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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01229397
• Other study ID #: INF-V-A005
• Status: Completed
• Phase: Phase 3
• First received: October 22, 2010
• Last updated: January 7, 2014
• Start date: October 2010
• Est. completion date: November 2010

Study information

• Verified date: August 2013
• Source: Crucell Holland BV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 35 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza

Intervention

Biological:
• Inflexal V
vaccination with Inflexal V 0.25 mL administered twice, 4 weeks apart
• Inflexal V
Inflexal V 0.5 mL administrated once only

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Crucell Holland BV

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	Yes