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

NCT01967368 | Unknown Phase 4

• 1 other identifier: UW 12339
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Influenza, Human

Keywords

Influenza vaccine; intradermal; intramuscular; efficacy; safety

Outcome Measures

Primary Outcomes (1)

• Change from baseline in neutralization antibody titre against influenza

  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%.

  day 0 (baseline), day 21 and day 180 of vaccination

Secondary Outcomes (1)

• Adverse effects

  day 0 and day 7 of vaccination

Study Arms (2)

Intanza

EXPERIMENTAL

intradermal injection (15ug hemagglutinin 2013/2014 trivalent influenza vaccine) delivered with the Intanza, single dose injection

Drug: Intanza

Vaxigrip

ACTIVE COMPARATOR

intramuscular injection (15ug hemagglutinin 2013/2014 trivalent influenza vaccine) delivered with the Vaxigrip, single dose injection

Drug: Vaxigrip

Interventions

Intanza DRUG

Principal Investigator would be responsible for injecting the intradermal vaccine in a sterile technique.

Also known as: Intanza, intradermal trivalent influenza vaccine

Intanza

Vaxigrip DRUG

Principal Investigator would be responsible for injecting the intrmuscular vaccine in a sterile technique.

Also known as: Vaxigrip, intramuscular trivalent influenza vaccine

Vaxigrip

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Clinically significant immune-related diseases and significant recent co-morbidities

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital and Fung Yiu King Hospital, Hong Kong West Cluster, Hospital Authority

Hong Kong, China

RECRUITING

Related Publications (1)

• Chan TC, Hung IF, Chan KH, Li CP, Li PT, Luk JK, Chu LW, Chan FH. Immunogenicity and safety of intradermal trivalent influenza vaccination in nursing home older adults: a randomized controlled trial. J Am Med Dir Assoc. 2014 Aug;15(8):607.e5-12. doi: 10.1016/j.jamda.2014.05.002. Epub 2014 Jun 21.

  PMID: 24957950 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

vaxigrip

Condition Hierarchy (Ancestors)

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

Study Officials

• Tuen Ching Chan, MBBS

  The University of Hong Kong, Department of Medicine, Queen Mary Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuen Ching Chan, MBBS

CONTACT

85266816077; tuenching@yahoo.com.hk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Specialist

Study Record Dates

• First Submitted: October 16, 2013
• First Posted: October 22, 2013
• Study Start: October 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2015
• Last Updated: October 22, 2013

Record last verified: 2013-10

Locations

CN (1)