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

Seqirus370 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

370

Conditions

Influenza Caused by the Novel Influenza A (H1N1) Virus

Interventions

CSL425BIOLOGICAL

CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free

CSL425BIOLOGICAL

CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 8 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (5)

Study Site

Westmead, New South Wales, Australia

Study Site

Brisbane, Queensland, Australia

Study Site

North Adelaide, South Australia, Australia

Study Site

Carlton, Victoria, Australia

Study Site

Outcomes

Primary Outcomes

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.

Time frame: Before and 21 days after the first vaccination

HI Antibody Titre Seroconversion Rate After the Second Vaccination

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 21 days after the first vaccination

Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination

Time frame: 21 days after the second vaccination

Data from ClinicalTrials.gov

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Secondary Outcomes

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.

Time frame: During the 7 days after each vaccination

Duration of Solicited AEs After the First Vaccination

Solicited AEs included AEs that were specifically sought for.

Time frame: 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.

Time frame: During the 7 days after the second vaccination and up to Day 20 after the second vaccination if AE was ongoing at Day 7.

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).

Time frame: Up to 180 days after the last vaccination

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.

Time frame: During the 21 days after each vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs