Condition category
Infections and Infestations
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Ms Saskia van der Lee


Contact details

National Institute of Public Health and Environmental Protection (RIVM)
Antoni van Leeuwenhoeklaan 9
3720 BA
+31 (0)30 274 3407

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

The longitudinal kinetics of long term cellular memory immunity against Bordetella pertussis in Dutch 8 to 9 year old children after acellular pertussis vaccine (ACV) booster vaccination


Study hypothesis

Whooping cough is a respiratory disease, caused by Bordetella pertussis. Whooping cough is a serious disease in the young, vulnerable infant. Older children and adults are the main source of infection.

Since the incidence of whooping cough (pertussis) is increasing in the Netherlands, the effect of vaccination against Bordetella pertussis needs to be addressed. Because of the increasing incidence of whooping cough at the age of 4, an acellular pertussis vaccine (ACV) booster vaccination at 4 years of age was introduced in the Netherlands in 2001. However, nowadays the peak incidence of whooping cough in children has shifted to 8 to 9 year old children. In addition, we also see a rise in notifications in adolescents and adults. Therefore, in some countries, e.g. Germany and France, an extra acellular booster vaccination has been given to the 9 to 14 year old children. Also in Belgium they will introduce an extra booster vaccination in 14 to 16 year old children. Because of the shift in the prevalence peak, the effect of the booster vaccination on the long term immunity against Bordetella pertussis needs to be addressed in this specific age group.

This study aims to investigate the longitudinal kinetics of the effect of the ACV booster vaccination on the memory of B- and T-cell immunity in children who are primary vaccinated with whole cell vaccine (WCV) and boostered with ACV. Furthermore, the relationship between the cellular immunity and the antibody responses after ACV booster will be addressed in order to gain insight if further booster vaccinations are required.

On 13/05/2015 the following changes were made to the trial record:
1. The overall trial end date was changed from 01/06/2010 to 11/11/2014.
2. The target number of participants was changed from 70 to 86.

Ethics approval

The Dutch Central Committee on Research involving Human Subjects (CCMO), 23/12/2008, ref: NL 23149.000.08

Study design

Single-centre interventional single-arm non-randomised study

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Whooping cough


The combination vaccine diphtheria, tetanus, pertussis acellular vaccination, poliomyelitis (DTPacv-IPV) (Boostrix polio™, 0.5 ml) produced by GlaxoSmithKline (GSK) containing a three-component ACV (pertussis toxin [Ptx], filamentous haemagglutinin [FHA] and pertactin [Prn]), tetanustoxoid, difterietoxoid and inactivated polio virus, will be given intramuscularly to 8 to 9 year old children who received the DTPwcv-IPV-(Hib) at 2, 3, 4 and 11 months old and DTP and a three component ACV (monovalent ACV by GSK) as a booster vaccination at 4 years old. The extra pertussis vaccination is combined with the DT-IPV and measles, mumps and rubella (MMR) vaccination which they receive in the regular immunisation program. One pre- and two post-vaccination (28 days and 1 year) blood samples will be taken.

Added 13/05/2015:
In addition, from a subset of children, a blood sample will be collected 5.5 years after vaccination.

Intervention type



Drug names

Primary outcome measure

The main study parameters will be pertussis specific memory B- and T-cell responses as well as antibody levels and affinity against the various proteins of pertussis and the other components of the DTPacv-IPV-Hib vaccine.

Secondary outcome measures

If there are enough lymphocytes, the immune response (memory B- and T-cells and antibody responses) to other vaccine preventable diseases, like measles, mumps, diphtheria, tetanus and polio will also be measured.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Healthy 8 to 9 year old children, either sex
2. Received four vaccinations at 2, 3, 4 and 11 months with diphtheria, tetanus, pertussis whole cell vaccine, poliomyelitis - haemophilus influenzae type b (DTPwcv IPV-Hib)
3. Received a booster vaccination at 4 years old with a three component ACV

Participant type


Age group




Target number of participants


Participant exclusion criteria

Any of the following criteria will exclude a volunteer from participation, at start of the study:
1. Present evidence of serious disease(s) demanding immunosuppressive medical treatment, like corticosteroids that might interfere with the results of the study within three months
2. Any known primary or secondary immunodeficiency

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

National Institute of Public Health and Environmental Protection (RIVM)
3720 BA

Sponsor information


National Institute of Public Health and Environmental Protection (RIVM) (Netherlands)

Sponsor details

Antoni van Leeuwenhoeklaan 9
3720 BA

Sponsor type

Research organisation



Funder type

Research organisation

Funder name

National Institute of Public Health and Environmental Protection (RIVM) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

2011 results in:
2012 results in:

Publication citations

  1. Results

    Schure RM, de Rond L, Oztürk K, Hendrikx L, Sanders E, Berbers G, Buisman AM, Pertussis circulation has increased T-cell immunity during childhood more than a second acellular booster vaccination in Dutch children 9 years of age., PLoS ONE, 2012, 7, 7, e41928, doi: 10.1371/journal.pone.0041928.

  2. Results

    Hendrikx LH, Felderhof MK, Ozturk K, de Rond LG, van Houten MA, Sanders EA, Buisman AM, Enhanced memory B-cell immune responses after a second acellular pertussis booster vaccination in children 9 years of age, Vaccine, 2011, 30, 1, 51-58, doi: 10.1016/j.vaccine.2011.10.048.

Additional files

Editorial Notes