Pneumococcal InfectionsNCT04912297
Immunity to Serotype 19A Streptococcus Pneumoniae in Children Vaccinated With PCV10
An observational study of Pneumococcal Infections, run by Finnish Institute for Health and Welfare at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 months to 3 years
- Conditions the study is for
- Pneumococcal Infections
- What is being tested?
- 10-valent pneumococcal conjugate vaccine, PCV10
- Type of treatment
- Vaccines
- How many people
- 186 participants
- Where
- 1 siteFinland
- Study dates
- 12 Nov 2009to 7 May 2013
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 months to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- 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
Who cannot join
- PCV13 or PPV23 dose received
- Informed consent withdrawn
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Persistence of Humoral Immunity to Serotype 19A Streptococcus Pneumoniae in Children Vaccinated With the 10-valent Pneumococcal Conjugate Vaccine in Finland
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.
Read the detailed description
The primary objective is to evaluate the long-term persistence of humoral immunity to vaccine-related pneumococcal serotypes after vaccination with PCV10.
- Conditions
- Pneumococcal Infections
- Being tested
- 10-valent pneumococcal conjugate vaccine, PCV10
- Keywords
- Streptococcus pneumoniae, antibody
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10-valent pneumococcal conjugate vaccine, PCV10Biological
10-valent pneumococcal conjugate vaccine, PCV10
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Biological: 10-valent pneumococcal conjugate vaccine, PCV10 | |
| 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). Receives: Biological: 10-valent pneumococcal conjugate vaccine, PCV10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two years following last PCV10 vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start12 Nov 2009
- Primary completion7 May 2013
- Study completion7 May 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pneumococcal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 186 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Finnish Institute for Health and Welfare
- Sponsor type
- Other government
- Collaborators
- Turku University Hospital, GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Arto Palmu, MD, PhD, Principal investigator, Finnish Institute for Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912297
- Sponsor's protocol ID
- THL/1019/6.00.00/2017
- Status last verified
- Aug 2021
- First submitted
- 28 May 2021
- Last updated
- 11 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistence of Humoral Immunity to Serotype 19A Streptococcus Pneumoniae in Children Vaccinated With the 10-valent Pneumococcal Conjugate Vaccine in Finland
- ClinicalTrials.gov ID
- NCT04912297
- Acronym / sponsor ID
- THL/1019/6.00.00/2017
- Conditions
- Pneumococcal Infections
- Keywords
- Streptococcus pneumoniae, antibody
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Finnish Institute for Health and WelfareOther government
- Collaborators
- Turku University Hospital, GlaxoSmithKline
- Study start
- 12 Nov 2009 (actual)
- Primary completion
- 7 May 2013 (actual)
- Study completion
- 7 May 2013 (actual)
- First posted
- 3 Jun 2021 (actual)
- Results
- Posted 10 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCV10 2+1 schedule | – | Biological: 10-valent pneumococcal conjugate vaccine, PCV10Ten-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 | – | Biological: 10-valent pneumococcal conjugate vaccine, PCV10Ten-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). |
Who may qualify
- Ages
- 13 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- PCV13 or PPV23 dose received
- Informed consent withdrawn
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10-valent pneumococcal conjugate vaccine, PCV1010-valent pneumococcal conjugate vaccine, PCV10 | Biological | PCV10 2+1 schedule, PCV10 3+1 schedule |
Primary outcome
Persistence of Humoral Immunity Following PCV10 Vaccination
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Pneumococcal Infections
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
Active, not recruitingObservational study
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
Pneumococcal Disease
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arto Palmu, MD, PhD principal investigator
Finnish Institute for Health and Welfare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumococcal Infections, run by Finnish Institute for Health and Welfare at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Persistence of Humoral Immunity Following PCV10 Vaccination (time frame: Two years following last PCV10 vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2021.