Zanamivir Versus Trivalent Split Virus Influenza Vaccine

NCT00784784 | Completed Phase 3 Results

• 2 other identifiers: 08-0189-ACRT113936
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Influenza

Keywords

antiviral drugs; influenza vaccines

Outcome Measures

Primary Outcomes (1)

• 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)

  6 months

Secondary Outcomes (1)

• Number of Subjects Adhering to Long-term Zanamivir Prophylaxis

  5 months

Study Arms (2)

Influenza vaccine

EXPERIMENTAL

Influenza vaccine, using Fluviral trivalent split virus vaccine

Biological: Fluviral

Antiviral prophylaxis

EXPERIMENTAL

Zanamivir antiviral prophylaxis

Drug: Zanamivir

Interventions

Fluviral BIOLOGICAL

One dose

Influenza vaccine

Zanamivir DRUG

10 mg, OD, for duration of influenza season (10-23 weeks)

Also known as: Relenza

Antiviral prophylaxis

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines; Zanamivir

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; Guanidines; Amidines; Organic Chemicals; Sialic Acids; Neuraminic Acids; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amino Sugars; Carbohydrates

Limitations and Caveats

Pilot study: Limited number of participants

Results Point of Contact

• Title: Dr. Brenda Coleman
• Organization: Mount Sinai Hospital

bcoleman@mtsinai.on.ca

416-586-4800

Study Officials

• Allison McGeer, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 3, 2008
• First Posted: November 4, 2008
• Study Start: November 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: June 1, 2009
• Last Updated: November 21, 2014
• Results First Posted: September 2, 2011

Record last verified: 2014-11

Locations

CA (1)