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

Phase 3

Completed

• Conditions: Fever; Influenza

• 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

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)

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

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

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

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

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

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

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

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