Trials Sponsors Conditions Drugs Pricing

Conditions

Fever Influenza

Keywords

Influenzachildren and adolescentstrivalent vaccinecell cultureembryonated chicken eggs

Outcome Measures

Primary Outcomes (3)

Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity 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.
Day 1 to Day 7 after any vaccination
Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.
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.
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.
Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination.
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.
Day 1 to Day 183 for previously vaccinated subjects and Day 213 for not-previously vaccinated subjects

Study Arms (2)

TIVc

EXPERIMENTAL

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.

Biological: Mammalian cell based flu vaccine

TIVf

ACTIVE COMPARATOR

Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.

Biological: Egg based flu vaccine

Interventions

Mammalian cell based flu vaccineBiological

TIVc

Egg based flu vaccineBiological

TIVf

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age4 Years - 17 Years

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

\- Healthy subjects 4-17 years of age

You may not qualify if:

Sponsors & Collaborators

Novartis Vaccines
Industrylead

Study Sites (34)

320, Novartis Investigational Site

Mobile, Alabama, 36608, United States

312, Novartis Investigational Site

Ponte Vedra, Florida, 32081, United States

313, Novartis Investigational Site

Augusta, Kansas, 67010, United States

305, Novartis Investigational Site

Newton, Kansas, 67114, United States

302, Novartis Investigational Site

Wichita, Kansas, 67205, United States

301, Novartis Investigational Site

Wichita, Kansas, 67207, United States

311, Novartis Investigational Site

Fremont, Nebraska, 68025, United States

Related Publications (1)

Nolan T, Chotpitayasunondh T, Capeding MR, Carson S, Senders SD, Jaehnig P, de Rooij R, Chandra R. 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. Vaccine. 2016 Jan 4;34(2):230-236. doi: 10.1016/j.vaccine.2015.11.040. Epub 2015 Nov 29.
PMID: 26643931DERIVED

MeSH Terms

Conditions

Influenza, HumanFever

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title: Posting Director
Organization: Novartis Vaccines and Diagnostics

Study Officials

Novartis Vaccines and Diagnostics
Novartis Vaccines
STUDY CHAIR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Enrollment

2,055 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 16, 2013

First Posted

May 20, 2013

Study Start

May 2013

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (2)

TIVc

TIVf

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (34)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Study Arms (2)

TIVc

TIVf

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (34)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Locations