Comparison of the Efficacy of Inflexal V With a Commercially Available Influenza Vaccine in Young Children

NCT ID: NCT01310400

Last Updated: 2014-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1356 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-01-31

Brief Summary

A study to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine Inflexal V is as immunogenic as a locally sourced competitor vaccine in young children.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Inflexal 0.5 mL

Group Type: EXPERIMENTAL

Inflexal V

Intervention Type: BIOLOGICAL

Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose:

• 15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus
• 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus
• 15 µg HA antigen of B/Brisbane/60/2008-like virus

Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Days 0 and 28

Inflexal 0.25 mL

Group Type: EXPERIMENTAL

Inflexal V

Intervention Type: BIOLOGICAL

Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose:

• 15 µg HA antigen of A/Brisbane/59/2007 (H1N1)-like virus
• 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus
• 15 µg HA antigen of B/Brisbane/60/2008-like virus

Dose: intramuscular administration (M. deltoideus) of a single dose of 0.25 mL on Days 0 and 28

Agrippal 0.25 mL

Group Type: EXPERIMENTAL

Agrippal

Intervention Type: BIOLOGICAL

Agrippal influenza vaccine

Dose: intramuscular administration (M. deltoideus) of a single dose of 0.25 mL on Days 0 and 28

Interventions

Inflexal V

Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose:

• 15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus
• 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus
• 15 µg HA antigen of B/Brisbane/60/2008-like virus

Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Days 0 and 28

Intervention Type: BIOLOGICAL

Inflexal V

Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose:

• 15 µg HA antigen of A/Brisbane/59/2007 (H1N1)-like virus
• 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus
• 15 µg HA antigen of B/Brisbane/60/2008-like virus

Dose: intramuscular administration (M. deltoideus) of a single dose of 0.25 mL on Days 0 and 28

Intervention Type: BIOLOGICAL

Agrippal

Agrippal influenza vaccine

Dose: intramuscular administration (M. deltoideus) of a single dose of 0.25 mL on Days 0 and 28

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• ≥6months to ≤35 months-old healthy children (male or female) born at term after normal pregnancy
• Recording of medical history and physical examination reveal no abnormality
• The parent/legal guardian of the participating child must sign the written informed consent and agree to provide a blood sample taken from the child pre- and post-immunization

Exclusion Criteria

• Hypersensitivity to eggs, chicken proteins, polymyxin B, neomycin or any component of the vaccine
• Previous vaccination against influenza
• At time of enrollment, presentation of clinical symptoms of active infection and/or body temperature ≥38°C
• Confirmation or suspicion of immunosuppressed status (including cancer), or confirmation of immunodeficiency disease (congenital or acquired including HIV)
• Medical treatment (>2 weeks) with immune suppressant or immune modulating drugs including systemic steroids during the last 3 months before immunization or at present, as follows: long-term oral prednisone or other equivalent steroid: ≥0.5mg/kg/day (note: administration of local or inhaled steroids before or during the study is allowed)
• Treatment with immunoglobulins or blood products during the last 3 months before immunization or such treatment scheduled during the study
• Participation in other clinical trials during the last 3 months before immunization or intention to participate during this study period
• At present or during the last 6 months before immunization: radiotherapy or treatment with cytotoxic drugs
• Other vaccination with a killed vaccine within 14 days before immunization or with an attenuated vaccine within 28 days before immunization (note: after subject inclusion vaccines of the immunization program for children are allowed upon the physician's discretion. However, immunization on the same day must be avoided)
• Family history of Guillain-Barré Syndrome
• Severe congenital deficiency or disease
• Antecedent of neurological disease or epileptic attack
• Severe cardiopulmonary disease with possibility to influence the study result
• Disturbance of coagulation or under anticoagulant treatment, likely to be contraindicated to i.m. injection
• Suspected non-compliance

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 35 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Crucell Holland BV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rongcheng Li, MD

Role: PRINCIPAL_INVESTIGATOR

Guangxi Zhuang Autonomous Region CDC

Locations

Guangxi Zhuang Autonomous Region CDC

Nanning, Guangxi, China

Countries

China

Other Identifiers

TG0826INF

Identifier Type: -

Identifier Source: org_study_id