Trials Sponsors Conditions Drugs Pricing

Conditions

Influenza Vaccination in Seniors

Keywords

influenza, humaninfluenza vaccinesolder adultsimmune response

Outcome Measures

Primary Outcomes (3)

Reactogenicity of the vaccine regimens
Reactogenicity of the vaccine regimens (Intanza+resiquimod gel; Intanza+placebo gel) will be collected from Day 0 (pre vaccination) to Day 7. The change from Day 0 to Day 7 will be measured. The following information will be collected and compared 1) local pain (none, mild, moderate, severe; 2) injection site redness, swelling, induration measured in millimeters; itchiness present or not 3) bruising; 4) fever-values greater than or equal to 38.0 will be considered fever; 5) general symptoms-shivering, sweating nausea, vomiting diarrhea will be measured for presence or absence; 6) general symptoms-myalgia (muscle aches), arthralgia (joint aches), malaise (feeling unwell), tiredness/fatigue, headache and sleep disturbance will be measured as mild, moderate or severe
Day 0 - Day 28
HAI (hemagglutination inhibition)titres
The primary immunologic outcome will be the 28 day post vaccination immune (HAI, hemagglutination immune assay titer)responses to the 3 vaccine strains present in each vaccine, assessed by the EMEA/CHMP (European Medicines Evaluation/Committee on Human Medicinal Products) Agency criteria for evaluation on immune response to influenza vaccines in persons over 60 years of age. The measurements include seroconversion rate (CHMP threshold greater than 30%), geometric mean titre (GMT) fold-increase or ratio (threshold greater than 2) and seroprotection rate (threshold greater than 60%). Whether the CHMP threshold for each measurement is met or exceeded per strain will be noted between products as descriptive information.
Day 28 post vaccination
Granzyme B levels and Interferon gamma to interleukin 10 ratios
The day 0 (pre vaccination) and day 28 Granzyme B levels and Interferon gamma to interleukin 10 ratios will be measured and the change in levels from Day 0 to Day 28 will be compared in the 2 groups: 1) Intanza+resiquimod gel; 2) Intanza+placebo gel
Day 0 and Day 28 post vaccination

Secondary Outcomes (2)

Change in Microneutralization titres
Day 0 and Day 28 post vaccination
baseline Granzyme B Activity
Day 0 and Day 28 post vaccination

Study Arms (2)

Intanza+resiquimod gel

ACTIVE COMPARATOR

Intanza 15mcg intradermal injection + resiquimod gel applied to the vaccination site immediately post vaccination.

Drug: resiquimod

Intanza + placebo gel

PLACEBO COMPARATOR

Intanza 15mcg intradermal injection + placebo gel applied to the vaccination site immediately post vaccination.

Drug: placebo gel

Interventions

resiquimodDrug

Also known as: R-848

Intanza+resiquimod gel

placebo gelDrug

Intanza + placebo gel

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age65 Years - 75 Years

Sexall

Healthy VolunteersYes

Age GroupsOlder 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

Sponsors & Collaborators

University of British Columbia
Otherlead

Study Sites (1)

University of British Columbia Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

MeSH Terms

Conditions

Influenza, Human

Interventions

resiquimod

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

Jan P Dutz, MD
University of British Columbia
PRINCIPAL INVESTIGATOR

Enrollment

59 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 21, 2012

First Posted

November 29, 2012

Study Start

April 2013

Date type not reported

This date has not been verified as actual or estimated.

Enhancing Influenza Vaccination in Seniors With TLR (Toll Like Receptor) Agonists

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (2)

Study Arms (2)

Intanza+resiquimod gel

Intanza + placebo gel

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (2)

Study Arms (2)

Intanza+resiquimod gel

Intanza + placebo gel

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations