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

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:

MedlinePlus related topics: Flu

U.S. FDA Resources

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

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:	March 20, 2013
Health Authority:	Italy: Ministry of Health

Keywords provided by Crucell Holland BV:

Influenza
Virus
Vaccination
Immunisation

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013