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

Influenza Clinical Trial

Official title:

A Phase III, Observer-Blind, Randomized Multicenter Study to Evaluate the Safety of Trivalent Subunit Influenza Vaccines, Produced Either in Mammalian Cell Culture (TIVc) or in Embryonated Eggs (TIV), in Children and Adolescents 3 to <18 Years of Age at Risk for Influenza-Related Complications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01998477
• Other study ID #: V58P15
• Secondary ID: 2013-002080-26
• Status: Completed
• Phase: Phase 3
• First received: October 30, 2013
• Last updated: April 19, 2017
• Start date: October 2013
• Est. completion date: July 2014

Study information

• Verified date: April 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• 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
• 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.

Locations

Country	Name	City	State
Italy	Novartis Investigational Site 022	Firenze
Italy	Novartis Investigational Site 020	Genova
Italy	Novartis Investigational Site 021	Milano
Italy	Novartis Investigational Site 023	Roma
Spain	Novartis Investigational Site 031	Badalona	Barcelona
Spain	Novartis Investigational Site 017	Burriana	Castellon
Spain	Novartis Investigational Site 016	Castellon de la Plana	Castellon
Spain	Novartis Investigational Site 015	L'Eliana	Valencia
Spain	Novartis Investigational Site 030	Madrid
Spain	Novartis Investigational Site 011	Malaga
Spain	Novartis Investigational Site 010	Marbella	Malaga
Spain	Novartis Investigational Site 013	Paiporta	Valencia
Spain	Novartis Investigational Site 018	Quart de Poblet	Valencia
Spain	Novartis Investigational Site 012	Valencia
Spain	Novartis Investigational Site 014	Valencia
Spain	Novartis Investigational Site 019	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Countries where clinical trial is conducted

Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Reporting Solicited Adverse Events (AEs) Following Vaccination With Either TIVc or TIV by Overall Age Group	Safety was assessed in terms of number of the subjects (3 to < 18 years of age) who reported solicited local, systemic AEs as well as other solicited AEs after receiving one or two doses of either TIVc or TIV	Day 1 through Day 7 post injection 1 and Day 29 through Day 35 post injection 2
Primary	Number of Subjects Reporting Solicited Adverse Events (AEs), Following Vaccination With Either TIVc or TIV by Age Sub-strata	Safety was assessed in terms of number of the subjects (3 to <6 years,(= 6 to < 9 years and 9 to <18 Years of age) who reported solicited local, systemic AEs as well as other solicited AEs after receiving one or two doses of either TIVc or TIV	Day 1 through Day 7 after any vaccination
Primary	Number of Subjects Reporting Unsolicited Adverse Events Following Vaccination With Either TIVc or TIV by Overall Age Group and Age Sub-strata	Safety was assessed in terms of number of subjects who reported any unsolicited AEs (four weeks after 1st vaccination and up to three weeks after 2nd vaccination), serious adverse events (SAEs), new onset of chronic diseases (NOCD), medically attended AEs and AEs leading to vaccine/study withdrawal after receiving one or two doses of either TIVc or TIV by overall age group (3 to <18 years) and age sub-strata (3 to <9 years and 9 to <18 years)	Day 1 -Day 181(one dose group) Day 1 -Day 209(two dose group)