Safety and Efficacy of Intradermal Trivalent Influenza Vaccination in Institutionalized Older Adults

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by The University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
Dr. Chan Tuen Ching, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01967368
First received: October 16, 2013
Last updated: October 17, 2013
Last verified: October 2013
  Purpose

Influenza is associated with significant morbidity and mortality. Institutionalized older adults (age>65) is the group associated with highest risk of complications. Influenza vaccines are the cornerstone of influenza prevention but one systematic review has found that there is no statistically significant difference against laboratory confirmed influenza. A major reason is immune senescence in older adults which result in weaker response towards vaccines when compared with young adults. Intradermal administration of vaccine has been suggested to improve immune response due to the abundance of immunostimulatory cells, such as dendritic cells in the dermis. Intradermal administration of influenza vaccine has been shown to have comparable or superior efficacy compared with intramuscular administration in the >60-year old population and the rates of adverse events post-vaccination were also comparable between them. The immunogenicity of intradermal administration has also been shown to be better in immunocompromised patients, including community dwelling older adults. In addition, intradermal vaccination has good acceptability and safety profile in different countries, so it has been licensed in Hong Kong and worldwide. However, there is little study regarding the efficacy of intradermal vaccination of influenza in institutionalized older adults, investigators therefore would like to perform a prospective, randomized study to compare the safety and immunogenicity between conventional full dose intramuscular immunization and full dose intradermal immunization of the trivalent influenza vaccine in institutionalized older adults.

The hypothesis is that full dose intradermal trivalent influenza vaccination is as effective as full-dose standard intramuscular injection in terms of seroconversion and seroprotection rate in institutionalized older adults. Finding of this study will be important in the vaccination of institutionalized older adults and immunocompromised patients as intradermal vaccine may induce a better immune response against influenza infection.


Condition Intervention Phase
Influenza, Human
Drug: Intanza
Drug: Vaxigrip
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Efficacy of Intradermal Trivalent Influenza Vaccination in Institutionalized Older Adults

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Change from baseline in neutralization antibody titre against influenza [ Time Frame: day 0 (baseline), day 21 and day 180 of vaccination ] [ Designated as safety issue: No ]
    Neutralization antibody titre against the 3 influenza viruses are tested 3 times at day 0, day 21 and day 180 of vaccination for comparison. The titer of neutralization antibody is defined as the maximum dilution of serum at which the percentage of cytopathic effect is less than or equal to 50%.


Secondary Outcome Measures:
  • Adverse effects [ Time Frame: day 0 and day 7 of vaccination ] [ Designated as safety issue: Yes ]
    Adverse effects due to vaccination from day 0 to day 7 will be recorded. Adverse effects boardly divided into local and systemic. Local adverse effect include swelling, erythema, pruritis, pain. Systemic adverse effect include fever, malaise, myalgia


Estimated Enrollment: 100
Study Start Date: October 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intanza
intradermal injection (15ug hemagglutinin 2013/2014 trivalent influenza vaccine) delivered with the Intanza, single dose injection
Drug: Intanza
Principal Investigator would be responsible for injecting the intradermal vaccine in a sterile technique.
Other Name: Intanza, intradermal trivalent influenza vaccine
Active Comparator: Vaxigrip
intramuscular injection (15ug hemagglutinin 2013/2014 trivalent influenza vaccine) delivered with the Vaxigrip, single dose injection
Drug: Vaxigrip
Principal Investigator would be responsible for injecting the intrmuscular vaccine in a sterile technique.
Other Name: Vaxigrip, intramuscular trivalent influenza vaccine

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Institutionalized older adult patients at the age of 65 or above

Exclusion Criteria:

  • Clinically significant immune-related diseases and significant recent co-morbidities
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01967368

Contacts
Contact: Tuen Ching Chan, MBBS 85266816077 tuenching@yahoo.com.hk

Locations
China
Queen Mary Hospital and Fung Yiu King Hospital, Hong Kong West Cluster, Hospital Authority Recruiting
Hong Kong, China
Contact: Tuen Ching Chan, MBBS    85266816077    tuenching@yahoo.com.hk   
Principal Investigator: Tuen Ching Chan, MBBS         
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Tuen Ching Chan, MBBS The University of Hong Kong, Department of Medicine, Queen Mary Hospital
  More Information

No publications provided by The University of Hong Kong

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Chan Tuen Ching, Resident Specialist, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01967368     History of Changes
Other Study ID Numbers: UW 12339
Study First Received: October 16, 2013
Last Updated: October 17, 2013
Health Authority: Hong Kong: Department of Health
Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
Influenza vaccine
intradermal
intramuscular
efficacy
safety

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014