Infections, RotavirusPhase 3NCT00134732
Study of 2 Doses of Oral Live Attenuated Human Rotavirus (HRV) Vaccine for the Prophylaxis of Rotavirus Gastroenteritis
A Phase 3 study testing Live attenuated human rotavirus vaccine in people with Infections, Rotavirus, run by GlaxoSmithKline at 6 sites in South Korea.
Trial summary
Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring the hospitalization of infants and young children in developed and developing countries and can be a frequent cause of death in children less than 5 years of age (estimated nearly 500,000 annual deaths worldwide). 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
- What is being tested?
- Live attenuated human rotavirus vaccine
- Type of treatment
- Vaccines
- How many people
- 150 participants
- Where
- 6 sitesSouth Korea
- Study dates
- Jul 2005to May 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems, as established by medical history and physical examination, before entering into the study.
- Subjects for whom the vaccination history is available from vaccination diary cards or medical charts or patient diary cards.
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 first dose of study vaccine or placebo, or planned use during the study period.
- Planned administration of a vaccine (including routine paediatric vaccines) not foreseen by the study protocol during the period starting from 14 days before each dose of study vaccine(s) and ending 14 days after.
- Any clinically significant history of chronic gastrointestinal (GI) disease including any uncorrected congenital malformation of the GI tract or other serious medical condition, as determined by the investigator.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
- Major congenital defects or serious chronic illnesses such as malignant disease (e.g. melanotic neuroectodermal tumor, malignant rhabdoid tumor, etc.), serious atopic dermatitis, conditions that are the result of premature birth, etc.
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- Acute disease at time of enrolment. (Acute disease is defined as the presence of moderate or severe illness with or without fever i.e. temperature >= 37.5°C as measured by an axillary thermometer or >= 38.0°C as measured by a rectal thermometer. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.)
- GE within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
- Administration of immunoglobulins and/or blood products since birth or planned administration during the study period. Oral intake of immunoglobulins via, e.g., breastfeeding is allowed.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
- Previous confirmed occurrence of RV GE.
- Household contact with an immunosuppressed individual
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
GSK Investigational Site
Bucheon-si, 420-767
GSK Investigational Site
Daejeon
GSK Investigational Site
Jeonju, 561-712
GSK Investigational Site
Seoul, 130-702
GSK Investigational Site
Seoul, 139-711
GSK Investigational Site
Seoul
About this study
Official title: Assess the Immunogenicity, Safety & Reactogenicity of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants (6-12 Weeks of Age at First Dose) Previously Uninfected With Human Rotavirus
Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring the hospitalization of infants and young children in developed and developing countries and can be a frequent cause of death in children less than 5 years of age (estimated nearly 500,000 annual deaths worldwide). GlaxoSmithKline (GSK) Biologicals has developed a vaccine against human rotavirus gastroenteritis. This study will provide data for Korean regulatory authorities about the immunogenicity and safety of this vaccine in Korean children aged 2 months at the time of the first dose.
Read the detailed description
The study consists of two groups of children recruited in different centers in Korea. One group will receive the HRV vaccine and one group will receive the placebo. The vaccine or placebo will be administered starting at 2 months of age according to a two dose schedule (0, 2 months). The study will consist of three visits. At the first visit, one blood sample will be taken before vaccination and the first dose will be administered. At the second visit (2 months after first dose), the second vaccine will be administered. At the third visit (2 months after second dose), a blood sample will be taken. A 15-day (Day 0 - 14) follow-up period will be observed for general symptoms solicited in the study (fever, fussiness/irritability, diarrhea, vomiting, loss of appetite and cough/runny nose). A 43-day (Day 0 - 42) follow-up will be observed for other unsolicited symptoms. Serious adverse events will be followed-up throughout the study. A stool sample should be collected from the child at any point during the study if he/she develops any GE.
- Conditions
- Infections, Rotavirus
- Being tested
- Live attenuated human rotavirus vaccine
- Keywords
- Prophylaxis of Rotavirus Gastroenteritis
- Medical subject headings
- Rotavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live attenuated human rotavirus vaccineBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent who seroconverted (anti-rota serum IgA, 2 months post dose 2)
Secondary outcomes (5)
Grade 2 and 3 fever, vomiting, diarrhea, solicited symptoms
Unsolicited events
Serious adverse events (SAEs)
Presence of rota in GE tools
Concentration IgA 2 months post dose 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2005 (estimated)
- Study startJul 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants
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
- NCT00134732
- Sponsor's protocol ID
- 103478
- Status last verified
- Sep 2016
- First submitted
- 24 Aug 2005
- Last updated
- 23 Sep 2016
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assess the Immunogenicity, Safety & Reactogenicity of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine in Healthy Infants (6-12 Weeks of Age at First Dose) Previously Uninfected With Human Rotavirus
- ClinicalTrials.gov ID
- NCT00134732
- Acronym / sponsor ID
- 103478
- Conditions
- Infections, Rotavirus
- Keywords
- Prophylaxis of Rotavirus Gastroenteritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Study completion
- May 2006 (actual)
- First posted
- 25 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rotavirus (RV) is the most important cause of acute gastroenteritis (GE) requiring the hospitalization of infants and young children in developed and developing countries and can be a frequent cause of death in children less than 5 years of age (estimated nearly 500,000 annual deaths worldwide). GlaxoSmithKline (GSK) Biologicals has developed a vaccine against human rotavirus gastroenteritis. This study will provide data for Korean regulatory authorities about the immunogenicity and safety of this vaccine in Korean children aged 2 months at the time of the first dose.
Detailed description
The study consists of two groups of children recruited in different centers in Korea. One group will receive the HRV vaccine and one group will receive the placebo. The vaccine or placebo will be administered starting at 2 months of age according to a two dose schedule (0, 2 months). The study will consist of three visits. At the first visit, one blood sample will be taken before vaccination and the first dose will be administered. At the second visit (2 months after first dose), the second vaccine will be administered. At the third visit (2 months after second dose), a blood sample will be taken. A 15-day (Day 0 - 14) follow-up period will be observed for general symptoms solicited in the study (fever, fussiness/irritability, diarrhea, vomiting, loss of appetite and cough/runny nose). A 43-day (Day 0 - 42) follow-up will be observed for other unsolicited symptoms. Serious adverse events will be followed-up throughout the study. A stool sample should be collected from the child at any point during the study if he/she develops any GE.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Free of obvious health problems, as established by medical history and physical examination, before entering into the study.
- Subjects for whom the vaccination history is available from vaccination diary cards or medical charts or patient diary cards.
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 first dose of study vaccine or placebo, or planned use during the study period.
- Planned administration of a vaccine (including routine paediatric vaccines) not foreseen by the study protocol during the period starting from 14 days before each dose of study vaccine(s) and ending 14 days after.
- Any clinically significant history of chronic gastrointestinal (GI) disease including any uncorrected congenital malformation of the GI tract or other serious medical condition, as determined by the investigator.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
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 |
|---|---|---|
| Live attenuated human rotavirus vaccine | Biological | – |
Primary outcome
Percent who seroconverted (anti-rota serum IgA, 2 months post dose 2)
5 secondary outcomes
Grade 2 and 3 fever, vomiting, diarrhea, solicited symptoms
Unsolicited events
Serious adverse events (SAEs)
Presence of rota in GE tools
Concentration IgA 2 months post dose 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
- 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. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Live attenuated human rotavirus vaccine in people with Infections, Rotavirus, run by GlaxoSmithKline at 6 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 4 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 23 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent who seroconverted (anti-rota serum IgA, 2 months post dose 2). 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 23 Sep 2016.