Rotavirus GastroenteritisPhase 3NCT04596696
Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac in Healthy Infants in Vietnam
A Phase 3 study testing Rotavac in people with Rotavirus Gastroenteritis, run by Bharat Biotech International Limited at 1 site in Vietnam.
Trial summary
An open label study to evaluate immunogenicity, safety, and reactogenicity of Rotavac® (live attenuated oral rotavirus vaccine) as a 3-dose series in healthy infants aged between 6 weeks and 8 weeks in Vietnam 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
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteVietnam
- Study dates
- 20 Dec 2017to 30 Jun 2019
- 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
- Age: 6-8 weeks
- Weight ≥2.5kgs at birth
- Infants receiving EPI vaccines as per Vietnam immunization program
- 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 diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion).
- Presence of fever (>37.5C) or hypothermia (<35.5C) on the day of enrollment (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.
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- Prior receipt of rotavirus vaccine.
- A known sensitivity or allergy to any components of the study vaccines.
- Major congenital or genetic defect.
- 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 or planned administration during the study period.
- History of chronic administration (defined as more than 14 days) of immunosuppressant 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label Study to Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac® (Live Attenuated Rotavirus Vaccine) as a 3-dose Series in Healthy Infants Aged Between 6 Weeks and 8 Weeks in Vietnam
An open label study to evaluate immunogenicity, safety, and reactogenicity of Rotavac® (live attenuated oral rotavirus vaccine) as a 3-dose series in healthy infants aged between 6 weeks and 8 weeks in Vietnam
Read the detailed description
- The study is an open labeled, clinical trial in infants 6-8 weeks of age will be assigned to receive 3 doses of Rotavac® to evaluate the immunogenicity and safety.
- Active surveillance will be conducted for all participants for 14 \& 28 days after each dose of vaccine to obtain information on adverse events. ("Reactogenicity")
- Childhood vaccines including pentavalent (Diptheria, Tetanus, Pertussis, Hib, Hepatitis B) and oral polio vaccine as well as injectable polio vaccine will be administered along with the study vaccines as per Expanded Program on Immunization (EPI)
- Safety assessments will include observation in the study clinic for 30 minutes after each vaccine administration to record immediate adverse events. A subject diary card and personal contact with the subjects will be made to record adverse events during the 14-day period following vaccine administration.
- Conditions
- Rotavirus Gastroenteritis
- Being tested
- Rotavac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RotavacBiological
Rotavac Is a monovalent vaccine containing suspension of live attenuated rotavirus 116E strain, a naturally occurring reassortant strain G9P[11], containing one bovine rotavirus gene P[11] and 10 human rotavirus genes prepared in Vero cells administered orally at 6, 10 and 14 weeks of age.
| Study group | Role | What they receive |
|---|---|---|
| Single arm Rotavac | Other | Single arm Open Label study without comparator Receives: Biological: Rotavac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate immunogenicity of 3-dose regimen of Rotavac
Immunogenicity of 3-dose regimen of Rotavac with respect to geometric mean titres (GMT) of serum anti-rotavirus IgA at baseline and post-vaccination 4-6 weeks after third dose
Measured: At the end of 28 days after last dose
Secondary outcomes (1)
Assess and compare reactogenicity and safety (adverse events)
Reactogenicity and safety of Rotavac in terms of adverse event
Measured: At the end of 28 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start20 Dec 2017
- Primary completion30 Dec 2018
- Study completion30 Jun 2019
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bharat Biotech International Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Krishana Mohan, MD, Study director, Bharat Biotech International Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596696
- Sponsor's protocol ID
- BBIL/ROTAVAC/Vietnam/2017
- Status last verified
- Oct 2020
- First submitted
- 14 May 2018
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study to Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac® (Live Attenuated Rotavirus Vaccine) as a 3-dose Series in Healthy Infants Aged Between 6 Weeks and 8 Weeks in Vietnam
- ClinicalTrials.gov ID
- NCT04596696
- Acronym / sponsor ID
- BBIL/ROTAVAC/Vietnam/2017
- Conditions
- Rotavirus Gastroenteritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Bharat Biotech International LimitedIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 22 Oct 2020 (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.
An open label study to evaluate immunogenicity, safety, and reactogenicity of Rotavac® (live attenuated oral rotavirus vaccine) as a 3-dose series in healthy infants aged between 6 weeks and 8 weeks in Vietnam
Detailed description
- The study is an open labeled, clinical trial in infants 6-8 weeks of age will be assigned to receive 3 doses of Rotavac® to evaluate the immunogenicity and safety.
- Active surveillance will be conducted for all participants for 14 \& 28 days after each dose of vaccine to obtain information on adverse events. ("Reactogenicity")
- Childhood vaccines including pentavalent (Diptheria, Tetanus, Pertussis, Hib, Hepatitis B) and oral polio vaccine as well as injectable polio vaccine will be administered along with the study vaccines as per Expanded Program on Immunization (EPI)
- Safety assessments will include observation in the study clinic for 30 minutes after each vaccine administration to record immediate adverse events. A subject diary card and personal contact with the subjects will be made to record adverse events during the 14-day period following vaccine administration.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm Rotavac | Other | Biological: RotavacSingle arm Open Label study without comparator |
Who may qualify
- Ages
- 6 to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy infants as established by medical history and clinical examination
- Age: 6-8 weeks
- Weight ≥2.5kgs at birth
- Infants receiving EPI vaccines as per Vietnam immunization program
- Parental ability and willingness to provide informed consent.
Key exclusion criteria (14 listed)
- Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion).
- Presence of fever (>37.5C) or hypothermia (<35.5C) on the day of enrollment (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 |
|---|---|---|
| RotavacRotavac Is a monovalent vaccine containing suspension of live attenuated rotavirus 116E strain, a naturally occurring reassortant strain G9P[11], containing one bovine rotavirus gene P[11] and 10 human rotavirus genes prepared in Vero cells administered orally at 6, 10 and 14 weeks of age. | Biological | Single arm Rotavac |
Primary outcome
Demonstrate immunogenicity of 3-dose regimen of Rotavac
Time frame: At the end of 28 days after last dose
Immunogenicity of 3-dose regimen of Rotavac with respect to geometric mean titres (GMT) of serum anti-rotavirus IgA at baseline and post-vaccination 4-6 weeks after third dose
1 secondary outcome
Assess and compare reactogenicity and safety (adverse events)
Time frame: At the end of 28 days after last 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 23 Oct 2020.
- 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.
Dr Krishana Mohan, MD study director
Bharat Biotech International Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rotavac in people with Rotavirus Gastroenteritis, run by Bharat Biotech International Limited at 1 site in Vietnam.
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 6 inclusion and 14 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 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. 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?
Demonstrate immunogenicity of 3-dose regimen of Rotavac (time frame: At the end of 28 days after last dose). 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 23 Oct 2020.