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Completed

NCT Number: NCT00959049

A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine in a Pediatric Population

The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US licensed comparator Influenza Virus Vaccine in a pediatric population aged greater than or equal to 6 months to less than 18 years.

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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–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chandler, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male or non-pregnant female participants aged ≥ 6 calendar months to < 18 years at the time of the first study vaccination.
  • For participants aged ≥ 6 months to < 9 years, born after a normal gestation period (between 36 and 42 weeks).
  • Females of childbearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for at least 2 months after vaccination. Females aged ≥ 9 years must also return a negative urine pregnancy test at enrollment.

Exclusion criteria

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

Treatment and study plan

CSL's Influenza Virus Vaccine (Afluria)

Biological

0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines

Influenza virus vaccine (Fluzone)

Biological

0.25 mL (one or two doses) or 0.5 mL (one or two doses) by intramuscular injection as directed by immunization guidelines

Primary outcomes

  1. Geometric Mean Titer 30 Days After the Last Study Vaccination

    Time frame: 30 days after the last study vaccination

  2. Percentage of Participants With Seroconversion 30 Days After the Last Study Vaccination

    Time frame: 30 days after the last study vaccination

    Seroconversion rate was defined as the proportion of participants with either a titer of less than 1:10 before vaccination achieving a HI antibody titer of 1:40 or more after vaccination, or a HI titer of 1:10 or more before vaccination achieving a four-fold or greater increase in HI titer after vaccination.

Secondary outcomes

  1. Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)

    Time frame: 7 days after each vaccination

  2. Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort B

    Time frame: 7 days after each vaccination

  3. Frequency and Intensity of Local and Systemic Solicited Symptoms, Cohort C

    Time frame: 7 days after vaccination

  4. Frequency and Intensity of Unsolicited Adverse Events (UAEs)

    Time frame: 30 days after each vaccination

    UAE stands for Unsolicited Adverse Events

  5. New Onset of Chronic Illnesses (NOCIs)

    Time frame: 6 months after last study vaccination

    New onset of chronic illness after any vaccine dose. A new onset of chronic illness was defined as the diagnosis of a new medical condition which was chronic in nature, including those potentially controllable by medication (e.g., diabetes, asthma).

  6. Serious Adverse Events (SAEs)

    Time frame: 6 months after last study vaccination

  7. Duration of Local and Systemic Solicited Symptoms, Cohort A (6 Months to < 3 Years)

    Time frame: 7 days after each vaccination

  8. Duration of Local and Systemic Solicited Symptoms, Cohort B

    Time frame: 7 days after each vaccination

  9. Duration of Local and Systemic Solicited Symptoms, Cohort C

    Time frame: 7 days after vaccination

Sponsors and collaborators

Lead sponsor

Seqirus

Industry

Registry information

Official study title

A Phase III, Randomized, Observer-blind, Multi-center, Noninferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Trivalent Inactivated Split-Virion Influenza Vaccine in a Pediatric Population Aged Greater Than or Equal to 6 Months to Less Than 18 Years.

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Aug 14, 2009
Registry last updated
May 16, 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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