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

Phase 2

Completed

• Conditions: Influenza Caused by the Novel Influenza A (H1N1) Virus
• Interventions: Biological: CSL425

• Registration Number: NCT00940108
• Lead Sponsor: Seqirus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-13
• Study First Submitted QC: 2009-07-14
• Study First Posted: 2009-07-15
• Study Start: 2009-08
• Primary Completion: 2009-10
• Study Completion: 2010-04
• Results First Submitted: 2013-07-09
• Results First Submitted QC: 2013-10-28
• Results First Posted: 2013-11-20
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-25
• Last Update Posted: 2018-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 370

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CSL425 (30 mcg)	CSL425	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
CSL425 (15 mcg)	CSL425	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

Primary Outcome Measures

Name	Time	Method
Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination	Before and 21 days 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.
Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination	21 days after the second vaccination
Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination	Before and 21 days 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.
HI Antibody Titre Seroconversion Rate After the Second Vaccination	Before and 21 days 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.
GMFI in the HI Antibody Titre After the Second Vaccination	Before and 21 days 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.
Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination	21 days after the first vaccination

Secondary Outcome Measures

Name	Time	Method
Duration of Solicited AEs After the Second Vaccination	During the 7 days after the second vaccination and up to Day 20 after the second vaccination if AE was ongoing at Day 7.	Solicited AEs included AEs that were specifically sought for.
Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination	During the 7 days after each 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.
Duration of Solicited AEs After the First Vaccination	During the 7 days after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7.	Solicited AEs included AEs that were specifically sought for.
Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)	Up to 180 days after the last vaccination	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).
Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination	During the 21 days after each vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs	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.

Trial Locations

Locations (1)

Study Site; 🇦🇺 Subiaco, Western Australia, Australia