Condition category
Respiratory
Date applied
23/09/2009
Date assigned
20/10/2009
Last edited
20/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Li Rocheng

ORCID ID

Contact details

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

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

http://www.crucell.com/

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

Publication citations

Additional files

Editorial Notes