No registrations found.
Source
Brief title
Health condition
Asymptomatic pneumococcal carriage, infectious diseases, Streptococcus pneumoniae, viral presence, bacterial commensals
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
The 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 outcome
1. 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.
Background summary
Surveillance 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.
Study objective
Vaccination 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.
Study design
1. 11 month timepoint before the 11 month booster (11-month-old infant);
2. 24 month timepoint (24-month-old infant and parent).
Intervention
N/A
Inclusion criteria
1. 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 criteria
Infants:
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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL3462 |
NTR-old | NTR3614 |
Other | RIVM : VAC-264 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |