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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01229397
First Posted: October 27, 2010
Last Update Posted: February 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Crucell Holland BV
  Purpose
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.

Condition Intervention Phase
Influenza Biological: Inflexal V Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Crucell Holland BV:

Primary Outcome Measures:
  • 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 [ Time Frame: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen ]
    Seroprotection rate

  • 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 [ Time Frame: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen ]
    Seroconversion rate

  • 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 [ Time Frame: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen ]
    GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value


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

Enrollment: 205
Study Start Date: October 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Inflexal V 0.25 mL x 2 Biological: Inflexal V
vaccination with Inflexal V 0.25 mL administered twice, 4 weeks apart
Experimental: Inflexal V 0.5 mL x 1 Biological: Inflexal V
Inflexal V 0.5 mL administrated once only

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 35 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01229397


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

Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01229397     History of Changes
Other Study ID Numbers: INF-V-A005
First Submitted: October 22, 2010
First Posted: October 27, 2010
Results First Submitted: October 23, 2012
Results First Posted: May 20, 2013
Last Update Posted: February 6, 2014
Last Verified: August 2013

Keywords provided by Crucell Holland BV:
Influenza
Virus
Vaccination
Immunisation