Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage

Pneumococcal Infections Clinical Trial

— FinIPcarr  

Official title:

Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage: a FinIP Effectiveness Trial Satellite Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01311024
• Other study ID #: THL/1843/6.02.01/2010
• Status: Completed
• Start date: April 2011
• Est. completion date: December 2017

Study information

• Verified date: February 2021
• Source: Finnish Institute for Health and Welfare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2341
• Est. completion date: December 2017
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pneumococcal Infections

Intervention

Biological:
• PCV GSK1024850A
2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)
• hepatitis B vaccine or hepatitis A vaccine
2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)

Locations

Country	Name	City	State
Finland	National Institute for Health and Welfare	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
Arto Palmu	GlaxoSmithKline

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Carriage Due to Any Pneumococcal Serotype Included in the Ten-valent Pneumococcal Conjugate Vaccine (PCV10) Vaccine in Older Siblings of Children Vaccinated With Infant Schedules	Carriage due to any pneumococcal serotype included in the ten-valent pneumococcal conjugate vaccine (PCV10) vaccine in older siblings of children vaccinated with infant schedules. Nasopharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age	one sampling at 3 to 7 years of age
Secondary	Carriage Due to Any Pneumococcal Serotype	Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age	one sampling at 3 to 7 years of age
Secondary	Carriage Due to Haemophilus Influenzae	Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age	one sampling at 3 to 7 years of age
Secondary	Invasive Pneumococcal Disease	Register follow-up up to 8 years after the vaccination of the younger sibling in the family	Up to 8 years
Secondary	Hospital-diagnosed Pneumonia	Register follow-up up to 8 years after the vaccination of the younger sibling in the family	Up to 8 years
Secondary	Tympanostomy Tube Surgery	Register follow-up up to 8 years after the vaccination of the younger sibling in the family	Up to 8 years
Secondary	Outpatient Antibiotic Treatment	Register follow-up up to 8 years after the vaccination of the younger sibling in the family	Up to 8 years

External Links

•   Public webpage for the FinIP trial and the carriage study