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 designObserver-blind randomised controlled safety/immunogenicity study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleAssessment 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 objectivesThe 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) studiedInfluenza
InterventionBiological: two doses of trivalent virosomal adjuvanted influenza vaccine (Inflexal® V) or control vaccine. Total duration of follow-up: approximately 1.5 months.
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)2009/2010-season virosomal influenza vaccine (Inflexal® V)
Primary outcome measureImmunogenicity, assessed by haemagglutination inhibition test; blood to be collected at baseline and approximately three weeks after second dose administration.
Secondary outcome measuresSafety, 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 date28/09/2009
Completion date30/04/2010

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Months
Upper age limit35 Months
SexBoth
Target number of participants1239
Key inclusion criteria1. Healthy children (male or female) aged 6 to 35 months
2. Written informed consent
Key exclusion criteria1. 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 enrolment28/09/2009
Date of final enrolment30/04/2010

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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan