frailty score 1-5) (33) and able to attend clinic appointments
- Receipt of at least one dose of TIV within the previous 2 influenza seasons, documented by written record or attested by a confident personal recollection. This refers to the trivalent seasonal vaccine, not the H1N12009 pandemic vaccine.
Key exclusion criteria (12 listed)
- receipt of non-study influenza vaccine for 2011-12
- receipt of any live vaccine within 4 weeks or inactivated vaccine within one week of Visit 1 or planned administration of any non-study vaccines between Visits 1 and 2
- systemic hypersensitivity to influenza vaccine, hen's eggs or other vaccine constituent (eg neomycin sulphate, kanamycin, formalin)
- severe reaction to any previous influenza vaccine or vaccine component
- bleeding disorder, including anticoagulant therapy or thrombocytopenia, that contraindicates IM injection or blood collection (does not include daily low-dose ASA).
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 |
|---|---|---|
| Agriflu0.5mL dose IM vaccination | Biological | Trivalent Influenza vaccine subunit |
| Fluad0.5mL dose of vaccine given IM | Biological | Adjuvanted Tri-valent Influenza Vaccine |
| Intanza0.5mL dose vaccine given IM | Biological | Intradermal Tri-valent Influenza vaccine |
| Vaxigrip0.5mL dose vaccine given IM | Biological | Trivalent Split-virion Influenza vaccine |
Primary outcome
HAI response
Time frame: Day 0; Day 21; Day 180
The primary outcome measures will be the 3-week post-vaccination immune (HAI) responses to the 3 vaccine strains present in each product, assessed by the EMEA/CHMP criteria for evaluation of immune responses to influenza vaccines in persons >60 years of age.
2 secondary outcomes
Seroprotection rates using microneutralization titres and cytokine testing
Time frame: Day 0; Day 21; and Day 70
Safety and Acceptability
Time frame: Days 0-6; Day 21; Day 70; and Day 180
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 Apr 2015.
- Derived from this study: PubMed 22872731Skowronski DM, Janjua NZ, De Serres G, Purych D, Gilca V, Scheifele DW, Dionne M, Sabaiduc S, Gardy JL, Li G, Bastien N, Petric M, Boivin G, Li Y. Cross-reactive and vaccine-induced antibody to an emerging swine-origin variant of influenza A virus subtype H3N2 (H3N2v). J Infect Dis. 2012 Dec 15;206(12):1852-61. doi: 10.1093/infdis/jis500. Epub 2012 Aug 7.
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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.
David W Scheifele, MD principal investigator
University of Britich Columbia
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Agriflu, Fluad and Intanza in people with Influenza Vaccine, run by University of British Columbia at 8 sites 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 5 inclusion and 12 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 Apr 2015. 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 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
HAI response (time frame: Day 0; Day 21; Day 180). 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 NCT01368796, 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 15 Apr 2015.