Contact information
Type
Scientific
Primary contact
Dr G. Berbers
ORCID ID
Contact details
National Institute for Public Health and the Environment (RIVM)
P.O. Box 1
Bilthoven
3720 BA
Netherlands
+31 (0)30 274 2496
guy.berbers@rivm.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LTR134
Study information
Scientific title
Acronym
aKwK trial
Study hypothesis
To compare the immunogenicity of the whole cell (DTwP) versus the acellular (DTaP) pertussis component of the Diphtheria, Tetanus, Pertussis, Poliomyelitis - Haemophilus influenzae type b (DTP IPV-Hib) vaccine as measured by the antibody titres at 11 months before the fourth vaccination and at 12 months.
Ethics approval
Approval received from the CCMO (Central Committee on Research inv.
Human Subjects) on the 18th October 2004 (ref: P04.1099C)
Study design
Interventional, non-randomised, non-controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Single-centre
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Pertussis, whooping cough
Intervention
Four groups of 75 children aged 11 months:
1. DTwP IPV-Hib primary series and booster (11 months) (n = 32)
2. DTwP IPV-Hib primary series and DTaP IPV-Hib booster (Infanrix) (n = 79)
3. DTaP IPV-Hib (Infanrix) primary series and booster (n = 95)
4. DTaP IPV-Hib (Pediacel) primary series and booster with (n = 75) and without (n = 75) pneumococcal vaccination (Prevenar)
Intervention type
Drug
Phase
Not Specified
Drug names
Diphtheria, Tetanus, Pertussis, Poliomyelitis - Haemophilus influenzae type b (DTP IPV-Hib) vaccine
Primary outcome measures
To compare the immunogenicity of the whole cell versus the acellular pertussis component of the DTP IPV-Hib vaccine as measured by the antibody titres at 11 months before the fourth vaccination and at 12 months. The antibody titres are determined by a twofold serial dilution Enzyme Linked Immunosorbent Assay (ELISA).
Secondary outcome measures
Antibody titres for all vaccine components are measured at 11 months before vaccination and at four to eight weeks after the fourth DTP IPV-Hib vaccination. This will also allow to investigate:
1. The effect of the changes in the production process of the Pertussis whole cell component compared to the old whole cell component (data on file)
2. The adjuvant effect of the whole cell versus two different acellular Pertussis components in the DTP IPV-Hib vaccine as used in The Netherlands
3. The immunogenicity and the adjuvant effect of the two different acellular Pertussis components in the DTP IPV-Hib vaccines (Infanrix versus Pediacel) with or without pneumococcal vaccination (Prevenar)
Overall trial start date
03/11/2004
Overall trial end date
01/08/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Infants in good general health eligible for the fourth DTP IPV-Hib vaccination
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
400
Participant exclusion criteria
1. Severe acute illness or fever (greater than 38.5°C) within two days before vaccination
2. Present evidence of serious disease(s) demanding medical treatment that might interfere with the results of the study
3. Known or suspected allergy to any of the vaccine components
4. Known or suspected immune disorder
5. History of any neurological disorder, including epilepsy
6. Previous administration of plasma products (including immunoglobulins)
7. Previous vaccination with any other vaccine than those used in the National Immunisation Programme
Recruitment start date
03/11/2004
Recruitment end date
01/08/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
National Institute for Public Health and the Environment (RIVM)
Bilthoven
3720 BA
Netherlands
Sponsor information
Organisation
National Institute of Public Health and Environmental Protection (RIVM) (The Netherlands)
Sponsor details
P.O. Box 1
Bilthoven
3720 BA
Netherlands
+31 (0)30 274 9111
info@rivm.nl
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Netherlands Ministry of Health, Welfare and Sport (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