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

Phase 4

Completed

• Conditions: Influenza, Human
• Interventions: Biological: trivalent inactivated influenza

• Registration Number: NCT02101749
• Lead Sponsor: Mahidol University

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. 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.

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 Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-12-28
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Study First Submitted QC: 2014-03-27
• Study First Posted: 2014-04-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-22
• Last Update Posted: 2016-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
trivalent inactivated influenza (INTANZA)	trivalent inactivated influenza	Intradermal injection
trivalent inactivated influenza (VAXIGRIP)	trivalent inactivated influenza	Intramuscle injection

Primary Outcome Measures

Name	Time	Method
Immunological end point	with in 60 days post vaccination	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)

Secondary Outcome Measures

Name	Time	Method
To assess safety	60 Days	To assess safety of the following trivalent inactivated seasonal influenza vaccine in the older age group

Trial Locations

Locations (1)

Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University,; 🇹🇭 Bangkok, Thailand