Primary: To determine trends in nasopharyngeal colonization with total vaccine- and non-vaccine serotypes of S. pneumoniae in healthy 11-month-old and 24-month-old infants who have been immunized according to the Dutch National Immunization Program…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
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
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.
The percentage of infants and parents with nasopharyngeal swabs positive for S.
aureus, H. influenzae and M. catarrhalis as determined by culture.
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
Diseases caused by Streptococcus pneumoniae are always preceded by asymptomatic
nasopharyngeal acquisition and colonization. Pneumococcal vaccination reduces
acquisition and density of colonization of vaccine-serotype pneumococci in the
nasopharynx of vaccinated infants and subsequent transmission to others leading
to an indirect protection of the community (herd effects). The vacant niche in
the nasopharynx of vaccinated infants is however immediately filled by
non-vaccine pneumococci and possibly other potential pathogens that may be
involved in respiratory or invasive disease like S. aureus, H. influenzae, M.
catarrhalis. 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. The
nasopharyngeal swabs collected during the current study will be assessed for
the concurrent presence of other respiratory pathogens like S. aureus, H.
influenzae, M. catarrhalis. As part of one of the exploratory objectives a
comparison will be made between the presence of nasopharyngeal pneumococcal
serotypes, respiratory non-pneumococcal bacteria (Mycoplasma pneumoniae,
Neisseria meningitides, and Bordetella pertussis) and respiratory viruses in
infants and parents to those found in elderly subjects, sampled in a parallel
study by the same institute. Carriage in the parents is however influenced by
the close contacts with their infants who have relatively high carriage rate of
S. Pneumoniae. Addition of an extra group of adults with limited contact with
children < 6 years will therefore allow a better assessment of a true
age-related effect on nasopharyngeal pathogen carriage including a true
assessment of the herd effect.
Study objective
Primary:
To determine trends in nasopharyngeal colonization with total vaccine- and
non-vaccine serotypes of S. pneumoniae in healthy 11-month-old and 24-month-old
infants who have been immunized according to the Dutch National Immunization
Program 6.5 years after implementation of PCV-7 and 1.5 years after
implementation of PCV-10.
Secondary:
To determine trends in nasopharyngeal pneumococcal colonization with total
vaccine- and non-vaccine serotypes in the parents of 24-month-old infants.
To determine trends in colonization of other respiratory pathogens like S.
aureus, H. influenzae, M. catarrhalis in infants and parents of 24-month-old
infants.
To determine trends in individual serotype colonization in healthy 11-month-old
and 24-month-old infants who have been immunized according to the Dutch NIP as
well as in parents of 24-month-old infants.
Study design
This is an observational, cross-sectional surveillance study
Study burden and risks
The burden is minimal and the risk associated with participation in this trial
is minimal. The study involves only one home visit during which a trained
personnel member of the research team will collect a transnasal nasopharyngeal
swab and two saliva samples from the infants of 11-and 24-months and
participating adults with an additional collection of a transoral
nasopharyngeal swab from the adults. Blood samples will be collected on a
voluntary basis from the infants and adults. The nose swab may cause a minor
self-limiting nose bleeding (less than 1:3000 from own experience). No risk is
involved in the saliva sample collection using a sponge in the mouth. The
voluntary blood collection is harmless but may be slightly painful and can
cause a bruise at the injection site.
The infants participating in this study have already received the vaccinations
against pneumococcal disease according to the Dutch National Immunization
Program and this is not part of the study. All adults are asked to fill in a
small questionnaire together with the visiting researcher. Overall, the home
visit will take 45 minutes. The infants and adults themselves have no benefit
in participating in this study.
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Listed location countries
Age
Inclusion criteria
Infants:
The infants have to be of normal health (same health criteria apply as used in well-baby clinics when an infant receives a vaccination, e.g. also infants with small increases in temperature or cold are seen as infants with normal health)
The parents have to be willing and able to participate in the trial according to procedure
The infant is 11 or 24 months old (± 4 weeks) dependent on the group
The infant has been vaccinated according to the Dutch 3+1 schedule and received 3 pneumococcal vaccinations before the age of 6 months (11-month-old infant) and the 11 month booster (24-month-old infant).
Presence of a signed informed consent signed by both parents/legal representatives.
Parents:
Parents are included when their 24 month-old infant fulfils the inclusion criteria.
Adults with limited contact with children < 6 years:
The adults are aged 20-49 years (both inclusive).
The adults have no contact with children < 6 years for more than 8 hours per week.
The adults have to be willing and able to participate in the trial according to procedure.
Presence of a signed informed consent.
Exclusion criteria
Infants:
Previous vaccinations with pneumococcal vaccine using a schedule that differs from the Dutch 3+1 schedule
Previous vaccinations with other pneumoccocal vaccines than Synflorix (11-month-old infant) or Prevenar-7 (24-month-old infant)
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 and adults with limited contact with children < 6 years:
Chromosomal abnormalities or craniofacial abnormalities, known or suspected immunodeficiency disease or other medical conditions that will severely affect immunological responses
Coagulation disorder/anticoagulant medication
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2012-001458-24-NL |
| CCMO | NL40288.094.12 |