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

NCT02212106 | Completed Phase 4 Results DMC

• 2 other identifiers: CSLCT-USF-10-692015-000175-27
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 11

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.

Conditions

Influenza, Human

Outcome Measures

Primary Outcomes (1)

• 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)

  7 days after each administration of vaccine.

Secondary Outcomes (6)

• 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 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.

• 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 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 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.

Study Arms (2)

bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)

EXPERIMENTAL

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).

Biological: bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)

Comparator Quadrivalent Influenza Virus Vaccine

ACTIVE COMPARATOR

The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.

Biological: Comparator Quadrivalent Influenza Virus Vaccine

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.

bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)

Comparator Quadrivalent Influenza Virus Vaccine BIOLOGICAL

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

Also known as: Fluzone Quadrivalent

Comparator Quadrivalent Influenza Virus Vaccine

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seqirus: lead

Study Sites (11)

Site 286

Los Angeles, California, 90036, United States

Location

Site 289

Boise, Idaho, 83642, United States

Location

Site 287

St Louis, Missouri, 63141, United States

Location

Site 285

Binghamton, New York, 13901, United States

Location

Site 290

Durham, North Carolina, 27704, United States

Location

Site 281

Raleigh, North Carolina, 27609, United States

Location

Site 280

Winston-Salem, North Carolina, 27103, United States

Location

Site 284

Charleston, South Carolina, 29403, United States

Location

Site 283

Austin, Texas, 78705, United States

Location

Site 282

Fort Worth, Texas, 76135, United States

Location

Site 288

San Angelo, Texas, 76904, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Clinical Program Director
• Organization: bioCSL PTY LTD

bioCSL.ClinicalTrials@biocsl.com.au

Study Officials

• bioCSL Pty Ltd Clinical Program Director

  Seqirus

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: August 8, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 16, 2015
• Results First Posted: October 16, 2015

Record last verified: 2015-09

Locations

US (11)