Two-site Intradermal Influenza Vaccination in Elderly

NCT01202552 | Completed DMC

• 1 other identifier: TIC 5301
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Keywords

influenza; aged; intradermal injection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• comparison of the immunogenicity

  4 months

• safety

  4 months

Study Arms (3)

group 1

EXPERIMENTAL

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

group 2

EXPERIMENTAL

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

group 3

EXPERIMENTAL

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

Interventions

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

Also known as: influenza vaccine 2010 southern hemisphere, lot no 0700302A

group 1

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy male or female volunteer aged at least 60 years old
• willing to participate in this study

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen Saovabha Memorial Institute: lead

Study Sites (1)

Queen Saovabha Memorial Institute

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Suda Sibunruang, MD

  Queen Saovabha Memorial Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 13, 2010
• First Posted: September 16, 2010
• Study Start: October 1, 2010
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 6, 2018

Record last verified: 2018-04

Locations

TH (1)