Infections, RotavirusNCT00750893

Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix (Human Rotavirus Vaccine) in Infants

An observational study of Infections, Rotavirus, 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.

Official record

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Trial summary

Who is it for?: Ages 6 to 24 weeksHealthy volunteers can take part
Conditions the study is for: Infections, Rotavirus
What is being tested?: Rotarix or Rotarix liquid formulation
Type of treatment: Vaccines, Pill or oral medicine, Injection or infusion
How many people: 3,111 participants
Where: 1 siteSouth Korea
Study dates: 2 Sep 2008to 15 Jun 2013
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 6 to 24 weeks
All sexes
Healthy volunteers accepted
Child

Study population: Infants aged at least 6 weeks will be administered two doses of Rotarix or Rotarix liquid formulation (oral suspension or prefilled syringe) orally as per the prescribing information in Korea.

Who may be able to join

Infants who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the PMS.
A male or female infant from the age of 6 weeks at the time of the first vaccination.
Written informed consent obtained from the parent or guardian of the infant.

Who cannot join

At the time of PMS entry, the contraindications and precautions of use indicated in the prescribing information should be checked and the infant must not be included in the PMS if there is any contraindication. Any changes in the locally approved Prescribing Information must be implemented immediately.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

GSK Investigational Site
Seoul, 122-896

Other trials in South Korea

About this study

Official title: Safety of GlaxoSmithKline Biologicals' Oral Live Attenuated Human Rotavirus Vaccine, Rotarix or Rotarix Liquid Formulation (Oral Suspension or Prefilled Syringe) When Administered According to the Prescribing Information in Korea

This protocol posting deals with objectives and outcome measures of the primary phase at one month post-Dose 2. This Post Marketing Surveillance (PMS) will collect safety data on the use of human rotavirus vaccine in at least 3000 evaluable infants in Korea. This study involves male or female infants from the age of 6 weeks at the time of the first vaccination. The vaccination course must be completed by the age of 24 weeks.

Read the detailed description

The protocol posting has been amended to reflect the two new vaccine presentations that have been launched in Korea. The current PMS will thus collect safety information from subjects who have received either Rotarix or Rotarix liquid formulation (oral suspension or prefilled syringe) in the course of their routine clinical practice according to the prescribing information in Korea.

Conditions: Infections, Rotavirus
Being tested: Rotarix or Rotarix liquid formulation
Keywords: Gastroenteritis
Medical subject headings: Rotavirus Infections, Gastroenteritis

What participants receive

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

Rotarix or Rotarix liquid formulationBiological
GSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine (oral suspension or prefilled syringe).

Study groups in NCT00750893
Study group	Role	What they receive
Rotarix Group		Subjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age. Receives: Biological: Rotarix or Rotarix liquid formulation

What is being measured

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

Number of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed include cough, diarrhoea, irritability, loss of appetite, temperature and vomiting.
Measured: During the 8-day follow-up period after each vaccine dose for Year 1 & Year 2 study period
Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 1 & Year 2 Study Period
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Measured: During the 31-day follow-up period after each vaccine dose for Year 1 & Year 2 study period
Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 3 & Year 4 Study Period
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Measured: During the 31-day follow-up period after each vaccine dose for Year 3 & Year 4 study period
Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 5 Study Period
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Measured: During the 31 day follow-up period after each vaccine dose for Year 5 study period
Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 1 to Year 6 Study Period
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Measured: During the 31-day follow-up period after each vaccine dose for Year 1 to Year 6 study period
Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 1 & Year 2 Study Period
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.
Measured: During the post-marketing study period for Year 1 & Year 2 study period
Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 3 & Year 4 Study Period
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.
Measured: During the post-marketing study period for Year 3 & Year 4 study period
Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 5 Study Period
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.
Measured: During the post-marketing study period for Year 5 study period
Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 1 to Year 6 Study Period
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.
Measured: During the post-marketing study period for Year 1 to Year 6 study period

Timeline

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

2 Sep 200815 Jun 2013

First posted11 Sep 2008 (estimated)
Study start2 Sep 2008
Primary completion15 Jun 2013
Study completion15 Jun 2013

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 Infections, RotavirusStudies 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: 3,111 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00750893
Sponsor's protocol ID: 111700
Status last verified: Feb 2020
First submitted: 10 Sep 2008
Last updated: 3 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

Publications

Shin SM, Kim CS, Karkada N, Liu A, Jayadeva G, Han HH. Post-marketing safety surveillance conducted in Korea (2008-2013) following the introduction of the rotavirus vaccine, RIX4414 (Rotarix). Hum Vaccin Immunother. 2016 Oct 2;12(10):2590-2594. doi: 10.1080/21645515.2016.1189046. Epub 2016 Aug 5.
PubMed 27494163

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

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Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety of GlaxoSmithKline Biologicals' Oral Live Attenuated Human Rotavirus Vaccine, Rotarix or Rotarix Liquid Formulation (Oral Suspension or Prefilled Syringe) When Administered According to the Prescribing Information in Korea
ClinicalTrials.gov ID: NCT00750893
Acronym / sponsor ID: 111700
Conditions: Infections, Rotavirus
Keywords: Gastroenteritis
Study type: Observational
Recruitment status: Completed
Enrolment: 3,111 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 2 Sep 2008 (actual)
Primary completion: 15 Jun 2013 (actual)
Study completion: 15 Jun 2013 (actual)
First posted: 11 Sep 2008 (estimated)
Results: Posted 25 Feb 2011

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
Rotarix Group	–	Biological: Rotarix or Rotarix liquid formulationSubjects who received 2 oral doses of Rotarix. The first dose was administered before the age of 6 weeks and the second one at least 4 weeks after, preferably before the age of 16 weeks. The 2 doses had to be given before 24 weeks of age.

Who may qualify

Ages: 6 to 24 weeks
Sex: All
Healthy volunteers: Accepted
Age groups: Child
Study population: Infants aged at least 6 weeks will be administered two doses of Rotarix or Rotarix liquid formulation (oral suspension or prefilled syringe) orally as per the prescribing information in Korea.

Key inclusion criteria (3 listed)

Infants who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the PMS.
A male or female infant from the age of 6 weeks at the time of the first vaccination.
Written informed consent obtained from the parent or guardian of the infant.

Key exclusion criteria (1 listed)

At the time of PMS entry, the contraindications and precautions of use indicated in the prescribing information should be checked and the infant must not be included in the PMS if there is any contraindication. Any changes in the locally approved Prescribing Information must be implemented immediately.

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
Rotarix or Rotarix liquid formulationGSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine (oral suspension or prefilled syringe).	Biological	Rotarix Group

Primary outcome

Number of Subjects Reporting Solicited General Symptoms
Time frame: During the 8-day follow-up period after each vaccine dose for Year 1 & Year 2 study period
Solicited general symptoms assessed include cough, diarrhoea, irritability, loss of appetite, temperature and vomiting.
Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 1 & Year 2 Study Period
Time frame: During the 31-day follow-up period after each vaccine dose for Year 1 & Year 2 study period
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 3 & Year 4 Study Period
Time frame: During the 31-day follow-up period after each vaccine dose for Year 3 & Year 4 study period
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 5 Study Period
Time frame: During the 31 day follow-up period after each vaccine dose for Year 5 study period
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 1 to Year 6 Study Period
Time frame: During the 31-day follow-up period after each vaccine dose for Year 1 to Year 6 study period
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 1 & Year 2 Study Period
Time frame: During the post-marketing study period for Year 1 & Year 2 study period
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.
Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 3 & Year 4 Study Period
Time frame: During the post-marketing study period for Year 3 & Year 4 study period
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.
Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 5 Study Period
Time frame: During the post-marketing study period for Year 5 study period
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.
Number of Subjects Reporting Serious Adverse Events (SAEs) During the Post-marketing Study Period for Year 1 to Year 6 Study Period
Time frame: During the post-marketing study period for Year 1 to Year 6 study period
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject.

Results and safety

Results posted to the registry on 25 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rotarix Group	3,111	2,569

Primary outcome: Number of Subjects Reporting Solicited General Symptoms

Time frame: During the 8-day follow-up period after each vaccine dose for Year 1 & Year 2 study period. Count of participants. Unit: Participants

Measure	Rotarix Group n = 876
Cough	204
Diarrhoea	50
Irritability	405
Loss of appetite	259
Temperature	135
Vomiting	200

Population analysed: Analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least one dose of Rotarix vaccine administration documented and for whom data were available at Year 1 and Year 2.

Primary outcome: Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 1 & Year 2 Study Period

Time frame: During the 31-day follow-up period after each vaccine dose for Year 1 & Year 2 study period. Count of participants. Unit: Participants

Measure	Rotarix Group n = 876
Value	334

Primary outcome: Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 3 & Year 4 Study Period

Time frame: During the 31-day follow-up period after each vaccine dose for Year 3 & Year 4 study period. Count of participants. Unit: Participants

Measure	Rotarix Group n = 1052
Value	413

Primary outcome: Number of Subjects Reporting Unsolicited Adverse Events (AEs) During the 31-day Follow-up Period After Each Vaccine Dose for Year 5 Study Period

Time frame: During the 31 day follow-up period after each vaccine dose for Year 5 study period. Count of participants. Unit: Participants

Measure	Rotarix Group n = 708
Value	254

Adverse events

Time frame: Serious adverse events: during Years 1, 2, 3, 4, 5 and 6 post-marketing study period. Systematically and non-systematically assessed frequent adverse events: during the 8-day and 31-day follow-up period after each vaccine dose, respectively.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rotarix Group	26 of 3,111 (0.8%)	684 of 3,111 (22%)	0 of 3,111

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27494163Shin SM, Kim CS, Karkada N, Liu A, Jayadeva G, Han HH. Post-marketing safety surveillance conducted in Korea (2008-2013) following the introduction of the rotavirus vaccine, RIX4414 (Rotarix). Hum Vaccin Immunother. 2016 Oct 2;12(10):2590-2594. doi: 10.1080/21645515.2016.1189046. Epub 2016 Aug 5.
Full CSR posting.Link provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Infections, Rotavirus

Active, not recruitingPhase 1
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Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
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The Efficacy of Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants
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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 Infections, Rotavirus, 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 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 3 Mar 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 25 Feb 2011). 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 Solicited General Symptoms (time frame: During the 8-day follow-up period after each vaccine dose for Year 1 & Year 2 study period). The study lists 9 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 NCT00750893, 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 3 Mar 2020.