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.

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR946
• Date of registration: 04/04/2007
• Primary sponsor: National Institute for Public Health and the Environment (RIVM)
• Public 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.
• 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. - aKwK trial
• Date of first enrolment: 3/11/2004
• Target sample size: 400
• Recruitment status: complete
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=946
• Study type: intervention
• Study design: Randomised: No; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, non-randomized

Countries of recruitment

The Netherlands

Contacts

• Name: G. Berbers

• Name: G. Berbers

Key inclusion & exclusion criteria

Inclusion criteria: 1. Infants in good general health eligible for the fourth DTP IPV-Hib vaccination.

Exclusion criteria: 1. Severe acute illness or fever (>38.5) 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.


Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Infectious diseases, Whooping cough, Bordetella pertussis

Intervention(s)

4 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).

Primary Outcome(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 titers at 11 months before the 4th vaccination and at 12 months. The antibody titers are determined by a twofold serial dilution ELISA.

Secondary Outcome(s)

Antibody titers for all vaccine components are measured at 11 months before vaccination and at 4-8 weeks after the 4th 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).

Secondary ID(s)

ISRCTN97785537

LTR134

Source(s) of Monetary Support

Dutch Ministry of Health, Welfare and Sport