Immunogenicity and Safety of V70P5 Revaccination Subjects

Novartis Vaccines197 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

197

Conditions

Influenza

Interventions

Adjuvanted seasonal influenza vaccineBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 MonthsMax age: 96 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (16)

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

Biokatu 10, Tampere, Finland

Helsinki South, Vaccine Research Clinic, Vuorikatu 18, 3 floor

Outcomes

Primary Outcomes

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

Time frame: 22 days post vaccination

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

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

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

Primary immunogenicity outcomes as per CBER criteria

Time frame: Day 22

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

Time frame: Day 22

Data from ClinicalTrials.gov

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