Rotavirus GastroenteritisPhase 3NCT02584816
Phase III Study on Rotavirus Vaccine to Evaluate Lot-to-lot Consistency and Interference With Routine UIP Immunization
A Phase 3 study testing BRV-PV Lot A + DPT-HepB-Hib + OPV, BRV-PV Lot B + DPT-HepB-Hib + OPV and BRV-PV Lot C + DPT-HepB-Hib + OPV in people with Rotavirus Gastroenteritis, run by Serum Institute of India Pvt. Ltd. at 10 sites in India.
Trial summary
This is a Phase 3, open-label, randomized study to evaluate lot-to-lot consistency in the manufacture of Bovine Rotavirus Pentavalent Vaccine (BRV-PV). 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?
- BRV-PV Lot A + DPT-HepB-Hib + OPV, BRV-PV Lot B + DPT-HepB-Hib + OPV and BRV-PV Lot C + DPT-HepB-Hib + OPV
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 10 sitesIndia
- Study dates
- Nov 2015to Jun 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 written informed consent.
- Parent who intends to remain in the area with the child during the study period.
- Receipt of birth dose of Hepatitis B vaccine and OPV.
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 at any point throughout the entire timeframe for this study.
- Presence of significant malnutrition or any systemic disorder 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.
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- Known or suspected impairment of immunological function based on medical history and physical examination.
- Household contact with an immunosuppressed individual or pregnant woman.
- Prior receipt or intent to receive rotavirus and / or diphtheria, tetanus, pertussis, Haemophilus Influenzae type b, Hepatitis B vaccine (other than birth dose) or inactivated polio vaccine (IPV) during the study period and outside of the study. OPV dose received during national / subnational immunization days will be allowed.
- A known sensitivity or allergy to any components of the study vaccine.
- Clinically detectable congenital or genetic defect.
- History of persistent diarrhea (defined as diarrhea that lasts 14 days or longer).
- Receipt of 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 written informed consent.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
India10 sites
Sri Ramachandra Medical Centre
Chennai, Tamil Nadu, 600116
Gandhi Medical College and Gandhi Hospital
Hyderabad, Andhra Pradesh, 500020
Institute of Child Health
Kolkata, West Bengal, 700017
T. N. Medical College and B. Y. L. Nair Charitable
Mumbai, Maharashtra, 400008
Seth G S Medical College & KEM Hospital
Mumbai, Maharashtra, 400012
JSS Medical College and Hospital
Mysore, Karnataka, 570004
Maulana Azad Medical College
New Delhi
Bharati Vidyapeeth Medical College and Hospital
Pune, Maharashtra, 411043
KEM Hospital and Research Centre, Vadu
Pune, Maharashtra, 412216
King George Hospital
Visakhapatnam, Andhra Pradesh, 530002
About this study
Official title: A Phase III, Multicenter, Open Label, Randomized Study of Bovine Rotavirus Pentavalent Vaccine (BRV-PV) to Evaluate Lot-To-Lot Consistency and to Investigate Potential Interference With Routine UIP Vaccinations in Healthy Infants in India.
This is a Phase 3, open-label, randomized study to evaluate lot-to-lot consistency in the manufacture of Bovine Rotavirus Pentavalent Vaccine (BRV-PV).
Read the detailed description
The study is designed to evaluate lot-to-lot consistency in the manufacturing of Rotavirus vaccine by testing the vaccine in infants in order to demonstrate equivalence in the induction of specific anti-rotavirus IgA antibodies across three production lots. The study will also examine the potential interference of vaccine with UIP vaccines that will be administered concurrently by assessing non-inferiority in the immune responses to those vaccines when administered with / without the study vaccine.
- Conditions
- Rotavirus Gastroenteritis
- Being tested
- BRV-PV Lot A + DPT-HepB-Hib + OPV, BRV-PV Lot B + DPT-HepB-Hib + OPV, BRV-PV Lot C + DPT-HepB-Hib + OPV, ROTARIX + DPT-HepB-Hib + OPV
- Keywords
- BRV-PV, Rotavirus vaccine, lot-to-lot consistency, interference with routine immunization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRV-PV Lot A + DPT-HepB-Hib + OPVBiological
Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week
BRV-PV Lot B + DPT-HepB-Hib + OPVBiological
Also called Live Attenuated human-bovine reassortant pentavalent rotavirus vaccine
Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week
BRV-PV Lot C + DPT-HepB-Hib + OPVBiological
Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week
ROTARIX + DPT-HepB-Hib + OPVBiological
Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week (Third dose-Placebo)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - BRV-PV Lot A | Experimental | BRV-PV Lot A + DPT- HepB-Hib + OPV Receives: Biological: BRV-PV Lot A + DPT-HepB-Hib + OPV |
| Group 2 - BRV-PV Lot B | Experimental | BRV-PV Lot B+ DPT- HepB-Hib + OPV Receives: Biological: BRV-PV Lot B + DPT-HepB-Hib + OPV |
| Group 3 - BRV-PV Lot C | Experimental | BRV-PV Lot C + DPT- HepB-Hib + OPV Receives: Biological: BRV-PV Lot C + DPT-HepB-Hib + OPV |
| Group 4 - ROTARIX | Active comparator | ROTARIX + DPT-HepB-Hib + OPV Receives: Biological: ROTARIX + DPT-HepB-Hib + OPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotavirus vaccine lots Immunogenicity
Serum anti- rotavirus IgA antibody concentrations expressed as GMCs for the BRV-PV to demonstrate equivalence in lot consistency among three lots.
Measured: Four weeks after the third dose of vaccination
Immunogenicity of UIP vaccines
Measured: Four weeks after the third dose of vaccination
Secondary outcomes (2)
Immediate adverse events and Solicited post -vaccination reactogenicity
Measured: AEs within 30 minutes post-vaccination and post vacc reactogenicity during 7 days after each vaccination
Rotavirus Immunogenicity:
Serum anti- rotavirus IgA antibody concentrations expressed as GMCs and proportion of subjects with post-vaccination IgA antibody concentration ≥20 U/ml for the comparison of BRV-PV vaccine and licensed rotavirus vaccine.
Measured: Four weeks after the third dose of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionApr 2017
- Study completionJun 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
- None (open label)
- Enrolment
- 1,500 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
- Dr Prasad Kulkarni, M.D., Study director, Serum Institute of India Pvt. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584816
- Sponsor's protocol ID
- ROTA: 04 / VAC-020
- Status last verified
- Sep 2018
- First submitted
- 6 Oct 2015
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Desai S, Rathi N, Kawade A, Venkatramanan P, Kundu R, Lalwani SK, Dubey AP, Venkateswara Rao J, Narayanappa D, Ghildiyal R, Gogtay NJ, Venugopal P, Palkar S, Munshi R, Bavdekar A, Juvekar S, Ganguly N, Niyogi P, Uttam KG, Kondekar A, Kumbhar D, Mohanlal S, Agarwal MC, Shetty P, Antony K, Gunale B, Dharmadhikari A, Deshpande J, Nalavade U, Sharma D, Bansal A, Tang Y, Flores J, Kulkarni PS. Non-interference of Bovine-Human reassortant pentavalent rotavirus vaccine ROTASIIL(R) with the immunogenicity of infant vaccines in comparison with a licensed rotavirus vaccine. Vaccine. 2018 Sep 5;36(37):5519-5523. doi: 10.1016/j.vaccine.2018.07.064. Epub 2018 Aug 10.
PubMed 30104114
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Open Label, Randomized Study of Bovine Rotavirus Pentavalent Vaccine (BRV-PV) to Evaluate Lot-To-Lot Consistency and to Investigate Potential Interference With Routine UIP Vaccinations in Healthy Infants in India.
- ClinicalTrials.gov ID
- NCT02584816
- Acronym / sponsor ID
- ROTA: 04 / VAC-020
- Conditions
- Rotavirus Gastroenteritis
- Keywords
- BRV-PV, Rotavirus vaccine, lot-to-lot consistency, interference with routine immunization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Serum Institute of India Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- PATH
- Study start
- Nov 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 23 Oct 2015 (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, open-label, randomized study to evaluate lot-to-lot consistency in the manufacture of Bovine Rotavirus Pentavalent Vaccine (BRV-PV).
Detailed description
The study is designed to evaluate lot-to-lot consistency in the manufacturing of Rotavirus vaccine by testing the vaccine in infants in order to demonstrate equivalence in the induction of specific anti-rotavirus IgA antibodies across three production lots. The study will also examine the potential interference of vaccine with UIP vaccines that will be administered concurrently by assessing non-inferiority in the immune responses to those vaccines when administered with / without the study vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 - BRV-PV Lot A | Experimental | Biological: BRV-PV Lot A + DPT-HepB-Hib + OPVBRV-PV Lot A + DPT- HepB-Hib + OPV |
| Group 2 - BRV-PV Lot B | Experimental | Biological: BRV-PV Lot B + DPT-HepB-Hib + OPVBRV-PV Lot B+ DPT- HepB-Hib + OPV |
| Group 3 - BRV-PV Lot C | Experimental | Biological: BRV-PV Lot C + DPT-HepB-Hib + OPVBRV-PV Lot C + DPT- HepB-Hib + OPV |
| Group 4 - ROTARIX | Active comparator | Biological: ROTARIX + DPT-HepB-Hib + OPVROTARIX + DPT-HepB-Hib + OPV |
Who may qualify
- Ages
- 6 to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 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 written informed consent.
- Parent who intends to remain in the area with the child during the study period.
- Receipt of birth dose of Hepatitis B vaccine and OPV.
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 at any point throughout the entire timeframe for this study.
- Presence of significant malnutrition or any systemic disorder 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.
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 |
|---|---|---|
| BRV-PV Lot A + DPT-HepB-Hib + OPVDose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week | Biological | Group 1 - BRV-PV Lot A |
| BRV-PV Lot B + DPT-HepB-Hib + OPVAlso: Live Attenuated human-bovine reassortant pentavalent rotavirus vaccineDose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week | Biological | Group 2 - BRV-PV Lot B |
| BRV-PV Lot C + DPT-HepB-Hib + OPVDose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week | Biological | Group 3 - BRV-PV Lot C |
| ROTARIX + DPT-HepB-Hib + OPVDose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week (Third dose-Placebo) | Biological | Group 4 - ROTARIX |
Primary outcome
Rotavirus vaccine lots Immunogenicity
Time frame: Four weeks after the third dose of vaccination
Serum anti- rotavirus IgA antibody concentrations expressed as GMCs for the BRV-PV to demonstrate equivalence in lot consistency among three lots.
Immunogenicity of UIP vaccines
Time frame: Four weeks after the third dose of vaccination
2 secondary outcomes
Immediate adverse events and Solicited post -vaccination reactogenicity
Time frame: AEs within 30 minutes post-vaccination and post vacc reactogenicity during 7 days after each vaccination
Rotavirus Immunogenicity:
Time frame: Four weeks after the third dose of vaccination
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 11 Sep 2018.
- Results publication: PubMed 30104114Desai S, Rathi N, Kawade A, Venkatramanan P, Kundu R, Lalwani SK, Dubey AP, Venkateswara Rao J, Narayanappa D, Ghildiyal R, Gogtay NJ, Venugopal P, Palkar S, Munshi R, Bavdekar A, Juvekar S, Ganguly N, Niyogi P, Uttam KG, Kondekar A, Kumbhar D, Mohanlal S, Agarwal MC, Shetty P, Antony K, Gunale B, Dharmadhikari A, Deshpande J, Nalavade U, Sharma D, Bansal A, Tang Y, Flores J, Kulkarni PS. Non-interference of Bovine-Human reassortant pentavalent rotavirus vaccine ROTASIIL(R) with the immunogenicity of infant vaccines in comparison with a licensed rotavirus vaccine. Vaccine. 2018 Sep 5;36(37):5519-5523. doi: 10.1016/j.vaccine.2018.07.064. Epub 2018 Aug 10.
- 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.
Dr Prasad Kulkarni, M.D. study director
Serum Institute of India Pvt. Ltd.
10 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 BRV-PV Lot A + DPT-HepB-Hib + OPV, BRV-PV Lot B + DPT-HepB-Hib + OPV and BRV-PV Lot C + DPT-HepB-Hib + OPV in people with Rotavirus Gastroenteritis, run by Serum Institute of India Pvt. Ltd. at 10 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 5 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 11 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 10 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?
Rotavirus vaccine lots Immunogenicity (time frame: Four weeks after the third dose of vaccination). The study lists 2 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 NCT02584816, 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 11 Sep 2018; AzTrials last refreshed its copy on 6 Nov 2026.