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Two-site Intradermal Influenza Vaccination in Elderly

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ClinicalTrials.gov Identifier: NCT01202552
Recruitment Status : Completed
First Posted : September 16, 2010
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Suda Sibunruang, Queen Saovabha Memorial Institute

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.

Condition or disease Intervention/treatment Phase
Influenza Biological: seasonal influenza vaccine Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Two-site Intradermal Influenza Vaccination in Elderly
Study Start Date : October 2010
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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
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
Other Names:
  • influenza vaccine 2010 southern hemisphere
  • lot no 0700302A
Experimental: group 2
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 0.1 ml each, containing at least 3 microgram of hemagglutinin antigen per strain per site and group
Other Names:
  • influenza vaccine 2010 southern hemisphere
  • lot no 0700302A
Experimental: group 3
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 two-site intradermal dose of 0.2 ml each, containing at least 6 microgram of hemagglutinin antigen per strain per site
Other Names:
  • influenza vaccine 2010 southern hemisphere
  • lot no 0700302A



Primary Outcome Measures :
  1. immunogenicity [ Time Frame: 4 months ]
    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 :
  1. comparison of the immunogenicity [ Time Frame: 4 months ]
    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

  2. safety [ Time Frame: 4 months ]

    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))



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Ages Eligible for Study:   60 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202552


Locations
Thailand
Queen Saovabha Memorial Institute
Bangkok, Thailand, 10330
Sponsors and Collaborators
Queen Saovabha Memorial Institute
Investigators
Principal Investigator: Suda Sibunruang, MD Queen Saovabha Memorial Institute

Responsible Party: Suda Sibunruang, Principal investigator, Queen Saovabha Memorial Institute
ClinicalTrials.gov Identifier: NCT01202552     History of Changes
Other Study ID Numbers: TIC 5301
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018

Keywords provided by Suda Sibunruang, Queen Saovabha Memorial Institute:
influenza
aged
intradermal injection

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Hemagglutinins
Immunologic Factors
Physiological Effects of Drugs
Agglutinins