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Completed

NCT Number: NCT01311024

Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage

The purpose of this study is to assess the indirect effects of a pneumococcal conjugate vaccine administered to infants on vaccinees' elder non-vaccinated siblings aged 3 to 7 years.

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Key information

Conditions

Pneumococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Streptococcal Infections

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institute for Health and Welfare

Tampere, Finland

About this study

The purpose of this study is to assess the indirect effects of a pneumococcal conjugate vaccine administered to infants on vaccinees' elder non-vaccinated siblings aged 3 to 7 years.

This study includes a cross-sectional sampling of nasopharyngeal and oropharyngeal swabs in 2011 and a register-based follow-up study for invasive disease, hospital-diagnosed pneumonia, tympanostomy tube surgery and outpatient antimicrobial treatment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 3 to 7 years
  • younger sibling at least 12 months of age living in the same household participates in the FinIP or 053 trial (regardless of the vaccination schedule)
  • at least one parent with fluent Finnish
  • informed consent from one parent

Exclusion criteria

  • commercial PCV vaccination administered
  • study-related PCV vaccination administered (open or blind)
  • history of antimicrobial treatment within 4 weeks (the child can be enrolled later)

Treatment and study plan

PCV GSK1024850A

Biological

2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)

Other names: GSK Biologicals' Synflorix TM vaccine

hepatitis B vaccine or hepatitis A vaccine

Biological

2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)

Other names: GSK Biologicals' Engerix TM (hepatitis B) vaccine, GSK Biologicals' Havrix TM (hepatitis A) vaccine

Primary outcomes

  1. Carriage Due to Any Pneumococcal Serotype Included in the Ten-valent Pneumococcal Conjugate Vaccine (PCV10) Vaccine in Older Siblings of Children Vaccinated With Infant Schedules

    Time frame: one sampling at 3 to 7 years of age

    Carriage due to any pneumococcal serotype included in the ten-valent pneumococcal conjugate vaccine (PCV10) vaccine in older siblings of children vaccinated with infant schedules. Nasopharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age

Secondary outcomes

  1. Carriage Due to Any Pneumococcal Serotype

    Time frame: one sampling at 3 to 7 years of age

    Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age

  2. Carriage Due to Haemophilus Influenzae

    Time frame: one sampling at 3 to 7 years of age

    Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age

  3. Invasive Pneumococcal Disease

    Time frame: Up to 8 years

    Register follow-up up to 8 years after the vaccination of the younger sibling in the family

  4. Hospital-diagnosed Pneumonia

    Time frame: Up to 8 years

    Register follow-up up to 8 years after the vaccination of the younger sibling in the family

  5. Tympanostomy Tube Surgery

    Time frame: Up to 8 years

    Register follow-up up to 8 years after the vaccination of the younger sibling in the family

  6. Outpatient Antibiotic Treatment

    Time frame: Up to 8 years

    Register follow-up up to 8 years after the vaccination of the younger sibling in the family

Sponsors and collaborators

Lead sponsor

Arto Palmu

Other Gov

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage: a FinIP Effectiveness Trial Satellite Study

Acronym: FinIPcarr

Important dates

Study start
2011
Primary completion
2013
Study completion
2017
First posted
Mar 9, 2011
Registry last updated
Mar 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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