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Completed

NCT Number: NCT00958243

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

The purpose of this study is to evaluate the immunogenicity and safety profile of CSL425 (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population.

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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

6 month–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chandler, Arizona, 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 >= 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 gestation.

Exclusion criteria

  • Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine

Treatment and study plan

CSL's 2009 H1N1 Influenza Vaccine (CSL425)

Biological

0.5 mL intramuscular injection on Day 0 and Day 21

Placebo

Biological

Placebo

Primary outcomes

  1. Seroconversion Rate 21 Days After First Study Vaccination

    Time frame: 21 days after the first study 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.

  2. Seroconversion Rate 21 Days After Second Study Vaccination

    Time frame: 21 days after the second study 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 First Study Vaccination

    Time frame: 21 days after the first study vaccination

  4. Percentage of Participants Achieving an Hemagglutination Inhibition (HI) Antibody Titer of 1:40 or More 21 Days After Second Study Vaccination

    Time frame: 21 days after the second study vaccination

Secondary outcomes

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

    Time frame: During the 7 days after each study vaccination

    Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Cried when limb was moved/spontaneously painful (aged < 3 years) for injection site pain; Size > 30 mm for injection site redness and injection site induration/swelling; Oral temperature > 104.0°F (40.0°C) or axillary temperature > 103.1°F (39.5°C) for fevers.

  2. Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort A

    Time frame: During the 7 days after each study vaccination

  3. Frequency and Intensity of Solicited Adverse Events After the First or Second Study Vaccination, Cohort B

    Time frame: During the 7 days after each study vaccination

    Grade 3 solicited AE definitions: Prevented normal daily activities or required medical intervention for systemic AEs; Prevented normal daily activities (aged >= 3 years)for injection site pain; Size > 30 mm for injection site redness and injection site induration/swelling; Oral temperature > 104.0°F (40.0°C) or axillary temperature > 103.1°F (39.5°C) for fevers.

  4. Duration of Solicited Adverse Events After the First and Second Study Vaccination, Cohort B

    Time frame: During the 7 days after each study vaccination

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

    Time frame: During the 21 days after each vaccination

    UAE grading:

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

    Grade 2: Enough discomfort to cause some interference with daily activities. Grade 3: Symptoms that prevented normal, everyday activities.

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

    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 (e.g., diabetes, asthma).

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 a Healthy Pediatric Population

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Aug 13, 2009
Registry last updated
May 23, 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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