Rotavirus GastroenteritisPhase 3NCT02133690
A Clinical Trial to Study the Effect and Safety of Rotavirus Vaccine Against Severe Rotavirus Gastroenteritis in Healthy Indian Infants
A Phase 3 study testing Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV) in people with Rotavirus Gastroenteritis, run by Serum Institute of India Pvt. Ltd. at 6 sites in India.
Trial summary
This is a Phase 3 multicentre, randomized, double blind, placebo-controlled study to determine the effectiveness of the rotavirus vaccine. Read more about this study
- Who is it for?
- Ages 6 to 8 weeksHealthy volunteers can take part
- Conditions the study is for
- Rotavirus Gastroenteritis
- What is being tested?
- Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7,500 participants
- Where
- 6 sitesIndia
- Study dates
- May 2014to Mar 2017
- 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 8 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants as established by medical history and clinical examination before entering the study.
- Age: 6-8 weeks at the time of enrollment.
- Parental ability and willingness to provide informed consent.
- Parent who intends to remain in the area with the child during the study period.
Who cannot join
- Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion)
- Presence of fever on the day of enrollment (temporary exclusion).
- Acute disease at the time of enrollment (temporary exclusion)
- Concurrent participation in another clinical trial throughout the entire timeframe for this study.
- Presence of significant malnutrition (weight-for-height z-score <-3SD median) or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the subject's health or is likely to result in nonconformance to the protocol. History of congenital abdominal disorders, intussusception or abdominal surgery
- Known or suspected impairment of immunological function based on medical history and physical examination.
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- Household contact with an immunosuppressed individual or pregnant woman.
- Prior receipt of rotavirus vaccine.
- A known sensitivity or allergy to any components of the study vaccine.
- Major congenital or genetic defect.
- History of persistent diarrhea (defined as diarrhea more than 14 days).
- Participant's parents not able, available or willing to accept active weekly follow-up by the study staff.
- Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period.
- History of chronic administration (defined as more than 14 days) of immunosuppressants including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study.
- History of any neurologic disorders or seizures.
- Any medical condition in the parents/infant which, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parents' ability to give informed consent.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
India6 sites
Dr Dinesh Kumar Government Medical College, Jammu Department of Community Medicine, Government Medical College
Jammu, Jammu and Kashmir
National Institute of Cholera & Enteric Diseases
Kolkata, West Bengal
Kasturba Medical College, Manipal
Manipal, Karnataka
Center for Health Research and Development (CHRD) -Society for applied studies (SAS)
New Delhi, National Capital Territory of Delhi
KEM Hospital and Research Centre
Pune, Maharashtra
Dr. Sushila Nayar School of Public Health ,Mahatma Ghandi School of Medicine
Sewāgrām, Maharashtra
About this study
Official title: Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Live Attenuated Bovine-Human Rotavirus Reassortant Pentavalent Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis in Healthy Indian Infants
This is a Phase 3 multicentre, randomized, double blind, placebo-controlled study to determine the effectiveness of the rotavirus vaccine.
Read the detailed description
The hypothesis is that a three dose series of BRV-PV administered orally to healthy Indian infants, with the initial dose given at 6-8 weeks of age and followed by vaccinations at monthly intervals, will significantly reduce the incidence of severe rotavirus gastroenteritis (SRVGE). Duration of follow-up is until aged 2 years of each enrolled child. The study is powered to detect vaccine efficacy significantly greater than 10% (95% confidence interval lower bound > 10%) if the true vaccine efficacy is 50% or higher.
- Conditions
- Rotavirus Gastroenteritis
- Being tested
- Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV), Placebo
- Keywords
- rotavirus, rotavirus vaccine, BRV-PV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV)Biological
Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV), at a dosage of ≥ Log10^5.6 fluorescent focus units (FFU)/Serotype/Dose in 2.5 ml of buffered diluent
PlaceboOther
Lyophilized minimal essential medium (MEM) + excipients reconstituted in 2.5 ml of buffered diluents
| Study group | Role | What they receive |
|---|---|---|
| Vaccine Arm | Experimental | 3 doses, 4 weeks apart, of Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV), at a dosage of ≥ Log10^5.6 fluorescent focus units (FFU)/Serotype/Dose in 2.5 ml of buffered diluent Receives: Biological: Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV) |
| Placebo group | Placebo comparator | 3 doses, 4 weeks apart, of Lyophilized minimal essential medium (MEM) + excipients reconstituted in 2.5 ml of buffered diluents Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of Severe Rotavirus Gastroenteritis
Laboratory confirmed cases of severe rotavirus gastroenteritis occurring in infants receiving the complete vaccination regimen occurring from 14 days after the third vaccine dose until 122 cases are accrued, or until all participating infants reach two years of age (per protocol analysis).
Measured: Up to 2 years of age of participants
Secondary outcomes (1)
Safety
Occurrence of SAE
- Solicited post-vaccination reactions
- SAEs
- Severe AEs
- Unsolicited AEs
- Intussusception
- Death
Measured: Until completion of 2 years age of participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startMay 2014
- Primary completionMar 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotavirus GastroenteritisStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serum Institute of India Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PATH
- Responsible party
- Sponsor
- Investigators
- Prasad Kulkarni, MD, Study director, Serum Institute of India Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02133690
- Sponsor's protocol ID
- ROTA:03/12
- Status last verified
- Sep 2018
- First submitted
- 6 May 2014
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kulkarni PS, Desai S, Tewari T, Kawade A, Goyal N, Garg BS, Kumar D, Kanungo S, Kamat V, Kang G, Bavdekar A, Babji S, Juvekar S, Manna B, Dutta S, Angurana R, Dewan D, Dharmadhikari A, Zade JK, Dhere RM, Fix A, Power M, Uprety V, Parulekar V, Cho I, Chandola TR, Kedia VK, Raut A, Flores J; SII BRV-PV author group. A randomized Phase III clinical trial to assess the efficacy of a bovine-human reassortant pentavalent rotavirus vaccine in Indian infants. Vaccine. 2017 Oct 27;35(45):6228-6237. doi: 10.1016/j.vaccine.2017.09.014. Epub 2017 Sep 26.
PubMed 28967523
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Live Attenuated Bovine-Human Rotavirus Reassortant Pentavalent Vaccine (BRV-PV) Against Severe Rotavirus Gastroenteritis in Healthy Indian Infants
- ClinicalTrials.gov ID
- NCT02133690
- Acronym / sponsor ID
- ROTA:03/12
- Conditions
- Rotavirus Gastroenteritis
- Keywords
- rotavirus, rotavirus vaccine, BRV-PV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,500 participants (actual)
- Lead sponsor
- Serum Institute of India Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- PATH
- Study start
- May 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 8 May 2014 (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.
This is a Phase 3 multicentre, randomized, double blind, placebo-controlled study to determine the effectiveness of the rotavirus vaccine.
Detailed description
The hypothesis is that a three dose series of BRV-PV administered orally to healthy Indian infants, with the initial dose given at 6-8 weeks of age and followed by vaccinations at monthly intervals, will significantly reduce the incidence of severe rotavirus gastroenteritis (SRVGE). Duration of follow-up is until aged 2 years of each enrolled child. The study is powered to detect vaccine efficacy significantly greater than 10% (95% confidence interval lower bound > 10%) if the true vaccine efficacy is 50% or higher.
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 |
|---|---|---|
| Vaccine Arm | Experimental | Biological: Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV)3 doses, 4 weeks apart, of Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV), at a dosage of ≥ Log10^5.6 fluorescent focus units (FFU)/Serotype/Dose in 2.5 ml of buffered diluent |
| Placebo group | Placebo comparator | Other: Placebo3 doses, 4 weeks apart, of Lyophilized minimal essential medium (MEM) + excipients reconstituted in 2.5 ml of buffered diluents |
Who may qualify
- Ages
- 6 to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy infants as established by medical history and clinical examination before entering the study.
- Age: 6-8 weeks at the time of enrollment.
- Parental ability and willingness to provide informed consent.
- Parent who intends to remain in the area with the child during the study period.
Key exclusion criteria (16 listed)
- Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion)
- Presence of fever on the day of enrollment (temporary exclusion).
- Acute disease at the time of enrollment (temporary exclusion)
- Concurrent participation in another clinical trial throughout the entire timeframe for this study.
- Presence of significant malnutrition (weight-for-height z-score <-3SD median) or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the subject's health or is likely to result in nonconformance to the protocol. History of congenital abdominal disorders, intussusception or abdominal surgery
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 Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV)Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV), at a dosage of ≥ Log10^5.6 fluorescent focus units (FFU)/Serotype/Dose in 2.5 ml of buffered diluent | Biological | Vaccine Arm |
| PlaceboLyophilized minimal essential medium (MEM) + excipients reconstituted in 2.5 ml of buffered diluents | Other | Placebo group |
Primary outcome
occurrence of Severe Rotavirus Gastroenteritis
Time frame: Up to 2 years of age of participants
Laboratory confirmed cases of severe rotavirus gastroenteritis occurring in infants receiving the complete vaccination regimen occurring from 14 days after the third vaccine dose until 122 cases are accrued, or until all participating infants reach two years of age (per protocol analysis).
1 secondary outcome
Safety
Time frame: Until completion of 2 years age of participant
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 10 Sep 2018.
- Results publication: PubMed 28967523Kulkarni PS, Desai S, Tewari T, Kawade A, Goyal N, Garg BS, Kumar D, Kanungo S, Kamat V, Kang G, Bavdekar A, Babji S, Juvekar S, Manna B, Dutta S, Angurana R, Dewan D, Dharmadhikari A, Zade JK, Dhere RM, Fix A, Power M, Uprety V, Parulekar V, Cho I, Chandola TR, Kedia VK, Raut A, Flores J; SII BRV-PV author group. A randomized Phase III clinical trial to assess the efficacy of a bovine-human reassortant pentavalent rotavirus vaccine in Indian infants. Vaccine. 2017 Oct 27;35(45):6228-6237. doi: 10.1016/j.vaccine.2017.09.014. Epub 2017 Sep 26.
- Related InfoLink provided by the sponsor.
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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.
Prasad Kulkarni, MD study director
Serum Institute of India Pvt. Ltd.
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 Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV) in people with Rotavirus Gastroenteritis, run by Serum Institute of India Pvt. Ltd. at 6 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 4 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 10 Sep 2018. 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 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. 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 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?
occurrence of Severe Rotavirus Gastroenteritis (time frame: Up to 2 years of age of participants). 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 NCT02133690, 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 10 Sep 2018.