Status:
COMPLETED
Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V
Lead Sponsor:
Crucell Holland BV
Conditions:
Influenza
Eligibility:
All Genders
6-35 years
Phase:
PHASE3
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-reg...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT01229397
Start Date
October 1 2010
End Date
November 1 2010
Last Update
February 6 2014
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Pediatrics, Department of Clinical Sciences, Università di Milano, L. Sacco Hospital
Milan, Italy, 20157
2
Institute of Paediatrics, University of Milan, Fondazione IRCCS "Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena"
Milan, Italy, 20122