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

A Phase IV, Multicenter, Randomized, Observer-blind, Parallel-arm Study to Evaluate the Safety and Tolerability of CSL's Trivalent Influenza Virus Vaccine (CSL TIV) in Children 5 to Less Than 9 Years of Age.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02212106

Enrollment

402

Registered

2014-08-08

Start date

2014-09-30

Completion date

2014-12-31

Last updated

2015-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza, Human

Brief summary

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.

Interventions

BIOLOGICALbioCSL Trivalent Influenza Virus Vaccine (CSL TIV)

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

BIOLOGICALComparator Quadrivalent Influenza Virus Vaccine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

5 Years to 8 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine.	7 days after each administration of 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)

Secondary

Measure	Time frame	Description
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.	7 days after each administration of 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).
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.	7 days after each administration of 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.
The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of the Comparator Influenza Virus Vaccine.	7 days after each administration of 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).
The Frequency and Intensity of Unsolicited AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.	7 days after each administration of vaccine.	The overall frequency and intensity of unsolicited Adverse Events (AEs) occurring during the 7 days after each administration of CSL 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. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall.
The Incidence of Serious Adverse Events (SAEs) Occurring up to 7 Days After the Last Administration of CSL TIV or the Comparator Influenza Virus Vaccine.	7 days after each administration of vaccine.	The number of subjects experiencing at least one SAE.
The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.	7 days after each administration of vaccine.	The overall frequency and intensity of solicited systemic Adverse Events (AEs) occurring during the 7 days after each administration of CSL 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.

Countries

United States

Participant flow

Recruitment details

First Patient In: 22-SEP-2014, Last Patient In: 15-OCT-2014, Last Patient Last Visit: 05-DEC-2014. Number of activated sites that enrolled subjects: 11 (all based in USA).

Pre-assignment details

Number of subjects screened: 407 Number of screen failures: 5 (Reason: all due to not meeting inclusion/exclusion criteria).

Participants by arm

Arm	Count
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV) The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season). bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.	302
Comparator Quadrivalent Influenza Virus Vaccine The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season. Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.	100
Total	402

Baseline characteristics

Characteristic	bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)	Comparator Quadrivalent Influenza Virus Vaccine	Total
Age, Continuous	6.7 years STANDARD_DEVIATION 1.05	6.6 years STANDARD_DEVIATION 1.02	6.6 years STANDARD_DEVIATION 1.04
Age, Customized Age 5 to < 9 years	302 participants	100 participants	402 participants
Region of Enrollment United States	302 participants	100 participants	402 participants
Sex: Female, Male Female	147 Participants	46 Participants	193 Participants
Sex: Female, Male Male	155 Participants	54 Participants	209 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	222 / 292	75 / 98
serious Total, serious adverse events	1 / 292	0 / 98

Outcome results

Primary

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)