A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults in the USA

A Phase II, Multicenter, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults Aged 18 Years and Older

The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: CSL425; Biological: CSL425; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1313
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35802
      • Study Site
  • California
    • San Diego, California, United States, 92108
      • Study Site
  • Florida
    • Melbourne, Florida, United States, 32935
      • Study Site
  • Illinois
    • Peoria, Illinois, United States, 61602
      • Study Site
  • Indiana
    • South Bend, Indiana, United States, 46601
      • Study Site
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Study Site
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Study Site
    • Rockville, Maryland, United States, 20850
      • Study Site
  • Texas
    • Austin, Texas, United States, 78705
      • Study Site
    • Fort Worth, Texas, United States, 76135
      • Study Site
  • Utah
    • Salt Lake City, Utah, United States, 84124
      • Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female aged 18 and older, inclusive, at the time of providing informed consent.
• Females of child bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child bearing potential must return a negative urine pregnancy test result at enrolment and prior to each study vaccination.

Exclusion Criteria:

• Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thimerosal, neomycin, polymyxin, or any components of the Study Vaccine.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CSL425 (30 mcg); 30 mcg of hemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21	Biological: CSL425; CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free.; Biological: CSL425; CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume).
Experimental: CSL425 (7.5 mcg); 7.5 mcg of hemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21	Biological: CSL425; CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free.; Biological: CSL425; CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume).
Experimental: CSL425 (15 mcg); 15 mcg of hemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.	Biological: CSL425; CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free.; Biological: CSL425; CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume).
Placebo Comparator: Placebo; Vaccine diluent. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.	Biological: Placebo; Vaccine diluent, thimerosal 0.01% (weight/volume).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroconversion Rate 21 Days After the First Vaccination	Seroconversion rate: the proportion of participants achieving seroconversion in hemagglutination inhibition (HI) antibody titer. Seroconversion is defined as participants with a baseline titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a baseline HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.	21 days after the first vaccination
Seroconversion Rate 21 Days After the Second Vaccination	Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.	21 days after the second vaccination
Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination		21 days after the first vaccination
Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination		21 days after the second vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and Intensity of Solicited Adverse Events After the First Vaccination	Grade 3 solicited adverse event (AE) definitions: Prevented normal daily activities; Size > 100 mm for injection site redness or induration/swelling; Temperature 102.2°F (39.0°C) or more for fevers.	During the 7 days after the first vaccination
Duration of Solicited Local Adverse Events After the First Vaccination		During the 7 days after the first vaccination, and day 7 - day 21 for ongoing AEs
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI)	A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (eg, diabetes, asthma).	Up to 180 days after the last vaccination
Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination	Unsolicited adverse event (UAE) grading: Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities. Grade 2 (moderate): Enough discomfort to cause some interference with daily activities. Grade 3 (severe): Symptoms that prevented normal, everyday activities.	Day 0 to Day 20 after each vaccination; up to Day 180 after the last vaccination for SAEs, AESI and NOCI

Collaborators and Investigators

• Sponsor: Seqirus
• Investigators: Study Director: Director, Vaccines Clinical Development, Seqirus

Publications and helpful links

General Publications

• Talaat KR, Greenberg ME, Lai MH, Hartel GF, Wichems CH, Rockman S, Jeanfreau RJ, Ghosh MR, Kabongo ML, Gittleson C, Karron RA. A single dose of unadjuvanted novel 2009 H1N1 vaccine is immunogenic and well tolerated in young and elderly adults. J Infect Dis. 2010 Nov 1;202(9):1327-37. doi: 10.1086/656601.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: August 12, 2009
• First Submitted That Met QC Criteria: August 12, 2009
• First Posted (Estimate): August 13, 2009

Study Record Updates

• Last Update Posted (Actual): November 21, 2017
• Last Update Submitted That Met QC Criteria: October 18, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: CSLCT-CAL-09-61