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OpenTrials
Completed

NCT Number: NCT01857206

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

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

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Key information

Conditions

Influenza Body Temperature Changes Fever Infections Influenza, Human Orthomyxoviridae Infections Pathological Conditions, Signs and Symptoms RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Virus Diseases

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

100, Novartis Investigational Site, Westmead, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mammalian cell based flu vaccine

Biological

Egg based flu vaccine

Biological

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 20, 2013
Registry last updated
Dec 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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