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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
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.
Details
| Lead sponsor | Fluart Innovative Vaccine Ltd, Hungary |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 120 |
| Start date | 2014-10 |
| Completion | 2014-12 |
Conditions
- Human Influenza
Interventions
- Vaccination with Fluval AB Novo suspension for injection, half dose of a single intramuscular dose (0.25 ml)
- Vaccination with Fluval AB Novo suspension for injection, single intramuscular dose (0.5 ml)
Primary outcomes
- Increase in Geometric Mean Titre Ratio, A/H1N1 Strain — 21-28 days after vaccination
Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres Requirement: \> 2.5 - Increase in Geometric Mean Titre Ratio, A/H3N2 Strain — 21-28 days after vaccination
Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres Requirement: \> 2.5 - Increase in Geometric Mean Titre Ratio, B Strain — 21-28 days after vaccination
Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres Requirement: \> 2.5 - Seroconversion, A/H1N1 Strain — 21-28 days after vaccination
Proportion of subjects seroconverted or had a significant increase in titres Requirement: \> 40 % - Seroconversion, A/H3N2 Strain — 21-28 days after vaccination
Proportion of subjects seroconverted or had a significant increase in titres Requirement: \> 40 % - Seroconversion, B Strain — 21-28 days after vaccination
Proportion of subjects seroconverted or had a significant increase in titres Requirement: \> 40 %