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

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.

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Key information

Conditions

Pneumococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Streptococcal Infections

Age range

13 month–3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Finnish Institute for Health and Welfare

Helsinki, Finland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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Informed consent withdrawn

Treatment and study plan

10-valent pneumococcal conjugate vaccine, PCV10

Biological

10-valent pneumococcal conjugate vaccine, PCV10

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.

Sponsors and collaborators

Lead sponsor

Finnish Institute for Health and Welfare

Other Gov

Collaborators

GlaxoSmithKline
Turku University Hospital

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2013
Study completion: 2013
First posted: Jun 3, 2021
Registry last updated: Aug 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed