Phase 4 N=15,044 Randomized Triple-blind Prevention

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

Bottom Line

View on ClinicalTrials.gov: NCT00562484 ↗

Enrolled (actual)

15,044

Serious AEs

1.0%

Results posted

Sep 2011

Primary outcome: Primary: CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection — 2.24; 3.87 Ratio

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: CSL Limited Influenza Vaccine (Biological); Placebo (Biological)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Seqirus
Primary completion: Nov 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY CSL's IVV Overall Vaccine Efficacy (VE) Versus Placebo Through Assessment of Incidence of Laboratory Confirmed Influenza A/B Infection	2.24; 3.87	—
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	0.59; 1.47	—
SECONDARY Incidence of Influenza-like Illness (ILI)	11.9; 13.5; 1.5; 2.4; 2.6; 3.6	—
SECONDARY Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2008	99; 42; 97; 35; 77; 13	—
SECONDARY Percentage of Participants With a Minimum Post-vaccination Hemagglutination Inhibition (HI) Titer of 1:40, Year 2009	94; 36; 94; 43; 89; 30	—
SECONDARY Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2008	81; 1; 87; 1; 63; 1	—
SECONDARY Percentage of Participants With Seroconversion 21 Days After Study Vaccination, Year 2009	78; 1; 81; 1; 61; 0	—
SECONDARY Geometric Mean Fold Increase in HI Titer 21 Days After Study Vaccination, Year 2008	21; 1; 18; 1; 8; 1	—
SECONDARY Geometric Mean Fold Increase in HI Titer Rate 21 Days After Study Vaccination, Year 2009	13; 1; 15; 1; 6; 1	—
SECONDARY Frequency and Intensity of Local and Systemic Solicited Symptoms	7474; 1021; 4850; 539; 19; 0	—
SECONDARY Frequency and Intensity of Unsolicited Adverse Events (UAEs)	3519; 1698; 1604; 750; 1536; 784	—
SECONDARY Serious Adverse Events (SAEs)	100; 44; 0; 0	—
SECONDARY New Onsets of Chronic Illness (NOCI)	80; 46; 3; 0	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00562484). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.