Two-site Intradermal Influenza Vaccination in Elderly

NCT ID: NCT01202552

Last Updated: 2018-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2018-04-30

Brief Summary

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One-site dose sparing intradermal influenza vaccination in elderly had been studied but resulted in unsatisfactory outcomes. The investigators evaluate the safety and immunogenicity of the two-site intradermal injection of influenza vaccine containing all 6 and 12 micrograms of hemagglutinin antigen per strain (with 4/10th and 8/10th of a regular 15 microgram HA/strain intramuscular vaccine respectively) in elderly over 60 years of age. An influenza vaccine administered intramuscularly at the standard dose is used as the reference vaccine.

Detailed Description

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The subjects would be randomly divided into three groups of 60 subjects each. Group1 receives a single intramuscular dose of 0.5 ml of trivalent influenza vaccine, containing at least 15 microgram of hemagglutinin antigen per strain, Group II receives two-site intradermal dose of 0.1 ml each, containing at least 3 microgram of hemagglutinin antigen per strain per site and group III receives two-site intradermal dose of 0.2 ml each, containing at least 6 microgram of hemagglutinin antigen per strain per site. Check for HA Antibody

Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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group 1

receives a single intramuscular dose of 0.5 ml of trivalent influenza vaccine, containing at least 15 microgram of hemagglutinin antigen per strain

Group Type EXPERIMENTAL

seasonal influenza vaccine

Intervention Type BIOLOGICAL

receives a single intramuscular dose of 0.5 ml of trivalent influenza vaccine, containing at least 15 microgram of hemagglutinin antigen per strain

group 2

receives two-site intradermal dose of 0.1 ml each, containing at least 3 microgram of hemagglutinin antigen per strain per site

Group Type EXPERIMENTAL

seasonal influenza vaccine

Intervention Type BIOLOGICAL

receives two-site intradermal dose of 0.1 ml each, containing at least 3 microgram of hemagglutinin antigen per strain per site and group

group 3

receives two-site intradermal dose of 0.2 ml each, containing at least 6 microgram of hemagglutinin antigen per strain per site

Group Type EXPERIMENTAL

seasonal influenza vaccine

Intervention Type BIOLOGICAL

receives two-site intradermal dose of 0.2 ml each, containing at least 6 microgram of hemagglutinin antigen per strain per site

Interventions

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seasonal influenza vaccine

receives a single intramuscular dose of 0.5 ml of trivalent influenza vaccine, containing at least 15 microgram of hemagglutinin antigen per strain

Intervention Type BIOLOGICAL

seasonal influenza vaccine

receives two-site intradermal dose of 0.1 ml each, containing at least 3 microgram of hemagglutinin antigen per strain per site and group

Intervention Type BIOLOGICAL

seasonal influenza vaccine

receives two-site intradermal dose of 0.2 ml each, containing at least 6 microgram of hemagglutinin antigen per strain per site

Intervention Type BIOLOGICAL

Other Intervention Names

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influenza vaccine 2010 southern hemisphere lot no 0700302A influenza vaccine 2010 southern hemisphere lot no 0700302A influenza vaccine 2010 southern hemisphere lot no 0700302A

Eligibility Criteria

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Inclusion Criteria

* healthy male or female volunteer aged at least 60 years old
* willing to participate in this study

Exclusion Criteria

* previous influenza vaccination within 6 months
* systemic ypersensitivity to egg or chicken proteins or any of the vaccine components
* history of a life-threatening reaction to the study vaccine or a vaccine containing the same constituents.
* ongoing acute febrile illness (oral temperature, ≥37.5 c )
* congenital or acquired immunodeficiency
* treatment with immunosuppressive or other immune- modifying drugs or cancer therapy within previous 6 months
* long-term treatment with systemic corticosteroids
* receipt of blood or blood-derived products in the previous 3 months
* history of thrombocytopenia or a bleeding disorder contraindicating for intramuscular vaccination.
Minimum Eligible Age

60 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Queen Saovabha Memorial Institute

OTHER

Sponsor Role lead

Responsible Party

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Suda Sibunruang

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suda Sibunruang, MD

Role: PRINCIPAL_INVESTIGATOR

Queen Saovabha Memorial Institute

Locations

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Queen Saovabha Memorial Institute

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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TIC 5301

Identifier Type: -

Identifier Source: org_study_id

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