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A Study to Evaluate the Safety of Two Influenza Vaccines in Children and Adolescents 3 to <18 Years of Age at Risk for Influenza-Related Complications

NCT ID: NCT01998477

Last Updated: 2017-04-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

430 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-07-31

Brief Summary

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The study is designed to evaluate the safety of TIVc or TIV vaccine in children 3 to \< 18 years of age who are at risk of complications of influenza disease due to underlying diseases.

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Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TIVc

flu vaccine

Group Type EXPERIMENTAL

TIVc

Intervention Type BIOLOGICAL

Madin Darby Canine Kidney (MDCK) cell culture derived subunit influenza vaccine TIVc contained the purified viral envelope glycoproteins, hemagglutinin (HA) and neuraminidase (NA) derived from 3 strains (including HA for each strain \[A/H1N1-like, A/H3N2-like, and B-like\]) intramuscular (IM) injection recommended by the WHO for the 2013-2014 influenza season in the Northern Hemisphere

TIV

flu vaccine

Group Type ACTIVE_COMPARATOR

TIV

Intervention Type BIOLOGICAL

A conventional egg derived subunit influenza vaccine (TIV) contained the purified viral envelope-glycoproteins, HA and NA derived from 3 strains (including HA for each strain \[A/ H1N1-like, A/H3N2-like, and B-like\]) IM injection recommended by the WHO for the 2013-2014 influenza season in the Northern Hemisphere.

Interventions

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TIVc

Madin Darby Canine Kidney (MDCK) cell culture derived subunit influenza vaccine TIVc contained the purified viral envelope glycoproteins, hemagglutinin (HA) and neuraminidase (NA) derived from 3 strains (including HA for each strain \[A/H1N1-like, A/H3N2-like, and B-like\]) intramuscular (IM) injection recommended by the WHO for the 2013-2014 influenza season in the Northern Hemisphere

Intervention Type BIOLOGICAL

TIV

A conventional egg derived subunit influenza vaccine (TIV) contained the purified viral envelope-glycoproteins, HA and NA derived from 3 strains (including HA for each strain \[A/ H1N1-like, A/H3N2-like, and B-like\]) IM injection recommended by the WHO for the 2013-2014 influenza season in the Northern Hemisphere.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Individuals 3 to \<18 years of age with underlying medical conditions that indicate an increased risk of complications from influenza infection.
* Further eligibility criteria may be discussed by contacting the site(s)

Exclusion Criteria

* Individuals with any fatal prognosis of an underlying medical condition (\<12 month life expectancy).
* Individuals hospitalized at the time of enrolment.
* Individuals with a history of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any of the vaccine components.
* Further eligibility criteria may be discussed by contacting the site(s)
Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Vaccines

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Vaccines

Role: STUDY_CHAIR

Novartis Vaccines

Locations

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Novartis Investigational Site 022

Florence, , Italy

Site Status

Novartis Investigational Site 020

Genova, , Italy

Site Status

Novartis Investigational Site 021

Milan, , Italy

Site Status

Novartis Investigational Site 023

Roma, , Italy

Site Status

Novartis Investigational Site 031

Badalona, Barcelona, Spain

Site Status

Novartis Investigational Site 017

Burriana, Castellon, Spain

Site Status

Novartis Investigational Site 016

Castellon, Castellon, Spain

Site Status

Novartis Investigational Site 010

Marbella, Malaga, Spain

Site Status

Novartis Investigational Site 015

L'Eliana, Valencia, Spain

Site Status

Novartis Investigational Site 013

Paiporta, Valencia, Spain

Site Status

Novartis Investigational Site 018

Quart de Poblet, Valencia, Spain

Site Status

Novartis Investigational Site 030

Madrid, , Spain

Site Status

Novartis Investigational Site 011

Málaga, , Spain

Site Status

Novartis Investigational Site 019

Valencia, , Spain

Site Status

Novartis Investigational Site 014

Valencia, , Spain

Site Status

Novartis Investigational Site 012

Valencia, , Spain

Site Status

Countries

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Italy Spain

References

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Diez-Domingo J, de Martino M, Lopez JG, Zuccotti GV, Icardi G, Villani A, Moreno-Perez D, Hernandez MM, Aldean JA, Mateen AA, Enweonye I, de Rooij R, Chandra R. Safety and tolerability of cell culture-derived and egg-derived trivalent influenza vaccines in 3 to <18-year-old children and adolescents at risk of influenza-related complications. Int J Infect Dis. 2016 Aug;49:171-8. doi: 10.1016/j.ijid.2016.06.018. Epub 2016 Jun 23.

Reference Type DERIVED
PMID: 27343983 (View on PubMed)

Other Identifiers

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2013-002080-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V58P15

Identifier Type: -

Identifier Source: org_study_id

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