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NCT04912297 Clinical Trial

Immunity to Serotype 19A Streptococcus Pneumoniae in Children Vaccinated With PCV10

Pneumococcal Infections Clinical Trial

Official title:
Persistence of Humoral Immunity to Serotype 19A Streptococcus Pneumoniae in Children Vaccinated With the 10-valent Pneumococcal Conjugate Vaccine in Finland

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04912297
Other study ID # THL/1019/6.00.00/2017
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 12, 2009
Est. completion date May 7, 2013

Study information
Verified date August 2021
Source Finnish Institute for Health and Welfare
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Description:

The primary objective is to evaluate the long-term persistence of humoral immunity to vaccine-related pneumococcal serotypes after vaccination with PCV10.

Recruitment information / eligibility
Status Completed
Enrollment 186
Est. completion date May 7, 2013
Est. primary completion date May 7, 2013
Accepts healthy volunteers No
Gender All
Age group 13 Months to 3 Years
Eligibility 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consent obtained covering the planned analyses Exclusion Criteria: - PCV13 or PPV23 dose received - Informed consent withdrawn

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• 10-valent pneumococcal conjugate vaccine, PCV10
10-valent pneumococcal conjugate vaccine, PCV10

Locations
Country Name City State
Finland Finnish Institute for Health and Welfare Helsinki

Sponsors (3)
Lead Sponsor Collaborator
Finnish Institute for Health and Welfare GlaxoSmithKline, Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Persistence of Humoral Immunity Following 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. Two years following last PCV10 vaccination
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