Effects of Routine Infant Vaccination With the 7-valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Colonization with Streptococcus pneumoniae in Children and Parents in the Netherlands - Impact of PCV-7 on pneumococcal carriage in infants and parents

Phase 1

• Conditions: This study investigates the influence of the Prevenar® vaccination schedule in the NIP on colonisation with vaccine- and non-vaccine serotypes in the third year after implementation of Prevenar® in the NIP. We also determine the impact on other nasopharyngeal colonising bacteria.

• Registration Number: EUCTR2008-004972-37-NL
• Lead Sponsor: etherlands Vaccine Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-07-23
• Study Completion: 2009-07-10
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 660

Inclusion Criteria

•The children have to be of normal health (same health criteria apply as used in well-baby clinics when a child receives a vaccination, e.g. also children with small increases in temperature or cold are seen as children with normal health)
•They have to be willing and able to participate in the trial according to procedure
•Presence of a signed informed consent (the parents/legally representatives have
given written informed consent after receiving oral and written information)
•The children have received the Prevenar® vaccinations according to the 3+1 schedule of the Dutch NIP
Parents
•Parents are included when their children fulfil inclusion criteria

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Previous vaccinations with Prevenar® using a schedule that differs from the Dutch 3+1 schedule
•Previous vaccinations with other pneumoccocal vaccines
•Previous vaccinations of older brother(s) and/or sister(s) and/or parents with a pneumococcal conjugate vaccine (e.g. brother(s) and/or sister(s) that participated in the MINOES trial)
•Chromosomal abnormalities or craniofacial abnormalities (like Trisomy 21 or schisis), known or suspected immunodeficiency disease or other medical conditions that will severely affect immunological responses to vaccinations or nasopharyngeal carriage rates.
•Coagulation disorder/anticoagulant medication

Parents are excluded
•when they have a bleeding disorder/ anticoagulant medication (because of the transnasal swab)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine trends in vaccine- and nonvaccine-serotype S. pneumoniae colonisation in 11-month-old and 24-month-old infants who have been immunized according to the Dutch NIP with pneumococcal conjugate vaccinations Prevenar® in the third year after implementation of PCV-7 ( Prevenar®) in the Dutch NIP.;Secondary Objective: •To determine vaccine- and nonvaccine-serotype pneumococcal colonisation in one parent of 24-month-old children <br>•To determine the influence of altered vaccine- and nonvaccine- serotype composition on other colonising bacteria like S.aureus, H. influenzae, M. catarrhalis in children and parents <br>;Primary end point(s): The percentage of the (the seven) vaccine and non-vaccines pneumococcal serotypes found in the NP swabs from children at 11 and 24 months of age and parents of the 24-month-old children.