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

Crucell

Status and phase

Completed

Phase 3

Conditions

Influenza

Treatments

Biological: Agrippal

Biological: Inflexal V

Study type

Interventional

Funder types

Industry

Identifiers

NCT01310400

TG0826INF

Details and patient eligibility

About

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.

Enrollment

1,356 patients

Sex

All

Ages

6 to 35 months old

Volunteers

Accepts Healthy Volunteers

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