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

Recruiting in Palo Alto (17 mi)

+10 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Seqirus

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

bioCSL Pty Ltd Clinical Program Director

Principal Investigator

Seqirus

Eligibility Criteria

Inclusion Criteria

The subject's parent or guardian to provide written informed consent and be willing and able to adhere to all protocol requirements.

Males or females aged 5 to less than 9 years at the time of first study vaccination.

In good health, as determined by medical history and a targeted physical examination (if warranted).

Treatment Details

Interventions

bioCSL Trivalent Influenza Virus Vaccine (CSL TIV) (Virus Vaccine)
Comparator Quadrivalent Influenza Virus Vaccine (Virus Vaccine)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)Experimental Treatment1 Intervention

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).

Group II: Comparator Quadrivalent Influenza Virus VaccineActive Control1 Intervention

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