Primary:To determine trends in vaccine- and nonvaccine-serotype S. pneumoniae asymptomatic colonisation in healthy 11-month-old and 24-month-old infants who have been immunized according to the Dutch NIP with 7-valent pneumococcal conjugate vaccine…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The percentage of vaccine and nonvaccine-serotypes found in the nasopharyngeal
swabs at 11 and 24 months of age
Secondary outcome
The percentage of vaccine and nonvaccine-serotypes found in the nasopharyngeal
swabs from the parents of the 24-month-old children
The percentage of children and parents positive for S. aureus, H. influenzae or
M. catarrhalis
Background summary
All disease caused by Streptococcus pneumoniae is preceded by asymptomatic
nasopharyngeal (NP) colonization. The peak age for colonization and person to
person transmission is in the first years of life. Apart from protection
against invasive pneumococcal disease (IPD), the pneumococcal conjugate vaccine
also reduces NP colonisation of vaccine-serotype pneumococci. At the same time,
there is an increase of NP colonisation by nonvaccine-serotype pneumococci,
filling the ecological niche. Next to IPD monitoring in countries where PCV-7
has been introduced, surveys of NP carriage in vaccine recipients and
non-vaccinated contacts for indirect effects are considered relevant for
monitoring of changes in circulating pneumococcal serotypes and predicting herd
effects or potential future replacement disease. The aim of the present study
is to determine the impact of national PCV-7 implementation on NP pneumococcal
carriage in children of 11 and 24 months of age and to evaluate NP colonization
of one parent of a 24-month-old child, in the third year after implementation
of PCV-7 in the Dutch NIP.
Study objective
Primary:
To determine trends in vaccine- and nonvaccine-serotype S. pneumoniae
asymptomatic colonisation in healthy 11-month-old and 24-month-old infants who
have been immunized according to the Dutch NIP with 7-valent pneumococcal
conjugate vaccine Prevenar®
Secondary objectives
To determine vaccine-and nonvaccine-serotype pneumococcal colonisation in one
of the parents of 24-month-old children To determine the influence of altered
VT and NVT serotype composition on other colonising bacteria (S. aureus,
H.influenzae, M. catarrhalis).
Exploratory:
Exploration of possible trends in serotype-specific colonisation in healthy
11-month-old and 24-month-old infants who have been immunized according to the
Dutch NIP with pneumococcal conjugate vaccinations Prevenar®
Study design
Observational study
Study burden and risks
The burden is minimal and the risk associated with participation in this study
is minimal since it involves only one home visit during which a transnasal
nasopharyngeal swab will be taken by a trained personnel member of the research
team. The nose swab may cause a minor, self-limiting nose bleeding (less than
1:1000 from own experience). For the parents, one transnasal and transoral swab
will be collected. The nose swab may cause a minor, self-limiting nose bleeding
(less than 1:1000 from own experience). Parents and children with coagulation
disorders/anticoagulant medication are excluded.
The children participating in the study have been vaccinated acccording to the
current Dutch NIP with Prevenar vaccinations.
The parents are ased to fill in a small questionnaire during the home visit
together with the member of the research team.
The home visit will take 40 minutes.
The children or parents themselves have no benefit in participating in the
study.
Postbus 457
3720 AL Bilthoven
Nederland
Postbus 457
3720 AL Bilthoven
Nederland
Listed location countries
Age
Inclusion criteria
These criteria are derived from the related MINOES study, in order to increase comparability with historical unvaccinated controls
- 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 the 24-month-old children fulfil inclusion criteria
Exclusion criteria
These criteria are derived from the related MINOES study with PCV-7 unvaccinated children
•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/medication;Parents are excluded
•when they have a bleeding disorder/ anticoagulant medication (because of the transnasal swab)
Design
Recruitment
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 | EUCTR2008-004972-37-NL |
| CCMO | NL24116.000.08 |