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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

186 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-12

Study Completion Date

2013-05-07

Brief Summary

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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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Detailed Description

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

Conditions

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Pneumococcal Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PCV10 2+1 schedule

Ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GlaxoSmithKline) administered with a 2+1 schedule (two vaccinations with minimum 8-week intervals followed by a booster dose at least 4 months after the last primary dose).

10-valent pneumococcal conjugate vaccine, PCV10

Intervention Type BIOLOGICAL

10-valent pneumococcal conjugate vaccine, PCV10

PCV10 3+1 schedule

Ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GlaxoSmithKline) administered with a 3+1 schedule (three vaccinations with minimum 4-week intervals, followed by a booster dose at least 4 months after the last primary dose).

10-valent pneumococcal conjugate vaccine, PCV10

Intervention Type BIOLOGICAL

10-valent pneumococcal conjugate vaccine, PCV10

Interventions

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10-valent pneumococcal conjugate vaccine, PCV10

Intervention Type BIOLOGICAL

Eligibility Criteria

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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