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Completed

NCT Number: NCT00958126

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

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

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Study Site, Huntsville, Alabama, United States

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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 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.

Treatment and study plan

CSL425

Biological

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

Placebo

Biological

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

Primary outcomes

  1. Seroconversion Rate 21 Days After the First Vaccination

    Time frame: 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.

  2. Seroconversion Rate 21 Days After the Second Vaccination

    Time frame: 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.

  3. 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

  4. 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

  1. Frequency and Intensity of Solicited Adverse Events After the First Vaccination

    Time frame: During the 7 days 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.

  2. Duration of Solicited Local Adverse Events After the First Vaccination

    Time frame: During the 7 days after the first vaccination, and day 7 - day 21 for ongoing AEs

  3. Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI) and New Onset of Chronic Illness (NOCI)

    Time frame: Up to 180 days after the last vaccination

    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).

  4. Frequency and Intensity of Unsolicited Adverse Events (UAE) After the First or Second Vaccination

    Time frame: Day 0 to Day 20 after each vaccination; up to Day 180 after the last vaccination for SAEs, AESI and NOCI

    Unsolicited adverse event (UAE) grading:

    Grade 1 (mild): Symptoms were easily tolerated and did not interfere with daily activities.

    Grade 2 (moderate): Enough discomfort to cause some interference with daily activities.

    Grade 3 (severe): Symptoms that prevented normal, everyday activities.

Sponsors and collaborators

Lead sponsor

Seqirus

Industry

Registry information

Official study title

A Phase II, Multicenter, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Adults Aged 18 Years and Older

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Aug 13, 2009
Registry last updated
Nov 21, 2017

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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