Immune Response of Intradermal and Intramuscular Preparations of Inactive Seasonal Influenza Vaccine in Older Age Group.

Comparative Immune Response of Intradermal and Intramuscular Preparations of

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. Seasonal inactivated intradermal influenza vaccine (15 μg HA (hemagglutinin) per strain/ 0.1 ml dose) (group A - 110 participants)
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.

Study Overview

• Status: Completed
• Conditions: Influenza, Human
• Intervention / Treatment: Biological: trivalent inactivated influenza

Detailed Description

The consent form will be reviewed and signed by the participant prior to any study-related procedures.

Potential study participants will be assessed based on inclusion and exclusion criteria. Screening procedures, which include taking medical history, vital signs, random blood for dextrostix and vaccination will be performed on day 1.

A total of 220 participants will be randomized into 2 study arms, of which each group of 110 vaccinees will receive either seasonal intradermal influenza vaccine [group A] or seasonal intramuscular influenza vaccine [group B]. The randomization route of vaccination will be kept in concealed envelope at the study site. It will be open after subject signed informed consent form and all inclusion exclusion criteria met for enrollment. Groups A and B will receive the vaccine at day 1. Clinical activities for groups A and B during each visit (total of 5 visits). Blood will be drawn and assayed (for baseline assessment) using HAI (hemagglutination inhibition assay) to the three influenza strains.

• Study Type: Interventional
• Enrollment (Actual): 221
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• 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

Exclusion criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: trivalent inactivated influenza (INTANZA); Intradermal injection	Biological: trivalent inactivated influenza; intradermal or intramuscular injection in the deltoid area.
Active Comparator: trivalent inactivated influenza (VAXIGRIP); Intramuscle injection	Biological: trivalent inactivated influenza; intradermal or intramuscular injection in the deltoid area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess safety	To assess safety of the following trivalent inactivated seasonal influenza vaccine in the older age group	60 Days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess other related immune response	Exploratory objective to assess other related immune response (e.g. anti-neuraminidase)	60 days

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Punnee Pitisuttithum, MD, Mahidol University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: December 28, 2013
• First Submitted That Met QC Criteria: March 27, 2014
• First Posted (Estimate): April 2, 2014

Study Record Updates

• Last Update Posted (Estimate): March 23, 2016
• Last Update Submitted That Met QC Criteria: March 22, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: trivalent inactivated influenza vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: Elderly Flu vaccine