Streptococcus Pneumoniae Infection Clinical Trial
— MNOESOfficial title:
Effect of 2 Versus 3 Pneumococcal Conjugate Vaccinations Prevnar on Nasopharyngeal Carriage, Transmission and Herd-immunity;a Randomized, Controlled Study
Two( 2) or three (3) instead of four vaccinations before the age of 6 months with pneumococcal conjugate vaccine are presumed to protect children against invasive pneumococcal disease like meningitis, at least on the short term till 18-24 months of age. The current hypothesis in this study is 2 or 3 vaccinations will protect against IPD but will not alter pneumococcal nasopharyngeal carriage in infants, and consequently not change pneumococcal transmission and induce no herd-immunity. Furthermore, antibody development and memory may benefit from carriage of vaccine type S. pneumoniae
Status | Completed |
Enrollment | 1005 |
Est. completion date | |
Est. primary completion date | February 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 2 Months to 3 Months |
Eligibility |
Inclusion Criteria: - Newborn infants eligible for participation in the national infant vaccination program in the Netherlands Exclusion Criteria: exclusion from the national vaccination program because of the presence of - a medical condition requiring treatment that can interfere with the effect of vaccinations - known or suspected allergy to components of the pneumococcal conjugate vaccine - known or suspected immunodeficiency disease - previous treatment with plasma or immunoglobulins - previous vaccinations other than hepatitis B vaccinations - coagulation disorders |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
UMC Utrecht | Netherlands Vaccine Institute, Netherlands: Ministry of Health, Welfare and Sports |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nasopharyngeal bacterial (pneumococcal) colonization at 6 weeks, 6, 12, 18 and 24 months in infants and at 12 and 24 months of family members | duration of study, 23 months per subject | No | |
Primary | transmission to family members( sib, caregiver) | at infants age of 12 and 24 months | No | |
Secondary | anti-pneumococcal antibody levels at 12 and 24 months of age | 23 months | No | |
Secondary | antibody levels and B-memory cells after vaccination at 24 months | 23 months | No |
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