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

• 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: Crucell Holland BV
• Information provided by (Responsible Party): Crucell Holland BV

Tracking Information

• First Submitted Date: October 22, 2010
• First Posted Date: October 27, 2010
• Results First Submitted Date: October 23, 2012
• Results First Posted Date: May 20, 2013
• Last Update Posted Date: February 6, 2014
• Study Start Date: October 2010
• Actual Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]
• Current Secondary Outcome Measures (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 (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: 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: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Influenza

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 18, 2012): 205
• Original Estimated Enrollment (submitted: October 26, 2010): 240
• Actual Study Completion Date: November 2010
• Actual Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 6 Months to 35 Months (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT01229397
• Other Study ID Numbers: INF-V-A005
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Crucell Holland BV
• Study Sponsor: Crucell Holland BV
• Collaborators: Not Provided

Investigators

• 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