Clinical trial NCT01229397: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza
Virus
Vaccination
Immunisation
Lead sponsor: Crucell Holland BV
Sponsor class: INDUSTRY
First posted: 2010-10-27
Enrollment: 205
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: 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
timeFrame: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen
measure: 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
timeFrame: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen
measure: 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
timeFrame: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen
Secondary outcomes:
measure: Number of Participants With Local and Systemic Adverse Events as a Measure of Safety and Tolerability
timeFrame: Solicited local and systemic AEs were collected from Day 1 (day of vaccination) to Day 4 inclusive using a subject diary
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Institute of Paediatrics, University of Milan, Fondazione IRCCS "Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena"
city: Milan
country: Italy
facility: Department of Pediatrics, Department of Clinical Sciences, Università di Milano, L. Sacco Hospital
Study officials:
affiliation: Institute of Paediatrics, University of Milan, Fondazione IRCCS "Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena", Via Commenda 9, 20122, Milano, Italy
name: Nicola Principi, Prof Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pediatrics, Department of Clinical Sciences, Università di Milano, L. Sacco Hospital, 74, Via GB Grassi,
name: Gian Vincenzo Zuccotti, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References: