Comparison of 4 Influenza Vaccines in Seniors

NCT01368796 | Completed Phase 4

• 1 other identifier: H11-01457
• Study Type: interventional
• Target: 953
• Locations: 1 country
• Sites: 8

Brief 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.
• 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.

Conditions

Influenza Vaccine

Keywords

Vaccine; Influenza vaccine; Adjuvanted Influenza vaccine; Intradermal Influenza vaccine; Seniors; Acceptability of vaccines; Influenza

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0; Day 21; Day 180

Secondary Outcomes (2)

• Seroprotection rates using microneutralization titres and cytokine testing

  Day 0; Day 21; and Day 70

• Safety and Acceptability

  Days 0-6; Day 21; Day 70; and Day 180

Study Arms (4)

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.

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.

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.

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.

Biological: Vaxigrip

Interventions

Agriflu BIOLOGICAL

0.5mL dose IM vaccination

Trivalent Influenza vaccine subunit

Fluad BIOLOGICAL

0.5mL dose of vaccine given IM

Adjuvanted Tri-valent Influenza Vaccine

Intanza BIOLOGICAL

0.5mL dose vaccine given IM

Intradermal Tri-valent Influenza vaccine

Vaxigrip BIOLOGICAL

0.5mL dose vaccine given IM

Trivalent Split-virion Influenza vaccine

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• PHAC/CIHR Influenza Research Network: collaborator

Study Sites (8)

University of British Columbia, VITALiTY Research Center

Vancouver, British Columbia, Canada

Location

University of Manitoba, Department of Medicine

Winnipeg, Manitoba, Canada

Location

Canadian Centre for Vaccinology Dalhousie University

Halifax, Nova Scotia, Canada

Location

McMaster University

Hamilton, Ontario, Canada

Location

The Ottawa Hospital Research Institute, University of Ottawa

Ottawa, Ontario, Canada

Location

University of Toronto, Mt Sinai Hospital

Toronto, Ontario, Canada

Location

McGill University Health Center - Vaccine Study Center

Montreal, Quebec, Canada

Location

Unité de Recherche en Santé Publique (CHUQ),

Québec, Quebec, Canada

Location

Related Publications (1)

• 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.

  PMID: 22872731 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines; fluad vaccine; vaxigrip

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• David W Scheifele, MD

  University of Britich Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2011
• First Posted: June 8, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: May 1, 2012
• Last Updated: April 15, 2015

Record last verified: 2015-04

Locations

CA (8)