ong-term memory immunity against Bordetella pertussis in children 9 years of age who have been vaccinated with acellular pertussis vaccines: effect of an extra preadolescent acellular booster vaccinatio

Phase 4

Completed

Conditions: Vaccination against Pertussis
10004018

Registration Number: NL-OMON50356

Lead Sponsor: RIVM

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

• Good general health;
• 8-9 years of age;
• Vaccinated with Infanrix-IPV + Hib (GSK) at 2, 3, 4, and 11 months of age and
with Infanrix-IPV (GSK) at 4 years of age;
• Received all other regular vaccines according to the Dutch NIP;
• Provision of written informed consent by both parents or legal
representatives;
• Adherent to protocol and available during the study period

Exclusion Criteria

• Present evidence of serious disease(s) demanding immunosuppressive medical
treatment, like corticosteroids, that might interfere with the results of the
study. Treatment within the 3 months before the study (chronic infection,
clotting disorder, genetic disorder);
• Serious infection disease or fever (>38.5°C) within 14 days before the
vaccination;
• Antibiotic use within 14 days before vaccination;
• Any known primary or secondary immunodeficiency;
• Previous administration of plasma products (including immunoglobulins) within
the last 6 months;
• Vaccination with any other pertussis vaccine than those described in the
inclusion criteria (i.e. vaccinated with Pediacel or Triaxis (both from Sanofi
Pasteur MSD));
• Vaccination other than those used in the NIP within a month before
vaccination/ venapuncture;
• (suspected) Presence of allergy against (one of the) components of het
vaccine;
• In the past an allergic reactions after vaccination;
• Neurologic condition (like epilepsy).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>• To assess pertussis specific IgG antibody levels in serum to determine the<br /><br>effects of a second aP booster vaccination and determine whether there is a<br /><br>difference in IgG levels between wP and aP primed children at 8-9 years of age;<br /><br>• To assess memory B- and T-cell responses against the various B. pertussis<br /><br>proteins to determine the effects of a second aP booster vaccination and<br /><br>determine whether there is a difference between wP and aP primed children at 9<br /><br>years of age.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• To assess pertussis specific IgG-subclasses and -avidity;<br /><br>• To measure serum specific IgG-antibodies, -subclasses and -avidity and memory<br /><br>B- and T-cell responses against the other vaccine components (Diphtheria,<br /><br>Tetanus, Polio, Mumps, Measles and Rubella);<br /><br>• To measure serum specific IgG-antibodies, -subclasses and -avidity against<br /><br>other vaccine components from the NIP;<br /><br>• To measure IgA- and IgE- antibodies in serum against the proteins of B.<br /><br>pertussis and other vaccine components from the NIP;<br /><br>• To measure serum specific IgG-antibodies and cellulair immune responses<br /><br>against other infectious diseases occurring in Dutch children.</p><br>