MedTrace Logo

Two-site Intradermal Influenza Vaccination in Elderly

NCT01202552 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2018-04-06

No results posted yet for this study

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

Interventions

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

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

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

Sponsors & Collaborators

  • Queen Saovabha Memorial Institute

    lead OTHER

Principal Investigators

  • Suda Sibunruang, MD · Queen Saovabha Memorial Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • Thailand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01202552 on ClinicalTrials.gov