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 |
| Protocol serial number | TG0826INF |
| Sponsor | Berna Biotech Ltd, a Crucell Company (Switzerland) |
| Funder | Berna Biotech Ltd, a Crucell Company (Switzerland) |
- 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
Scientific
Guangxi Zhuang Autonomous Region CDC
N 18C Jinzhou Road
Nanning, Guangxi, China
530028
China
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Observer-blind randomised controlled safety/immunogenicity study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | 2009/2010-season virosomal influenza vaccine (Inflexal® V) |
| Primary outcome measure(s) | Immunogenicity, assessed by haemagglutination inhibition test; blood to be collected at baseline and approximately three weeks after second dose administration. |
| Key secondary outcome measure(s) | 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). |
| Completion date | 30/04/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 35 Months |
| Sex | All |
| Target sample size at registration | 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
530028
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
