Condition category
Infections and Infestations
Date applied
02/05/2007
Date assigned
02/05/2007
Last edited
08/05/2007
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 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

http://www.rivm.nl/en/

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

Publication citations

Additional files

Editorial Notes