Contact information
Type
Scientific
Primary contact
Dr L.B.S. Gelinck
ORCID ID
Contact details
Leiden University Medical Centre (LUMC)
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 526 9111
L.B.S.Gelinck@LUMC.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
p05.115; NTR273
Study information
Scientific title
Comparison of antibody response upon influenza vaccination after intradermal versus intramuscular injection in immunocompromised hosts
Acronym
RICH 2
Study hypothesis
Intradermal vaccination with one fifth of the total vaccine dose intradermally is just as efficient as intramuscular vaccination with the regular dose.
Ethics approval
Received from the local medical ethics committee
Study design
Multicentre, randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Influenza vaccination response
Intervention
1. Intradermal vaccination
2. Intramuscular vaccination
Intervention type
Drug
Phase
Not Specified
Drug names
Influenza vaccination
Primary outcome measures
Geometric mean titre (GMT) 30 days post-vaccination
Secondary outcome measures
Protection rates
Overall trial start date
04/10/2005
Overall trial end date
01/04/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Immunocompromised patients at least 18 years of age.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
580
Participant exclusion criteria
1. Active infection
2. Pregnancy
3. Life expectancy of less than 6 months
4. Thrombocytopenia
5. Coumarin therapy
6. Thin skin with steroids
7. Known allergies
8. Influenza vaccination within last 9 months
Recruitment start date
04/10/2005
Recruitment end date
01/04/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Centre (LUMC)
Leiden
2300 RC
Netherlands
Sponsor information
Organisation
Leiden University Medical Centre (LUMC) (Netherlands)
Sponsor details
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Leiden University Medical Centre (LUMC) (The Netherlands)
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