Tolerability and Immunogenicity Study of Fluval AB Suspension for Injection

Influenza Prophylaxis Clinical Trial

Official title: Tolerability and Immunogenicity Study of Fluval AB Suspension for Injection (Trivalent, Seasonal Influenza Vaccine, Active Ingredient Content: 15 μgHA/Strain/0.5mL) for the Use in the Season 2013/2014 in Adult and Elderly Subjects

Status Completed

Clinical Trial 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.

Clinical Trial Description

Aim of the study:

To assess immunogenicity and safety of Fluval AB seasonal influenza vaccine with 3 x 15 μgHA active ingredient in two age groups (18-59 years and ≥60 years) in accordance with CPMP/BWP/214/96: "Note for Guidance on Harmonization of Requirements for Influenza Vaccines", 12 March 1997

Primary objective:

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 test.

Methods:

In this open label, uncontrolled, multi-centre immunogenicity and tolerability study subjects were enrolled in two groups according to age (18-59 years and ≥60 years) and assigned to the following vaccine group:

Group 1: Single injection of Fluval AB suspension for injection. Subjects were observed for 30 minutes after the injection on Visit 1 (Day 0) for any immediate reactions.

All subjects were requested to complete a diary card to record local reactions (injection site pain, erythema, swelling, induration and ecchymosis) and systemic reactions (fever, shivering, headache, malaise, fatigue, sweating, nausea, myalgia and arthralgia) started on the day of vaccination on Visit 1 (Day 0) until 7 (seven) days following that.

All adverse events were collected during the period of Visit 1 (Day 0) to Visit 2 (between Day 21 and Day 28).

Serum samples for immunogenicity assays were collected immediately before immunization on Visit 1 (Day 0) and on Visit 2 (between Day 21 and Day 28) in all subjects. Immunogenicity was evaluated by HI test. ;

Related Conditions & MeSH terms

• Influenza Prophylaxis
• Influenza, Human

• NCT number: NCT01863849
• Study type: Interventional
• Source: Fluart Innovative Vaccine Ltd, Hungary
• Status: Completed
• Phase: Phase 4
• Start date: August 22, 2013
• Completion date: September 17, 2013