Clinical trial NCT01310400: Comparison of the Efficacy of Inflexal V With a Commercially Available Influenza Vaccine in Young Children
Official title: Observer-blind, Randomized, Controlled Study to Determine the Immunogenicity and Safety of a Two-dose Regimen of Virosomal Subunit Influenza Vaccine Inflexal V in Healthy Young Children (≥6 Months to ≤35 Months) in Comparison With the Subunit Influenza Vaccine Agrippal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza
Virus
Vaccination
Immunisation
Lead sponsor: Crucell Holland BV
Sponsor class: INDUSTRY
First posted: 2011-03-08
Enrollment: 1356
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Immunogenicity, Assessed by the Haemagglutination (HI) Test
timeFrame: 3 weeks after the 2nd vaccination
Secondary outcomes:
measure: Fold Increase in Geometric Mean Titer (GMT)
timeFrame: 3 weeks after the 2nd vaccination
measure: Seroprotection
timeFrame: 3 weeks after the 2nd vaccination
measure: Safety: Incidence of Solicited and Unsolicited Adverse Events
timeFrame: Solicited AEs: Days 1-4 and 28-31, and Days 28 and 49; unsolicited AEs: until study end
Other outcomes:
Locations:
city: Nanning
country: China
facility: Guangxi Zhuang Autonomous Region CDC
state: Guangxi
Study officials:
affiliation: Guangxi Zhuang Autonomous Region CDC
name: Rongcheng Li, MD
role: PRINCIPAL_INVESTIGATOR
References: