Comparison of 4 Influenza Vaccines in Seniors (PCIRNRT09)
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|ClinicalTrials.gov Identifier: NCT01368796|
Recruitment Status : Completed
First Posted : June 8, 2011
Last Update Posted : April 15, 2015
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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.
|Condition or disease||Intervention/treatment||Phase|
|Influenza Vaccine||Biological: Agriflu Biological: Fluad Biological: Intanza Biological: Vaxigrip||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||953 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Controlled Comparison in Canadian Seniors of Seasonal Influenza Vaccines for 2011-2012|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||May 2012|
Active Comparator: Trivalent Influenza vaccine subunit
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.
0.5mL dose IM vaccination
Active Comparator: Adjuvanted Tri-valent Influenza Vaccine
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.
0.5mL dose of vaccine given IM
Active Comparator: Intradermal Tri-valent Influenza vaccine
(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.
0.5mL dose vaccine given IM
Active Comparator: Trivalent Split-virion Influenza vaccine
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.
0.5mL dose vaccine given IM
- 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.
- Seroprotection rates using microneutralization titres and cytokine testing [ Time Frame: Day 0; Day 21; and Day 70 ]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.
- Safety and Acceptability [ Time Frame: Days 0-6; Day 21; Day 70; and Day 180 ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||65 Years and older (Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01368796
|Canada, British Columbia|
|University of British Columbia, VITALiTY Research Center|
|Vancouver, British Columbia, Canada|
|University of Manitoba, Department of Medicine|
|Winnipeg, Manitoba, Canada|
|Canada, Nova Scotia|
|Canadian Centre for Vaccinology Dalhousie University|
|Halifax, Nova Scotia, Canada|
|Hamilton, Ontario, Canada|
|The Ottawa Hospital Research Institute, University of Ottawa|
|Ottawa, Ontario, Canada|
|University of Toronto, Mt Sinai Hospital|
|Toronto, Ontario, Canada|
|McGill University Health Center - Vaccine Study Center|
|Montreal, Quebec, Canada|
|Unité de Recherche en Santé Publique (CHUQ),|
|Quebec City, Quebec, Canada|
|Principal Investigator:||David W Scheifele, MD||University of Britich Columbia|
|Responsible Party:||University of British Columbia|
|Other Study ID Numbers:||
|First Posted:||June 8, 2011 Key Record Dates|
|Last Update Posted:||April 15, 2015|
|Last Verified:||April 2015|
Adjuvanted Influenza vaccine
Intradermal Influenza vaccine
Acceptability of vaccines
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases