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

A Phase II, Multicentre, Randomised, Observer-blind Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children Aged >= 6 Months to < 9 Years.

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 children.

Study Overview

• Status: Completed
• Conditions: Influenza Caused by the Novel Influenza A (H1N1) Virus
• Intervention / Treatment: Biological: CSL425

• Study Type: Interventional
• Enrollment (Actual): 370
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Study Site
  • Queensland
    • Brisbane, Queensland, Australia, 4006
      • Study Site
  • South Australia
    • North Adelaide, South Australia, Australia, 5006
      • Study Site
  • Victoria
    • Carlton, Victoria, Australia, 3010
      • Study Site
  • Western Australia
    • Subiaco, Western Australia, Australia, 6027
      • Study Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female aged >= 6 months to < 9 years at the time of the first study vaccination.
• For children < 3 years of age at the time of first vaccination, born at or after 36 weeks of gestation.

Exclusion Criteria:

• Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thiomersal, 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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination	HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.	Before and 21 days after the first vaccination
HI Antibody Titre Seroconversion Rate After the Second Vaccination	HI antibody titre seroconversion was defined as participants with a pre-vaccination titre of less than 1:10 achieving a post-vaccination HI antibody titre of 1:40 or more; or participants with a pre-vaccination HI titre of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titre.	Before and 21 days after the second vaccination
Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination	GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.	Before and 21 days after the first vaccination
GMFI in the HI Antibody Titre After the Second Vaccination	GMFI in HI antibody titre was defined as the geometric mean of the fold increase in the post-vaccination antibody titre over the pre-vaccination antibody titre.	Before and 21 days after the second vaccination
Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination		21 days after the first vaccination
Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination		21 days after the second vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)	An AESI was defined as an AE for which the association with seasonal influenza vaccine was unclear. 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 Solicited Adverse Events (AEs) After the First or Second Vaccination	Solicited AEs included AEs that were specifically sought for. Grade 3 solicited AE definitions: Cried when limb was moved/spontaneously painful (Cohort A) or prevented normal daily activities (Cohort B) for injection site pain; Size > 100 mm for injection site redness and induration/swelling; Temperature > 103.1°F (39.5°C) for fevers; Prevented normal daily activities or required medical intervention for all other systemic AEs.	During the 7 days after each vaccination
Duration of Solicited AEs After the First Vaccination	Solicited AEs included AEs that were specifically sought for.	During the 7 days after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7.
Duration of Solicited AEs After the Second Vaccination	Solicited AEs included AEs that were specifically sought for.	During the 7 days after the second vaccination and up to Day 20 after the second vaccination if AE was ongoing at Day 7.
Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination	Unsolicited AEs included AEs other than those specifically sought for. Grade 1 unsolicited AE definition: Easily tolerated and did not interfere with normal daily activities. Grade 2 unsolicited AE definition: Some interference with normal daily activities. Grade 3 unsolicited AE definition: Prevented normal daily activities.	During the 21 days after each vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Nolan T, McVernon J, Skeljo M, Richmond P, Wadia U, Lambert S, Nissen M, Marshall H, Booy R, Heron L, Hartel G, Lai M, Basser R, Gittleson C, Greenberg M. Immunogenicity of a monovalent 2009 influenza A(H1N1) vaccine in infants and children: a randomized trial. JAMA. 2010 Jan 6;303(1):37-46. doi: 10.1001/jama.2009.1911. Epub 2009 Dec 21.

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: July 13, 2009
• First Submitted That Met QC Criteria: July 14, 2009
• First Posted (Estimate): July 15, 2009

Study Record Updates

• Last Update Posted (Actual): June 28, 2018
• Last Update Submitted That Met QC Criteria: April 25, 2018
• Last Verified: April 1, 2018

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-09-60