Clinical trial NCT01925222: Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage
Official title: Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage: a FinIP Effectiveness Trial Satellite Study During PCV National Vaccination Programme
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasopharyngeal Carriage of Streptococcus Pneumoniae
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
Collaborators: name: GlaxoSmithKline
First posted: 2013-08-19
Enrollment: 3900
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children vaccinated in infancy in the cluster-randomized Finnish Invasive pneumococcal Disease (FinIP) Trial (ClinicalTrials.gov Identifier:NCT00861380) during 2009 to 2011 and their unvaccinated older siblings.

Brief summary: 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.

Detailed description: This study includes a cross-sectional sampling of nasopharyngeal and oropharyngeal swabs in 2013 from vaccinated and unvaccinated children.

Eligibility criteria: 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)

Primary outcomes:
measure: Carriage due to any pneumococcal serotype included in the ten-valent pneumococcal conjugate vaccine (PCV10) in children vaccinated in infancy
timeFrame: one sampling at 3 to 5 years of age
Secondary outcomes:
measure: Carriage due to any pneumococcal serotype in children vaccinated in infancy
timeFrame: one sampling at 3 to 5 years of age
Other outcomes:
measure: Carriage due to any pneumococcal serotype included in the PCV vaccine in unvaccinated older siblings of the PCV10-vaccinated children
timeFrame: one sampling at 5 to 9 years of age
Locations:
city: Tampere
country: Finland
facility: National Institute for Health and Welfare
Study officials:
affiliation: Finnish Institute for Health and Welfare
name: Arto A Palmu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.