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

Phase 2

Completed

• Conditions: Influenza
• Interventions: Biological: Placebo; Biological: CSL's 2009 H1N1 Influenza Vaccine (CSL425)

• Registration Number: NCT00958243
• Lead Sponsor: Seqirus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-12
• Study First Submitted QC: 2009-08-12
• Study First Posted: 2009-08-13
• Primary Completion: 2009-11
• Study Completion: 2010-04
• Results First Submitted: 2011-07-13
• Results First Submitted QC: 2011-07-13
• Results First Posted: 2011-08-09
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-25
• Last Update Posted: 2018-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 473

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
CSL425 (15 mcg)	CSL's 2009 H1N1 Influenza Vaccine (CSL425)	15 mcg of hemagglutinin antigen per dose
CSL425 (7.5 mcg)	CSL's 2009 H1N1 Influenza Vaccine (CSL425)	7.5 mcg of hemagglutinin antigen per dose

Primary Outcome Measures

Name	Time	Method
Seroconversion Rate 21 Days After Second Study Vaccination	21 days after the 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.
Seroconversion Rate 21 Days After First Study Vaccination	21 days after the 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.
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

Name	Time	Method
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Study Vaccination, Cohort A	During the 7 days after each study vaccination	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.
Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination	During the 21 days after each 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.
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	During the 7 days after each study vaccination	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	During the 7 days after each study vaccination
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and New Onset of Chronic Illness (NOCIs)	Up to 180 days after the last vaccination	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).