Immunogenicity and adjuvant effect of the whole cell Pertussis component of the Dutch combined Diphtheria, Tetanus, Pertussis, Poliomyelitis - Haemophilus influenzae type b vaccine in infants compared to the old whole cell P vaccine and a new acellular P vaccine component

ISRCTN	ISRCTN97785537
DOI	https://doi.org/10.1186/ISRCTN97785537
Protocol serial number	LTR134
Sponsor	National Institute of Public Health and Environmental Protection (RIVM) (The Netherlands)
Funder	The Netherlands Ministry of Health, Welfare and Sport (The Netherlands)

Submission date: 02/05/2007
Registration date: 02/05/2007
Last edited: 23/09/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr G. Berbers
Scientific

National Institute for Public Health and the Environment (RIVM)
P.O. Box 1
Bilthoven
3720 BA
Netherlands

Phone	+31 (0)30 274 2496
Email	guy.berbers@rivm.nl

Study information

Primary study design	Interventional
Study design	Interventional, non-randomised, non-controlled, parallel group trial
Secondary study design	Single-centre
Scientific title	Immunogenicity and adjuvant effect of the whole cell Pertussis component of the Dutch combined Diphtheria, Tetanus, Pertussis, Poliomyelitis - Haemophilus influenzae type b vaccine in infants compared to the old whole cell P vaccine and a new acellular P vaccine component
Study acronym	aKwK trial
Study objectives	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(s)	Approval received from the CCMO (Central Committee on Research inv. Human Subjects) on the 18th October 2004 (ref: P04.1099C)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Diphtheria, Tetanus, Pertussis, Poliomyelitis - Haemophilus influenzae type b (DTP IPV-Hib) vaccine
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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)
Completion date	01/08/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Not Specified
Target sample size at registration	400
Key inclusion criteria	1. Infants in good general health eligible for the fourth DTP IPV-Hib vaccination
Key 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
Date of first enrolment	03/11/2004
Date of final enrolment	01/08/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

National Institute for Public Health and the Environment (RIVM)

Bilthoven
3720 BA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Editorial Notes

23/09/2021: Proactive update review. No publications found. Search options exhausted.