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

ISRCTN	ISRCTN10483274
DOI	https://doi.org/10.1186/ISRCTN10483274
Secondary identifying numbers	TG0826INF

Submission date: 23/09/2009
Registration date: 20/10/2009
Last edited: 20/10/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Li Rocheng
Scientific

Guangxi Zhuang Autonomous Region CDC
N 18C Jinzhou Road
Nanning, Guangxi, China
530028
China

Study information

Study design	Observer-blind randomised controlled safety/immunogenicity study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	The Northern Hemisphere 2009/2010-season virosomal influenza vaccine is as immunogenic as the comparator vaccine.
Ethics approval(s)	Local Medical Ethics Committee in China approved on the 11th September 2009 (ref: IRB No.00001594)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	2009/2010-season virosomal influenza vaccine (Inflexal® V)
Primary outcome measure	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 study start date	28/09/2009
Completion date	30/04/2010

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	35 Months
Sex	Both
Target number of participants	1239
Key inclusion criteria	1. Healthy children (male or female) aged 6 to 35 months 2. Written informed consent
Key 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
Date of first enrolment	28/09/2009
Date of final enrolment	30/04/2010

Locations

Countries of recruitment

China

Study participating centre

Guangxi Zhuang Autonomous Region CDC

Nanning, Guangxi, China
530028
China

Sponsor information

Berna Biotech Ltd, a Crucell Company (Switzerland)
Industry

Rehhagstrasse 79
Bern
CH-3018
Switzerland

Phone	+41 (0)31 980 6251
Email	info@crucell.ch
Website	http://www.crucell.com/

Funders

Funder type

Industry

Berna Biotech Ltd, a Crucell Company (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan