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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:
Information provided by (Responsible Party):
Crucell Holland BV
ClinicalTrials.gov Identifier:
NCT01229397
First received: October 22, 2010
Last updated: January 7, 2014
Last verified: August 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   6 Months to 35 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01229397

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

No publications provided

Responsible Party: Crucell Holland BV
ClinicalTrials.gov Identifier: NCT01229397     History of Changes
Other Study ID Numbers: INF-V-A005
Study First Received: October 22, 2010
Results First Received: October 23, 2012
Last Updated: January 7, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by Crucell Holland BV:
Influenza
Virus
Vaccination
Immunisation

ClinicalTrials.gov processed this record on November 25, 2014