Clinical trial NCT00940108: A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children
Official title: A Phase II, Multicentre, Randomised, Observer-blind Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children Aged >= 6 Months to < 9 Years.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza Caused by the Novel Influenza A (H1N1) Virus
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2009-07-15
Enrollment: 370
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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 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.

Primary outcomes:
measure: Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination
timeFrame: Before and 21 days after the first vaccination
measure: HI Antibody Titre Seroconversion Rate After the Second Vaccination
timeFrame: Before and 21 days after the second vaccination
measure: Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination
timeFrame: Before and 21 days after the first vaccination
measure: GMFI in the HI Antibody Titre After the Second Vaccination
timeFrame: Before and 21 days after the second vaccination
measure: Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination
timeFrame: 21 days after the first vaccination
measure: Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination
timeFrame: 21 days after the second vaccination
Secondary outcomes:
measure: Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination
timeFrame: During the 7 days after each vaccination
measure: Duration of Solicited AEs After the First Vaccination
timeFrame: During the 7 days after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7.
measure: Duration of Solicited AEs After the Second Vaccination
timeFrame: During the 7 days after the second vaccination and up to Day 20 after the second vaccination if AE was ongoing at Day 7.
measure: Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)
timeFrame: Up to 180 days after the last vaccination
measure: Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination
timeFrame: During the 21 days after each vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: Study Site
state: New South Wales
city: Brisbane
country: Australia
facility: Study Site
state: Queensland
city: North Adelaide
country: Australia
facility: Study Site
state: South Australia
city: Carlton
country: Australia
facility: Study Site
state: Victoria
city: Subiaco
country: Australia
facility: Study Site
state: Western Australia
Study officials:
affiliation: Seqirus
name: Clinical Director Vaccines
role: STUDY_DIRECTOR
References:
citation: Nolan T, McVernon J, Skeljo M, Richmond P, Wadia U, Lambert S, Nissen M, Marshall H, Booy R, Heron L, Hartel G, Lai M, Basser R, Gittleson C, Greenberg M. Immunogenicity of a monovalent 2009 influenza A(H1N1) vaccine in infants and children: a randomized trial. JAMA. 2010 Jan 6;303(1):37-46. doi: 10.1001/jama.2009.1911. Epub 2009 Dec 21.