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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sibling vaccinated with PCV GSK1024850A | 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) |
| |
| 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) NOTE: the primary analysis cohort include siblings of the PCV-vaccinated according to infant schedules (excluding siblings of catch-up vaccinated children) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCV GSK1024850A | Biological | 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Carriage Due to Haemophilus Influenzae |
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Inclusion Criteria:
Exclusion Criteria:
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Non-PCV-vaccinated 3 to 7 year-old siblings living in the same household with a younger child vaccinated in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)
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| Name | Affiliation | Role |
|---|---|---|
| Arto A Palmu, M.D. | Finnish Institute for Health and Welfare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute for Health and Welfare | Tampere | Finland |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). Evaluable subjects with NPS sample analysed 482 Siblings of infant-vaccinated children in the PCV 2+1 arm and 445 Siblings of infant-vaccinated children in the PCV 3+1 arm and 568 Siblings of catch-up vaccinated children in the PCV arms 1495 in total |
| FG001 | 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) Evaluable subjects with NPS sample analysed 518 Siblings of infant-vaccinated children in the control arms and 271 Siblings of catch-up vaccinated children 789 in total |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
These numbers include only the siblings of the infant-vaccinated FinIP children.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | percentage of subjects | one sampling at 3 to 7 years of age |
|
Study-related adverse events collected, i.e. those due to NPS and OPS sampling.
Note, this study did not include active vaccination of the participants, but indirect impact of the vaccination given to younger siblings was evaluated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). Evaluable subjects with NPS sample analysed 482 Siblings of infant-vaccinated children in the PCV 2+1 arm and 445 Siblings of infant-vaccinated children in the PCV 3+1 arm and 568 Siblings of catch-up vaccinated children in the PCV arms 1495 in total |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arto Palmu, MD, PhD Research manager, | head of Clinical Research Unit, National Institute for Health and Welfare | +358295247910 | arto.palmu@thl.fi |
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| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C433226 | twinrix |
| D017325 | Hepatitis B Vaccines |
| D014612 | Vaccines |
| D022362 | Hepatitis A Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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Nasopharyngeal and oropharyngeal swabs obtained.
|
| hepatitis B vaccine or hepatitis A vaccine | Biological | 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380) |
|
|
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 |
| Invasive Pneumococcal Disease | Register follow-up up to 8 years after the vaccination of the younger sibling in the family | Up to 8 years |
| Hospital-diagnosed Pneumonia | Register follow-up up to 8 years after the vaccination of the younger sibling in the family | Up to 8 years |
| Tympanostomy Tube Surgery | Register follow-up up to 8 years after the vaccination of the younger sibling in the family | Up to 8 years |
| Outpatient Antibiotic Treatment | Register follow-up up to 8 years after the vaccination of the younger sibling in the family | Up to 8 years |
| BG001 | 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) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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) Evaluable subjects with NPS sample analysed 518 Siblings of infant-vaccinated children in the control arms and 271 Siblings of catch-up vaccinated children 789 in total |
|
|
| 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 | Not Posted | one sampling at 3 to 7 years of age | Participants |
| 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 | Not Posted | one sampling at 3 to 7 years of age | Participants |
| Secondary | Invasive Pneumococcal Disease | Register follow-up up to 8 years after the vaccination of the younger sibling in the family | Not Posted | Up to 8 years | Participants |
| Secondary | Hospital-diagnosed Pneumonia | Register follow-up up to 8 years after the vaccination of the younger sibling in the family | Not Posted | Up to 8 years | Participants |
| Secondary | Tympanostomy Tube Surgery | Register follow-up up to 8 years after the vaccination of the younger sibling in the family | Not Posted | Up to 8 years | Participants |
| Secondary | Outpatient Antibiotic Treatment | Register follow-up up to 8 years after the vaccination of the younger sibling in the family | Not Posted | Up to 8 years | Participants |
| 0 |
| 1,495 |
| 0 |
| 1,495 |
| EG001 | 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) Evaluable subjects with NPS sample analysed 518 Siblings of infant-vaccinated children in the control arms and 271 Siblings of catch-up vaccinated children 789 in total | 0 | 789 | 0 | 789 |
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| D007239 | Infections |