A Re-licensing Study to Assess the Efficacy of Inflexal V Formulated With WHO Recommended 2008/2009 Influenza Virus Strains for the Northern Hemisphere

Phase 4

Completed

• Conditions: Influenza
• Interventions: Biological: Inflexal V

• Registration Number: NCT01303510
• Lead Sponsor: Crucell Holland BV

Brief Summary

A study to assess whether the Northern Hemisphere 2008/2009 season influenza vaccine Inflexal V fulfills the EMEA requirements for re-registration of influenza vaccines

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Study First Submitted: 2011-02-23
• Study First Submitted QC: 2011-02-23
• Study First Posted: 2011-02-24
• Results First Submitted: 2011-10-10
• Results First Submitted QC: 2011-11-15
• Results First Posted: 2011-12-19
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-29
• Last Update Posted: 2013-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Inflexal V	Adults from 18 to 60 years old inclusive
Group B	Inflexal V	Elderly subjects aged over 60 years

Primary Outcome Measures

Name	Time	Method
Seroconversion	Day 22 ± 2 days	Seroconversion rate was defined as the proportion of subjects with ≥4-fold increase in haemagglutination inhibition (HI) antibody titer and with a titer of ≥1:40
Seroprotection	Day 22 ± 2 days	Seroprotection rate, defined as the proportion of subjects with HI antibody titer ≥1:40
Fold Increase in Geometric Mean Titer (GMT)	Day 22/Day 1	GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value

Secondary Outcome Measures

Name	Time	Method
Safety: Incidence of Solicited Local Adverse Events	Days 1 to 4 inclusive, and Day 22	Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination
Incidence of Solicited Systemic Adverse Events	Days 1 to 4 inclusive, and Day 22	Safety assessments are made by the investigator at baseline and on Day 22 as well as by the subjects themselves (in a Subject Diary) for the 4-day period immediately following vaccination

Trial Locations

Locations (1)

Covance Clinical Research Unit AG; 🇨🇭 Allschwil, Switzerland