CompletedPhase 2

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

Australia240 participantsStarted 2009-07

Plain-language summary

The purpose of the study is to determine whether CSL425 is a safe and effective vaccine for eliciting an immune response to H1N1 influenza in healthy adults.

Who can participate

Age range18 Years – 64 Years

SexALL

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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 \>= 18 to \< 65 years at the time of providing informed consent. 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) and Microneutralisation (MN) Antibody Titre Seroconversion Rate After the First Vaccination

Timeframe: Before and 21 days after the first vaccination

HI and MN 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 and MN Antibody Titre After the First Vaccination

Timeframe: Before and 21 days after the first vaccination

GMFI in the HI and MN Antibody Titer After the Second Vaccination

Timeframe: Before and 21 days after the second vaccination

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

Timeframe: 21 days after the first vaccination

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

Timeframe: 21 days after the second vaccination

Trial details

NCT IDNCT00938639

SponsorSeqirus

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-09

Results submitted2013-07-24

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