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

The purpose of this study is to evaluate the immunogenicity and safety profile of CSL425 (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Placebo; Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425); Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425)

• Study Type: Interventional
• Enrollment (Actual): 473
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
  • Florida
    • Melbourne, Florida, United States, 32935
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
  • Louisiana
    • Metairie, Louisiana, United States, 70006
  • Nebraska
    • Omaha, Nebraska, United States, 68134
  • Ohio
    • Austintown, Ohio, United States, 44515
    • Cincinnati, Ohio, United States, 45246
  • Pennsylvania
    • Latrobe, Pennsylvania, United States, 15650
    • Pittsburgh, Pennsylvania, United States, 15227
  • Texas
    • Austin, Texas, United States, 78705
    • Fort Worth, Texas, United States, 76135
    • Houston, Texas, United States, 77030
  • Utah
    • Murray, Utah, United States, 84107

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 9 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 gestation.

Exclusion Criteria:

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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Biological: Placebo; Placebo
Experimental: CSL425 (7.5 mcg); 7.5 mcg of hemagglutinin antigen per dose	Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425); 0.5 mL intramuscular injection on Day 0 and Day 21; Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425); 0.25 mL intramuscular injection on Day 0 and Day 21
Experimental: CSL425 (15 mcg); 15 mcg of hemagglutinin antigen per dose	Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425); 0.5 mL intramuscular injection on Day 0 and Day 21; Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425); 0.25 mL intramuscular injection on Day 0 and Day 21

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroconversion Rate 21 Days After First Study 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 first study vaccination
Seroconversion Rate 21 Days After Second Study 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 study vaccination
Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After First Study Vaccination		21 days after the first study vaccination
Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination		21 days after the second study vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A	Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Cried when limb was moved/spontaneously painful (aged < 3 years) for injection site pain; Size > 30 mm for injection site redness and injection site induration/swelling; Oral temperature > 104.0°F (40.0°C) or axillary temperature > 103.1°F (39.5°C) for fevers.	During the 7 days after each study vaccination
Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A		During the 7 days after each study vaccination
Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B	Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Prevented normal daily activities (aged >= 3 years)for injection site pain; Size > 30 mm for injection site redness and injection site induration/swelling; Oral temperature > 104.0°F (40.0°C) or axillary temperature > 103.1°F (39.5°C) for fevers.	During the 7 days after each study vaccination
Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B		During the 7 days after each study vaccination
Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination	UAE grading: Grade 1: Symptoms were easily tolerated and did not interfere with daily activities. Grade 2: Enough discomfort to cause some interference with daily activities. Grade 3: Symptoms that prevented normal, everyday activities.	During the 21 days after each vaccination
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs)	A NOCI was defined as the diagnosis of a new medical condition that was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma).	Up to 180 days after the last vaccination

Collaborators and Investigators

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

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): May 23, 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; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: CSLCT-CAL-09-62