Respiratory bacteria and virusses in the nasopharynx of infants and parents

• Conditions: The study investigates the presence of nasopharyngeal vaccine- and non-vaccine pneumococcal serotypes in 11- and 24-month-old infants and parents, 6.5 years after implementation of a pneumococcal vaccine in the National Immunization Program. We also determine nasopharyngeal colonising of respiratory non-pneumococcal bacteria and of virusses.; Therapeutic area: Body processes [G] - Biological Phenomena [G16]

• Registration Number: EUCTR2012-001458-24-NL
• Lead Sponsor: RIVM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-10
• Last Update Posted: 15 July 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 660
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 330
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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:
Chromosomal abnormalities or craniofacial abnormalities, known or suspected immunodeficiency disease or other medical conditions that will severely affect immunological responses
Coagulation disorder/anticoagulant medication

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified