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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

September 28, 2010
January 27, 2012
September 2010
January 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01210898 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Influenza
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
    Intervention: Biological: Adjuvanted seasonal influenza vaccine
  • Experimental: Group 2
    Intervention: Biological: Adjuvanted seasonal influenza vaccine
  • Experimental: Group 3
    Intervention: Biological: Adjuvanted seasonal influenza vaccine
  • Experimental: Group 4
    Intervention: Biological: Adjuvanted seasonal influenza vaccine
  • Experimental: Group 5
    Intervention: Biological: Adjuvanted seasonal influenza vaccine
  • Experimental: Group 6
    Intervention: Biological: Adjuvanted seasonal influenza vaccine
  • Experimental: Group 7
    Intervention: Biological: Adjuvanted seasonal influenza vaccine
  • Experimental: Group 8
    Intervention: Biological: Adjuvanted seasonal influenza vaccine
  • Experimental: Group 9
    Intervention: Biological: Adjuvanted seasonal influenza vaccine
  • Experimental: Group 10
    Intervention: Biological: Adjuvanted seasonal influenza vaccine
  • Experimental: Group 11
    Intervention: Biological: Adjuvanted seasonal influenza vaccine
  • Experimental: Group 12
    Intervention: Biological: Adjuvanted seasonal influenza vaccine
  • Experimental: Group 13
    Intervention: Biological: Adjuvanted seasonal influenza vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
197
December 2011
January 2011   (final data collection date for primary outcome measure)

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.
Both
18 Months to 96 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01210898
V70P5E1, 2010-021644-18
Not Provided
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Not Provided
Novartis
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP