Comparison of the Cellular and the Humoral Immunogenicity, Safety of Different Trivalent Influenza Vaccines

NCT01119157 | Unknown Phase 4 DMC

• 2 other identifiers: FLUSECURE-OEK-H012008-002307-22
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, single-blinded, Phase IV, monocentric study in healthy adults aged \> 18 and \< 60 years to evaluate the cellular and humoral immunogenicity as well as the reactogenicity of intramuscular, inactivated, trivalent influenza vaccines, including aluminium adjuvanted whole virus vaccine, split vaccine and subunit vaccine.

Conditions

Healthy Volunteers

Keywords

influenza vaccine; cellular immune response; humoral immune response

Outcome Measures

Primary Outcomes (1)

• Number of seroconversions, > 4-fold increase in Haemagglutination inhibition (HI), mean geometric increase and antibody titre the proportion of subjects achieving an HI titre > 40, virus neutralization assay, Granzyme B, INF-gamma, IL-10, side effects.

  There remains substantial uncertainty about the clinical effectiveness of influenza vaccines based on current health care literature. The standard methodology to determine vaccine efficacy is based on hemagglutinin inhibition assay. Assays based on the immune response against the N antigen and based on the cellular immune response are now being designed and validated in the EU-funded Flusecure project. Importantly, recent EMEA regulations for registration of vaccines against avian influenza require an assessment of the cellular and the N-specific immune responses (EMEA/CHMP/VWP/263499/2006).

  Day 35

Secondary Outcomes (1)

• Side effects

  65 days after vaccination

Study Arms (2)

humoral and cellular immune response

EXPERIMENTAL

Biological: influenza vaccine

reactogenicity

EXPERIMENTAL

Biological: influenza vaccine

Interventions

influenza vaccine BIOLOGICAL

whole virus influenza vaccine adjuvanted with aluminium phosphate, 3 x 15 μg HA / 0.5 ml, for i.m. administration subunit influenza vaccine 3 x 15 μg HA / 0.5 ml, for i.m. administration split influenza vaccine 3 x 15 μg HA / 0.5 ml, for i.m. administration

Also known as: FluvalAB adjuvanted trivalent seasonal influenza vaccine, Vaxigrip, Influvac

humoral and cellular immune response; reactogenicity

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult volunteers \> 18 and \< 60 years of age, both sexes;
• Full contractual capacity of the participants
• Are in good health (as determined by vital signs and medical history);
• Negative urine or serum pregnancy test for females of childbearing potential.
• If the subject is female and of childbearing potential, she must use an acceptable contraception method and not become pregnant for the duration of the study. (Acceptable contraception includes implants, injectables, combined oral contraceptives, effective intrauterine devices (IUDs), sexual abstinence, or a vasectomized partner);
• Are able to understand and comply with planned study procedures;
• Signed informed consent prior to initiation of study procedures;

You may not qualify if:

• Known allergy to eggs OR other components of any of the vaccines (in particular mercury);
• History of Guillain-Barré syndrome;
• Pregnancy OR breast feeding OR positive pregnancy test prior to vaccination;
• Immunosuppressive therapy in the preceding 36 months;
• Active neoplasm (i.e. requiring any form of anti-neoplastic therapy);
• Concomitant corticosteroid therapy, including inhaled corticosteroids. Local corticosteroid or corticosteroid nasal spray are permitted.
• Psychiatric illness and/or concomitant psychiatric drug therapy that may have effect on full contractual capacity of the participant;
• Immunoglobulin (or similar blood product) therapy within 3 months prior to vaccination;
• Vaccine therapy within 4 weeks prior to the study;
• Influenza vaccination within 2 years prior to the study;
• Chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the immune response;
• Documented HIV, HBV or HCV infection;
• Acute febrile respiratory illness within one week prior to vaccination;
• Experimental drug therapy within 1 month prior to vaccination;
• Alcohol or drug abuse

Sponsors & Collaborators

• National Centre for Epidemiology, Hungary: lead
• Netherlands Vaccine Institute: collaborator
• National Public Health Institute, Finland: collaborator

Study Sites (1)

National Health Centre

Budapest, H-1134, Hungary

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines; vaxigrip; influvac

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Ildikó Visontai, MD

  National Centre for Epidemiology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 7, 2010
• Study Start: November 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: August 1, 2010
• Last Updated: May 7, 2010

Record last verified: 2010-05

Locations

HU (1)