Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age

Phase 3

Completed

• Conditions: Fever; Influenza
• Interventions: Biological: Mammalian cell based flu vaccine; Biological: Egg based flu vaccine

• Registration Number: NCT01857206
• Lead Sponsor: Novartis Vaccines

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-16
• Study First Submitted QC: 2013-05-17
• Study First Posted: 2013-05-20
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Results First Submitted: 2014-09-18
• Results First Submitted QC: 2014-10-28
• Status Verified: 2014-11
• Results First Posted: 2014-11-02
• Last Update Submitted: 2014-11-18
• Last Update Posted: 2014-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2055

Inclusion Criteria

• Healthy subjects 4-17 years of age

Exclusion Criteria

• Subjects who are not healthy,
• Subjects who are pregnant or breast feeding,
• Subjects with a history of severe allergic reaction or allergic to any of the vaccine components.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TIVc	Mammalian cell based flu vaccine	Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
TIVf	Egg based flu vaccine	Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.

Primary Outcome Measures

Name	Time	Method
Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination.	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.	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.	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.

Trial Locations

Locations (34)

100, Novartis Investigational Site; 🇦🇺 Westmead, New South Wales, Australia

105, Novartis Investigational Site; 🇦🇺 Subiaco, Western Australia, Australia

311, Novartis Investigational Site; 🇺🇸 Fremont, Nebraska, United States

304, Novartis Investigational Site; 🇺🇸 Salt Lake City, Utah, United States

317, Novartis Investigational Site; 🇺🇸 Cleveland, Ohio, United States

320, Novartis Investigational Site; 🇺🇸 Mobile, Alabama, United States

309, Novartis Investigational Site; 🇺🇸 Tulsa, Oklahoma, United States

308, Novartis Investigational Site; 🇺🇸 Winston-salem, North Carolina, United States

314, Novartis Investigational Site; 🇺🇸 Warwick, Rhode Island, United States

301, Novartis Investigational Site; 🇺🇸 Wichita, Kansas, United States

313, Novartis Investigational Site; 🇺🇸 Augusta, Kansas, United States

305, Novartis Investigational Site; 🇺🇸 Newton, Kansas, United States

302, Novartis Investigational Site; 🇺🇸 Wichita, Kansas, United States

306, Novartis Investigational Site; 🇺🇸 Salt Lake City, Utah, United States

303, Novartis Investigational Site; 🇺🇸 South Jordan, Utah, United States

104, Novartis Investigational Site; 🇦🇺 North Adelaide, South Australia, Australia

312, Novartis Investigational Site; 🇺🇸 Ponte Vedra, Florida, United States

310, Novartis Investigational Site; 🇺🇸 Bristol, Tennessee, United States

151, Novartis Investigational Site; 🇳🇿 Takapuna, Auckland, New Zealand

150, Novartis Investigational Site; 🇳🇿 Beckenham, Christchurch, New Zealand

254, Novartis Investigational Site; 🇵🇭 Muntinlupa City, Alabang, Philippines

253, Novartis Investigational Site; 🇵🇭 Manila, Ermita, Philippines

202, Novartis Investigational Site; 🇹🇭 Bangkoknoi, Siriraj, Thailand

318, Novartis Investigational Site; 🇺🇸 Nashville, Tennessee, United States

108, Novartis Investigational Site; 🇦🇺 Auchenflower, Queensland, Australia

107, Novartis Investigational Site; 🇦🇺 Sherwood, Queensland, Australia

103, Novartis Investigational Site; 🇦🇺 Carlton, Victoria, Australia

319, Novartis Investigational Site; 🇺🇸 Mount Pleasant, South Carolina, United States

315, Novartis Investigational Site; 🇺🇸 Salt Lake, Utah, United States

252, Novartis Investigation Site; 🇵🇭 Manila, Sampaloc, Philippines

201, Novartis Investigational Site; 🇹🇭 Khon Kaen, Muang, Thailand

250, Novartis Investigational Site; 🇵🇭 Muntinlupa City, Alabang, Philippines

251, Novartis Investigational Site; 🇵🇭 Muntinlupa City, Alabang, Philippines

200, Novartis Investigational Site; 🇹🇭 Bangkok, Rajathevi, Thailand