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

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

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Inflexal V; Biological: Inflexal V

• Study Type: Interventional
• Enrollment (Actual): 205
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20157
    • Department of Pediatrics, Department of Clinical Sciences, Università di Milano, L. Sacco Hospital
  • Milano, Italy, 20122
    • Institute of Paediatrics, University of Milan, Fondazione IRCCS "Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 2 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Inflexal V 0.25 mL x 2	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
Experimental: Inflexal V 0.5 mL x 1	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen
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	This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen
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	This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Local and Systemic Adverse Events as a Measure of Safety and Tolerability	Solicited local and systemic AEs were collected from Day 1 (day of vaccination) to Day 4 inclusive using a subject diary

Collaborators and Investigators

• Sponsor: Crucell Holland BV
• 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,

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: October 22, 2010
• First Submitted That Met QC Criteria: October 26, 2010
• First Posted (Estimate): October 27, 2010

Study Record Updates

• Last Update Posted (Estimate): February 6, 2014
• Last Update Submitted That Met QC Criteria: January 7, 2014
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Influenza; Vaccination; Immunisation; Virus
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: INF-V-A005