Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage

NCT01311024 | Completed Results

• 1 other identifier: THL/1843/6.02.01/2010
• Study Type: observational
• Target: 2,341
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pneumococcal Infections

Keywords

Children; Pneumococcal Vaccines

Outcome Measures

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

  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

  one sampling at 3 to 7 years of age

Secondary Outcomes (6)

• Carriage Due to Any Pneumococcal Serotype

  one sampling at 3 to 7 years of age

• Carriage Due to Haemophilus Influenzae

  one sampling at 3 to 7 years of age

• Invasive Pneumococcal Disease

  Up to 8 years

• Hospital-diagnosed Pneumonia

  Up to 8 years

• Tympanostomy Tube Surgery

  Up to 8 years

Study Arms (2)

Sibling vaccinated with PCV GSK1024850A

Older sibling of a child vaccinated with Pneumococcal conjugate vaccine GSK1024850A in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380) NOTE: the primary analysis cohort include siblings of the PCV-vaccinated according to infant schedules (excluding siblings of catch-up vaccinated children)

Biological: PCV GSK1024850A

Control-vaccinated sibling

Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380) NOTE: the primary analysis cohort include siblings of the PCV-vaccinated according to infant schedules (excluding siblings of catch-up vaccinated children)

Biological: hepatitis B vaccine or hepatitis A vaccine

Interventions

PCV GSK1024850A BIOLOGICAL

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

Also known as: GSK Biologicals' Synflorix TM vaccine

Sibling vaccinated with PCV GSK1024850A

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)

Also known as: GSK Biologicals' Engerix TM (hepatitis B) vaccine, GSK Biologicals' Havrix TM (hepatitis A) vaccine

Control-vaccinated sibling

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Non-PCV-vaccinated 3 to 7 year-old siblings living in the same household with a younger child vaccinated in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Arto Palmu: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

National Institute for Health and Welfare

Tampere, Finland

Location

Related Links

• Public webpage for the FinIP trial and the carriage study

Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasopharyngeal and oropharyngeal swabs obtained.

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

twinrix; Hepatitis B Vaccines; Vaccines; Hepatitis A Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Arto Palmu, MD, PhD Research manager,
• Organization: head of Clinical Research Unit, National Institute for Health and Welfare

arto.palmu@thl.fi

+358295247910

Study Officials

• Arto A Palmu, M.D.

  Finnish Institute for Health and Welfare

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Clinical Research Unit

Study Record Dates

• First Submitted: March 7, 2011
• First Posted: March 9, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2017
• Last Updated: March 1, 2021
• Results First Posted: May 5, 2014

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)