NCT04912297CompletedNot Applicable
Persistence of Humoral Immunity to Serotype 19A Streptococcus Pneumoniae in Children Vaccinated With the 10-valent Pneumococcal Conjugate Vaccine in Finland
Finnish Institute for Health and Welfare1 site in 1 country186 target enrollmentStarted: November 12, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 186
- Locations
- 1
- Primary Endpoint
- Persistence of Humoral Immunity Following PCV10 Vaccination
Study Overview
Brief Summary
The aim of the study are to assess the persistence of immunity against vaccine serotypes (VSTs) and vaccine-related serotypes in PCV10 vaccinated children in Finland.
Detailed Description
The primary objective is to evaluate the long-term persistence of humoral immunity to vaccine-related pneumococcal serotypes after vaccination with PCV10.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 13 Months to 3 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Completed PCV10 vaccination with 3 or 4 doses (2+1 or 3+1 schedule) before blood sampling at age of 13 months
- •Age at sample collection 13 months, 2 years or 3 years
- •PCV10 vaccination received 2-6 weeks before sample collection at the age of 1 year
- •Informed consent obtained covering the planned analyses
Exclusion Criteria
- •PCV13 or PPV23 dose received
- •Informed consent withdrawn
Outcomes
Primary Outcomes
Persistence of Humoral Immunity Following PCV10 Vaccination
Time Frame: Two years following last PCV10 vaccination
Persistence of humoral immunity to vaccine- and vaccine-related pneumococcal serotypes after vaccination with PCV10. The serotype 19A specific geometric mean IgG antibody concentrations are reported as micrograms per ml with 95% confidence intervals.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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