NCT01857206

A Phase III, Observer Blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Chicken Eggs (Fluvirin®), in Healthy Children and Adolescents 4 to 17 Years of Age.

Completed Phase 3 Results posted Last updated 18 November 2014

What this trial tests

Phase 3 trial testing Mammalian cell based flu vaccine in Influenza in 2,055 participants. Completed in 1 June 2014.

Timeline

1 May 2013

Primary endpoint
1 June 2014

1 June 2014

Quick facts

Lead sponsor	Novartis Vaccines
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	2,055
Start date	1 May 2013
Primary completion	1 June 2014
Estimated completion	1 June 2014
Sites	34 locations across United States, Australia, New Zealand, Philippines, Thailand

Drugs / interventions tested

• Mammalian cell based flu vaccine — full drug profile →
• Egg based flu vaccine — full drug profile →

Conditions studied

• Influenza — all drugs for Influenza →
• Fever — all drugs for Fever →

Sponsor

Novartis Vaccines — full company profile →

Who can join

Adults 4 to 17, any sex, with Influenza or Fever. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination.
  Time frame: Day 1 to Day 7 after any vaccination
  Safety was assessed as the number of subjects who reported solicited local and systemic adverse events and other indicators of reactogenicity following two doses of either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.
• Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.
  Time frame: Day 1 to Day49 for subjects aged ≥4 To ≤8 years not previously vaccinated. Day 1 to Day 38 for subjects aged ≥4 To ≤8 years previously vaccinated and all subjects aged ≥9 To ≤17 years.
  Safety was assessed as the number of subjects who reported unsolicited adverse events following vaccination with either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.
• Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination.
  Time frame: Day 1 to Day 183 for previously vaccinated subjects and Day 213 for not-previously vaccinated subjects
  Safety was assessed as the number of subjects who reported serious adverse events (SAEs), medically attended AEs and new onset of chronic diseases (NOCD) in subjects aged ≥4 To ≤17 Years.

Sponsor's own description

Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents 4 to 17 years of age.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Safety and tolerability of a cell culture derived trivalent subunit inactivated influenza vaccine administered to healthy children and adolescents: A Phase III, randomized, multicenter, observer-blind study.
   Nolan T, Chotpitayasunondh T, Capeding MR, Carson S, et al · · 2016 · cited 10× · PMID 26643931 · DOI 10.1016/j.vaccine.2015.11.040