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

Seqirus1,313 enrolled

Overview

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 adults

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

1,313

Conditions

Influenza

Interventions

CSL425BIOLOGICAL

CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free.

CSL425BIOLOGICAL

CSL's 2009 H1N1 Influenza Vaccine, thimerosal 0.01% (weight/volume).

PlaceboBIOLOGICAL

Vaccine diluent, thimerosal 0.01% (weight/volume).

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female aged 18 and older, inclusive, at the time of providing informed consent. * Females of child bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child bearing potential must return a negative urine pregnancy test result at enrolment and prior to each study vaccination. Exclusion Criteria: * Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, thimerosal, neomycin, polymyxin, or any components of the Study Vaccine.

Locations (11)

Study Site

Huntsville, Alabama, United States

Study Site

San Diego, California, United States

Study Site

Melbourne, Florida, United States

Study Site

Outcomes

Primary Outcomes

Seroconversion Rate 21 Days After the First Vaccination

Seroconversion rate: the proportion of participants achieving seroconversion in hemagglutination inhibition (HI) antibody titer. Seroconversion is defined as participants with a baseline titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a baseline HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.

Time frame: 21 days after the first vaccination

Seroconversion Rate 21 Days After the Second Vaccination

Seroconversion rate: the percentage of participants achieving seroconversion in HI antibody titer. Seroconversion is defined as participants with a pre-vaccination titer of less than 1:10 achieving a post-vaccination HI antibody titer of 1:40 or more; or participants with a pre-vaccination HI titer of 1:10 or more achieving a four-fold or greater increase in post-vaccination HI titer.

Time frame: 21 days after the second vaccination

Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After the First Vaccination

Time frame: 21 days after the first vaccination

Percentage of Participants Achieving an HI Antibody Titer of 1:40 or More 21 Days After the Second Vaccination

Time frame: 21 days after the second vaccination

Secondary Outcomes

Frequency and Intensity of Solicited Adverse Events After the First Vaccination

Grade 3 solicited adverse event (AE) definitions: Prevented normal daily activities; Size \> 100 mm for injection site redness or induration/swelling; Temperature 102.2°F (39.0°C) or more for fevers.

Time frame: During the 7 days after the first vaccination

Duration of Solicited Local Adverse Events After the First Vaccination

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.