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Respiratory bacteria and viruses in the nasopharynx of infants and parents.


- candidate number13326
- NTR NumberNTR3614
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-sep-2012
- Secondary IDsVAC-264 RIVM
- Public TitleRespiratory bacteria and viruses in the nasopharynx of infants and parents.
- Scientific TitleCross-sectional surveillance study on pneumococcal serotypes and other pathogens in nasopharyngeal samples from infants and parents performed 6.5 years after introduction of pneumococcal vaccination in The Netherlands.
- ACRONYMOKIDOKI-3
- hypothesisVaccination against pneumococcal bacteria results in eradication of nasopharyngeal colonization by pneumococcal serotypes present in the pneumococcal vaccine in vaccinated children and their parents but serotypes not included in the vaccine fill in the vacant niche. This replacement of serotypes is not random and new types become dominant and may cause disease. Pneumococcal serotype replacement may affect the presence of other commensals in the nasopharynx.
- Healt Condition(s) or Problem(s) studiedInfectious diseases, Asymptomatic pneumococcal carriage, Streptococcus pneumoniae, Viral presence, Bacterial commensals
- Inclusion criteria1. Healthy infants;
2. Parents are willing and able to participate;
3. Infant is 11 or 24 months old ( 4 weeks) dependent on the group;
4. Infant received 3 pneumococcal vaccinations before the age of 6 months (11-month-old infant) and the 11 month booster (24-month-old infant);
5. Informed consent signed by both parents/legal representatives.
- Exclusion criteriaInfants:
1. Previous vaccinations not according to Dutch 3+1 schedule;
2. Previous vaccinations with other pneumoccocal vaccines than Synflorix (11-month-old infant) or Prevenar-7 (24-month-old infant).

Infants and parents of 24-month-old infants:
1. 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;
2. Coagulation disorder/anticoagulant medication.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-okt-2012
- planned closingdate1-mrt-2013
- Target number of participants990
- InterventionsN/A
- Primary outcomeThe percentage of total vaccine- and non-vaccine pneumococcal serotypes found in the nasopharyngeal swabs from infants at 11 and 24 months of age by conventional culture. Serotyping is performed at single colony level by Quellung reaction as in previous surveillance studies.
- Secondary outcome1. The percentage of total vaccine- and non-vaccine pneumococcal serotypes found in the nasopharyngeal swabs from parents of the 24-month-old infants as determined by culture and Quellung;
2. The percentage of infants and parents with nasopharyngeal swabs positive for S. aureus, H. influenzae and M. catarrhalis as determined by culture;
3. The percentage of individual pneumococcal serotypes found in the nasopharyngeal swabs from infants at 11 and 24 months of age and parents of the 24-month-old infants as determined by culture and Quellung.
- Timepoints1. 11 month timepoint before the 11 month booster (11-month-old infant);
2. 24 month timepoint (24-month-old infant and parent).
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. Marianne Bruijn, de
- CONTACT for SCIENTIFIC QUERIESDr. Marianne Bruijn, de
- Sponsor/Initiator National Institute for Public Health and the Environment (RIVM)
- Funding
(Source(s) of Monetary or Material Support)
Ministry of Health, Welfare and Sports
- PublicationsN/A
- Brief summarySurveillance of nasopharyngeal carriage of pneumococci is important to evaluate shifts in circulation of specific serotypes and to potentially make timely adjustments in the vaccination program. Previous surveillance studies were performed immediately before introduction of pneumococcal vaccination and 3 and 4.5 years after introduction, i.e. respectively the MINOES, OKIDOKI-1 and OKIDOKI-2 studies. The nasopharyngeal swabs collected during the current study will be assessed for the concurrent presence of other respiratory bacterial pathogens like S. aureus, H. influenzae, M. catarrhalis or viral pathogens like Influenza.
- Main changes (audit trail)
- RECORD18-sep-2012 - 4-jul-2013


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