Rotavirus InfectionsPhase 1/2NCT00757926
Safety and Immunogenicity Study of the Recombinant Human Bovine Reassortant Rotavirus Vaccine in Healthy Indian Infants
A Phase 1/2 study testing Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV] in people with Rotavirus Infections, run by Shantha Biotechnics Limited at 1 site in India.
Trial summary
A randomized, double-blind, placebo-controlled, staged dosage escalation study to evaluate the safety, tolerability, and immunogenicity of a 3-dose series of Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV] administered to healthy Indian infants concurrently with other standard… Read more about this study
- Who is it for?
- Ages 6 to 8 weeksHealthy volunteers can take part
- Conditions the study is for
- Rotavirus Infections
- What is being tested?
- Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV]
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2009to Sep 2010
- Phase
- Phase 1/2
- 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 6-8 weeks of age of either sex;
- Born after a gestational period of 36-42 weeks with birth weight >2 kg;
- Father, mother or other legally acceptable representative (guardian) properly informed about the study and having signed the informed consent form (ICF);
- Parent or guardian available for the entire period of the study and reachable by study staff for post-vaccination follow-up.
Who cannot join
- History of congenital abdominal disorders, intussusception, or abdominal surgery;
- Known or suspected impairment of immunological function;
- Known hypersensitivity to any component of the rotavirus vaccine;
- Prior receipt of any rotavirus vaccine;
- Fever, with an oral temperature ≥38.1oC (≥100.5oF); presumably measured by study staff?
- History of known rotavirus disease, chronic diarrhea, or failure to thrive;
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- Baseline level of ALT or AST >2.5 times the upper limit of normal;
- Clinical evidence of active gastrointestinal illness (infants with GERD can participate in the study so long as this condition is well controlled with or without medication);
- Receipt of any IM, oral, or IV corticosteroid treatment (infants on inhaled steroids may be permitted to participate in the study);
- Infants residing in a household with an immuno-compromised person (e.g., individuals with a congenital immunodeficiency, HIV infection, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, generalized malignancy, chronic renal failure, nephrotic syndrome, organ or bone marrow transplantation, or those receiving immunosuppressive chemotherapy including long-term systemic corticosteroids);
- Infants testing positive for HBV, HCV, or HIV infection;
- Prior receipt of a blood transfusion or blood products, including immunoglobulins;
- Any infants who can not be adequately followed for safety by telephone and/or a home visit;
- Any conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II, Randomized, Double-blind, Placebo-controlled, Staged Dosage Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 3-dose Series of Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV] Administered to Healthy Indian Infants Concurrently With Other Standard EPI Vaccines
A randomized, double-blind, placebo-controlled, staged dosage escalation study to evaluate the safety, tolerability, and immunogenicity of a 3-dose series of Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV] administered to healthy Indian infants concurrently with other standard EPI vaccines would be undertaken to evaluate the study hypothesis that a 3-dose series of BRV-TV (containing the VP7 serotypes G1, G2, G3, and G4) administered orally to healthy Indian infants at 6-8, 10-12, and 14-16 weeks of age concurrently with other standard EPI vaccines would be generally well tolerated and immunogenic.
- Conditions
- Rotavirus Infections
- Being tested
- Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV], Placebo
- Medical subject headings
- Rotavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV]Biological
Three oral doses of the vaccine (0.5 ml each) following oral administration of antacid.
PlaceboOther
Three oral doses of the placebo (0.5 ml each)following oral administration of antacid.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV] |
| 2 | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Measured: Upto one month after each of the three doses of vaccine/ placebo
Secondary outcomes (2)
Immunogenicity
Measured: At one month after each of the three doses of vaccine/ placebo
Viral Shedding
Measured: After each of the three doses of the vaccine/placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2008 (estimated)
- Study startSep 2009
- Primary completionAug 2010 (estimated)
- Study completionSep 2010 (estimated)
Why it stopped: Replaced with an alternate study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotavirus InfectionsStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shantha Biotechnics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PATH
- Investigators
- Raman Rao, MD, Study director, Shantha Biotechnics Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757926
- Sponsor's protocol ID
- SBL/BRV-TV/PhI/2008/0100
- Status last verified
- Feb 2010
- First submitted
- 22 Sep 2008
- Last updated
- 3 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II, Randomized, Double-blind, Placebo-controlled, Staged Dosage Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 3-dose Series of Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV] Administered to Healthy Indian Infants Concurrently With Other Standard EPI Vaccines
- ClinicalTrials.gov ID
- NCT00757926
- Acronym / sponsor ID
- SBL/BRV-TV/PhI/2008/0100
- Conditions
- Rotavirus Infections
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Replaced with an alternate study
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Shantha Biotechnics LimitedIndustry (pharma, biotech, devices)
- Collaborators
- PATH
- Study start
- Sep 2009
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 23 Sep 2008 (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.
A randomized, double-blind, placebo-controlled, staged dosage escalation study to evaluate the safety, tolerability, and immunogenicity of a 3-dose series of Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV] administered to healthy Indian infants concurrently with other standard EPI vaccines would be undertaken to evaluate the study hypothesis that a 3-dose series of BRV-TV (containing the VP7 serotypes G1, G2, G3, and G4) administered orally to healthy Indian infants at 6-8, 10-12, and 14-16 weeks of age concurrently with other standard EPI vaccines would be generally well tolerated and immunogenic.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV] |
| 2 | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 6 to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy infants 6-8 weeks of age of either sex;
- Born after a gestational period of 36-42 weeks with birth weight >2 kg;
- Father, mother or other legally acceptable representative (guardian) properly informed about the study and having signed the informed consent form (ICF);
- Parent or guardian available for the entire period of the study and reachable by study staff for post-vaccination follow-up.
Key exclusion criteria (14 listed)
- History of congenital abdominal disorders, intussusception, or abdominal surgery;
- Known or suspected impairment of immunological function;
- Known hypersensitivity to any component of the rotavirus vaccine;
- Prior receipt of any rotavirus vaccine;
- Fever, with an oral temperature ≥38.1oC (≥100.5oF); presumably measured by study staff?
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 Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV]Three oral doses of the vaccine (0.5 ml each) following oral administration of antacid. | Biological | 1 |
| PlaceboThree oral doses of the placebo (0.5 ml each)following oral administration of antacid. | Other | 2 |
Primary outcome
Safety and tolerability
Time frame: Upto one month after each of the three doses of vaccine/ placebo
2 secondary outcomes
Immunogenicity
Time frame: At one month after each of the three doses of vaccine/ placebo
Viral Shedding
Time frame: After each of the three doses of the vaccine/placebo
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2010.
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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.
Raman Rao, MD study director
Shantha Biotechnics Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV] in people with Rotavirus Infections, run by Shantha Biotechnics Limited at 1 site 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 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: withdrawn, as of the sponsor's last update on 3 Feb 2010. 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 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Safety and tolerability (time frame: Upto one month after each of the three doses of vaccine/ placebo). 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 3 Feb 2010.