CompletedPhase 2

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

Australia370 participantsStarted 2009-08

Plain-language 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.

Who can participate

Age range6 Months – 8 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: Before and 21 days after the first vaccination

HI Antibody Titre Seroconversion Rate After the Second Vaccination

Timeframe: Before and 21 days after the second vaccination

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

Timeframe: Before and 21 days after the first vaccination

GMFI in the HI Antibody Titre After the Second Vaccination

Timeframe: 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

Timeframe: 21 days after the first vaccination

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

Timeframe: 21 days after the second vaccination

Trial details

NCT IDNCT00940108

SponsorSeqirus

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-10

Results submitted2013-07-09

View on ClinicalTrials.gov More Influenza Caused by the Novel Influenza A (H1N1) Virus trials

Who can participate

Age range6 Months – 8 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Before and 21 days after the first vaccination

HI Antibody Titre Seroconversion Rate After the Second Vaccination

Timeframe: Before and 21 days after the second vaccination

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

Timeframe: Before and 21 days after the first vaccination

GMFI in the HI Antibody Titre After the Second Vaccination

Timeframe: 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

Timeframe: 21 days after the first vaccination

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

Timeframe: 21 days after the second vaccination