Condition category
Infections and Infestations
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
14/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.lumc.nl/

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

Publication citations

Additional files

Editorial Notes