Immunogenicity and Safety of V70P5 Revaccination Subjects

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

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 Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Adjuvanted seasonal influenza vaccine

• Study Type: Interventional
• Enrollment (Actual): 197
• Phase: Phase 3

Contacts and Locations

Study Locations

• Finland
  • Biokatu 10, Tampere, Finland, FI-33520
    • University of Tampere Medical School, Vaccine Research Center / Tampere yliopisto rokotetutkimuskeskus
  • Helsinki, Finland, FI-00100
    • Helsinki South, Vaccine Research Clinic, Vuorikatu 18, 3 floor
  • Helsinki, Finland, FI-00930
    • Helsinki East, Vaccine Research Clinic, Itäkeskuksen kauppakeskus/Agenttitalo, Turunlinnantie 8, 4.floor
  • Järvenpää, Finland, FI-04400
    • Järvenpää, Vaccine Research Clinic, Yhteiskouluntie 17
  • Kokkola, Finland, FI-67100
    • Kokkola Vaccine Research Clinic, Rantakatu 7
  • Kotka, Finland, FI-48600
    • Kotka Vaccine Research Clinic, Karjalantie 10-12
  • Kuopio, Finland, 70211
    • Kuopio Vaccine Research Clinic, Microkatu 1, N-building, 2nd floor, PL 1188
  • Lahti, Finland, FI-15140
    • Lahti Vaccine Research Clinic, Vesijärvenkatu 74
  • Oulu, Finland, FI-90220
    • Oulu Vaccine Research Clinic, Kiviharjunlenkki 6
  • Pori, Finland, FI-28100
    • Pori Vaccine Research Clinic, Yrjönkatu 23 (4th floor)
  • Seinäjoki, Finland, FI-60100
    • Seinäjoki Vaccine Research Clinic, Keskuskatu 6
  • Tampere, Finland, FI-33100
    • Tampere Vaccine Research Clinic, Pinninkatu 47 (1. floor)
  • Tapiontori 1, Espoo, Finland, FI-02100
    • Espoo Vaccine Research Clinic, Länsituulentie 10, 4th floor
  • Turku, Finland, FI-20520
    • Turku Vaccine Research Clinic, Lemminkäisenkatu 14-18 B (4th floor)
  • Vantaa, Finland, FI-01300
    • Vantaa East, Vaccine Research Clinic, Asematie 11 a 16
  • Vantaa, Finland, FI-01600
    • Vantaa West, Vaccine Research Clinic, Jönsaksentie 6 B, 3rd floor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 8 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

13

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 2	Biological: Adjuvanted seasonal influenza vaccine; Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine
Experimental: Group 1	Biological: Adjuvanted seasonal influenza vaccine; Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine
Experimental: Group 3	Biological: Adjuvanted seasonal influenza vaccine; Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine
Experimental: Group 4	Biological: Adjuvanted seasonal influenza vaccine; Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine
Experimental: Group 5	Biological: Adjuvanted seasonal influenza vaccine; Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine
Experimental: Group 6	Biological: Adjuvanted seasonal influenza vaccine; Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine
Experimental: Group 7	Biological: Adjuvanted seasonal influenza vaccine; Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine
Experimental: Group 8	Biological: Adjuvanted seasonal influenza vaccine; Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine
Experimental: Group 9	Biological: Adjuvanted seasonal influenza vaccine; Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine
Experimental: Group 10	Biological: Adjuvanted seasonal influenza vaccine; Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine
Experimental: Group 11	Biological: Adjuvanted seasonal influenza vaccine; Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine
Experimental: Group 12	Biological: Adjuvanted seasonal influenza vaccine; Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine
Experimental: Group 13	Biological: Adjuvanted seasonal influenza vaccine; Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Novartis Vaccines

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: September 28, 2010
• First Submitted That Met QC Criteria: September 28, 2010
• First Posted (Estimate): September 29, 2010

Study Record Updates

• Last Update Posted (Estimate): December 1, 2016
• Last Update Submitted That Met QC Criteria: November 30, 2016
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Children; Influenza; Vaccine; Trivalent; Adjuvanted
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: V70P5E1; 2010-021644-18 (EudraCT Number)