Pneumococcal Infections
Conditions
Keywords
Children, Pneumococcal Vaccines
Brief 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.
Detailed 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.
Interventions
BIOLOGICALPCV GSK1024850A
2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)
BIOLOGICALhepatitis 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)
Sponsors
GlaxoSmithKline
Arto Palmu
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Hospital-diagnosed Pneumonia | Up to 8 years | Register follow-up up to 8 years after the vaccination of the younger sibling in the family |
Countries
Finland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PCV-vaccinated Sibling (GSK1024850A) Older sibling of a child vaccinated with PCV in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)
Pneumococcal conjugate vaccine GSK1024850A: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380) | 927 |
| Control-vaccinated Sibling 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)
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) | 518 |
| Total | 1,445 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 35 | 22 |
Baseline characteristics
| Characteristic | PCV-vaccinated Sibling (GSK1024850A) | Control-vaccinated Sibling | Total |
|---|---|---|---|
| Age, Continuous | 4 years | 4 years | 4 years |
| Sex: Female, Male Female | 468 Participants | 257 Participants | 725 Participants |
| Sex: Female, Male Male | 459 Participants | 261 Participants | 720 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 1,495 | 0 / 789 |
| serious Total, serious adverse events | 0 / 1,495 | 0 / 789 |
Outcome results
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
Time frame: one sampling at 3 to 7 years of age
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PCV-vaccinated Sibling (GSK1024850A) | 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 | 14.5 percentage of subjects |
| Control-vaccinated Sibling | 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 | 19.3 percentage of subjects |
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
Time frame: 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
Time frame: one sampling at 3 to 7 years of age
Secondary
Hospital-diagnosed Pneumonia
Register follow-up up to 8 years after the vaccination of the younger sibling in the family
Time frame: Up to 8 years
Secondary
Invasive Pneumococcal Disease
Register follow-up up to 8 years after the vaccination of the younger sibling in the family
Time frame: 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
Time frame: 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
Time frame: Up to 8 years