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| Name | Class |
|---|---|
| Turku University Hospital | OTHER_GOV |
| GlaxoSmithKline | INDUSTRY |
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The aim of the study are to assess the persistence of immunity against vaccine serotypes (VSTs) and vaccine-related serotypes in PCV10 vaccinated children in Finland.
The primary objective is to evaluate the long-term persistence of humoral immunity to vaccine-related pneumococcal serotypes after vaccination with PCV10.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCV10 2+1 schedule | Ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GlaxoSmithKline) administered with a 2+1 schedule (two vaccinations with minimum 8-week intervals followed by a booster dose at least 4 months after the last primary dose). |
| |
| PCV10 3+1 schedule | Ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GlaxoSmithKline) administered with a 3+1 schedule (three vaccinations with minimum 4-week intervals, followed by a booster dose at least 4 months after the last primary dose). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10-valent pneumococcal conjugate vaccine, PCV10 | Biological | 10-valent pneumococcal conjugate vaccine, PCV10 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Persistence of Humoral Immunity Following PCV10 Vaccination | Persistence of humoral immunity to vaccine- and vaccine-related pneumococcal serotypes after vaccination with PCV10. The serotype 19A specific geometric mean IgG antibody concentrations are reported as micrograms per ml with 95% confidence intervals. | Two years following last PCV10 vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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Children born in 2008-2010 in the Hospital District of Southwest Finland. These children participated in the Finnish Invasive Pneumococcal Disease (FinIP) Vaccine Trial before introduction of PCV10 into the national immunization program in 2010. Serum samples from the children were collected in The Steps to the Healthy Development and Well-being of Children (STEPS) Study at the ages of 13 months, 2 years and 3 years.
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| Name | Affiliation | Role |
|---|---|---|
| Arto Palmu, MD, PhD | Finnish Institute for Health and Welfare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Finnish Institute for Health and Welfare | Helsinki | Finland |
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| ID | Title | Description |
|---|---|---|
| FG000 | PCV10 2+1 Schedule | Ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GlaxoSmithKline) administered with a 2+1 schedule (two vaccinations with minimum 8-week intervals followed by a booster dose at least 4 months after the last primary dose). 10-valent pneumococcal conjugate vaccine, PCV10: 10-valent pneumococcal conjugate vaccine, PCV10 |
| FG001 | PCV10 3+1 Schedule | Ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GlaxoSmithKline) administered with a 3+1 schedule (three vaccinations with minimum 4-week intervals, followed by a booster dose at least 4 months after the last primary dose). 10-valent pneumococcal conjugate vaccine, PCV10: 10-valent pneumococcal conjugate vaccine, PCV10 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PCV10 2+1 Schedule | Ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GlaxoSmithKline) administered with a 2+1 schedule (two vaccinations with minimum 8-week intervals followed by a booster dose at least 4 months after the last primary dose). 10-valent pneumococcal conjugate vaccine, PCV10: 10-valent pneumococcal conjugate vaccine, PCV10 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Persistence of Humoral Immunity Following PCV10 Vaccination | Persistence of humoral immunity to vaccine- and vaccine-related pneumococcal serotypes after vaccination with PCV10. The serotype 19A specific geometric mean IgG antibody concentrations are reported as micrograms per ml with 95% confidence intervals. | IgG concentrations to serotype 19A at two years following last PCV vaccination in subjects vaccinated with PCV10 with a 2+1 or 3+1 schedule | Posted | Geometric Mean | 95% Confidence Interval | micrograms per ml | Two years following last PCV10 vaccination |
|
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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 | PCV10 2+1 Schedule | Ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GlaxoSmithKline) administered with a 2+1 schedule (two vaccinations with minimum 8-week intervals followed by a booster dose at least 4 months after the last primary dose). 10-valent pneumococcal conjugate vaccine, PCV10: 10-valent pneumococcal conjugate vaccine, PCV10 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Merit Melin, Research manager | Finnish Institute for Health and Welfare | merit.melin@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 |
|---|---|
| C586648 | 10-valent pneumococcal conjugate vaccine |
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Serum samples collected at 13 months, 2 years or 3 years from children vaccinated with PCV10 with 2+1 or 3+1 schedule
| BG001 | PCV10 3+1 Schedule | Ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GlaxoSmithKline) administered with a 3+1 schedule (three vaccinations with minimum 4-week intervals, followed by a booster dose at least 4 months after the last primary dose). 10-valent pneumococcal conjugate vaccine, PCV10: 10-valent pneumococcal conjugate vaccine, PCV10 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | PCV10 3+1 Schedule | Ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GlaxoSmithKline) administered with a 3+1 schedule (three vaccinations with minimum 4-week intervals, followed by a booster dose at least 4 months after the last primary dose). 10-valent pneumococcal conjugate vaccine, PCV10: 10-valent pneumococcal conjugate vaccine, PCV10 |
|
|
| 0 |
| 68 |
| 0 |
| 68 |
| EG001 | PCV10 3+1 Schedule | Ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10; GlaxoSmithKline) administered with a 3+1 schedule (three vaccinations with minimum 4-week intervals, followed by a booster dose at least 4 months after the last primary dose). 10-valent pneumococcal conjugate vaccine, PCV10: 10-valent pneumococcal conjugate vaccine, PCV10 | 0 | 54 | 0 | 54 |
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| D007239 | Infections |