Rotavirus GastroenteritisPhase 3ROTAVAC5CNCT04819412
To Determine the Safety and Efficacy of Liquid ROTAVAC 5C Vaccine Against Childhood Diarrhea Caused by Rotavirus
A Phase 3 study testing ROTAVAC®, ROTAVAC 5C -F1 and ROTAVAC 5C -F2 in people with Rotavirus Gastroenteritis, run by Bharat Biotech International Limited.
Trial summary
Study Rationale A single Rotavirus vaccine container with the vaccine virus and antacid buffer would be ideal for logistical, administrative and distribution ease, especially in routine immunization program. 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?
- ROTAVAC®, ROTAVAC 5C -F1 and ROTAVAC 5C -F2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,975 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2015to 30 Dec 2016
- 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
- Weight ≥2.5 kgs at birth.
- Infants received EPI vaccines (OPV, BCG and Hep B) at birth.
- Parental ability and willingness to provide informed consent.
- Parent who intends to remain in the area with the participant during the study period.
- -
Who cannot join
- Presence of diarrhoea or vomiting in the previous 72 hours or on the day of enrolment (temporary exclusion).
- Presence of fever on the day of enrolment (temporary exclusion).
- Concurrent participation in another clinical trial.
- Presence of significant malnutrition or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, immuno-logical, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the child's health or is likely to result in non-conformance to the protocol.
- History of congenital abdominal disorders, intussusception, abdominal surgery
- Known or suspected impairment of immunological function based on medical history and physical examination.
Show all 16Show fewer
- 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 vaccines.
- Major congenital or genetic defect.
- History of persistent diarrhoea (defined as diarrhoea more than 14 days).
- Participant's parents not able, available or willing to accept active follow-up by the study staff.
- Has received any immunoglobulin therapy and/or blood products since birth.
- 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/infants that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parent's/legally acceptable representative's ability to give informed consent.
About this study
Official title: A Seamless, Sequential Phase III, Randomized, Multi Center Single Blind Study to Evaluate Immunogenicity, Safety, Reactogenicity of Liquid ROTAVAC 5C Vaccine as a 3-dose Series When Compared With ROTAVAC® in Infants
Study Rationale A single Rotavirus vaccine container with the vaccine virus and antacid buffer would be ideal for logistical, administrative and distribution ease, especially in routine immunization program.
- The advantages of the liquid vaccines are: Liquid vaccines take lesser time to administer compared to the current practice of giving antacid buffer prior to vaccine which takes 40% more time to administer.
- Easier to transport as it is stable at 2-80C compared to the frozen formulation that needs to be stored at -200C and transported in dry ice.
- Chances of human error during administration are lesser than the sequential administration of antacid and vaccine.
Read the detailed description
Study Design and plan The study is designed as an adaptive, seamless sequential multicenter, single-blinded, randomized clinical trial with two phases: exploratory phase and confirmatory phase.
Exploratory phase:
- Infants of 6-8 weeks of age will randomly be assigned to receive 3 doses of two different formulations of ROTAVAC 5C (BBIL-R2014-1 \&BBILR2014-2) or ROTAVAC®. In this phase, immunogenicity and safety of the two new formulations will be compared with each other and with ROTAVAC® in the three treatment arms when administered at 4 weeks interval (+1week window). The first dose will be administered at 6-8 weeks of age. Each of the rotavirus vaccine formulations contains NLT 105fluorescent focus units (FFU)/Dose. After completion of the exploratory phase, analyses will be undertaken for selection of the most suitable formulation to undergo confirmatory phase of the study.
Confirmatory Phase:
- Infants of 6-8 weeks of age will randomly be assigned to receive 3 doses of the selected formulation of ROTAVAC 5C (3 production lots) and ROTAVAC® to evaluate lot consistency. Additionally, non-interference with immune response to antigens contained in childhood vaccines will be evaluated.
- Active surveillance will be conducted for all participants for seven days after each dose of vaccine to ascertain information on solicited adverse events.("Reactogenicity")
- Surveillance for unsolicited AEs for all participants will be conducted from the time between first dose and 4-6 weeks after the 3rd dose.
Surveillance for SAEs for all participants will be conducted from the time between first dose and 4-6 weeks after the 3rd dose
- Conditions
- Rotavirus Gastroenteritis
- Being tested
- ROTAVAC®, ROTAVAC 5C -F1, ROTAVAC 5C -F2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROTAVAC®Biological
ROTAVAC® with 5 minutes prior administration of 2.5 ml of buffer
ROTAVAC 5C -F1Biological
ROTAVAC 5C formulation BBIL-R2014-1
ROTAVAC 5C -F2Biological
ROTAVAC 5C formulation BBIL-R2014-2
| Study group | Role | What they receive |
|---|---|---|
| ROTAVAC 5C -F1 | Experimental | ROTAVAC 5C formulation BBIL-R2014-1 Receives: Biological: ROTAVAC 5C -F1 |
| ROTAVAC 5C -F2 | Experimental | ROTAVAC5C formulation BBIL-R2014-2 Receives: Biological: ROTAVAC 5C -F2 |
| ROTAVAC® | Active comparator | ROTAVAC® with 5 minutes prior administration of 2.5 ml of buffer Receives: Biological: ROTAVAC® |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the immunogenicity in terms of GMT and four-fold seroconversion
Immunogenicity
Measured: from Baseline 84 days.
Secondary outcomes (2)
Occurrence of adverse events and Serious Adverse events
safety
Measured: from base line to 84 days
Evaluation of shedding of rotavirus.
Viral shedding
Measured: Stool specimen: Day 3 and 7 after each vaccine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start20 Mar 2015
- Primary completion30 Oct 2015
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,975 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bharat Biotech International Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Georgia Institute for Clinical Research, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819412
- Sponsor's protocol ID
- BBIL/ROTA5C/III/2014
- Acronym
- ROTAVAC5C
- Status last verified
- Mar 2021
- First submitted
- 11 Jul 2020
- Last updated
- 29 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Seamless, Sequential Phase III, Randomized, Multi Center Single Blind Study to Evaluate Immunogenicity, Safety, Reactogenicity of Liquid ROTAVAC 5C Vaccine as a 3-dose Series When Compared With ROTAVAC® in Infants
- ClinicalTrials.gov ID
- NCT04819412
- Acronym / sponsor ID
- ROTAVAC5C / BBIL/ROTA5C/III/2014
- Conditions
- Rotavirus Gastroenteritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,975 participants (actual)
- Lead sponsor
- Bharat Biotech International LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Georgia Institute for Clinical Research, LLC
- Study start
- 20 Mar 2015
- Primary completion
- 30 Oct 2015 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 29 Mar 2021 (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.
Study Rationale A single Rotavirus vaccine container with the vaccine virus and antacid buffer would be ideal for logistical, administrative and distribution ease, especially in routine immunization program.
- The advantages of the liquid vaccines are: Liquid vaccines take lesser time to administer compared to the current practice of giving antacid buffer prior to vaccine which takes 40% more time to administer.
- Easier to transport as it is stable at 2-80C compared to the frozen formulation that needs to be stored at -200C and transported in dry ice.
- Chances of human error during administration are lesser than the sequential administration of antacid and vaccine.
Detailed description
Study Design and plan The study is designed as an adaptive, seamless sequential multicenter, single-blinded, randomized clinical trial with two phases: exploratory phase and confirmatory phase.
Exploratory phase:
- Infants of 6-8 weeks of age will randomly be assigned to receive 3 doses of two different formulations of ROTAVAC 5C (BBIL-R2014-1 \&BBILR2014-2) or ROTAVAC®. In this phase, immunogenicity and safety of the two new formulations will be compared with each other and with ROTAVAC® in the three treatment arms when administered at 4 weeks interval (+1week window). The first dose will be administered at 6-8 weeks of age. Each of the rotavirus vaccine formulations contains NLT 105fluorescent focus units (FFU)/Dose. After completion of the exploratory phase, analyses will be undertaken for selection of the most suitable formulation to undergo confirmatory phase of the study.
Confirmatory Phase:
- Infants of 6-8 weeks of age will randomly be assigned to receive 3 doses of the selected formulation of ROTAVAC 5C (3 production lots) and ROTAVAC® to evaluate lot consistency. Additionally, non-interference with immune response to antigens contained in childhood vaccines will be evaluated.
- Active surveillance will be conducted for all participants for seven days after each dose of vaccine to ascertain information on solicited adverse events.("Reactogenicity")
- Surveillance for unsolicited AEs for all participants will be conducted from the time between first dose and 4-6 weeks after the 3rd dose.
Surveillance for SAEs for all participants will be conducted from the time between first dose and 4-6 weeks after the 3rd dose
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ROTAVAC 5C -F1 | Experimental | Biological: ROTAVAC 5C -F1ROTAVAC 5C formulation BBIL-R2014-1 |
| ROTAVAC 5C -F2 | Experimental | Biological: ROTAVAC 5C -F2ROTAVAC5C formulation BBIL-R2014-2 |
| ROTAVAC® | Active comparator | Biological: ROTAVAC®ROTAVAC® with 5 minutes prior administration of 2.5 ml of buffer |
Who may qualify
- Ages
- 6 to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Healthy infants as established by medical history and clinical examination before entering the study.
- Age: 6-8 weeks
- Weight ≥2.5 kgs at birth.
- Infants received EPI vaccines (OPV, BCG and Hep B) at birth.
- Parental ability and willingness to provide informed consent.
Key exclusion criteria (16 listed)
- Presence of diarrhoea or vomiting in the previous 72 hours or on the day of enrolment (temporary exclusion).
- Presence of fever on the day of enrolment (temporary exclusion).
- Concurrent participation in another clinical trial.
- Presence of significant malnutrition or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, immuno-logical, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the child's health or is likely to result in non-conformance to the protocol.
- History of congenital abdominal disorders, intussusception, 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 |
|---|---|---|
| ROTAVAC®ROTAVAC® with 5 minutes prior administration of 2.5 ml of buffer | Biological | ROTAVAC® |
| ROTAVAC 5C -F1ROTAVAC 5C formulation BBIL-R2014-1 | Biological | ROTAVAC 5C -F1 |
| ROTAVAC 5C -F2ROTAVAC 5C formulation BBIL-R2014-2 | Biological | ROTAVAC 5C -F2 |
Primary outcome
To evaluate the immunogenicity in terms of GMT and four-fold seroconversion
Time frame: from Baseline 84 days.
Immunogenicity
2 secondary outcomes
Occurrence of adverse events and Serious Adverse events
Time frame: from base line to 84 days
Evaluation of shedding of rotavirus.
Time frame: Stool specimen: Day 3 and 7 after each vaccine dose
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 29 Mar 2021.
Related trials for Rotavirus Gastroenteritis
RecruitingPhase 2
PhaseⅡClinical Trial of Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells)
Rotavirus Gastroenteritis
Recruiting
Artificial Intelligence-driven Virtual Standardized Pediatric Patients Trial
Pneumococcal Pneumonia, Rotavirus Enteritis With Hypovolemic Shock
Active, not recruitingPhase 2
Safety and Immunogenicity Study of Recombinant Trivalent Rotavirus Subunit Vaccine in Healthy Infants and Toddlers
Rotavirus Infections, Rotavirus Gastroenteritis
Active, not recruitingPhase 4
Optimising Rotavirus Vaccine in Aboriginal Children
Viral Gastroenteritis Due to Rotavirus
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ROTAVAC®, ROTAVAC 5C -F1 and ROTAVAC 5C -F2 in people with Rotavirus Gastroenteritis, run by Bharat Biotech International Limited.
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 7 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 29 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
To evaluate the immunogenicity in terms of GMT and four-fold seroconversion (time frame: from Baseline 84 days.). 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 29 Mar 2021.