A Study of the Efficacy, Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine (CSL's IVV) Administered Intramuscularly in Healthy Adults
CSL's IVV
A Phase IV, Randomized, Observer-Blind, Placebo-Controlled, Multi-Centre Study to Evaluate the Efficacy, Safety and Tolerability of CSL Limited's Influenza Virus Vaccine in Adults Aged ≥ 18 to < 65 Years.
1 other identifier
interventional
7,500
2 countries
24
Brief Summary
This study will assess the Efficacy, Safety and Tolerability profile of CSL's Influenza Vaccine administered intramuscularly against laboratory-confirmed influenza illness in a population defined as being not at risk of severe complications following influenza infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2008
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2007
CompletedFirst Posted
Study publicly available on registry
November 22, 2007
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedResults Posted
Study results publicly available
September 12, 2011
CompletedNovember 21, 2017
October 1, 2017
1.7 years
November 20, 2007
July 8, 2011
October 18, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection
Incidence of Laboratory Confirmed Influenza A/B infection was assessed per the study population in the 2008 and 2009 Southern Hemisphere influenza seasons. Vaccine efficacy = 100 x (1 - ratio of incidence rate). Ratio of incidence rate = active Study Vaccine recipient infection rate / placebo recipient infection rate.
2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009
Secondary Outcomes (12)
CSL's IVV Vaccine Efficacy Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection Due to Strains Matched to Vaccine Strains
2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009
Incidence of Influenza-like Illness (ILI)
2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009
Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2008
21 days after study vaccination
Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009
21 days after study vaccination
Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2008
21 days after study vaccination
- +7 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL2
OTHERInterventions
A single 0.5 mL, intramuscular Injection in the deltoid region of the arm on day 0.
Eligibility Criteria
You may qualify if:
- Healthy males and females aged ≥ 18 to \< 65 years at the time of vaccination
- Non pregnant/ non lactating females
You may not qualify if:
- Hypersensitivity to influenza vaccine or allergy to any components of the Study Vaccines
- Vaccination against influenza in the previous 6 months
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality
- Known history of Guillain-Barré Syndrome;
- Clinical signs of active infection and/or an oral temperature of ≥ 37.8 oC.
- History of neurological disorders or seizures
- Confirmed or suspected immunosuppressive condition or a previously diagnosed immunodeficiency disorder
- Current or recent immunosuppressive or immunomodulative therapy, including systemic corticosteroids
- Administration of immunoglobulins and/or any blood products;
- Participation in a clinical trial or use of an investigational compound;
- Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior;
- Participants indicated to receive an influenza vaccine on an annual basis according to the local public health recommendations.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seqiruslead
Study Sites (24)
The Clinical Trials Unit, Canberra Hospital
Canberra, Australian Capital Territory, Australia
Australian Clinical Research Organisation
Brookvale, New South Wales, Australia
Australian Clinical Research Organisation
Caringbah, New South Wales, Australia
Eastern Area Health Service, Prince of Wales Hospital
Randwick, New South Wales, Australia
National Centre for Immunisation Research & Surveillance (NCIRS) The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Australian Clinical Research Organisation
Auchenflower, Queensland, 4066, Australia
Trialworks Clinical Research Services
Brisbane, Queensland, Australia
Australian Clinical Research Organisation Caboolture Clinical Research Centre
Caboolture, Queensland, 4510, Australia
School of Medicine, James Cook University, Cairns Base Hospital
Cairns, Queensland, Australia
Gold Coast Hospital
Gold Coast, Queensland, Australia
Australian Clinical Research Organisation
Kippa-Ring, Queensland, Australia
CMAX, a division of IDT Australia
Adelaide, South Australia, Australia
Paediatric Trials Unit, Women's and Children's Hospital
Adelaide, South Australia, Australia
Primary Old Port Road Medical and Dental Centre
Royal Park, South Australia, 5014, Australia
Sexual Health Service
Hobart, Tasmania, Australia
Barwon Health, Geelong Hospital
Geelong, Victoria, Australia
Emeritus Research
Malvern East, Victoria, Australia
Murdoch Childrens Research Institute
Melbourne, Victoria, Australia
Lung Institute of Western Australia
Perth, Western Australia, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
Auckland Clinical Studies
Auckland, New Zealand
198 Youth Health Centre
Christchurch, New Zealand
Southern Clinical Trials
Christchurch, New Zealand
RMC Medical Centre
Dunedin, New Zealand
Related Publications (1)
Mcbride WJH, Abhayaratna WP, Barr I, Booy R, Carapetis J, Carson S, De Looze F, Ellis-Pegler R, Heron L, Karrasch J, Marshall H, Mcvernon J, Nolan T, Rawlinson W, Reid J, Richmond P, Shakib S, Basser RL, Hartel GF, Lai MH, Rockman S, Greenberg ME. Efficacy of a trivalent influenza vaccine against seasonal strains and against 2009 pandemic H1N1: A randomized, placebo-controlled trial. Vaccine. 2016 Sep 22;34(41):4991-4997. doi: 10.1016/j.vaccine.2016.08.038. Epub 2016 Aug 29.
PMID: 27595443DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Study Disclosure Manager
- Organization
- Seqirus
Study Officials
- STUDY DIRECTOR
Clinical Director Vaccines
Seqirus
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2007
First Posted
November 22, 2007
Study Start
March 1, 2008
Primary Completion
November 1, 2009
Study Completion
January 1, 2010
Last Updated
November 21, 2017
Results First Posted
September 12, 2011
Record last verified: 2017-10