OKIDOKI-6: Research on carriage of pneumococcal bacteria and other bacteria and viruses in children and their parents

Not Applicable

Completed

• Conditions: Pneumococcal carriage in children and their parents; Infections and Infestations

• Registration Number: ISRCTN31549735
• Lead Sponsor: ational Institute for Public Health and the Environment

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-16
• Study Completion: 2023-02-20
• Last Update Posted: 18 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 660

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, fever >38.5°C in the last two days is not considered as normal health)
2. The parents/legal guardians have to be willing and able to participate in the trial according to procedure
3. The child is 24-months-old (± 4 weeks)
4. The child has been vaccinated according to the Dutch NIP
5. Presence of a signed informed consent (the parents/legal guardians have given written informed consent after receiving oral and written information)
6. Parents/legal guardians of 24-month-old children are included when the child fulfils the inclusion criteria and sign their own informed consent

Exclusion Criteria

A potential participating child who meets any of the following criteria will be excluded from participation in this study:
1. Previous vaccinations with PCV using a vaccine and schedule that differs from the Dutch NIP of that age group
2. Medical conditions that will severely affect immunological responses to vaccinations or nasopharyngeal carriage rates (certain chromosomal abnormalities or craniofacial abnormalities (like Trisomy 21 or schisis), known or suspected immunodeficiency disease or other medical conditions)

A parent/legal guardian who meets any of the following criteria will be excluded from participation in this study:
3. Medical conditions that will severely affect immunological responses to vaccinations or nasopharyngeal carriage rates (certain chromosomal abnormalities or craniofacial abnormalities (like Trisomy 21 or schisis), known or suspected immunodeficiency disease or other medical conditions)

Study & Design

• Study Type: Observational
• Study Design: Not specified