Rotavirus GastroenteritisPhase 2/3NCT03474055
Study on Liquid Bovine Rotavirus Pentavalent Vaccine (LBRV-PV) to Evaluate Lot-to-Lot Consistency and to Compare Non-Inferiority With ROTASIIL (Lyophilized BRV-PV) in Healthy Infants in India
A Phase 2/3 study testing Liquid Rotavirus Vaccine in people with Rotavirus Gastroenteritis, run by Serum Institute of India Pvt. Ltd. at 8 sites in India.
Trial summary
This study has been designed to compare the liquid formulation of BRV-PV (LBRV-PV) with the lyophilized formulation (ROTASIIL) by testing the vaccine in infants (three doses administered 4 weeks apart, starting at 6-8 weeks of age) in order to demonstrate the non-inferiority in the induction of specific anti-rotavirus… 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?
- Liquid Rotavirus Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 8 sitesIndia
- Study dates
- 30 Oct 2017to 25 Jun 2018
- Phase
- Phase 2/3
- 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.
- Acute disease at the time of enrollment (temporary exclusion)
- Concurrent participation in another clinical trial at any point throughout the entire time frame for this study
- History of congenital abdominal disorders, intussusception, or abdominal surgery.
- Known or suspected impairment of immunological function based on medical history and physical examination.
- 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
8 sites in 1 country.
8 sites in 1 country
India8 sites
Post Graduate Institute of Medical Education and Research, Chandigarh
Chandigarh, 160012
Sri Ramachandra Medical Centre, Chennai
Chennai, Tamil Nadu, 600116
Institute of Child Health, Kolkata
Kolkata, West Bengal, 700017
Hakeem Abdul Hameed Centenary Hospital
New Delhi, National Capital Territory of Delhi
KEM Hospital Research Centre
Pune, Maharashtra, 411028
Bharati Vidyapeeth Medical College and Hospital, Pune
Pune, Maharashtra, 411043
Centre for Vaccine Studies, Prasanna School of Public Health, Manipal University, Manipal,
Udupi, Karnataka, 576104
Department of community Medicine, Dr Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Sewagram
Wardha, Maharashtra, 442102
About this study
Official title: A Phase II/III, Multicenter, Open-Label, Randomized Study of Liquid Bovine Rotavirus Pentavalent Vaccine (LBRV-PV) to Evaluate Lot-to-Lot Consistency and to Compare Non-Inferiority With ROTASIIL (Lyophilized BRV-PV) in Healthy Infants in India
This study has been designed to compare the liquid formulation of BRV-PV (LBRV-PV) with the lyophilized formulation (ROTASIIL) by testing the vaccine in infants (three doses administered 4 weeks apart, starting at 6-8 weeks of age) in order to demonstrate the non-inferiority in the induction of specific anti-rotavirus IgA antibodies by these vaccines. The study will also evaluate lot-to-lot consistency in the manufacture of LBRV-PV by demonstrating equivalence in the induction of specific anti-rotavirus IgA antibodies across three production lots.
- Conditions
- Rotavirus Gastroenteritis
- Being tested
- Liquid Rotavirus Vaccine
- Keywords
- Liquid rotavirus vaccine, LBRV-PV, Gastroenteritis, Diarrhoea
- Medical subject headings
- Gastroenteritis, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid Rotavirus VaccineBiological
Also called ROTASIIL
Liquid Rotavirus Vaccine and Lyophilized Rotavirus Vaccine
| Study group | Role | What they receive |
|---|---|---|
| LBRV-PV Lot A | Experimental | The study participants in this arm will receive one of the three liquid rotavirus vaccine lots (LBRV-PV Lot A). Receives: Biological: Liquid Rotavirus Vaccine |
| LBRV-PV Lot B | Experimental | The study participants in this arm will receive one of the three liquid rotavirus vaccine lots (LBRV-PV Lot B). Receives: Biological: Liquid Rotavirus Vaccine |
| LBRV-PV Lot C | Experimental | The study participants in this arm will receive one of the three liquid rotavirus vaccine lots (LBRV-PV Lot C). Receives: Biological: Liquid Rotavirus Vaccine |
| ROTASIIL | Active comparator | The study participants in this arm will receive ROTASIIL, the licensed lyophilized rotavirus vaccine in India. Receives: Biological: Liquid Rotavirus Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity of rotavirus vaccine
Serum anti- rotavirus IgA antibody concentrations expressed as GMCs for the comparison of LBRV-PV vaccine and ROTASIIL
Measured: 28 days post dose 3
Secondary outcomes (2)
Immunogenicity Endpoints
GMCs of serum anti- rotavirus IgA antibody among the LBRV-PV lots at four weeks after the third vaccination.
Measured: 28 days post dose 3
Immunogenicity Endpoints
Proportion of subjects achieving IgA antibody concentration ≥20 U/ml for the comparison of LBRV-PV and ROTASIIL.
Measured: 28 days post dose 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start30 Oct 2017
- Primary completion25 Jun 2018
- Study completion25 Jun 2018
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 2/3
- Primary purpose
- Treatment
- 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)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474055
- Sponsor's protocol ID
- ROTA:06
- Status last verified
- Sep 2018
- First submitted
- 11 Feb 2018
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kawade A, Babji S, Kamath V, Raut A, Kumar CM, Kundu R, Venkatramanan P, Lalwani SK, Bavdekar A, Juvekar S, Dayma G, Patil R, Kulkarni M, Hegde A, Nayak D, Garg BS, Gupta S, Jategaonkar S, Bedi N, Maliye C, Ganguly N, Uttam KG, Niyogi P, Palkar S, Hanumante N, Goyal N, Arya A, Aslam M, Parulekar V, Dharmadhikari A, Gaikwad D, Zade J, Desai S, Kang G, Kulkarni PS. Immunogenicity and lot-to-lot consistency of a ready to use liquid bovine-human reassortant pentavalent rotavirus vaccine (ROTASIIL - Liquid) in Indian infants. Vaccine. 2019 May 1;37(19):2554-2560. doi: 10.1016/j.vaccine.2019.03.067. Epub 2019 Apr 4.
PubMed 30955982
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
- A Phase II/III, Multicenter, Open-Label, Randomized Study of Liquid Bovine Rotavirus Pentavalent Vaccine (LBRV-PV) to Evaluate Lot-to-Lot Consistency and to Compare Non-Inferiority With ROTASIIL (Lyophilized BRV-PV) in Healthy Infants in India
- ClinicalTrials.gov ID
- NCT03474055
- Acronym / sponsor ID
- ROTA:06
- Conditions
- Rotavirus Gastroenteritis
- Keywords
- Liquid rotavirus vaccine, LBRV-PV, Gastroenteritis, Diarrhoea
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Serum Institute of India Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 25 Jun 2018 (actual)
- Study completion
- 25 Jun 2018 (actual)
- First posted
- 22 Mar 2018 (actual)
- 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 study has been designed to compare the liquid formulation of BRV-PV (LBRV-PV) with the lyophilized formulation (ROTASIIL) by testing the vaccine in infants (three doses administered 4 weeks apart, starting at 6-8 weeks of age) in order to demonstrate the non-inferiority in the induction of specific anti-rotavirus IgA antibodies by these vaccines. The study will also evaluate lot-to-lot consistency in the manufacture of LBRV-PV by demonstrating equivalence in the induction of specific anti-rotavirus IgA antibodies across three production lots.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LBRV-PV Lot A | Experimental | Biological: Liquid Rotavirus VaccineThe study participants in this arm will receive one of the three liquid rotavirus vaccine lots (LBRV-PV Lot A). |
| LBRV-PV Lot B | Experimental | Biological: Liquid Rotavirus VaccineThe study participants in this arm will receive one of the three liquid rotavirus vaccine lots (LBRV-PV Lot B). |
| LBRV-PV Lot C | Experimental | Biological: Liquid Rotavirus VaccineThe study participants in this arm will receive one of the three liquid rotavirus vaccine lots (LBRV-PV Lot C). |
| ROTASIIL | Active comparator | Biological: Liquid Rotavirus VaccineThe study participants in this arm will receive ROTASIIL, the licensed lyophilized rotavirus vaccine in India. |
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 (7 listed)
- Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment.
- Acute disease at the time of enrollment (temporary exclusion)
- Concurrent participation in another clinical trial at any point throughout the entire time frame for this study
- History of congenital abdominal disorders, intussusception, or abdominal surgery.
- Known or suspected impairment of immunological function 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 |
|---|---|---|
| Liquid Rotavirus VaccineAlso: ROTASIILLiquid Rotavirus Vaccine and Lyophilized Rotavirus Vaccine | Biological | LBRV-PV Lot A, LBRV-PV Lot B, LBRV-PV Lot C, ROTASIIL |
Primary outcome
Immunogenicity of rotavirus vaccine
Time frame: 28 days post dose 3
Serum anti- rotavirus IgA antibody concentrations expressed as GMCs for the comparison of LBRV-PV vaccine and ROTASIIL
2 secondary outcomes
Immunogenicity Endpoints
Time frame: 28 days post dose 3
Immunogenicity Endpoints
Time frame: 28 days post dose 3
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.
- Derived from this study: PubMed 30955982Kawade A, Babji S, Kamath V, Raut A, Kumar CM, Kundu R, Venkatramanan P, Lalwani SK, Bavdekar A, Juvekar S, Dayma G, Patil R, Kulkarni M, Hegde A, Nayak D, Garg BS, Gupta S, Jategaonkar S, Bedi N, Maliye C, Ganguly N, Uttam KG, Niyogi P, Palkar S, Hanumante N, Goyal N, Arya A, Aslam M, Parulekar V, Dharmadhikari A, Gaikwad D, Zade J, Desai S, Kang G, Kulkarni PS. Immunogenicity and lot-to-lot consistency of a ready to use liquid bovine-human reassortant pentavalent rotavirus vaccine (ROTASIIL - Liquid) in Indian infants. Vaccine. 2019 May 1;37(19):2554-2560. doi: 10.1016/j.vaccine.2019.03.067. Epub 2019 Apr 4.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Liquid Rotavirus Vaccine in people with Rotavirus Gastroenteritis, run by Serum Institute of India Pvt. Ltd. at 8 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 7 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 8 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Immunogenicity of rotavirus vaccine (time frame: 28 days post dose 3). 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 NCT03474055, 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.