Two-site Intradermal Influenza Vaccination in Elderly

Influenza Clinical Trial

Official title:

Two-site Intradermal Influenza Vaccination in Elderly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01202552
• Other study ID #: TIC 5301
• Status: Completed
• Phase: N/A
• First received: September 13, 2010
• Last updated: April 5, 2018
• Start date: October 2010
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: Queen Saovabha Memorial Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Thailand	Queen Saovabha Memorial Institute	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Queen Saovabha Memorial Institute

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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