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Trial record 2 of 2 for:    Novartis AND Influenza ANd vaccine AND Christchurch

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

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ClinicalTrials.gov Identifier: NCT01857206
Recruitment Status : Completed
First Posted : May 20, 2013
Results First Posted : November 3, 2014
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

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

Condition or disease Intervention/treatment Phase
Influenza Fever Biological: Mammalian cell based flu vaccine Biological: Egg based flu vaccine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2055 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Phase III, Observer Blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Chicken Eggs (Fluvirin®), in Healthy Children and Adolescents 4 to 17 Years of Age.
Study Start Date : May 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: TIVc
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
Active Comparator: TIVf
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



Primary Outcome Measures :
  1. Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination. [ Time Frame: 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.

  2. Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. [ Time Frame: 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.

  3. Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination. [ Time Frame: 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.



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Ages Eligible for Study:   4 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857206


  Show 34 Study Locations
Sponsors and Collaborators
Novartis Vaccines
Investigators
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Study Chair: Novartis Vaccines and Diagnostics Novartis Vaccines

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT01857206     History of Changes
Other Study ID Numbers: V58_31
U1111-1139-9440 ( Other Identifier: Universal Trial Number (UTN) )
First Posted: May 20, 2013    Key Record Dates
Results First Posted: November 3, 2014
Last Update Posted: December 5, 2014
Last Verified: November 2014
Keywords provided by Novartis ( Novartis Vaccines ):
Influenza
children and adolescents
trivalent vaccine
cell culture
embryonated chicken eggs
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs