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Tolerability and Immunogenicity Study of Fluval AB Suspension for Injection

NCT01863849 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-04-05

Study results available
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Summary

To assess immunogenicity of a single intramuscular injection of Fluval AB suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 15 μgHA/0.5mL of seasonal A/H1N1, A/H3N2 and B influenza antigens each), as measured by haemagglutination inhibition (HI) test.

Conditions

  • Influenza Prophylaxis

Interventions

BIOLOGICAL

Vaccination with Fluval AB suspension for injection

Single intramuscular injection with Fluval AB suspension for injection in both age groups

Sponsors & Collaborators

  • Fluart Innovative Vaccine Ltd, Hungary

    lead INDUSTRY

Principal Investigators

  • Zsolt Németh · Fluart Innovative Vaccines Ltd.

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-22
Primary Completion
2013-09-17
Completion
2013-09-17

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01863849 on ClinicalTrials.gov