Immunogenicity and Safety of V70P5 Revaccination Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01210898
First received: September 28, 2010
Last updated: January 27, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: Adjuvanted seasonal influenza vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Evaluate immunogenicity of children primed and revaccinated with adjuvanted influenza vaccine by GMR, seroprotection [ Time Frame: 22 days post vaccination ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Primary immunogenicity outcomes as per CBER criteria [ Time Frame: Day 22 ] [ Designated as safety issue: No ]
  • Compare Immunogenicity of each randomization arm by GMT, GMR, seroconversion and seroprotection by Homologous and Heterologous strains [ Time Frame: Day 22 ] [ Designated as safety issue: No ]

Enrollment: 197
Study Start Date: September 2010
Study Completion Date: December 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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 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

  Eligibility

Ages Eligible for Study:   18 Months to 96 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01210898

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

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01210898     History of Changes
Other Study ID Numbers: V70P5E1, 2010-021644-18
Study First Received: September 28, 2010
Last Updated: January 27, 2012
Health Authority: Finland: FIMEA - Finnish Medicines Agency

Keywords provided by Novartis:
Influenza
Trivalent
Adjuvanted
Vaccine
Children

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014