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

Influenza Clinical Trial

— CSL's IVV  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00562484
• Other study ID #: CSLCT-USF-06-28
• Status: Completed
• Phase: Phase 4
• First received: November 20, 2007
• Last updated: October 18, 2017
• Start date: March 2008
• Est. completion date: January 2010

Study information

• Verified date: October 2017
• Source: Seqirus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7500
• Est. completion date: January 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• CSL Limited Influenza Vaccine
A single 0.5 mL, intramuscular Injection in the deltoid region of the arm on day 0.
• Placebo
Placebo

Locations

Country	Name	City	State
Australia	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	Auchenflower	Queensland
Australia	Trialworks Clinical Research Services	Brisbane	Queensland
Australia	Australian Clinical Research Organisation	Brookvale	New South Wales
Australia	Australian Clinical Research Organisation Caboolture Clinical Research Centre	Caboolture	Queensland
Australia	School of Medicine, James Cook University, Cairns Base Hospital	Cairns	Queensland
Australia	The Clinical Trials Unit, Canberra Hospital	Canberra	Australian Capital Territory
Australia	Australian Clinical Research Organisation	Caringbah	New South Wales
Australia	Barwon Health, Geelong Hospital	Geelong	Victoria
Australia	Gold Coast Hospital	Gold Coast	Queensland
Australia	Sexual Health Service	Hobart	Tasmania
Australia	Australian Clinical Research Organisation	Kippa Ring	Queensland
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	Eastern Area Health Service, Prince of Wales Hospital	Randwick	New South Wales
Australia	Primary Old Port Road Medical and Dental Centre	Royal Park	South Australia
Australia	National Centre for Immunisation Research & Surveillance (NCIRS) The Children's Hospital at Westmead	Westmead	New South Wales
New Zealand	Auckland Clinical Studies	Auckland
New Zealand	198 Youth Health Centre	Christchurch
New Zealand	Southern Clinical Trials	Christchurch
New Zealand	RMC Medical Centre	Dunedin

Sponsors (1)

Lead Sponsor	Collaborator
Seqirus

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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.	2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009
Secondary	Incidence of Influenza-like Illness (ILI)	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.	2008 and 2009 Southern Hemisphere influenza seasons, until 30 November 2009
Secondary	Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2008		21 days after study vaccination
Secondary	Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009		21 days after study vaccination
Secondary	Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2008	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.	21 days after study vaccination
Secondary	Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2009	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.	21 days after study vaccination
Secondary	Geometric Mean Fold Increase in HI Titer 21 Days After Study Vaccination, Year 2008	Geometric mean fold increase in HI titer was defined as the geometric mean titer (GMT) after vaccination divided by the GMT before vaccination.	21 days after study vaccination
Secondary	Geometric Mean Fold Increase in HI Titer Rate 21 Days After Study Vaccination, Year 2009	Geometric mean fold increase in HI titer was defined as the geometric mean titer (GMT) after vaccination divided by the GMT before vaccination.	21 days after study vaccination
Secondary	Frequency and Intensity of Local and Systemic Solicited Symptoms	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)	5 days after study vaccination
Secondary	Frequency and Intensity of Unsolicited Adverse Events (UAEs)	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.	21 days after study vaccination
Secondary	Serious Adverse Events (SAEs)	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	180 days after study vaccination
Secondary	New Onsets of Chronic Illness (NOCI)	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).	180 days after study vaccination