Assessment of the immunogenicity and safety of the Northern Hemisphere 2010/2011-season influenza vaccine in elderly and young subjects according to European Medicines Agency (EMEA) regulations
| ISRCTN | ISRCTN89337058 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN89337058 |
| Protocol serial number | INF-V-A004 |
| Sponsor | Crucell Switzerland AG (Switzerland) |
| Funder | Crucell Switzerland AG (Switzerland) |
- Submission date
- 12/05/2010
- Registration date
- 21/01/2011
- Last edited
- 08/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
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 Michael Seiberling
Scientific
Scientific
Covance Clinical Research Unit AG
Lettenweg 118
Allschwil
4123
Switzerland
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Open non-randomised uncontrolled safety/efficacy study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Assessment of the immunogenicity and safety of the Northern Hemisphere 2010/2011-season influenza vaccine in elderly and young subjects according to European Medicines Agency (EMEA) regulations: an open label, non-randomised uncontrolled safety and efficacy study |
| Study objectives | The Northern Hemisphere 2010/2011-season influenza vaccine fulfills the European Medicines Agency (EMEA) requirements for re-registration of influenza vaccines. |
| Ethics approval(s) | Local Medical Ethics Committee (Ethikkommission beider Basel [EKBB]), Switzerland, approved on the 21 April 2010 |
| Health condition(s) or problem(s) studied | Influenza |
| Intervention | Biological: single dose of trivalent virosomal adjuvanted influenza vaccine (Inflexal® V). Total duration of follow-up: approximately three weeks. |
| Intervention type | Biological/Vaccine |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
Immunogenicity, assessed by haemagglutination inhibition test; blood to be collected before, one, two and approximately three weeks after vaccination. |
| Key secondary outcome measure(s) |
Safety, assessed at baseline and at three weeks after vaccination, including a four-day adverse event questionnaire, soliciting a set of local and systemic adverse events (AEs) according to the European Medicines Agency (EMEA) specifications. |
| Completion date | 31/07/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 110 |
| Key inclusion criteria | 1. Healthy female and male volunteers equal to or older than 18 years of age on the day of enrolment 2. Written informed consent |
| Key exclusion criteria | 1. Pregnancy and lactation 2. Serious adverse reaction to any influenza vaccine |
| Date of first enrolment | 01/06/2010 |
| Date of final enrolment | 31/07/2010 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Covance Clinical Research Unit AG
Allschwil
4123
Switzerland
4123
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
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 |
Editorial Notes
08/02/2023: The study setting has been changed from ‘Other’.
