Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage

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.

• PCV GSK1024850A (Biological), also known as GSK Biologicals' Synflorix TM vaccine: 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 (Biological), also known as GSK Biologicals' Engerix TM (hepatitis B) vaccine, GSK Biologicals' Havrix TM (hepatitis A) vaccine: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)

Primary outcomes

• 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 [one sampling at 3 to 7 years of age]: 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

Secondary outcomes

• Carriage Due to Any Pneumococcal Serotype [one sampling at 3 to 7 years of age]: Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age
• Carriage Due to Haemophilus Influenzae [one sampling at 3 to 7 years of age]: Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age
• Invasive Pneumococcal Disease [Up to 8 years]: Register follow-up up to 8 years after the vaccination of the younger sibling in the family
• Hospital-diagnosed Pneumonia [Up to 8 years]: Register follow-up up to 8 years after the vaccination of the younger sibling in the family
• Tympanostomy Tube Surgery [Up to 8 years]: Register follow-up up to 8 years after the vaccination of the younger sibling in the family
• Outpatient Antibiotic Treatment [Up to 8 years]: Register follow-up up to 8 years after the vaccination of the younger sibling in the family

Sex: All, ages: 3 Years to 7 Years, 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)

Participant flow

Outcome results

• 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 (Primary), Number, percentage of subjects: PCV-vaccinated Sibling (GSK1024850A) 14.5; Control-vaccinated Sibling 19.3
• Carriage Due to Any Pneumococcal Serotype (Secondary)
• Carriage Due to Haemophilus Influenzae (Secondary)
• Invasive Pneumococcal Disease (Secondary)
• Hospital-diagnosed Pneumonia (Secondary)
• Tympanostomy Tube Surgery (Secondary)
• Outpatient Antibiotic Treatment (Secondary)

Adverse events

Time frame: Study-related adverse events collected, i.e. those due to NPS and OPS sampling.

• Arto A Palmu, M.D., Principal investigator, Finnish Institute for Health and Welfare