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Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection for Children and Adolescents

NCT02387294 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-03-11

Study results available
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Summary

Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection (trivalent, seasonal influenza vaccine, active ingredient content: 6 μg HA/strain/0.5 ml) for Children and Adolescents.

Conditions

  • Human Influenza

Interventions

BIOLOGICAL

Vaccination with Fluval AB Novo suspension for injection, half dose of a single intramuscular dose (0.25 ml)

vaccination

BIOLOGICAL

Vaccination with Fluval AB Novo suspension for injection, single intramuscular dose (0.5 ml)

vaccination

Sponsors & Collaborators

  • Fluart Innovative Vaccine Ltd, Hungary

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2014-12-31
Completion
2014-12-31

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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 NCT02387294 on ClinicalTrials.gov