DiphtheriaNCT00908115

Post Market Surveillance for Infanrix™

An observational study of Diphtheria and Acellular Pertussis, run by GlaxoSmithKline at 1 site in South Korea.

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 was to investigate the following questions through post-marketing surveillance: Unknown/Unexpected adverse events and the serious adverse events. The circumstances in which the adverse events occurred under the practical application. Factors considered to have influence on safety. Read more about this study

Who is it for?: Any age
Conditions the study is for: Diphtheria, Acellular Pertussis, Tetanus
What is being tested?: GSK Biologicals' Infanrix™
Type of treatment: Vaccines, Injection or infusion
How many people: 1,258 participants
Where: 1 siteSouth Korea
Study dates: 1 Aug 2003to 23 Jun 2008
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: All children receiving Infanrix™ were eligible for this survey.

Who may be able to join

All children receiving Infanrix™ were eligible for this survey.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

GSK Investigational Site
Daegu, 700-712

Other trials in South Korea

About this study

Official title: Evaluation of Safety and Efficacy Through Post Market Surveillance for Infanrix™, the DTaP Mixed Vaccine

The purpose of this study was to investigate the following questions through post-marketing surveillance:

Unknown/Unexpected adverse events and the serious adverse events.
The circumstances in which the adverse events occurred under the practical application.
Factors considered to have influence on safety.
Factors considered to have influence on efficacy.
Miscellaneous - Facts about mechanism, efficacy and safety which were not clearly known due to the inherent problems of the drugs.

Conditions: Diphtheria, Acellular Pertussis, Tetanus
Being tested: GSK Biologicals' Infanrix™
Medical subject headings: Diphtheria, Tetanus

What participants receive

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

GSK Biologicals' Infanrix™Biological
Also called DTPa
Primary and booster vaccination according to vaccination schedule. Intramuscular injection

Study groups in NCT00908115
Study group	Role	What they receive
Infanrix Group		Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination). Receives: Biological: GSK Biologicals' Infanrix™

What is being measured

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

Number of Subjects Reporting Serious Adverse Events
A serious adverse event is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Measured: Since the beginning of the study and during the entire study period (up to 6 years)
Number of Subjects Reporting Solicited Symptoms
Solicited local symptoms assessed include induration, itching, pain, redness, and swelling. Solicited general symptoms assessed include anorexia, convulsions, cough, diarrhea, drowsiness, eruption, fever, irritability, and vomiting.
Measured: During the 4-week follow-up period after each dose
Number of Subjects Reporting Unsolicited Adverse Events
An adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Within the 31-day (Day 0-30) following vaccination.

Timeline

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

1 Aug 200323 Jun 2008

First posted25 May 2009 (estimated)
Study start1 Aug 2003
Primary completion23 Jun 2008
Study completion23 Jun 2008

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 DiphtheriaStudies 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: Retrospective
Enrolment: 1,258 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00908115
Sponsor's protocol ID: 208355/128
Status last verified: Dec 2019
First submitted: 21 May 2009
Last updated: 2 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)

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

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 recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
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

All Diphtheria trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Safety and Efficacy Through Post Market Surveillance for Infanrix™, the DTaP Mixed Vaccine
ClinicalTrials.gov ID: NCT00908115
Acronym / sponsor ID: 208355/128
Conditions: Diphtheria, Acellular Pertussis, Tetanus
Study type: Observational
Recruitment status: Completed
Enrolment: 1,258 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 Aug 2003 (actual)
Primary completion: 23 Jun 2008 (actual)
Study completion: 23 Jun 2008 (actual)
First posted: 25 May 2009 (estimated)
Results: Posted 17 Jul 2009

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 was to investigate the following questions through post-marketing surveillance:

Unknown/Unexpected adverse events and the serious adverse events.
The circumstances in which the adverse events occurred under the practical application.
Factors considered to have influence on safety.
Factors considered to have influence on efficacy.
Miscellaneous - Facts about mechanism, efficacy and safety which were not clearly known due to the inherent problems of the drugs.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Infanrix Group	–	Biological: GSK Biologicals' Infanrix™Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: All children receiving Infanrix™ were eligible for this survey.

Key inclusion criteria (1 listed)

All children receiving Infanrix™ were eligible for this survey.

Key exclusion criteria (0 listed)

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
GSK Biologicals' Infanrix™Also: DTPaPrimary and booster vaccination according to vaccination schedule. Intramuscular injection	Biological	Infanrix Group

Primary outcome

Number of Subjects Reporting Serious Adverse Events
Time frame: Since the beginning of the study and during the entire study period (up to 6 years)
A serious adverse event is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Number of Subjects Reporting Solicited Symptoms
Time frame: During the 4-week follow-up period after each dose
Solicited local symptoms assessed include induration, itching, pain, redness, and swelling. Solicited general symptoms assessed include anorexia, convulsions, cough, diarrhea, drowsiness, eruption, fever, irritability, and vomiting.
Number of Subjects Reporting Unsolicited Adverse Events
Time frame: Within the 31-day (Day 0-30) following vaccination.
An adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Results and safety

Results posted to the registry on 17 Jul 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Infanrix Group	1,258	1,244

Primary outcome: Number of Subjects Reporting Serious Adverse Events

Time frame: Since the beginning of the study and during the entire study period (up to 6 years). Number. Unit: Subjects

Measure	Infanrix Group n = 1258
Value	3

Primary outcome: Number of Subjects Reporting Solicited Symptoms

Time frame: During the 4-week follow-up period after each dose. Number. Unit: Subjects

Measure	Infanrix Group n = 877
Induration after Dose 1 (n=798)	51
Induration after Dose 2 (n=843)	72
Induration after Dose 3 (n=877)	86
Induration after Booster at 15-18 Months (n=88)	19
Induration after Booster at 4-6 Years (n=22)	5
Itching after Dose 1 (n=798)	5
Itching after Dose 2 (n=843)	8
Itching after Dose 3 (n=877)	2

Population analysed: Analysis was performed on the subjects who received the considered dose.

Primary outcome: Number of Subjects Reporting Unsolicited Adverse Events

Time frame: Within the 31-day (Day 0-30) following vaccination.. Number. Unit: Subjects

Measure	Infanrix Group n = 1258
Value	144

Adverse events

Time frame: SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Infanrix Group	3 of 1,258 (0.2%)	90 of 877 (10.3%)	0 of 1,258

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. IPD is available via the Clinical Study Data Request site (click on the link provided below)

Related trials for Diphtheria

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 recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
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.

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 and Acellular Pertussis, 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 0 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 2 Jan 2020. 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 17 Jul 2009). 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 Subjects Reporting Serious Adverse Events (time frame: Since the beginning of the study and during the entire study period (up to 6 years)). 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 NCT00908115.

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 2 Jan 2020.