Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage
NCT ID: NCT01925222
Last Updated: 2017-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
3900 participants
OBSERVATIONAL
2013-08-31
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
These children have been vaccinated in infancy in the cluster-randomized Finnish Invasive pneumococcal Disease (FinIP) Trial (a separate protocol reported at ClinicalTrials.gov Identifier:NCT00861380) during 2009 to 2011.
Also the indirect effect on nasopharyngeal carriage will be assessed on vaccinees' elder non-vaccinated siblings aged 5 to 9 years.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage
NCT01311024
Immunity to Serotype 19A Streptococcus Pneumoniae in Children Vaccinated With PCV10
NCT04912297
Long-term Impact of Pneumococcal Conjugate Vaccine on Carriage
NCT00294021
Safety and Immunogenicity Study of 20vPnC in Healthy Children 15 Months Through 17 Years of Age
NCT04642079
Impact on Carriage, Acute Otitis Media, Immuno & Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A
NCT00839254
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PCV-vaccinated infant, 3+1 schedule
No interventions assigned to this group
PCV-vaccinated infant, 2+1 schedule
No interventions assigned to this group
Control-vaccinated infant
No interventions assigned to this group
PCV-vaccinated child, catch-up schedule
No interventions assigned to this group
Control-vaccinated child, catch-up schedule
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. enrolled in the FinIP trial and has received at least one dose of study vaccine in the infant vaccine schedule (3+1 or 2+1)
3. at least one parent with fluent Finnish
4. informed consent from one parent
1. age 5 to 9 years
2. younger sibling living in the same household having participated in the FinIP trial (regardless of the vaccination schedule)
3. at least one parent with fluent Finnish
4. informed consent from one parent
Exclusion Criteria
2. history of antimicrobial treatment within 4 weeks (the child can be enrolled later)
1. PCV vaccination administered
2. history of antimicrobial treatment within 4 weeks (the child can be enrolled later)
3 Years
9 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Arto Palmu
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Arto Palmu
Research manager
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Arto A Palmu, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Finnish Institute for Health and Welfare
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Institute for Health and Welfare
Tampere, , Finland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Palmu AA, Jokinen J, Borys D, Nieminen H, Ruokokoski E, Siira L, Puumalainen T, Lommel P, Hezareh M, Moreira M, Schuerman L, Kilpi TM. Effectiveness of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against invasive pneumococcal disease: a cluster randomised trial. Lancet. 2013 Jan 19;381(9862):214-22. doi: 10.1016/S0140-6736(12)61854-6. Epub 2012 Nov 16.
Related Links
Access external resources that provide additional context or updates about the study.
Public webpage for the FinIP trial and the carriage study
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FinIP-carriage13THL
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.