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Immunogenicity and Safety of V70P5 Revaccination Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01210898
Recruitment Status : Completed
First Posted : September 29, 2010
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Influenza Biological: Adjuvanted seasonal influenza vaccine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : September 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate immunogenicity of children primed and revaccinated with adjuvanted influenza vaccine by GMR, seroprotection [ Time Frame: 22 days post vaccination ]
  2. 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 ]
  3. 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 ]
  4. 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 Outcome Measures :
  1. Primary immunogenicity outcomes as per CBER criteria [ Time Frame: Day 22 ]
  2. Compare Immunogenicity of each randomization arm by GMT, GMR, seroconversion and seroprotection by Homologous and Heterologous strains [ Time Frame: Day 22 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Months to 96 Months   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01210898


Locations
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Finland
University of Tampere Medical School, Vaccine Research Center / Tampere yliopisto rokotetutkimuskeskus
Biokatu 10, Tampere, Finland, FI-33520
Helsinki South, Vaccine Research Clinic, Vuorikatu 18, 3 floor
Helsinki, Finland, FI-00100
Helsinki East, Vaccine Research Clinic, Itäkeskuksen kauppakeskus/Agenttitalo, Turunlinnantie 8, 4.floor
Helsinki, Finland, FI-00930
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
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Publications of Results:

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Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT01210898    
Other Study ID Numbers: V70P5E1
2010-021644-18 ( EudraCT Number )
First Posted: September 29, 2010    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: January 2012
Keywords provided by Novartis ( Novartis Vaccines ):
Influenza
Trivalent
Adjuvanted
Vaccine
Children
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases