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Completed

NCT Number: NCT01202552

Two-site Intradermal Influenza Vaccination in Elderly

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

60 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Saovabha Memorial Institute

Bangkok, 10330, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Seasonal Influenza Vaccine

Biological

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

Primary outcomes

  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 outcomes

  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))

Sponsors and collaborators

Lead sponsor

Queen Saovabha Memorial Institute

Other

Registry information

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
Sep 16, 2010
Registry last updated
Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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