Immunity induced by Yellow Fever vaccination in the elderly (60 years or OLDer) traveller
| ISRCTN | ISRCTN42180653 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42180653 |
| Secondary identifying numbers | LUMC |
- Submission date
- 05/09/2007
- Registration date
- 05/09/2007
- Last edited
- 07/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A.H.E. Roukens
Scientific
Scientific
Leiden University Medical Centre (LUMC)
PO Box 9600
Leiden
2300 RC
Netherlands
| a.h.e.roukens@lumc.nl |
Study information
| Study design | Multicentre randomized active-controlled parallel-group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | Immunity induced by Yellow Fever vaccination in the elderly (60 years or OLDer) traveller |
| Study acronym | YFOLD |
| Study objectives | The induction of immunity might be slower in older persons than in younger individuals. This could influence the occurrence of adverse events induced by the vaccine. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Yellow Fever vaccination |
| Intervention | Yellow fever vaccination (only an extra intervention in control group), blood drawing and urine sampling. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 1. Neutralizing antibodies 2. Yellow fever viremia |
| Secondary outcome measures | 1. Presence of yellow fever virus proteins in urine samples 2. Adverse events |
| Overall study start date | 01/10/2007 |
| Completion date | 01/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 58 |
| Key inclusion criteria | Elderly group: 1. Age of 60 years or older 2. Indication for yellow fever vaccination according to Dutch travel guidelines Control group: age under 60 years |
| Key exclusion criteria | 1. Immune suppression due to disease or medication 2. Pregnancy |
| Date of first enrolment | 01/10/2007 |
| Date of final enrolment | 01/10/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Centre (LUMC)
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Leiden University Medical Centre (LUMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Infectious Diseases
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 526 9111 |
|---|---|
| a.h.e.roukens@lumc.nl | |
| Website | http://www.lumc.nl/english/start_english.html |
"ROR" |
https://ror.org/027bh9e22 |
Funders
Funder type
Hospital/treatment centre
Leiden University Medical Centre (LUMC) (The Netherlands)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 07/12/2011 | 07/10/2021 | Yes | No |
Editorial Notes
07/10/2021: Publication reference and total final enrolment added.
