Pneumococcal Infections
Conditions
Keywords
Streptococcus pneumoniae, antibody
Brief summary
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.
Detailed description
The primary objective is to evaluate the long-term persistence of humoral immunity to vaccine-related pneumococcal serotypes after vaccination with PCV10.
Interventions
BIOLOGICAL10-valent pneumococcal conjugate vaccine, PCV10
10-valent pneumococcal conjugate vaccine, PCV10
Sponsors
Turku University Hospital
GlaxoSmithKline
Finnish Institute for Health and Welfare
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
13 Months to 3 Years
Healthy volunteers
No
Inclusion criteria
* Completed PCV10 vaccination with 3 or 4 doses (2+1 or 3+1 schedule) before blood sampling at age of 13 months * Age at sample collection 13 months, 2 years or 3 years * PCV10 vaccination received 2-6 weeks before sample collection at the age of 1 year * Informed consent obtained covering the planned analyses
Exclusion criteria
* PCV13 or PPV23 dose received * Informed consent withdrawn
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Persistence of Humoral Immunity Following PCV10 Vaccination | Two years following last 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. |
Countries
Finland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 68 |
| 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 | 54 |
| Total | 122 |
Baseline characteristics
| Characteristic | PCV10 2+1 Schedule | PCV10 3+1 Schedule | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 68 Participants | 54 Participants | 122 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Finland | 68 participants | 54 participants | 122 participants |
| Sex: Female, Male Female | 33 Participants | 25 Participants | 58 Participants |
| Sex: Female, Male Male | 35 Participants | 29 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 68 | 0 / 54 |
| serious Total, serious adverse events | 0 / 68 | 0 / 54 |
Outcome results
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.
Time frame: Two years following last PCV10 vaccination
Population: 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
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PCV10 2+1 Schedule | Persistence of Humoral Immunity Following PCV10 Vaccination | 0.32 micrograms per ml |
| PCV10 3+1 Schedule | Persistence of Humoral Immunity Following PCV10 Vaccination | 0.35 micrograms per ml |