Clinical trial NCT01210898: Immunogenicity and Safety of V70P5 Revaccination Subjects
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza
Trivalent
Adjuvanted
Vaccine
Children
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-09-29
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Maximum age (years): 96
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate immunogenicity of children primed and revaccinated with adjuvanted influenza vaccine by GMR, seroprotection
timeFrame: 22 days post vaccination
measure: Evaluate immunogenicity of children primed and revaccinated with a half dose of adjuvanted influenza vaccine by GMR, Seroprotection and seroconversion
timeFrame: 22 days post vaccination
measure: Evaluate immunogenicity of children primed with adjuvanted influenza vaccine and revaccinated with unadjuvanted influenza vaccine by GMR, Seroprotection and seroconversion
timeFrame: 22 days post vaccination
measure: Safety and tolerability of a single dose of adjuvanted or unadjuvanted influenza vaccine stratified according to previous influenza vaccine received
timeFrame: 22 days post vaccination
Secondary outcomes:
measure: Primary immunogenicity outcomes as per CBER criteria
timeFrame: Day 22
measure: Compare Immunogenicity of each randomization arm by GMT, GMR, seroconversion and seroprotection by Homologous and Heterologous strains
timeFrame: Day 22
Other outcomes:
Locations:
city: Biokatu 10, Tampere
country: Finland
facility: University of Tampere Medical School, Vaccine Research Center / Tampere yliopisto rokotetutkimuskeskus
city: Helsinki
country: Finland
facility: Helsinki South, Vaccine Research Clinic, Vuorikatu 18, 3 floor
city: Helsinki
country: Finland
facility: Helsinki East, Vaccine Research Clinic, Itäkeskuksen kauppakeskus/Agenttitalo, Turunlinnantie 8, 4.floor
city: Järvenpää
country: Finland
facility: Järvenpää, Vaccine Research Clinic, Yhteiskouluntie 17
city: Kokkola
country: Finland
facility: Kokkola Vaccine Research Clinic, Rantakatu 7
city: Kotka
country: Finland
facility: Kotka Vaccine Research Clinic, Karjalantie 10-12
city: Kuopio
country: Finland
facility: Kuopio Vaccine Research Clinic, Microkatu 1, N-building, 2nd floor, PL 1188
city: Lahti
country: Finland
facility: Lahti Vaccine Research Clinic, Vesijärvenkatu 74
city: Oulu
country: Finland
facility: Oulu Vaccine Research Clinic, Kiviharjunlenkki 6
city: Pori
country: Finland
facility: Pori Vaccine Research Clinic, Yrjönkatu 23 (4th floor)
city: Seinäjoki
country: Finland
facility: Seinäjoki Vaccine Research Clinic, Keskuskatu 6
city: Tampere
country: Finland
facility: Tampere Vaccine Research Clinic, Pinninkatu 47 (1. floor)
city: Tapiontori 1, Espoo
country: Finland
facility: Espoo Vaccine Research Clinic, Länsituulentie 10, 4th floor
city: Turku
country: Finland
facility: Turku Vaccine Research Clinic, Lemminkäisenkatu 14-18 B (4th floor)
city: Vantaa
country: Finland
facility: Vantaa East, Vaccine Research Clinic, Asematie 11 a 16
city: Vantaa
country: Finland
facility: Vantaa West, Vaccine Research Clinic, Jönsaksentie 6 B, 3rd floor
Study officials:
References:
citation: Vesikari T, Forsten A, Arora A, Tsai T, Clemens R. Influenza vaccination in children primed with MF59-adjuvanted or non-adjuvanted seasonal influenza vaccine. Hum Vaccin Immunother. 2015;11(8):2102-12. doi: 10.1080/21645515.2015.1044167.