Nasopharyngeal Carriage of Streptococcus Pneumoniae Clinical Trial
Official title:
Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage: a FinIP Effectiveness Trial Satellite Study During PCV National Vaccination Programme
| Verified date | March 2017 |
| Source | National Institute for Health and Welfare, Finland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this study is to assess the direct effects of the ten-valent pneumococcal
conjugate vaccine administered to infants on nasopharyngeal carriage at 3 to 5 years of age.
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.
| Status | Completed |
| Enrollment | 3900 |
| Est. completion date | December 2016 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 3 Years to 9 Years |
| Eligibility |
Inclusion Criteria for FinIP-vaccinated children: 1. age 3 to 5 years 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 Exclusion criteria for FinIP-vaccinated children 1. PCV vaccination administered, other than the randomized study vaccine 2. history of antimicrobial treatment within 4 weeks (the child can be enrolled later) Inclusion criteria for unvaccinated siblings 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 for unvaccinated siblings 1. PCV vaccination administered 2. history of antimicrobial treatment within 4 weeks (the child can be enrolled later) |
| Country | Name | City | State |
|---|---|---|---|
| Finland | National Institute for Health and Welfare | Tampere |
| Lead Sponsor | Collaborator |
|---|---|
| Arto Palmu | GlaxoSmithKline |
Finland,
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. Erratum in: Lancet. 2015 May 30;385(9983):2152. Lancet. 2013 May 18;381(9879):1720. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Carriage due to any pneumococcal serotype included in the PCV vaccine in unvaccinated older siblings of the PCV10-vaccinated children | one sampling at 5 to 9 years of age | ||
| Primary | Carriage due to any pneumococcal serotype included in the ten-valent pneumococcal conjugate vaccine (PCV10) in children vaccinated in infancy | Nasopharyngeal and oropharyngeal swabs taken once at 3 to 5 years of age | one sampling at 3 to 5 years of age | |
| Secondary | Carriage due to any pneumococcal serotype in children vaccinated in infancy | one sampling at 3 to 5 years of age |