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

Influenza Caused by the Novel Influenza A (H1N1) Virus Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00940108
• Other study ID #: CSLCT-CAL-09-60
• Status: Completed
• Phase: Phase 2
• Start date: August 2009
• Est. completion date: April 2010

Study information

• Verified date: April 2018
• Source: Seqirus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: April 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Influenza Caused by the Novel Influenza A (H1N1) Virus
• Influenza, Human

Intervention

Biological:
• CSL425
CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free
• CSL425
CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free

Locations

Country	Name	City	State
Australia	Study Site	Brisbane	Queensland
Australia	Study Site	Carlton	Victoria
Australia	Study Site	North Adelaide	South Australia
Australia	Study Site	Subiaco	Western Australia
Australia	Study Site	Westmead	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Seqirus

Country where clinical trial is conducted

Australia, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Before and 21 days after the first vaccination
Primary	HI Antibody Titre Seroconversion Rate 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.	Before and 21 days after the second vaccination
Primary	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.	Before and 21 days after the first vaccination
Primary	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.	Before and 21 days after the second vaccination
Primary	Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination		21 days after the first vaccination
Primary	Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination		21 days after the second vaccination
Secondary	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.	During the 7 days after each vaccination
Secondary	Duration of Solicited AEs After the First Vaccination	Solicited AEs included AEs that were specifically sought for.	During the 7 days after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7.
Secondary	Duration of Solicited AEs After the Second Vaccination	Solicited AEs included AEs that were specifically sought for.	During the 7 days after the second vaccination and up to Day 20 after the second vaccination if AE was ongoing at Day 7.
Secondary	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).	Up to 180 days after the last vaccination
Secondary	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.	During the 21 days after each vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs