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

NCT01229397 | Completed Phase 3 Results

• 1 other identifier: INF-V-A005
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 2

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

Keywords

Influenza; Virus; Vaccination; Immunisation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• 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

Study Arms (2)

Inflexal V 0.25 mL x 2

ACTIVE COMPARATOR

Biological: Inflexal V

Inflexal V 0.5 mL x 1

EXPERIMENTAL

Biological: Inflexal V

Interventions

Inflexal V BIOLOGICAL

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

Inflexal V 0.25 mL x 2

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Crucell Holland BV: lead

Study Sites (2)

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

Milan, 20157, Italy

Location

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

Milan, 20122, Italy

Location

MeSH Terms

Conditions

Influenza, Human; Virus Diseases

Interventions

Inflexal V

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Respiratory Tract Diseases

Results Point of Contact

• Title: Medical Affairs Director
• Organization: Crucell Switzerland AG

info@crucell.com

+41(0)319806111

Study Officials

• 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,

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2010
• First Posted: October 27, 2010
• Study Start: October 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 6, 2014
• Results First Posted: May 20, 2013

Record last verified: 2013-08

Locations

IT (2)