Infections, RotavirusPhase 4NCT00969228
Study to Evaluate Immunogenicity, Reactogenicity and Safety of Rotarix™ Vaccine in Korean Infants
A Phase 4 study testing Rotarix ™ in people with Infections, Rotavirus and Rotavirus Vaccines, run by GlaxoSmithKline at 18 sites in South Korea.
Trial summary
The aim of this study is to assess the immunogenicity, reactogenicity and safety of the human rotavirus (HRV) Rotarix ™ vaccine when administered in healthy infants aged approximately 6-12 weeks at the time of first vaccination. Read more about this study
- Who is it for?
- Ages 6 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Infections, Rotavirus, Rotavirus Vaccines
- What is being tested?
- Rotarix ™
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 684 participants
- Where
- 18 sitesSouth Korea
- Study dates
- 25 Aug 2009to 23 Jul 2010
- Phase
- Phase 4
- 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 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 6 to 12 weeks of age at the time of the first dose of the vaccination.
- Written informed consent obtained from the parents or guardians of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born after a normal gestation period of between 37 and 41 weeks + 6 days inclusive.
- Subjects for whom the vaccination history is available from vaccination diary cards or medical charts.
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine with the exception of the routine infant vaccines.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator.
Show all 12Show fewer
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Gastroenteritis (GE) within 7 days preceding the study vaccine administration.
- Previous confirmed occurrence of RV GE.
- Previous vaccination with rotavirus vaccine or planned use during the study period.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
South Korea18 sites
GSK Investigational Site
Busan, 614-735
GSK Investigational Site
Daegu, 700-712
GSK Investigational Site
Daegu, 701-600
GSK Investigational Site
Daejeon, 301-723
GSK Investigational Site
Daejeon
GSK Investigational Site
Goyang
GSK Investigational Site
Gwangju, 501-717
GSK Investigational Site
Iksan, 570-711
GSK Investigational Site
Incheon, 400-711
GSK Investigational Site
Jeonju Jeonbuk, 561-712
GSK Investigational Site
Kwangju
GSK Investigational Site
Seoul, 130-702
GSK Investigational Site
Seoul, 135-710
GSK Investigational Site
Seoul, 138-736
GSK Investigational Site
Seoul, 139-707
GSK Investigational Site
Seoul, 150-719
GSK Investigational Site
Seoul
GSK Investigational Site
Suwon, Kyonggi-do, 443-721
About this study
Official title: Immunogenicity, Reactogenicity and Safety Study to Evaluate Two Doses of the Lyophilised Formulation of the Human Rotavirus (HRV) Vaccine When Administered to Healthy Korean Infants Previously Uninfected With HRV
The aim of this study is to assess the immunogenicity, reactogenicity and safety of the human rotavirus (HRV) Rotarix ™ vaccine when administered in healthy infants aged approximately 6-12 weeks at the time of first vaccination.
- Conditions
- Infections, Rotavirus, Rotavirus Vaccines
- Being tested
- Rotarix ™, Placebo
- 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 ™Biological
Two oral doses
PlaceboBiological
Two oral doses
| Study group | Role | What they receive |
|---|---|---|
| Rotarix Group | Experimental | Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule. Receives: Biological: Rotarix ™ |
| Placebo Group | Placebo comparator | Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A
Seroconversion is defined as the appearance of antibodies with concentrations greater than or equal to 20 units per milliliter (U/mL) in the serum of subjects seronegative before vaccination.
Measured: One month after the second vaccine dose
Secondary outcomes (5)
Serum Anti-rotavirus Immunoglobulin A Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs). Note: In the Placebo Group the value was below the assay cut-off (20 units per milliliter).
Measured: One month after the second vaccine dose
Number of Subjects Reporting Solicited Symptoms
Solicited symptoms assessed include cough, diarrhoea, irritability, loss of appetite , fever and vomiting.
Measured: During the 8-day (Day 0 - Day 7) follow-up period after each vaccine dose.
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
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 (Day 0 - Day 30) follow-up period after each vaccine dose
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Measured: Throughout the study period (2-3 months).
Number of Subjects Reporting Rotavirus Gastroenteritis Episode(s)
Measured: From Dose 1 up to 1 month after Dose 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2009 (estimated)
- Study start25 Aug 2009
- Primary completion23 Jul 2010
- Study completion23 Jul 2010
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 (3)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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 684 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
- NCT00969228
- Sponsor's protocol ID
- 112269
- Other IDs
- 2015-001545-81, 2015
- Status last verified
- Jan 2020
- First submitted
- 20 Aug 2009
- Last updated
- 18 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)
Publications
Kim JS, Bae CW, Lee KY, Park MS, Choi YY, Kim KN, Kim JD, Park WS, Sin JB, Kim EA, Lee SG, Kim CS, Cha SH, Hong YJ, Shin SM, Shim GH, Choi KM, Yang JW, Liu A, Suryakiran PV, Han HH. Immunogenicity, reactogenicity and safety of a human rotavirus vaccine (RIX4414) in Korean infants: a randomized, double-blind, placebo-controlled, phase IV study. Hum Vaccin Immunother. 2012 Jun;8(6):806-12. doi: 10.4161/hv.19853. Epub 2012 Jun 1.
PubMed 22699440Kim JS et al. Assessment of immunogenicity, reactogenicity and safety of human rotavirus vaccine RIX4414 in Korean infants. Abstract presented at the Korean Society of Pediatric Infectious Diseases - 2011 Autumn Conference (KSPID). Seoul, S Korea, 12-15 November 2011.
Buyse H, Vinals C, Karkada N, Han HH. The human rotavirus vaccine Rotarix in infants: an integrated analysis of safety and reactogenicity. Hum Vaccin Immunother. 2014;10(1):19-24. doi: 10.4161/hv.26476. Epub 2013 Oct 8.
PubMed 24047799
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity, Reactogenicity and Safety Study to Evaluate Two Doses of the Lyophilised Formulation of the Human Rotavirus (HRV) Vaccine When Administered to Healthy Korean Infants Previously Uninfected With HRV
- ClinicalTrials.gov ID
- NCT00969228
- Acronym / sponsor ID
- 112269
- Conditions
- Infections, Rotavirus, Rotavirus Vaccines
- Keywords
- Gastroenteritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 684 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2009 (actual)
- Primary completion
- 23 Jul 2010 (actual)
- Study completion
- 23 Jul 2010 (actual)
- First posted
- 1 Sep 2009 (estimated)
- Results
- Posted 28 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to assess the immunogenicity, reactogenicity and safety of the human rotavirus (HRV) Rotarix ™ vaccine when administered in healthy infants aged approximately 6-12 weeks at the time of first vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotarix Group | Experimental | Biological: Rotarix ™Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule. |
| Placebo Group | Placebo comparator | Biological: PlaceboSubjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule. |
Who may qualify
- Ages
- 6 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 6 to 12 weeks of age at the time of the first dose of the vaccination.
- Written informed consent obtained from the parents or guardians of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Born after a normal gestation period of between 37 and 41 weeks + 6 days inclusive.
Key exclusion criteria (12 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine with the exception of the routine infant vaccines.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
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 ™Two oral doses | Biological | Rotarix Group |
| PlaceboTwo oral doses | Biological | Placebo Group |
Primary outcome
Number of Subjects Seroconverted for Anti-rotavirus Immunoglobulin A
Time frame: One month after the second vaccine dose
Seroconversion is defined as the appearance of antibodies with concentrations greater than or equal to 20 units per milliliter (U/mL) in the serum of subjects seronegative before vaccination.
5 secondary outcomes
Serum Anti-rotavirus Immunoglobulin A Antibody Concentrations
Time frame: One month after the second vaccine dose
Number of Subjects Reporting Solicited Symptoms
Time frame: During the 8-day (Day 0 - Day 7) follow-up period after each vaccine dose.
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Time frame: During the 31-day (Day 0 - Day 30) follow-up period after each vaccine dose
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time frame: Throughout the study period (2-3 months).
Number of Subjects Reporting Rotavirus Gastroenteritis Episode(s)
Time frame: From Dose 1 up to 1 month after Dose 2.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22699440Kim JS, Bae CW, Lee KY, Park MS, Choi YY, Kim KN, Kim JD, Park WS, Sin JB, Kim EA, Lee SG, Kim CS, Cha SH, Hong YJ, Shin SM, Shim GH, Choi KM, Yang JW, Liu A, Suryakiran PV, Han HH. Immunogenicity, reactogenicity and safety of a human rotavirus vaccine (RIX4414) in Korean infants: a randomized, double-blind, placebo-controlled, phase IV study. Hum Vaccin Immunother. 2012 Jun;8(6):806-12. doi: 10.4161/hv.19853. Epub 2012 Jun 1.
- BackgroundKim JS et al. Assessment of immunogenicity, reactogenicity and safety of human rotavirus vaccine RIX4414 in Korean infants. Abstract presented at the Korean Society of Pediatric Infectious Diseases - 2011 Autumn Conference (KSPID). Seoul, S Korea, 12-15 November 2011.
- Background: PubMed 24047799Buyse H, Vinals C, Karkada N, Han HH. The human rotavirus vaccine Rotarix in infants: an integrated analysis of safety and reactogenicity. Hum Vaccin Immunother. 2014;10(1):19-24. doi: 10.4161/hv.26476. Epub 2013 Oct 8.
- 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 Infections, Rotavirus
Active, not recruitingPhase 1
CDC-9 Inactivated Rotavirus Vaccine (IRV) Microneedle Patch (MNP) in Healthy Adults
Rotavirus Infections
RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
Active, not recruitingPhase 3
The Efficacy of Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants
Rotavirus Infection of Children
Recruiting
Artificial Intelligence-driven Virtual Standardized Pediatric Patients Trial
Pneumococcal Pneumonia, Rotavirus Enteritis With Hypovolemic Shock
Active, not recruitingPhase 2
Safety and Immunogenicity Study of Recombinant Trivalent Rotavirus Subunit Vaccine in Healthy Infants and Toddlers
Rotavirus Infections, Rotavirus Gastroenteritis
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
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rotarix ™ in people with Infections, Rotavirus and Rotavirus Vaccines, run by GlaxoSmithKline at 18 sites 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 6 inclusion and 12 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 18 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 18 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Nov 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 Seroconverted for Anti-rotavirus Immunoglobulin A (time frame: One month after the second vaccine dose). 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 NCT00969228, which also lists 3 linked publications.
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 18 Jan 2020.