Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage (FinIPcarr)

Arto Palmu

Status: Completed

Conditions: Pneumococcal Infections

Treatments: Biological: PCV GSK1024850A; Biological: hepatitis B vaccine or hepatitis A vaccine

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01311024

THL/1843/6.02.01/2010

Details and patient eligibility

About

The purpose of this study is to assess the indirect effects of a pneumococcal conjugate vaccine administered to infants on vaccinees' elder non-vaccinated siblings aged 3 to 7 years.

Full description

The purpose of this study is to assess the indirect effects of a pneumococcal conjugate vaccine administered to infants on vaccinees' elder non-vaccinated siblings aged 3 to 7 years.

This study includes a cross-sectional sampling of nasopharyngeal and oropharyngeal swabs in 2011 and a register-based follow-up study for invasive disease, hospital-diagnosed pneumonia, tympanostomy tube surgery and outpatient antimicrobial treatment.

Enrollment: 2,341 patients

Sex: All

Ages: 3 to 7 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age 3 to 7 years
• younger sibling at least 12 months of age living in the same household participates in the FinIP or 053 trial (regardless of the vaccination schedule)
• at least one parent with fluent Finnish
• informed consent from one parent

Exclusion criteria

• commercial PCV vaccination administered
• study-related PCV vaccination administered (open or blind)
• history of antimicrobial treatment within 4 weeks (the child can be enrolled later)

Trial design

2,341 participants in 2 patient groups

Sibling vaccinated with PCV GSK1024850A

Description:

Older sibling of a child vaccinated with Pneumococcal conjugate vaccine GSK1024850A in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380) NOTE: the primary analysis cohort include siblings of the PCV-vaccinated according to infant schedules (excluding siblings of catch-up vaccinated children)

Treatment:

Biological: PCV GSK1024850A

Control-vaccinated sibling

Description:

Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380) NOTE: the primary analysis cohort include siblings of the PCV-vaccinated according to infant schedules (excluding siblings of catch-up vaccinated children)

Treatment:

Biological: hepatitis B vaccine or hepatitis A vaccine