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Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V

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ClinicalTrials.gov Identifier: NCT01229397
Recruitment Status : Completed
First Posted : October 27, 2010
Results First Posted : May 20, 2013
Last Update Posted : February 6, 2014
Sponsor:
Information provided by (Responsible Party):
Crucell Holland BV

Tracking Information
First Submitted Date  ICMJE October 22, 2010
First Posted Date  ICMJE October 27, 2010
Results First Submitted Date  ICMJE October 23, 2012
Results First Posted Date  ICMJE May 20, 2013
Last Update Posted Date February 6, 2014
Study Start Date  ICMJE October 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2013)
  • Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference [ Time Frame: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen ]
    Seroprotection rate
  • Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference [ Time Frame: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen ]
    Seroconversion rate
  • Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference [ Time Frame: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen ]
    GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value
Original Primary Outcome Measures  ICMJE
 (submitted: October 26, 2010)
Immunogenicity of a single full (0.5 mL) dose and a 0.25 mL 2-dose regimen of Inflexal V,using the EMA guideline for the re-registration of the seasonal influenza vaccine in adults (aged ≥18 ≤60 years) as reference [ Time Frame: This assesment will be done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2013)
Number of Participants With Local and Systemic Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Solicited local and systemic AEs were collected from Day 1 (day of vaccination) to Day 4 inclusive using a subject diary ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2010)
Number of Participants With Local and Systemic Adverse Events as a Measure of Safety and Tolerability [ Time Frame: This assesment will be done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V
Official Title  ICMJE A Phase III Open, Randomized, Parallel, Multi-center Study in Children Aged 6 - 35 Months to Compare the Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V Administered According to a 0/4 Week Schedule
Brief Summary The study aims to evaluate the immunogenicity of a single full (0.5 mL) dose and a 0.25 mL 2-dose regime of Inflexal V in unprimed children aged 6 - <36 months, using the EMA guideline for the re-registration of the seasonal influenza vaccine in adults (aged ≥18 ≤60 years) as reference.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE
  • Biological: Inflexal V
    vaccination with Inflexal V 0.25 mL administered twice, 4 weeks apart
  • Biological: Inflexal V
    Inflexal V 0.5 mL administrated once only
Study Arms  ICMJE
  • Active Comparator: Inflexal V 0.25 mL x 2
    Intervention: Biological: Inflexal V
  • Experimental: Inflexal V 0.5 mL x 1
    Intervention: Biological: Inflexal V
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2012)
205
Original Estimated Enrollment  ICMJE
 (submitted: October 26, 2010)
240
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and female children
  • Aged ≥6 to <36 months on Day 1
  • Born at a gestational age ≥37 weeks
  • Written informed consent
  • No previous influenza vaccination

Exclusion Criteria:

  • Acute respiratory infection or other acute disease
  • Acute febrile illness (≥38.0 °C)
  • Past vaccination with an influenza vaccine, including vaccination against the influenza strain A/California/7/2009 (H1N1)-like virus
  • Laboratory-confirmed infection with any influenza strain, including the pandemic influenza strain H1N1 (A/California/7/2009 (H1N1)-like virus)
  • Known hypersensitivity to any vaccine component
  • Known history of egg protein allergy or severe atopy
  • Known blood coagulation disorder
  • Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent for ≥14 days (inhaled or topical steroids are allowed)
  • Known immunodeficiency (including leukemia, cancer, HIV seropositivity)
  • Investigational medicinal product received in the past 3 months (90 days)
  • Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
  • Vaccination with the MMR vaccine in the past 4 weeks, or planned within the study period
  • Participation in another clinical trial
  • Child or legal charge of the investigator or an employee at the study site, or living in the same household as the investigator/employee and/or dependent on the investigator/employee
  • Suspected non-compliance
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 35 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01229397
Other Study ID Numbers  ICMJE INF-V-A005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Crucell Holland BV
Study Sponsor  ICMJE Crucell Holland BV
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nicola Principi, Prof Dr Institute of Paediatrics, University of Milan, Fondazione IRCCS "Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena", Via Commenda 9, 20122, Milano, Italy
Principal Investigator: Gian Vincenzo Zuccotti, Prof Dr Department of Pediatrics, Department of Clinical Sciences, Università di Milano, L. Sacco Hospital, 74, Via GB Grassi,
PRS Account Crucell Holland BV
Verification Date August 2013

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