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

Influenza, Human Clinical Trial

Official title:

Comparative Immune Response of Intradermal and Intramuscular Preparations of

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02101749
• Other study ID #: Elderly Flu vaccine
• Status: Completed
• Phase: Phase 4
• First received: December 28, 2013
• Last updated: March 22, 2016
• Start date: November 2013
• Est. completion date: March 2014

Study information

• Verified date: March 2016
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza, Human

Intervention

Biological:
• trivalent inactivated influenza
intradermal or intramuscular injection in the deltoid area.

Locations

Country	Name	City	State
Thailand	Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University,	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assess other related immune response	Exploratory objective to assess other related immune response (e.g. anti-neuraminidase)	60 days	No
Primary	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	No
Secondary	To assess safety	To assess safety of the following trivalent inactivated seasonal influenza vaccine in the older age group	60 Days	Yes