Pertussis InfectionNCT01929473
Seroepidemiological Study of Pertussis and Other Infectious Diseases
An observational study of Pertussis Infection, run by Gifu Prefecture Medical Association at 1 site in Japan.
Trial summary
Serum samples will be corrected twice from the same youth subjects with one year interval. Seroincidence of pertussis will be estimated by the elevation of Ig-G-PT in paired sera from an identical individual. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pertussis Infection
- How many people
- 3,830 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2013to Nov 2014
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Students of junior high school, high school or college
Who may be able to join
- Students of junior high school, high schools or college in Gifu prefecture
- Students who can have the second blood drawing one year later
- Students (and their parent when students are underage) whose written consent is obtainable.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Serum samples will be corrected twice from the same youth subjects with one year interval.
Seroincidence of pertussis will be estimated by the elevation of Ig-G-PT in paired sera from an identical individual.
The relationship between the incidence and the demographic data or medical history of the subjects will be discussed.
- Conditions
- Pertussis Infection
- Keywords
- Pertussis infection, Risk factors
What is being measured
The primary outcome is the main question the study is designed to answer.
IgG
Seroincidence of pertussis estimated by the elevation of Ig-G-PT in paired sera(0day, 365day).
Measured: 0 day, 365 day (2 points)
Secondary outcomes (3)
Incidence of Pertussis
Questionnaire
Measured: 0 day
Antibodies of Varicella, Mumps and Rubella
Questionnaire
Measured: 0 day
Infection Risk Factors Including Family Numbers, Living Space, With or Without a Cough Patient in the Surroundings, Medical History and Hospitalization
Questionnaire
Measured: 365 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2014
- Study completionNov 2014
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 Pertussis InfectionStudies 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
- Prospective
- Enrolment
- 3,830 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gifu Prefecture Medical Association
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi Pasteur S.A.
- Responsible party
- Sponsor
- Investigators
- Naoki Kawai, Study chair, Gifu Prefecture Medial Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929473
- Sponsor's protocol ID
- G-P001
- Status last verified
- Jun 2016
- First submitted
- 15 Aug 2013
- Last updated
- 12 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroepidemiological Study of Pertussis and Other Infectious Diseases
- ClinicalTrials.gov ID
- NCT01929473
- Acronym / sponsor ID
- G-P001
- Conditions
- Pertussis Infection
- Keywords
- Pertussis infection, Risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,830 participants (actual)
- Lead sponsor
- Gifu Prefecture Medical AssociationUniversity, hospital or other
- Collaborators
- Sanofi Pasteur S.A.
- Study start
- Sep 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 28 Aug 2013 (estimated)
- Results
- Posted 12 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Serum samples will be corrected twice from the same youth subjects with one year interval.
Seroincidence of pertussis will be estimated by the elevation of Ig-G-PT in paired sera from an identical individual.
The relationship between the incidence and the demographic data or medical history of the subjects will be discussed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Students of junior high school, high school or college
Key inclusion criteria (3 listed)
- Students of junior high school, high schools or college in Gifu prefecture
- Students who can have the second blood drawing one year later
- Students (and their parent when students are underage) whose written consent is obtainable.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IgG
Time frame: 0 day, 365 day (2 points)
Seroincidence of pertussis estimated by the elevation of Ig-G-PT in paired sera(0day, 365day).
3 secondary outcomes
Incidence of Pertussis
Time frame: 0 day
Antibodies of Varicella, Mumps and Rubella
Time frame: 0 day
Infection Risk Factors Including Family Numbers, Living Space, With or Without a Cough Patient in the Surroundings, Medical History and Hospitalization
Time frame: 365 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Pertussis Infection
RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingObservational study
Assessment of the Acceptability of, and Factors Associated With, Recommended Vaccinations During Pregnancy in Maternity Units in the Ile-de-France Region
Vaccination Coverage Among Pregnant Women
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women
Diphtheria-Tetanus-acellular Pertussis Vaccines
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.
Naoki Kawai study chair
Gifu Prefecture Medial Association
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 Pertussis Infection, run by Gifu Prefecture Medical Association at 1 site in Japan.
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 3 inclusion and 1 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 12 Jul 2016. 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 Japan. 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 12 Jul 2016). 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?
IgG (time frame: 0 day, 365 day (2 points)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2016.