Pneumococcal InfectionsFinIPcarrNCT01311024

Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage

An observational study of Pneumococcal Infections, run by Arto Palmu at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 3 to 7 yearsHealthy volunteers can take part
Conditions the study is for: Pneumococcal Infections
What is being tested?: PCV GSK1024850A and hepatitis B vaccine or hepatitis A vaccine
Type of treatment: Vaccines
How many people: 2,341 participants
Where: 1 siteFinland
Study dates: Apr 2011to Dec 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 3 to 7 years
All sexes
Healthy volunteers accepted
Child

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)

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Finland1 site

National Institute for Health and Welfare
Tampere

Other trials in Finland

About this study

Official title: Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage: a FinIP Effectiveness Trial Satellite 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.

Read the detailed description

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.

Conditions: Pneumococcal Infections
Being tested: PCV GSK1024850A, hepatitis B vaccine or hepatitis A vaccine
Keywords: Children, Pneumococcal Vaccines
Medical subject headings: Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PCV GSK1024850ABiological
Also called GSK Biologicals' Synflorix TM vaccine
2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)
hepatitis B vaccine or hepatitis A vaccineBiological
Also called GSK Biologicals' Engerix TM (hepatitis B) vaccine, GSK Biologicals' Havrix TM (hepatitis A) vaccine
2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)

Study groups in NCT01311024
Study group	Role	What they receive
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) Receives: 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) Receives: Biological: hepatitis B vaccine or hepatitis A vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: one sampling at 3 to 7 years of age

Secondary outcomes (6)

Carriage Due to Any Pneumococcal Serotype
Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age
Measured: one sampling at 3 to 7 years of age
Carriage Due to Haemophilus Influenzae
Nasopharyngeal and oropharyngeal swabs taken once at 3 to 7 years of age when the vaccinated sibling is at least 12 months of age
Measured: one sampling at 3 to 7 years of age
Invasive Pneumococcal Disease
Register follow-up up to 8 years after the vaccination of the younger sibling in the family
Measured: Up to 8 years
Hospital-diagnosed Pneumonia
Register follow-up up to 8 years after the vaccination of the younger sibling in the family
Measured: Up to 8 years
Tympanostomy Tube Surgery
Register follow-up up to 8 years after the vaccination of the younger sibling in the family
Measured: Up to 8 years
Outpatient Antibiotic Treatment
Register follow-up up to 8 years after the vaccination of the younger sibling in the family
Measured: Up to 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011Dec 2017

First posted9 Mar 2011 (estimated)
Study startApr 2011
Primary completionJun 2013
Study completionDec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pneumococcal InfectionsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 2,341 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01311024
Sponsor's protocol ID: THL/1843/6.02.01/2010
Acronym: FinIPcarr
Status last verified: Feb 2021
First submitted: 7 Mar 2011
Last updated: 1 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
Active, not recruitingObservational study
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
Pneumococcal Disease
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine

All Pneumococcal Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Indirect Effects of Pneumococcal Vaccine on Nasopharyngeal Carriage: a FinIP Effectiveness Trial Satellite Study
ClinicalTrials.gov ID: NCT01311024
Acronym / sponsor ID: FinIPcarr / THL/1843/6.02.01/2010
Conditions: Pneumococcal Infections
Keywords: Children, Pneumococcal Vaccines
Study type: Observational
Recruitment status: Completed
Enrolment: 2,341 participants (actual)
Lead sponsor: Arto PalmuOther government
Collaborators: GlaxoSmithKline
Study start: Apr 2011 (actual)
Primary completion: Jun 2013 (actual)
Study completion: Dec 2017 (actual)
First posted: 9 Mar 2011 (estimated)
Results: Posted 5 May 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

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.

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
Sibling vaccinated with PCV GSK1024850A	–	Biological: PCV GSK1024850AOlder 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)
Control-vaccinated sibling	–	Biological: hepatitis B vaccine or hepatitis A vaccineOlder 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)

Who may qualify

Ages: 3 to 7 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child
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)

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PCV GSK1024850AAlso: GSK Biologicals' Synflorix TM vaccine2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)	Biological	Sibling vaccinated with PCV GSK1024850A
hepatitis B vaccine or hepatitis A vaccineAlso: GSK Biologicals' Engerix TM (hepatitis B) vaccine, GSK Biologicals' Havrix TM (hepatitis A) vaccine2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)	Biological	Control-vaccinated sibling

Primary outcome

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

6 secondary outcomes

Carriage Due to Any Pneumococcal Serotype
Time frame: one sampling at 3 to 7 years of age
Carriage Due to Haemophilus Influenzae
Time frame: one sampling at 3 to 7 years of age
Invasive Pneumococcal Disease
Time frame: Up to 8 years
Hospital-diagnosed Pneumonia
Time frame: Up to 8 years
Tympanostomy Tube Surgery
Time frame: Up to 8 years
Outpatient Antibiotic Treatment
Time frame: Up to 8 years

Results and safety

Results posted to the registry on 5 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PCV-vaccinated Sibling (GSK1024850A)	1,530	1,495
Control-vaccinated Sibling	811	789

Primary outcome: 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. Number. Unit: percentage of subjects

Measure	PCV-vaccinated Sibling (GSK1024850A) n = 927	Control-vaccinated Sibling n = 518
Value	14.5	19.3

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Study-related adverse events collected, i.e. those due to NPS and OPS sampling.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PCV-vaccinated Sibling (GSK1024850A)	0 of 1,495 (0%)	0 of 1,495 (0%)	Not reported
Control-vaccinated Sibling	0 of 789 (0%)	0 of 789 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Pneumococcal Infections

Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
Active, not recruitingObservational study
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
Pneumococcal Disease
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
RecruitingObservational study
National, Non Interventional Study of Invasive Pneumococcal Disease in Children and Newborns
Pneumococcal Infections, Pneumococcal Conjugate Vaccine

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Arto A Palmu, M.D. principal investigator

Finnish Institute for Health and Welfare

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pneumococcal Infections, run by Arto Palmu at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01311024.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2021.