An observational study in Pneumococcal Infections, sponsored by Finnish Institute for Health and Welfare. Completed at 1 site in Finland. Open to participants aged 13 Months to 3 Years. Per ClinicalTrials.gov, last updated 2021-08-11.
Sponsored by Finnish Institute for Health and Welfare · Observational
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.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's enrollment of 186 is close to the median of 203 across 688 observational studies indexed under Pneumonia.
Browse Pneumonia studies →Finnish Institute for Health and Welfare is the lead sponsor of 43 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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).
Biological: 10-valent pneumococcal conjugate vaccine, PCV10
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).
Biological: 10-valent pneumococcal conjugate vaccine, PCV10
10-valent pneumococcal conjugate vaccine, PCV10
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.
Time frame: Two years following last PCV10 vaccination
| Milestone | PCV10 2+1 Schedule | PCV10 3+1 Schedule |
|---|---|---|
| Started | 99 | 87 |
| Completed | 68 | 54 |
| Not completed | 31 | 33 |
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.
| micrograms per ml | PCV10 2+1 Schedule | PCV10 3+1 Schedule |
|---|---|---|
| Persistence of Humoral Immunity Following PCV10 Vaccination | 0.32 (0.22 to 0.48) | 0.35 (0.23 to 0.53) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PCV10 2+1 Schedule | — | 0/68 (0%) | 0/68 (0%) |
| PCV10 3+1 Schedule | — | 0/54 (0%) | 0/54 (0%) |
| Age, Categorical(Participants) | PCV10 2+1 Schedule | PCV10 3+1 Schedule | Total |
|---|---|---|---|
| <=18 years | 68 | 54 | 122 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | PCV10 2+1 Schedule | PCV10 3+1 Schedule | Total |
|---|---|---|---|
| Female | 33 | 25 | 58 |
| Male | 35 | 29 | 64 |
| Region of Enrollment(participants) | PCV10 2+1 Schedule | PCV10 3+1 Schedule | Total |
|---|---|---|---|
| Finland | 68 | 54 | 122 |
Plan to share: No
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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Finnish Institute for Health and Welfare