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

NCT ID: NCT01229397

Last Updated: 2014-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2010-11-30

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Inflexal V 0.25 mL x 2

Group Type: ACTIVE_COMPARATOR

Inflexal V

Intervention Type: BIOLOGICAL

vaccination with Inflexal V 0.25 mL administered twice, 4 weeks apart

Inflexal V 0.5 mL x 1

Group Type: EXPERIMENTAL

Inflexal V

Intervention Type: BIOLOGICAL

Inflexal V 0.5 mL administrated once only

Interventions

Inflexal V

vaccination with Inflexal V 0.25 mL administered twice, 4 weeks apart

Intervention Type: BIOLOGICAL

Inflexal V

Inflexal V 0.5 mL administrated once only

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 35 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Crucell Holland BV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicola Principi, Prof Dr

Role: PRINCIPAL_INVESTIGATOR

Institute of Paediatrics, University of Milan, Fondazione IRCCS "Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena", Via Commenda 9, 20122, Milano, Italy

Gian Vincenzo Zuccotti, Prof Dr

Role: PRINCIPAL_INVESTIGATOR

Department of Pediatrics, Department of Clinical Sciences, Università di Milano, L. Sacco Hospital, 74, Via GB Grassi,

Locations

Department of Pediatrics, Department of Clinical Sciences, Università di Milano, L. Sacco Hospital

Milan, , Italy

Institute of Paediatrics, University of Milan, Fondazione IRCCS "Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena"

Milan, , Italy

Countries

Italy

Other Identifiers

INF-V-A005

Identifier Type: -

Identifier Source: org_study_id