Rotavirus GastroenteritisPhase 1/2NCT01061658
Safety and Immunogenicity Study of the Tetravalent Rotavirus Vaccine
A Phase 1/2 study testing Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine in people with Rotavirus Gastroenteritis, run by Shantha Biotechnics Limited at 1 site in India.
Trial summary
A double blind placebo controlled Phase I/II study to evaluate the safety and immunogenicity of the Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV]in Indian infants. The study would be carried out in 90 healthy infants. 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?
- Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2010to Dec 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 at time of enrollment 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). In case of father, mother or other legally acceptable representative (guardian) being unable to read or write, having had the ICF explained to them in the presence of a study independent witness and the witness having signed the 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 axillary temperature ≥38.1oC (≥100.5oF); 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 in the past 30 days (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 suspected to be HIV, HBV or HCV positive from the available clinical history or born to mothers known to be HIV, HBV or HCV positive.
- Prior receipt of a blood transfusion or blood products, including immunoglobulins;
- Any infants who cannot be adequately followed for safety by a home visit;
- Any conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
- Parent/s or guardian of subject unable to maintain diary card
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Christian Medical College
Vellore, Tamil Nadu, 632002
Gagandeep Kang, MD PhD, +914162282052, gkang@cmcvellore.ac.in
Gagandeep Kang, MD PhD
About this study
Official title: Phase I/II, Randomized, Double-blind, Placebo-controlled, Dosage Selection (10e5.5 or 10e6.25 FFU of Each Constituent Serotype Per 0.5 mL) 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
A double blind placebo controlled Phase I/II study to evaluate the safety and immunogenicity of the Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV]in Indian infants. The study would be carried out in 90 healthy infants. Three doses of the rotavirus vaccine or placebo would be administered orally to each infant at 6-8, 10-12 and 14-16 weeks of age. The rotavirus vaccine would be administered at one of the two planned virus concentrations (10e5.5 or 10e6.25 FFU of each constituent serotype per 0.5 ml). Each administration of the vaccine/placebo would be preceded by oral administration of 2.0 mL of antacid.
- Conditions
- Rotavirus Gastroenteritis
- Being tested
- Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine, Placebo
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 VaccineBiological
Higher dosage of vaccine
Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus VaccineBiological
Lower dosage of vaccine
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Vaccine - High dosage | Experimental | Not described Receives: Biological: Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine |
| Vaccine - Lower dosage | Experimental | Not described Receives: Biological: Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency, severity, and causality of Reactogenicity Events and other Adverse Events.
Measured: After each dose and upto 28 days after third dose
Secondary outcomes (2)
The Seroconversion rate, Sero-response rate and the GMT of serum IgA antibody against rotavirus.
Measured: After each dose and upto 28 days after third dose
The frequency and duration of post-vaccination shedding of vaccine rotavirus in stool samples
Measured: After each dose and upto 7 days after third dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study startJul 2010
- Primary completionNov 2010 (estimated)
- Study completionDec 2010 (estimated)
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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shantha Biotechnics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Raman Rao, MD, Study director, Shantha Biotechnics Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061658
- Sponsor's protocol ID
- SBL/BRV-TV/Form1/PhI/2009/0100
- Status last verified
- Oct 2010
- First submitted
- 2 Feb 2010
- Last updated
- 4 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II, Randomized, Double-blind, Placebo-controlled, Dosage Selection (10e5.5 or 10e6.25 FFU of Each Constituent Serotype Per 0.5 mL) 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
- ClinicalTrials.gov ID
- NCT01061658
- Acronym / sponsor ID
- SBL/BRV-TV/Form1/PhI/2009/0100
- Conditions
- Rotavirus Gastroenteritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shantha Biotechnics LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 3 Feb 2010 (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 double blind placebo controlled Phase I/II study to evaluate the safety and immunogenicity of the Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine [BRV-TV]in Indian infants. The study would be carried out in 90 healthy infants. Three doses of the rotavirus vaccine or placebo would be administered orally to each infant at 6-8, 10-12 and 14-16 weeks of age. The rotavirus vaccine would be administered at one of the two planned virus concentrations (10e5.5 or 10e6.25 FFU of each constituent serotype per 0.5 ml). Each administration of the vaccine/placebo would be preceded by oral administration of 2.0 mL of antacid.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vaccine - High dosage | Experimental | Biological: Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine |
| Vaccine - Lower dosage | Experimental | Biological: Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine |
| Placebo | 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 at time of enrollment 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). In case of father, mother or other legally acceptable representative (guardian) being unable to read or write, having had the ICF explained to them in the presence of a study independent witness and the witness having signed the 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 (15 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 axillary temperature ≥38.1oC (≥100.5oF); 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 VaccineHigher dosage of vaccine | Biological | Vaccine - High dosage |
| Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus VaccineLower dosage of vaccine | Biological | Vaccine - Lower dosage |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
The frequency, severity, and causality of Reactogenicity Events and other Adverse Events.
Time frame: After each dose and upto 28 days after third dose
2 secondary outcomes
The Seroconversion rate, Sero-response rate and the GMT of serum IgA antibody against rotavirus.
Time frame: After each dose and upto 28 days after third dose
The frequency and duration of post-vaccination shedding of vaccine rotavirus in stool samples
Time frame: After each dose and upto 7 days after third dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 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 in people with Rotavirus Gastroenteritis, 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 15 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: status not confirmed, as of the sponsor's last update on 4 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mandeep S Dhingra, MD (+914066301000 ext. 1801, drmandeep@shanthabiotech.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency, severity, and causality of Reactogenicity Events and other Adverse Events. (time frame: After each dose and upto 28 days after third 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 4 Oct 2010.