Diphtheria-Tetanus-acellular Pertussis VaccinesNCT01929291
Post-marketing Surveillance to Assess the Safety of Boostrix Vaccine Given According to Prescribing Information in Korea
An observational study of Diphtheria-Tetanus-acellular Pertussis Vaccines, run by GlaxoSmithKline at 1 site in South Korea.
Trial summary
The purpose of this study is to collect safety information from pre-adolescents, adolescents and adults after Boostrix vaccination is administered according to the approved prescribing information in Korea. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diphtheria-Tetanus-acellular Pertussis Vaccines
- What is being tested?
- Boostrix and Safety data collection
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 682 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Sep 2013to 11 Jan 2016
- 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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pre-adolescents, adolescents adults and elderly who receive Boostrix as a part of routine practice at a private clinic or hospital.
Who may be able to join
- Written or signed informed consent obtained from the subject/ subject's parent(s)/Legally Acceptable Representative(s) of the child. Korean male or female subjects who were recently vaccinated or eligible to receive Boostrix according to the locally approved Prescribing Information.
Who cannot join
- Those who are not eligible for vaccination according to the local Prescribing Information.
- Child in care.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Safety of GlaxoSmithKline (GSK) Biologicals' Combined Reduced Antigen Content Diphtheria-tetanus Toxoids and Acellular Pertussis Vaccine (dTPa), Boostrix When Administered According to the Approved Prescribing Information in Korea
The purpose of this study is to collect safety information from pre-adolescents, adolescents and adults after Boostrix vaccination is administered according to the approved prescribing information in Korea.
Read the detailed description
Protocol amendment 3 rationale was as follows:
- Age for analysis set is specified.
- Subjects with pregnancy will be analyzed by their pregnancy status before/after vaccination.
- Pregnancy notifications must be done within 2 weeks
- Being tested
- Boostrix, Safety data collection
- Keywords
- Korea, Post-marketing surveillance, Boostrix, Prescribing information, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BoostrixBiological
Also called dTPa vaccine
Single intramuscular injection
Safety data collectionOther
Safety monitoring: recording of adverse events using diary cards and recording of serious adverse events using the latest version of Korea's Post-Marketing Surveillance Serious Adverse Event Reporting Form
| Study group | Role | What they receive |
|---|---|---|
| Boostrix Group | Pre-adolescents (aged (≥10 years to ˂12 years), adolescents (aged ≥12 to ˂19 years), adults (aged 19 to 64 years) and elderly (≥ 65) who received Boostrix as a part of routine practice at a private clinic or hospital in Korea. Receives: Biological: Boostrix; Other: Safety data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Unexpected Adverse Events (AEs)
Unexpected AEs were defined as adverse events that are not reflected in the approved Prescribing Information in Korea.
Measured: During the 30-day (Day 0 - Day 29) follow-up period after vaccination.
Number of Expected AEs.
Expected AEs were defined as an adverse event that was expected from the subject during the post-vaccination follow-up period as described in the locally approved Prescribing Information in Korea.
Measured: During the 30-day (Day 0 - Day 29) follow-up period after vaccination.
Number of Subjects With Serious Adverse Events (SAEs)
An SAE was defined as any AE that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or that was a congenital anomaly/birth defect in the offspring of a study subject.
Measured: During the 30-day (Day 0 - Day 29) follow-up period after vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study start23 Sep 2013
- Primary completion11 Jan 2016
- Study completion11 Jan 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diphtheria-Tetanus-acellular Pertussis VaccinesStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- 682 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929291
- Sponsor's protocol ID
- 115374
- Status last verified
- Sep 2019
- First submitted
- 22 Aug 2013
- Last updated
- 25 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Publications
Park HJ, Kim SJ, Song R, Chen J, Kim JH, Devadiga R, Kang HC. A 6-year Prospective, Observational, Multi-Center Post-Marketing Surveillance of the Safety of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis (Tdap) Vaccine in Korea. J Korean Med Sci. 2019 Mar 22;34(12):e105. doi: 10.3346/jkms.2019.34.e105. eCollection 2019 Apr 1.
PubMed 30940999
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety of GlaxoSmithKline (GSK) Biologicals' Combined Reduced Antigen Content Diphtheria-tetanus Toxoids and Acellular Pertussis Vaccine (dTPa), Boostrix When Administered According to the Approved Prescribing Information in Korea
- ClinicalTrials.gov ID
- NCT01929291
- Acronym / sponsor ID
- 115374
- Keywords
- Korea, Post-marketing surveillance, Boostrix, Prescribing information, Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 682 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2013 (actual)
- Primary completion
- 11 Jan 2016 (actual)
- Study completion
- 11 Jan 2016 (actual)
- First posted
- 27 Aug 2013 (estimated)
- Results
- Posted 29 Mar 2019
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 collect safety information from pre-adolescents, adolescents and adults after Boostrix vaccination is administered according to the approved prescribing information in Korea.
Detailed description
Protocol amendment 3 rationale was as follows:
- Age for analysis set is specified.
- Subjects with pregnancy will be analyzed by their pregnancy status before/after vaccination.
- Pregnancy notifications must be done within 2 weeks
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Boostrix Group | – | Biological: Boostrix, Other: Safety data collectionPre-adolescents (aged (≥10 years to ˂12 years), adolescents (aged ≥12 to ˂19 years), adults (aged 19 to 64 years) and elderly (≥ 65) who received Boostrix as a part of routine practice at a private clinic or hospital in Korea. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pre-adolescents, adolescents adults and elderly who receive Boostrix as a part of routine practice at a private clinic or hospital.
Key inclusion criteria (1 listed)
- Written or signed informed consent obtained from the subject/ subject's parent(s)/Legally Acceptable Representative(s) of the child. Korean male or female subjects who were recently vaccinated or eligible to receive Boostrix according to the locally approved Prescribing Information.
Key exclusion criteria (2 listed)
- Those who are not eligible for vaccination according to the local Prescribing Information.
- Child in care.
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 |
|---|---|---|
| BoostrixAlso: dTPa vaccineSingle intramuscular injection | Biological | Boostrix Group |
| Safety data collectionSafety monitoring: recording of adverse events using diary cards and recording of serious adverse events using the latest version of Korea's Post-Marketing Surveillance Serious Adverse Event Reporting Form | Other | Boostrix Group |
Primary outcome
Number of Unexpected Adverse Events (AEs)
Time frame: During the 30-day (Day 0 - Day 29) follow-up period after vaccination.
Unexpected AEs were defined as adverse events that are not reflected in the approved Prescribing Information in Korea.
Number of Expected AEs.
Time frame: During the 30-day (Day 0 - Day 29) follow-up period after vaccination.
Expected AEs were defined as an adverse event that was expected from the subject during the post-vaccination follow-up period as described in the locally approved Prescribing Information in Korea.
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the 30-day (Day 0 - Day 29) follow-up period after vaccination.
An SAE was defined as any AE that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or that was a congenital anomaly/birth defect in the offspring of a study subject.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30940999Park HJ, Kim SJ, Song R, Chen J, Kim JH, Devadiga R, Kang HC. A 6-year Prospective, Observational, Multi-Center Post-Marketing Surveillance of the Safety of Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis (Tdap) Vaccine in Korea. J Korean Med Sci. 2019 Mar 22;34(12):e105. doi: 10.3346/jkms.2019.34.e105. eCollection 2019 Apr 1.
- Individual participant dataSharing planned: No
Related trials for Diphtheria-Tetanus-acellular Pertussis Vaccines
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
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
Not yet recruitingObservational study
A Clinical Study on Immunogenicity Persistence of Adsorbed 5-component Acellular Pertussis, Diphtheria and Tetanus Combined Vaccine
Diphtheria, Tetanus
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.
GSK Clinical Trials study director
GlaxoSmithKline
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 Diphtheria-Tetanus-acellular Pertussis Vaccines, run by GlaxoSmithKline at 1 site in South Korea.
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 1 inclusion and 2 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 25 Sep 2019. 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 South Korea. 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 29 Mar 2019). 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?
Number of Unexpected Adverse Events (AEs) (time frame: During the 30-day (Day 0 - Day 29) follow-up period after vaccination.). The study lists 3 primary outcomes in all. 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 NCT01929291, which also lists 1 linked publication.
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 25 Sep 2019.