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

Finnish Institute for Health and Welfare

Status: Completed

Conditions: Pneumococcal Infections

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04912297

THL/1019/6.00.00/2017

Details and patient eligibility

About

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.

Full description

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

Enrollment: 186 patients

Sex: All

Ages: 13 months to 3 years old

Volunteers: No Healthy Volunteers

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• Informed consent withdrawn

Trial design

186 participants in 2 patient groups

PCV10 2+1 schedule

Description:

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).

Treatment:

Biological: 10-valent pneumococcal conjugate vaccine, PCV10

PCV10 3+1 schedule

Description:

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).

Treatment:

Biological: 10-valent pneumococcal conjugate vaccine, PCV10