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Effects of routine infant vaccination with the 7-valent pneumococcal conjugate vaccine on nasopharygeal colonization with streptococcus pneumoniae in children and parents in the Netherlands.

Effects of routine infant vaccination with the 7-valent pneumococcal conjugate vaccine on nasopharygeal colonization with streptococcus pneumoniae in children and parents in the Netherlands.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23549
Enrollment
660
Registered
2008-12-04
Start date
2008-12-15
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevenar vaccination, Immune system, pneumococcal carriage.

Interventions

2 groups of children, in both groups a transnasal nasopharyngeal swab will be collected of the children and transnasal and transoral swabs will be taken of the parents.

Sponsors

Nederlands Vaccin Instituut (NVI)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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); 2. They have to be willing and able to participate in the trial according to procedure; 3. Presence of a signed informed consent (the parents/legally representatives have given written informed consent after receiving oral and written information); 4. The children have received the Prevenar® vaccinations according to the 3+1 schedule of the Dutch NIP; 5. Parents are included when their children fulfil inclusion criteria.

Exclusion criteria

Exclusion criteria: 1. Previous vaccinations with Prevenar® using a schedule that differs from the Dutch 3+1 schedule; 2. Previous vaccinations with other pneumoccocal vaccines; 3. 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); 4. 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; 5. Coagulation disorder/anticoagulant medication; Parents are excluded: when they have a bleeding disorder/ anticoagulant medication (because of the transnasal swab).

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
The percentage of children and parents positive for S.aureus, H. influenzae and M. catarrhalis.

Contacts

Public ContactAlienke Wijmenga-Monsuur

RIVM

alienke.wijmenga@rivm.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)