Back to resultsA Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population in the USA
Primary Purpose
Influenza
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CSL's 2009 H1N1 Influenza Vaccine (CSL425)
CSL's 2009 H1N1 Influenza Vaccine (CSL425)
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Influenza
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
CSL425 (7.5 mcg)
CSL425 (15 mcg)
Arm Description
Placebo
7.5 mcg of hemagglutinin antigen per dose
15 mcg of hemagglutinin antigen per dose
Outcomes
Primary Outcome Measures
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.
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.
Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After First Study Vaccination
Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination
Secondary Outcome Measures
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.
Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A
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.
Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00958243
Brief Title
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population in the USA
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seqirus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
473 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
CSL425 (7.5 mcg)
Arm Type
Experimental
Arm Description
7.5 mcg of hemagglutinin antigen per dose
Arm Title
CSL425 (15 mcg)
Arm Type
Experimental
Arm Description
15 mcg of hemagglutinin antigen per dose
Intervention Type
Biological
Intervention Name(s)
CSL's 2009 H1N1 Influenza Vaccine (CSL425)
Intervention Description
0.5 mL intramuscular injection on Day 0 and Day 21
Intervention Type
Biological
Intervention Name(s)
CSL's 2009 H1N1 Influenza Vaccine (CSL425)
Intervention Description
0.25 mL intramuscular injection on Day 0 and Day 21
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Seroconversion Rate 21 Days After First Study Vaccination
Description
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.
Time Frame
21 days after the first study vaccination
Title
Seroconversion Rate 21 Days After Second Study Vaccination
Description
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.
Time Frame
21 days after the second study vaccination
Title
Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After First Study Vaccination
Time Frame
21 days after the first study vaccination
Title
Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination
Time Frame
21 days after the second study vaccination
Secondary Outcome Measure Information:
Title
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A
Description
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.
Time Frame
During the 7 days after each study vaccination
Title
Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A
Time Frame
During the 7 days after each study vaccination
Title
Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B
Description
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.
Time Frame
During the 7 days after each study vaccination
Title
Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B
Time Frame
During the 7 days after each study vaccination
Title
Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination
Description
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.
Time Frame
During the 21 days after each vaccination
Title
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs)
Description
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).
Time Frame
Up to 180 days after the last vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Director Vaccines
Organizational Affiliation
Seqirus
Official's Role
Study Director
Facility Information:
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32935
Country
United States
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
City
Austintown
State/Province
Ohio
ZIP/Postal Code
44515
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
City
Latrobe
State/Province
Pennsylvania
ZIP/Postal Code
15650
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15227
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population in the USA
We'll reach out to this number within 24 hrs