Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00479648
NCT00479648
Completed
Phase 2

A Phase II, Double-Blind, Randomised, Controlled, Multi-Centre Study to Evaluate the Immunogenicity, Safety and Tolerability of Three Formulations of CSL412 in Adults (≥ 18 to ≤ 45 Years) and Older Adults (≥ 60 Years)

Seqirus1 site in 1 country612 target enrollmentMay 2007
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsInfluenza

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Influenza
Sponsor
Seqirus
Enrollment
612
Locations
1
Primary Endpoint
seroprotection rate, HI titre & seroconversion/ significant increase
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Current influenza vaccines have a reduced efficacy in the elderly. This study will investigate the immunogenicity, safety and tolerability of an adjuvanted influenza vaccine in elderly participants.

Registry
clinicaltrials.gov
Start Date
May 2007
End Date
August 2007
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Seqirus

Eligibility Criteria

Inclusion Criteria

  • •Aged ≥ 18 to ≤ 45 OR ≥ 60
  • •Ability to provide pre-vaccination venous blood sample

Exclusion Criteria

  • •History of clinically significant medical conditions
  • •Immunomodulative therapy
  • •Acute infection

Outcomes

Primary Outcomes

seroprotection rate, HI titre & seroconversion/ significant increase

grade 3 or higher, vaccine associated fever or vaccine associated site ulceration, abscess or necrosis

Study Sites (1)

Loading locations...

Similar Trials

Completed
Phase 1
Safety Study of an Adjuvanted Candidate Influenza Vaccine to Prevent Influenza Disease in the Elderly PopulationInfluenza
NCT00318058GlaxoSmithKline84
Unknown
Not Applicable
Adjuvanted Influenza Vaccine Effectiveness in the Elderly (65+Yrs)Influenza
NCT01424371Fraser Health1,000
Completed
Phase 4
Response of Older Adults to Influenza Vaccination With Regard to Cytomegalovirus (CMV) StatusInfluenza
NCT00442975Public Health England100
Completed
Phase 2
Safety Study of Four Candidate Influenza Vaccines to Prevent Influenza Disease in the Elderly PopulationInfluenza
NCT00318149GlaxoSmithKline425
Completed
Phase 2
Study to Evaluate Reactogenicity and Immunogenicity of Revaccination With Adjuvanted Influenza Vaccine in ElderlyInfluenza
NCT00386113GlaxoSmithKline74