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Completed

NCT Number: NCT00940108

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

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.

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Key information

Conditions

Influenza Caused by the Novel Influenza A (H1N1) Virus Infections Virus Diseases

Age range

6 month–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Study Site, Westmead, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CSL425

Biological

CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free

Primary outcomes

  1. Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination

    Time frame: 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.

  2. HI Antibody Titre Seroconversion Rate After the Second Vaccination

    Time frame: 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.

  3. Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination

    Time frame: 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.

  4. GMFI in the HI Antibody Titre After the Second Vaccination

    Time frame: 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.

  5. 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

  6. 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

Secondary outcomes

  1. Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination

    Time frame: 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.

  2. Duration of Solicited AEs After the First Vaccination

    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.

    Solicited AEs included AEs that were specifically sought for.

  3. Duration of Solicited AEs After the Second Vaccination

    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.

    Solicited AEs included AEs that were specifically sought for.

  4. Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)

    Time frame: 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).

  5. Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seqirus

Industry

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Jul 15, 2009
Registry last updated
Jun 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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