Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V
Primary Purpose
Influenza
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Inflexal V
Inflexal V
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza, Virus, Vaccination, Immunisation
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
Sites / Locations
- Institute of Paediatrics, University of Milan, Fondazione IRCCS "Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena"
- Department of Pediatrics, Department of Clinical Sciences, Università di Milano, L. Sacco Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Inflexal V 0.25 mL x 2
Inflexal V 0.5 mL x 1
Arm Description
Outcomes
Primary Outcome Measures
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
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
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
GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value
Secondary Outcome Measures
Number of Participants With Local and Systemic Adverse Events as a Measure of Safety and Tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01229397
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Crucell Holland BV
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Virus, Vaccination, Immunisation
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
205 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inflexal V 0.25 mL x 2
Arm Type
Active Comparator
Arm Title
Inflexal V 0.5 mL x 1
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Inflexal V
Intervention Description
vaccination with Inflexal V 0.25 mL administered twice, 4 weeks apart
Intervention Type
Biological
Intervention Name(s)
Inflexal V
Intervention Description
Inflexal V 0.5 mL administrated once only
Primary Outcome Measure Information:
Title
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
Description
Seroprotection rate
Time Frame
This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen
Title
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
Description
Seroconversion rate
Time Frame
This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen
Title
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
Description
GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value
Time Frame
This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
35 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola Principi, Prof Dr
Organizational Affiliation
Institute of Paediatrics, University of Milan, Fondazione IRCCS "Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena", Via Commenda 9, 20122, Milano, Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gian Vincenzo Zuccotti, Prof Dr
Organizational Affiliation
Department of Pediatrics, Department of Clinical Sciences, Università di Milano, L. Sacco Hospital, 74, Via GB Grassi,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Paediatrics, University of Milan, Fondazione IRCCS "Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena"
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Department of Pediatrics, Department of Clinical Sciences, Università di Milano, L. Sacco Hospital
City
Milan
ZIP/Postal Code
20157
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
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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