Infections, RotavirusPhase 3NCT00289172
Assess the Immunogenicity & Safety of 2 Doses of Oral Live Attenuated Human Rota(HRV)Vaccine in Healthy Infants in India
A Phase 3 study testing Live attenuated human rotavirus vaccine in people with Infections, Rotavirus, run by GlaxoSmithKline at 4 sites in India.
Trial summary
Rotavirus disease is the most common cause of gastroenteritis and dehydration in young children worldwide. The global public health burden has prompted the development of a human rotavirus vaccine against rotavirus disease by GlaxoSmithKline Biologicals. Read more about this study
- Who is it for?
- Ages 8 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
- 360 participants
- Where
- 4 sitesIndia
- Study dates
- 10 Feb 2006to 8 Sep 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 8 to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
None listed.
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine or the routine UIP vaccines within 30 days preceding the first 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. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
- Any chronic drug therapy to be continued during the study period.
- Administration of a vaccine not foreseen by the study protocol within 6 weeks of the first dose of vaccine or planned administration during the study of a vaccine not foreseen by the study protocol, with the exception of diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib), OPV and vaccination against tuberculosis, which can be given with at least two weeks separation from the first and subsequent dose of the study vaccine.
- Prior administration of experimental rotavirus vaccine.
- History of confirmed rotavirus gastroenteritis.
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- Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection based on physical examination (no laboratory testing is required).
- A family history of congenital or hereditary immunodeficiency.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Gastroenteritis (diarrhea) within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or medical history.
- Administration of immunoglobulins and/or blood products since birth or planned administration during the study period. Oral intake of immunoglobulins via breastfeeding is allowed.
Trial locations and contacts
4 sites in 1 country.
India4 sites
GSK Investigational Site
Chandigarth, Oin-160 012
GSK Investigational Site
Kolkata, 700010
GSK Investigational Site
Pune, 411 011
GSK Investigational Site
Vellore, 632002
About this study
Official title: A Multicenter Study of the Immunogenicity & Safety of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine (RIX4414) as Primary Dosing of Healthy Infants in India Aged Approximately 8 Wks at the Time of the First Dose
Rotavirus disease is the most common cause of gastroenteritis and dehydration in young children worldwide. The global public health burden has prompted the development of a human rotavirus vaccine against rotavirus disease by GlaxoSmithKline Biologicals. This pre-registration study is undertaken to provide immunogenicity, reactogenicity and safety data for the vaccine when used in Indian infants aged approximately 8 weeks at the time of the first dose.
Read the detailed description
The study consists of two groups of children to be recruited in different centers in India. One group will receive the HRV vaccine and one group will receive the placebo. The vaccine or placebo will be administered starting at 8-12 weeks of age, according to a two dose schedule (0, 1 months schedule). The study will consist of three visits. A 8-day (Day 0 - 7) follow-up period will be observed for general symptoms solicited in the study. A 31-day (Day 0 - 30) follow-up will be observed for other unsolicited symptoms. Serious adverse events (SAEs) will be followed-up throughout the study. A stool sample will 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
- 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.
Percentage of seroconversion (anti-rota serum IgA) in children, after two doses of HRV vaccine versus two doses of placebo.
Secondary outcomes (1)
Fever, vomiting, diarrhea. Solicited symptoms. Unsolicited events. SAEs. Presence of rotavirus in GE stools.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2006 (estimated)
- Study start10 Feb 2006
- Study completion8 Sep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 360 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
- NCT00289172
- Sponsor's protocol ID
- 103792
- Status last verified
- May 2017
- First submitted
- 8 Feb 2006
- Last updated
- 30 May 2017
- 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.
Publications
Bhattacharya SK et al. Immune response in infants sero-positive at pre-vaccination human rotavirus vaccine Rotarix™. Poster presented at WSPID, Bangkok, Thailand,15-18 November 2007
Bose et al. Safety and immunogenicity of RIX4414 (Rotarix TM) live-attenuated human rotavirus vaccine in Indian infants. Poster presented at WSPID, Bangkok, Thailand, 15-18 November 2007.
Narang A, Bose A, Pandit AN, Dutta P, Kang G, Bhattacharya SK, Datta SK, Suryakiran PV, Delem A, Han HH, Bock HL. Immunogenicity, reactogenicity and safety of human rotavirus vaccine (RIX4414) in Indian infants. Hum Vaccin. 2009 Jun;5(6):414-9. doi: 10.4161/hv.5.6.8176. Epub 2009 Jun 15.
PubMed 19276664
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study of the Immunogenicity & Safety of 2 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine (RIX4414) as Primary Dosing of Healthy Infants in India Aged Approximately 8 Wks at the Time of the First Dose
- ClinicalTrials.gov ID
- NCT00289172
- Acronym / sponsor ID
- 103792
- Conditions
- Infections, Rotavirus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2006
- Study completion
- 8 Sep 2006 (actual)
- First posted
- 9 Feb 2006 (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 disease is the most common cause of gastroenteritis and dehydration in young children worldwide. The global public health burden has prompted the development of a human rotavirus vaccine against rotavirus disease by GlaxoSmithKline Biologicals. This pre-registration study is undertaken to provide immunogenicity, reactogenicity and safety data for the vaccine when used in Indian infants aged approximately 8 weeks at the time of the first dose.
Detailed description
The study consists of two groups of children to be recruited in different centers in India. One group will receive the HRV vaccine and one group will receive the placebo. The vaccine or placebo will be administered starting at 8-12 weeks of age, according to a two dose schedule (0, 1 months schedule). The study will consist of three visits. A 8-day (Day 0 - 7) follow-up period will be observed for general symptoms solicited in the study. A 31-day (Day 0 - 30) follow-up will be observed for other unsolicited symptoms. Serious adverse events (SAEs) will be followed-up throughout the study. A stool sample will 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
Who may qualify
- Ages
- 8 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (16 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine or the routine UIP vaccines within 30 days preceding the first 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. (For corticosteroids, this will mean prednisone, or equivalent, >= 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
- Any chronic drug therapy to be continued during the study period.
- Administration of a vaccine not foreseen by the study protocol within 6 weeks of the first dose of vaccine or planned administration during the study of a vaccine not foreseen by the study protocol, with the exception of diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib), OPV and vaccination against tuberculosis, which can be given with at least two weeks separation from the first and subsequent dose of the study vaccine.
- Prior administration of experimental rotavirus vaccine.
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
Percentage of seroconversion (anti-rota serum IgA) in children, after two doses of HRV vaccine versus two doses of placebo.
1 secondary outcome
Fever, vomiting, diarrhea. Solicited symptoms. Unsolicited events. SAEs. Presence of rotavirus in GE stools.
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 30 May 2017.
- BackgroundBhattacharya SK et al. Immune response in infants sero-positive at pre-vaccination human rotavirus vaccine Rotarix™. Poster presented at WSPID, Bangkok, Thailand,15-18 November 2007
- BackgroundBose et al. Safety and immunogenicity of RIX4414 (Rotarix TM) live-attenuated human rotavirus vaccine in Indian infants. Poster presented at WSPID, Bangkok, Thailand, 15-18 November 2007.
- Background: PubMed 19276664Narang A, Bose A, Pandit AN, Dutta P, Kang G, Bhattacharya SK, Datta SK, Suryakiran PV, Delem A, Han HH, Bock HL. Immunogenicity, reactogenicity and safety of human rotavirus vaccine (RIX4414) in Indian infants. Hum Vaccin. 2009 Jun;5(6):414-9. doi: 10.4161/hv.5.6.8176. Epub 2009 Jun 15.
- 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
4 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 4 sites in India.
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 0 inclusion and 16 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India. 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?
Percentage of seroconversion (anti-rota serum IgA) in children, after two doses of HRV vaccine versus two doses of placebo.. 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 NCT00289172, 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 30 May 2017.