A Phase 2 Study of Immunogenicity, Safety and Tolerability of CSL412 in Elderly Participants
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)
1 other identifier
interventional
612
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2007
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 25, 2007
CompletedFirst Posted
Study publicly available on registry
May 28, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedJuly 19, 2016
November 1, 2008
3 months
May 25, 2007
July 17, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
seroprotection rate, HI titre & seroconversion/ significant increase
grade 3 or higher, vaccine associated fever or vaccine associated site ulceration, abscess or necrosis
Study Arms (4)
1
ACTIVE COMPARATORInactivated trivalent influenza vaccine
2
EXPERIMENTALCSL412 formulation
3
EXPERIMENTALCSL412 formulation
4
EXPERIMENTALCSL412 formulation
Interventions
Eligibility Criteria
You may qualify if:
- Aged ≥ 18 to ≤ 45 OR ≥ 60
- Ability to provide pre-vaccination venous blood sample
You may not qualify if:
- History of clinically significant medical conditions
- Immunomodulative therapy
- Acute infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seqiruslead
Study Sites (1)
Chiltern International
Slough, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Hancox, Dr
Chiltern International
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 25, 2007
First Posted
May 28, 2007
Study Start
May 1, 2007
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
July 19, 2016
Record last verified: 2008-11