Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
TG0826INF
Study information
Scientific title
Assessment of the immunogenicity and safety of the Northern Hemisphere 2009/2010-season influenza vaccine in children aged 6 to 35 months in comparison to a commercially available influenza vaccine: an observer-blind, randomised, controlled, safety/immunogenicity study
Acronym
Study hypothesis
The Northern Hemisphere 2009/2010-season virosomal influenza vaccine is as immunogenic as the comparator vaccine.
Ethics approval
Local Medical Ethics Committee in China approved on the 11th September 2009 (ref: IRB No.00001594)
Study design
Observer-blind randomised controlled safety/immunogenicity study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Influenza
Intervention
Biological: two doses of trivalent virosomal adjuvanted influenza vaccine (Inflexal® V) or control vaccine. Total duration of follow-up: approximately 1.5 months.
Intervention type
Drug
Phase
Phase III
Drug names
2009/2010-season virosomal influenza vaccine (Inflexal® V)
Primary outcome measures
Immunogenicity, assessed by haemagglutination inhibition test; blood to be collected at baseline and approximately three weeks after second dose administration.
Secondary outcome measures
Safety, assessed at baseline and at three to four weeks after each vaccination, including a four-day adverse event questionnaire, soliciting a set of local and systemic adverse events (AEs).
Overall trial start date
28/09/2009
Overall trial end date
30/04/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Healthy children (male or female) aged 6 to 35 months
2. Written informed consent
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
1239
Participant exclusion criteria
1. Previous influenza vaccination
2. Serious adverse reaction to any influenza vaccine
3. Medical treatment with immune suppressant or immune modulating drugs
4. Presentation of clinical symptoms of active infection and/or body temperature greater than or equal to 38°C
Recruitment start date
28/09/2009
Recruitment end date
30/04/2010
Locations
Countries of recruitment
China
Trial participating centre
Guangxi Zhuang Autonomous Region CDC
Nanning, Guangxi, China
530028
China
Sponsor information
Organisation
Berna Biotech Ltd, a Crucell Company (Switzerland)
Sponsor details
Rehhagstrasse 79
Bern
CH-3018
Switzerland
+41 (0)31 980 6251
info@crucell.ch
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Berna Biotech Ltd, a Crucell Company (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary