Clinical trial NCT00562484: A Study of the Efficacy, Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine (CSL's IVV) Administered Intramuscularly in Healthy Adults
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2007-11-22
Enrollment: 7500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* Healthy males and females aged ≥ 18 to \< 65 years at the time of vaccination
* Non pregnant/ non lactating females

Exclusion Criteria:

* 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.

Primary outcomes:
measure: CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection
timeFrame: 2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009
Secondary outcomes:
measure: 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
timeFrame: 2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009
measure: Incidence of Influenza-like Illness (ILI)
timeFrame: 2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009
measure: Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2008
timeFrame: 21 days after study vaccination
measure: Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009
timeFrame: 21 days after study vaccination
measure: Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2008
timeFrame: 21 days after study vaccination
measure: Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2009
timeFrame: 21 days after study vaccination
measure: Geometric Mean Fold Increase in HI Titer 21 Days After Study Vaccination, Year 2008
timeFrame: 21 days after study vaccination
measure: Geometric Mean Fold Increase in HI Titer Rate 21 Days After Study Vaccination, Year 2009
timeFrame: 21 days after study vaccination
measure: Frequency and Intensity of Local and Systemic Solicited Symptoms
timeFrame: 5 days after study vaccination
measure: Frequency and Intensity of Unsolicited Adverse Events (UAEs)
timeFrame: 21 days after study vaccination
measure: Serious Adverse Events (SAEs)
timeFrame: 180 days after study vaccination
measure: New Onsets of Chronic Illness (NOCI)
timeFrame: 180 days after study vaccination
Other outcomes:
Locations:
city: Canberra
country: Australia
facility: The Clinical Trials Unit, Canberra Hospital
state: Australian Capital Territory
city: Brookvale
country: Australia
facility: Australian Clinical Research Organisation
state: New South Wales
city: Caringbah
country: Australia
facility: Australian Clinical Research Organisation
state: New South Wales
city: Randwick
country: Australia
facility: Eastern Area Health Service, Prince of Wales Hospital
state: New South Wales
city: Westmead
country: Australia
facility: National Centre for Immunisation Research & Surveillance (NCIRS) The Children's Hospital at Westmead
state: New South Wales
city: Auchenflower
country: Australia
facility: Australian Clinical Research Organisation
state: Queensland
city: Brisbane
country: Australia
facility: Trialworks Clinical Research Services
state: Queensland
city: Caboolture
country: Australia
facility: Australian Clinical Research Organisation Caboolture Clinical Research Centre
state: Queensland
city: Cairns
country: Australia
facility: School of Medicine, James Cook University, Cairns Base Hospital
state: Queensland
city: Gold Coast
country: Australia
facility: Gold Coast Hospital
state: Queensland
city: Kippa Ring
country: Australia
facility: Australian Clinical Research Organisation
state: Queensland
city: Adelaide
country: Australia
facility: CMAX, a division of IDT Australia
state: South Australia
city: Adelaide
country: Australia
facility: Paediatric Trials Unit, Women's and Children's Hospital
state: South Australia
city: Royal Park
country: Australia
facility: Primary Old Port Road Medical and Dental Centre
state: South Australia
city: Hobart
country: Australia
facility: Sexual Health Service
state: Tasmania
city: Geelong
country: Australia
facility: Barwon Health, Geelong Hospital
state: Victoria
city: Malvern East
country: Australia
facility: Emeritus Research
state: Victoria
city: Melbourne
country: Australia
facility: Murdoch Childrens Research Institute
state: Victoria
city: Perth
country: Australia
facility: Lung Institute of Western Australia
state: Western Australia
city: Perth
country: Australia
facility: Princess Margaret Hospital for Children
state: Western Australia
city: Auckland
country: New Zealand
facility: Auckland Clinical Studies
city: Christchurch
country: New Zealand
facility: 198 Youth Health Centre
city: Christchurch
country: New Zealand
facility: Southern Clinical Trials
city: Dunedin
country: New Zealand
facility: RMC Medical Centre
Study officials:
affiliation: Seqirus
name: Clinical Director Vaccines
role: STUDY_DIRECTOR
References:
citation: 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.