NCT02101749

Brief Summary

This is a prospective, Open label randomized study. A total of 220 adults aged ≥ 60 years will be enrolled and randomized to one of 2 study arms:

  1. 1.Seasonal inactivated intradermal influenza vaccine (15 μg HA (hemagglutinin) per strain/ 0.1 ml dose) (group A - 110 participants)
  2. 2.Seasonal inactivated intramuscular influenza vaccine (15 μg HA per strain/ 0.5 ml dose) (group B - 110 participants) Groups A and B will receive the vaccine at day 1. Total follow up period is 60 days.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 2, 2014

Completed
Last Updated

March 23, 2016

Status Verified

March 1, 2016

Enrollment Period

4 months

First QC Date

December 28, 2013

Last Update Submit

March 22, 2016

Conditions

Influenza, Human

Keywords

trivalent inactivated influenza vaccine

Outcome Measures

Primary Outcomes (1)

  • Immunological end point

    Vaccine is able to induce a 4-fold rise of Hemagglutination inhibition antibodies 70% of vaccinees within 60 days after vaccination (according to EMA (European Medicines Agency) and CBER (Center for Biologics Evaluation and Research) guidelines)

    with in 60 days post vaccination

Secondary Outcomes (1)

  • To assess safety

    60 Days

Other Outcomes (1)

  • Assess other related immune response

    60 days

Study Arms (2)

trivalent inactivated influenza (INTANZA)

ACTIVE COMPARATOR

Intradermal injection

Biological: trivalent inactivated influenza

trivalent inactivated influenza (VAXIGRIP)

ACTIVE COMPARATOR

Intramuscle injection

Biological: trivalent inactivated influenza

Interventions

trivalent inactivated influenzaBIOLOGICAL

intradermal or intramuscular injection in the deltoid area.

trivalent inactivated influenza (INTANZA)trivalent inactivated influenza (VAXIGRIP)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged ≥ 60 years
  • Healthy and/or medically stable with controlled chronic medical conditions (e.g. diabetes mellitus, hypertension ) able to help oneself

You may not qualify if:

  • Known history of systemic hypersensitivity to egg or chicken proteins or any of the vaccine components
  • Influenza infection within the past 3 months
  • History of Guillain Barre Syndrome (GBS) or brachial neuritis within 6 weeks of previous influenza vaccination
  • Treatment with immunosuppressive or other immune-modifying drugs or cancer therapy within the past 6 months
  • Any concomitant medication with aspirin
  • Participation in other intervention study
  • Incapacity to provide fully informed consent or be attentive to follow-up observations resulting from cognitive impairment, abuse of alcohol or drug addiction
  • Random blood for Dextrostix more than 200 mg/dL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University,

Bangkok, Bangkok, 10400, Thailand

Location

Related Publications (1)

  • Boonnak K, Dhitavat J, Thantamnu N, Kosoltanapiwat N, Auayporn M, Jiang L, Puthavathana P, Pitisuttithum P. Immune responses to intradermal and intramuscular inactivated influenza vaccine among older age group. Vaccine. 2017 Dec 19;35(52):7339-7346. doi: 10.1016/j.vaccine.2017.10.106. Epub 2017 Nov 20.

    PMID: 29157960DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Punnee Pitisuttithum, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2013

First Posted

April 2, 2014

Study Start

November 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 23, 2016

Record last verified: 2016-03

Locations

TH(1)