Back to resultsTwo-site Intradermal Influenza Vaccination in Elderly
Primary Purpose
Influenza
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
seasonal influenza vaccine
seasonal influenza vaccine
seasonal influenza vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring influenza, aged, intradermal injection
Eligibility Criteria
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.
Sites / Locations
- Queen Saovabha Memorial Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
group 1
group 2
group 3
Arm Description
receives a single intramuscular dose of 0.5 ml of trivalent influenza vaccine, containing at least 15 microgram of hemagglutinin antigen per strain
receives two-site intradermal dose of 0.1 ml each, containing at least 3 microgram of hemagglutinin antigen per strain per site
receives two-site intradermal dose of 0.2 ml each, containing at least 6 microgram of hemagglutinin antigen per strain per site
Outcomes
Primary Outcome Measures
immunogenicity
evaluate the immunogenicity of the two-site intradermal influenza vaccination 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 , as measured by the titer of hemagglutination inhibition (HAI) antibodies, in order to determine whether it would meet the guidelines of the European Committee for Proprietary Medicinal Products (CPMP) for the annual relicensure of influenza vaccines
Secondary Outcome Measures
comparison of the immunogenicity
comparison of the immunogenicity of the two-site influenza vaccine administered intradermally as the above reduced dose with those of the reference influenza vaccine administered intramuscularly at the standard dose
safety
evaluate for number of participants with adverse effects:
systemic effects such as fever, headache, myalgia
local effects such as redness, swelling, induration and pain by giving diary card for each participant to record the data once daily for 1 week. (the investigators explain how to grade the redness (no/yes), swelling by measure, induration by measure, pain (no/yes))
Full Information
NCT ID
NCT01202552
First Posted
September 13, 2010
Last Updated
April 5, 2018
Sponsor
Queen Saovabha Memorial Institute
1. Study Identification
Unique Protocol Identification Number
NCT01202552
Brief Title
Two-site Intradermal Influenza Vaccination in Elderly
Official Title
Two-site Intradermal Influenza Vaccination in Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen Saovabha Memorial Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
influenza, aged, intradermal injection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Experimental
Arm Description
receives a single intramuscular dose of 0.5 ml of trivalent influenza vaccine, containing at least 15 microgram of hemagglutinin antigen per strain
Arm Title
group 2
Arm Type
Experimental
Arm Description
receives two-site intradermal dose of 0.1 ml each, containing at least 3 microgram of hemagglutinin antigen per strain per site
Arm Title
group 3
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
seasonal influenza vaccine
Other Intervention Name(s)
influenza vaccine 2010 southern hemisphere, lot no 0700302A
Intervention Description
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
Intervention Name(s)
seasonal influenza vaccine
Other Intervention Name(s)
influenza vaccine 2010 southern hemisphere, lot no 0700302A
Intervention Description
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
Intervention Name(s)
seasonal influenza vaccine
Other Intervention Name(s)
influenza vaccine 2010 southern hemisphere, lot no 0700302A
Intervention Description
receives two-site intradermal dose of 0.2 ml each, containing at least 6 microgram of hemagglutinin antigen per strain per site
Primary Outcome Measure Information:
Title
immunogenicity
Description
evaluate the immunogenicity of the two-site intradermal influenza vaccination 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 , as measured by the titer of hemagglutination inhibition (HAI) antibodies, in order to determine whether it would meet the guidelines of the European Committee for Proprietary Medicinal Products (CPMP) for the annual relicensure of influenza vaccines
Time Frame
4 months
Secondary Outcome Measure Information:
Title
comparison of the immunogenicity
Description
comparison of the immunogenicity of the two-site influenza vaccine administered intradermally as the above reduced dose with those of the reference influenza vaccine administered intramuscularly at the standard dose
Time Frame
4 months
Title
safety
Description
evaluate for number of participants with adverse effects:
systemic effects such as fever, headache, myalgia
local effects such as redness, swelling, induration and pain by giving diary card for each participant to record the data once daily for 1 week. (the investigators explain how to grade the redness (no/yes), swelling by measure, induration by measure, pain (no/yes))
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suda Sibunruang, MD
Organizational Affiliation
Queen Saovabha Memorial Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Saovabha Memorial Institute
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
12. IPD Sharing Statement
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Two-site Intradermal Influenza Vaccination in Elderly
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