A Randomized, Double Blind, Multicentre Study to Evaluate Safety and Immunogenicity of Four Fluval AB-Like Influenza Vaccines With 3.5 μgHA, 6 μgHA, 9 μgHA Or 15 μgHA Of A/H1N1, A/H3N2 and B Influenza Antigens in Adult and Elderly Subjects

NCT01408290 NA COMPLETED

The purpose of this study is to determine the immunogenicity, tolerability and dose-effect relationship of one 0.5 mL intramuscular (IM) injection of four FLUVAL AB-like trivalent influenza vaccines containing either 3.5μgHA, 6μgHA,9μgHA or 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens in adults and elderly people.

Details

Lead sponsor	Fluart Innovative Vaccine Ltd, Hungary
Phase	NA
Status	COMPLETED
Enrolment	256
Start date	2011-09
Completion	2011-10

Conditions

• Influenza

Interventions

• Vaccination with FAB-3511
• Vaccination with FAB-6011
• Vaccination with FAB-9011
• Vaccination with FluvalAB

Primary outcomes

• MEASURES OF IMMUNOGENICITY — 21-28 days following vaccination
  The measures of immunogenicity, for all evaluable subjects by using HI test are: * the GMTs at Day 0, at Day 14 and at Day 21 as determined by HI; * the Day 14/Day 0, the Day 21/Day 0 and the Day 21/Day 14 geometric mean titer ratios (GMTRs) as determined by HI; * the percentage of subjects achieving seroconversion1 or significant increase in antibody titer2 at Day 14 an at Day 21, as determined by HI; * the percentage of subjects achieving a titer ≥40 at Day 0, at Day 14 and at Day 21 as determined by HI.

Countries

Hungary