An interventional study of seasonal influenza vaccine and seasonal influenza vaccine in Influenza, sponsored by Queen Saovabha Memorial Institute. Completed at 1 site in Thailand. Open to participants aged 60 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-06.
Sponsored by Queen Saovabha Memorial Institute · Not applicable, Interventional, and Prevention
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.
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
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 180 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Queen Saovabha Memorial Institute is the lead sponsor of 12 studies on the registry; none are open to participants now.
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Exclusion Criteria:
receives a single intramuscular dose of 0.5 ml of trivalent influenza vaccine, containing at least 15 microgram of hemagglutinin antigen per strain
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
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
Biological: 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
Also known as: influenza vaccine 2010 southern hemisphere, lot no 0700302A
receives two-site intradermal dose of 0.1 ml each, containing at least 3 microgram of hemagglutinin antigen per strain per site and group
Also known as: influenza vaccine 2010 southern hemisphere, lot no 0700302A
receives two-site intradermal dose of 0.2 ml each, containing at least 6 microgram of hemagglutinin antigen per strain per site
Also known as: influenza vaccine 2010 southern hemisphere, lot no 0700302A
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
Time frame: 4 months
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
Time frame: 4 months
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))
Time frame: 4 months
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Queen Saovabha Memorial Institute