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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: seasonal influenza vaccine; Biological: seasonal influenza vaccine; Biological: seasonal influenza 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

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10330
    • Queen Saovabha Memorial Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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; 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; 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
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 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; 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; 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
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 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; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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))	4 months

Collaborators and Investigators

• Sponsor: Queen Saovabha Memorial Institute
• Investigators: Principal Investigator: Suda Sibunruang, MD, Queen Saovabha Memorial Institute

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: September 13, 2010
• First Submitted That Met QC Criteria: September 15, 2010
• First Posted (Estimate): September 16, 2010

Study Record Updates

• Last Update Posted (Actual): April 6, 2018
• Last Update Submitted That Met QC Criteria: April 5, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: influenza; aged; intradermal injection
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: TIC 5301