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Two-site Intradermal Influenza Vaccination in Elderly

This study is currently recruiting participants.
Verified May 2012 by Queen Saovabha Memorial Institute
Sponsor:
Information provided by (Responsible Party):
Suda Sibunruang, Queen Saovabha Memorial Institute
ClinicalTrials.gov Identifier:
NCT01202552
First received: September 13, 2010
Last updated: May 30, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention
Influenza
 Biological: seasonal influenza vaccine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Two-site Intradermal Influenza Vaccination in Elderly

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Queen Saovabha Memorial Institute:

Primary Outcome Measures:
  • immunogenicity [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

    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))


Estimated Enrollment: 180
Study Start Date: October 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01202552

Contacts
Contact: Suda Sibunruang, MD 02-2520161-4 ext 125 sudapunrin@gmail.com
Contact: Terapong Tantawichien, MD 02-2520161-4 ext 132 terapong_tantawichien@hotmail.com

Locations
Thailand
Queen Saovabha Memorial Institute Recruiting
Bangkok, Thailand, 10330
Contact: terapong tantawichien, MD     02-2520161-4 ext 132     terapong_tantawichien@hotmail.com    
Contact: Saowaluck tepsumethanon, RN     02-2520161-4 ext 125        
Principal Investigator: suda sibunruang, MD            
Sponsors and Collaborators
Queen Saovabha Memorial Institute
Investigators
Principal Investigator: Suda Sibunruang, MD Queen Saovabha Memorial Institute
  More Information

No publications provided

Responsible Party: Suda Sibunruang, Principal investigator, Queen Saovabha Memorial Institute
ClinicalTrials.gov Identifier: NCT01202552     History of Changes
Other Study ID Numbers: TIC 5301
Study First Received: September 13, 2010
Last Updated: May 30, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by 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
 Hemagglutinins
Agglutinins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013