A Study of the Efficacy, Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine (CSL's IVV) Administered Intramuscularly in Healthy Adults

Phase 4

Completed

• Conditions: Influenza
• Interventions: Biological: CSL Limited Influenza Vaccine; Biological: Placebo

• Registration Number: NCT00562484
• Lead Sponsor: Seqirus

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-20
• Study First Submitted QC: 2007-11-21
• Study First Posted: 2007-11-22
• Study Start: 2008-03
• Primary Completion: 2009-11
• Study Completion: 2010-01
• Results First Submitted: 2011-07-08
• Results First Submitted QC: 2011-08-07
• Results First Posted: 2011-09-12
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-18
• Last Update Posted: 2017-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	CSL Limited Influenza Vaccine	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection	2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009	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.

Secondary Outcome Measures

Name	Time	Method
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 laboratory confirmed influenza A/B infection due to strains matched to vaccine strains 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.
Incidence of Influenza-like Illness (ILI)	2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009	The criteria for the protocol defined ILI were as follows: * At least one respiratory symptom: * cough, sore throat or nasal congestion; * And at least one systemic symptom: * fever (as defined by oral temperature ≥ 37.8°C (100.0°F), or feverishness (as defined by participant's subjective feeling of fever), chills or body aches.; The CDC ILI case definition was the occurrence of fever (100°F \[37.8°C\] or higher) in conjunction with either cough or sore throat.
Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2008	21 days after study vaccination	Seroconversion rate: defined as the percentage of participants with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2009	21 days after study vaccination	Seroconversion rate: defined as the percentage of participants with either a pre-vaccination HI titer \< 1:10 and a post-vaccination HI titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
Geometric Mean Fold Increase in HI Titer 21 Days After Study Vaccination, Year 2008	21 days after study vaccination	Geometric mean fold increase in HI titer was defined as the geometric mean titer (GMT) after vaccination divided by the GMT before vaccination.
Frequency and Intensity of Local and Systemic Solicited Symptoms	5 days after study vaccination	Adverse event grading: Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities.; Grade 2 (moderate): Discomfort was enough to cause some interference with daily activities.; Grade 3 (severe): Symptoms that prevented normal, everyday activities.; Fever Grade 1: ≥ 37.7°C - \< 38.0°C (≥ 99.9 - \< 100.4°F) Grade 2: ≥ 38.0°C - \< 39.0°C (≥ 100.4 - \< 102.2°F) Grade 3: ≥ 39.0°C (\> 102.2°F)
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
Geometric Mean Fold Increase in HI Titer Rate 21 Days After Study Vaccination, Year 2009	21 days after study vaccination	Geometric mean fold increase in HI titer was defined as the geometric mean titer (GMT) after vaccination divided by the GMT before vaccination.
Frequency and Intensity of Unsolicited Adverse Events (UAEs)	21 days after study vaccination	UAE grading: Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities.; Grade 2 (moderate): Discomfort was enough to cause some interference with daily activities.; Grade 3 (severe): Symptoms that prevented normal, everyday activities.
Serious Adverse Events (SAEs)	180 days after study vaccination	An SAE was any untoward medical occurrence that at any dose: * Resulted in death; * Was life-threatening; * Required an unexpected in-participant hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability / incapacity; * Was a congenital anomaly / birth defect; and / or; * Was medically significant (defined as an event that did not necessarily meet any of the SAE criteria, but was judged by the treating physician to potentially jeopardize the participant or require medical intervention to prevent one of the out
New Onsets of Chronic Illness (NOCI)	180 days after study vaccination	An NOCI was defined as the diagnosis of a chronic medical condition where the symptoms commenced or worsened following exposure to study vaccine and may have included those potentially controllable by medication (e.g., glaucoma, hypertension).

Trial Locations

Locations (21)

The Clinical Trials Unit, Canberra Hospital; 🇦🇺 Canberra, Australian Capital Territory, Australia

National Centre for Immunisation Research & Surveillance (NCIRS) The Children's Hospital at Westmead; 🇦🇺 Westmead, New South Wales, Australia

Trialworks Clinical Research Services; 🇦🇺 Brisbane, Queensland, Australia

Australian Clinical Research Organisation Caboolture Clinical Research Centre; 🇦🇺 Caboolture, Queensland, Australia

Sexual Health Service; 🇦🇺 Hobart, Tasmania, Australia

Barwon Health, Geelong Hospital; 🇦🇺 Geelong, Victoria, Australia

Emeritus Research; 🇦🇺 Malvern East, Victoria, Australia

Auckland Clinical Studies; 🇳🇿 Auckland, New Zealand

198 Youth Health Centre; 🇳🇿 Christchurch, New Zealand

Princess Margaret Hospital for Children; 🇦🇺 Perth, Western Australia, Australia

Southern Clinical Trials; 🇳🇿 Christchurch, New Zealand

RMC Medical Centre; 🇳🇿 Dunedin, New Zealand

CMAX, a division of IDT Australia; 🇦🇺 Adelaide, South Australia, Australia

Paediatric Trials Unit, Women's and Children's Hospital; 🇦🇺 Adelaide, South Australia, Australia

Australian Clinical Research Organisation; 🇦🇺 Kippa Ring, Queensland, Australia

Eastern Area Health Service, Prince of Wales Hospital; 🇦🇺 Randwick, New South Wales, Australia

School of Medicine, James Cook University, Cairns Base Hospital; 🇦🇺 Cairns, Queensland, Australia

Primary Old Port Road Medical and Dental Centre; 🇦🇺 Royal Park, South Australia, Australia

Lung Institute of Western Australia; 🇦🇺 Perth, Western Australia, Australia

Gold Coast Hospital; 🇦🇺 Gold Coast, Queensland, Australia

Murdoch Childrens Research Institute; 🇦🇺 Melbourne, Victoria, Australia