Immunogenicity and Safety of V70P5 Revaccination Subjects

Phase 3

Completed

• Conditions: Influenza
• Interventions: Biological: Adjuvanted seasonal influenza vaccine

• Registration Number: NCT01210898
• Lead Sponsor: Novartis Vaccines

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-28
• Study First Submitted QC: 2010-09-28
• Study First Posted: 2010-09-29
• Primary Completion: 2011-01
• Study Completion: 2011-12
• Status Verified: 2012-01
• Last Update Submitted: 2016-11-30
• Last Update Posted: 2016-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 5	Adjuvanted seasonal influenza vaccine	-
Group 7	Adjuvanted seasonal influenza vaccine	-
Group 9	Adjuvanted seasonal influenza vaccine	-
Group 2	Adjuvanted seasonal influenza vaccine	-
Group 8	Adjuvanted seasonal influenza vaccine	-
Group 1	Adjuvanted seasonal influenza vaccine	-
Group 3	Adjuvanted seasonal influenza vaccine	-
Group 4	Adjuvanted seasonal influenza vaccine	-
Group 6	Adjuvanted seasonal influenza vaccine	-
Group 10	Adjuvanted seasonal influenza vaccine	-
Group 12	Adjuvanted seasonal influenza vaccine	-
Group 11	Adjuvanted seasonal influenza vaccine	-
Group 13	Adjuvanted seasonal influenza vaccine	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of a single dose of adjuvanted or unadjuvanted influenza vaccine stratified according to previous influenza vaccine received	22 days post vaccination
Evaluate immunogenicity of children primed with adjuvanted influenza vaccine and revaccinated with unadjuvanted influenza vaccine by GMR, Seroprotection and seroconversion	22 days post vaccination
Evaluate immunogenicity of children primed and revaccinated with adjuvanted influenza vaccine by GMR, seroprotection	22 days post vaccination
Evaluate immunogenicity of children primed and revaccinated with a half dose of adjuvanted influenza vaccine by GMR, Seroprotection and seroconversion	22 days post vaccination

Secondary Outcome Measures

Name	Time	Method
Primary immunogenicity outcomes as per CBER criteria	Day 22
Compare Immunogenicity of each randomization arm by GMT, GMR, seroconversion and seroprotection by Homologous and Heterologous strains	Day 22

Trial Locations

Locations (16)

Helsinki South, Vaccine Research Clinic, Vuorikatu 18, 3 floor; 🇫🇮 Helsinki, Finland

Kotka Vaccine Research Clinic, Karjalantie 10-12; 🇫🇮 Kotka, Finland

Helsinki East, Vaccine Research Clinic, Itäkeskuksen kauppakeskus/Agenttitalo, Turunlinnantie 8, 4.floor; 🇫🇮 Helsinki, Finland

Lahti Vaccine Research Clinic, Vesijärvenkatu 74; 🇫🇮 Lahti, Finland

Järvenpää, Vaccine Research Clinic, Yhteiskouluntie 17; 🇫🇮 Järvenpää, Finland

Pori Vaccine Research Clinic, Yrjönkatu 23 (4th floor); 🇫🇮 Pori, Finland

Vantaa East, Vaccine Research Clinic, Asematie 11 a 16; 🇫🇮 Vantaa, Finland

Vantaa West, Vaccine Research Clinic, Jönsaksentie 6 B, 3rd floor; 🇫🇮 Vantaa, Finland

Kokkola Vaccine Research Clinic, Rantakatu 7; 🇫🇮 Kokkola, Finland

Oulu Vaccine Research Clinic, Kiviharjunlenkki 6; 🇫🇮 Oulu, Finland

Seinäjoki Vaccine Research Clinic, Keskuskatu 6; 🇫🇮 Seinäjoki, Finland

Tampere Vaccine Research Clinic, Pinninkatu 47 (1. floor); 🇫🇮 Tampere, Finland

Kuopio Vaccine Research Clinic, Microkatu 1, N-building, 2nd floor, PL 1188; 🇫🇮 Kuopio, Finland

Espoo Vaccine Research Clinic, Länsituulentie 10, 4th floor; 🇫🇮 Tapiontori 1, Espoo, Finland

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

Turku Vaccine Research Clinic, Lemminkäisenkatu 14-18 B (4th floor); 🇫🇮 Turku, Finland