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NCT Number: NCT01210898

Immunogenicity and Safety of V70P5 Revaccination Subjects

This study will evaluate the safety and immunogenicity of children previously primed in the V70P5 study when revaccinated with adjuvanted or unadjuvanted seasonal influenza vaccine.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 month–96 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Tampere Medical School, Vaccine Research Center / Tampere yliopisto rokotetutkimuskeskus, Biokatu 10, Tampere, Finland

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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 male or female children that have previously participated in the V70P5 study in Finland.

Exclusion criteria

  • Any condition which in the opinion of the investigator may interfere with the evaluation of the study objectives.

Treatment and study plan

Adjuvanted seasonal influenza vaccine

Biological

Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine

Primary outcomes

  1. Evaluate immunogenicity of children primed and revaccinated with adjuvanted influenza vaccine by GMR, seroprotection

    Time frame: 22 days post vaccination

  2. Evaluate immunogenicity of children primed and revaccinated with a half dose of adjuvanted influenza vaccine by GMR, Seroprotection and seroconversion

    Time frame: 22 days post vaccination

  3. Evaluate immunogenicity of children primed with adjuvanted influenza vaccine and revaccinated with unadjuvanted influenza vaccine by GMR, Seroprotection and seroconversion

    Time frame: 22 days post vaccination

  4. Safety and tolerability of a single dose of adjuvanted or unadjuvanted influenza vaccine stratified according to previous influenza vaccine received

    Time frame: 22 days post vaccination

Secondary outcomes

  1. Primary immunogenicity outcomes as per CBER criteria

    Time frame: Day 22

  2. Compare Immunogenicity of each randomization arm by GMT, GMR, seroconversion and seroprotection by Homologous and Heterologous strains

    Time frame: Day 22

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

A Phase IIIB, Observer-Blind, Randomized, Parallel Groups, Extension Study to Evaluate the Immunogenicity and Safety Following a Single Intramuscular Dose of a Sub-unit Adjuvanted or a Non-adjuvanted Influenza Vaccines in Healthy Children Previously Vaccinated in the V70P5 Study

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 29, 2010
Registry last updated
Dec 1, 2016

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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