A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years

Seqirus402 enrolled

Overview

This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in children aged 5 years to less than 9 years. Comparison will be made to a licensed Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the 2014/2015 influenza season in the US.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

402

Conditions

Influenza, Human

Interventions

bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)BIOLOGICAL

Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.

Comparator Quadrivalent Influenza Virus VaccineBIOLOGICAL

Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 8 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Males or females aged 5 to less than 9 years at the time of first study vaccination. * The subject's parent or guardian to provide written informed consent and be willing and able to adhere to all protocol requirements. * In good health, as determined by medical history and a targeted physical examination (if warranted). Exclusion Criteria: * Known hypersensitivity to a previous dose of Influenza Virus Vaccine or allergy to eggs or any components of the study vaccines. * Clinical signs of significant active infection or an elevated oral temperature at study entry. * A clinically significant medical or psychiatric condition. * A history of seizures or febrile convulsions or Guillain-Barré syndrome. * Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry. * Vaccination with a licensed vaccine within 14 days preceding study entry, or planning to be vaccinated with another licensed vaccine before the study exit evaluation. * Currently receiving systemic glucocorticoid therapy (excluding intra-articular, topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry. * Currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of the study vaccine. * Currently receiving treatment with warfarin or other anticoagulants.

Locations (11)

Site 286

Los Angeles, California, United States

Site 289

Boise, Idaho, United States

Site 287

St Louis, Missouri, United States

Site 285

Binghamton, New York, United States

Outcomes

Primary Outcomes

The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine.

The overall percentage of subjects reporting at least one fever event after administration of bioCSL TIV. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to \< 101.3°F (≥ 38.0 to \< 38.5°C) • Moderate: ≥ 101.3 to \< 102.2°F (≥ 38.5 to \< 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C)

Time frame: 7 days after each administration of vaccine.

Secondary Outcomes

The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of the Comparator Influenza Virus Vaccine.

The overall percentage of subjects reporting at least one fever event after administration of the comparator influenza virus vaccine. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to \< 101.3°F (≥ 38.0 to \< 38.5°C) • Moderate: ≥ 101.3 to \< 102.2°F (≥ 38.5 to \< 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C).

Time frame: 7 days after each administration of vaccine.

The Frequency and Intensity of Vaccine-related Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine or Comparator Influenza Virus Vaccine.

Percentage of subjects with a related fever event (overall) by study vaccine group based on the number of subjects contributing any follow up safety information for at least one data value of an individual sign/symptom. Excludes subjects with missing intensity information for the whole 7 days. Mild fever: ≥ 100.4 to \< 101.3º F (≥ 38.0 to \< 38.5º C). Moderate fever: ≥ 101.3 to \< 102.2º F (≥ 38.5 to \< 39.0º C). Severe fever: ≥ 102.2º F (≥ 39.0º C).

Time frame: 7 days after each administration of vaccine.

The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.

The overall frequency and intensity of solicited local Adverse Events (AEs) occurring during the 7 days after each administration of bioCSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. Percentages for intensity are based on the number of subjects with non-missing intensity data. Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.

Data from ClinicalTrials.gov

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