ISRCTN ISRCTN15762138
DOI https://doi.org/10.1186/ISRCTN15762138
Secondary identifying numbers p05.115; NTR273
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
14/11/2008
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 L.B.S. Gelinck
Scientific

Leiden University Medical Centre (LUMC)
P.O. Box 9600
Leiden
2300 RC
Netherlands

Phone +31 (0)71 526 9111
Email L.B.S.Gelinck@LUMC.nl

Study information

Study designMulticentre, randomised, active controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleComparison of antibody response upon influenza vaccination after intradermal versus intramuscular injection in immunocompromised hosts
Study acronymRICH 2
Study objectivesIntradermal vaccination with one fifth of the total vaccine dose intradermally is just as efficient as intramuscular vaccination with the regular dose.
Ethics approval(s)Received from the local medical ethics committee
Health condition(s) or problem(s) studiedInfluenza vaccination response
Intervention1. Intradermal vaccination
2. Intramuscular vaccination
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Influenza vaccination
Primary outcome measureGeometric mean titre (GMT) 30 days post-vaccination
Secondary outcome measuresProtection rates
Overall study start date04/10/2005
Completion date01/04/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants580
Key inclusion criteriaImmunocompromised patients at least 18 years of age.
Key exclusion criteria1. 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
Date of first enrolment04/10/2005
Date of final enrolment01/04/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Leiden University Medical Centre (LUMC)
Leiden
2300 RC
Netherlands

Sponsor information

Leiden University Medical Centre (LUMC) (Netherlands)
University/education

Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands

Website http://www.lumc.nl/
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan