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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1356

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

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Agrippal 0.25 mL	Agrippal	-
Inflexal 0.5 mL	Inflexal V	-
Inflexal 0.25 mL	Inflexal V	-

Primary Outcome Measures

Name	Time	Method
Immunogenicity, Assessed by the Haemagglutination (HI) Test	3 weeks after the 2nd vaccination	Seroconversion rate post-immunization. Seroconversion is defined as a post-vaccination titer of ≥1:40 for those with a pre-vaccination HI titer of \<1:10 and as ≥ four-fold increase in HI titer for those with a pre-vaccination HI titer of ≥1:10.

Secondary Outcome Measures

Name	Time	Method
Fold Increase in Geometric Mean Titer (GMT)	3 weeks after the 2nd vaccination	GMT-fold increase - calculated as the GMT on Day 49 divided by the baseline GMT value
Safety: Incidence of Solicited and Unsolicited Adverse Events	Solicited AEs: Days 1-4 and 28-31, and Days 28 and 49; unsolicited AEs: until study end	Safety assessements were made by the investigator at baseline and on Days 28 and 49, as well as by the subjects themselves (in Subjects Diaries) for the 4-day period following each vaccination.
Seroprotection	3 weeks after the 2nd vaccination	Seroprotection rate, defined as a post-vaccination HI titer of 1:40.