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

Not Applicable

Completed

• Conditions: Pertussis, whooping cough; Infections and Infestations; Infectious diseases

• Registration Number: ISRCTN97785537
• Lead Sponsor: ational Institute of Public Health and Environmental Protection (RIVM) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-05-02
• Study Completion: 2007-08-01
• Last Update Posted: 4 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
<br> 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:<br> 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)<br> 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<br> 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)<br>