Rotavirus InfectionsPhase 3NCT03367559
Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac® in Healthy Infants Aged Between 6-8 Weeks in Vietnam
A Phase 3 study testing ROTAVAC® in people with Rotavirus Infections, run by Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products 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 Infections
- What is being tested?
- ROTAVAC®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteVietnam
- Study dates
- 8 Feb 2018to May 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 before entering the study.
- Age: 6-8 weeks
- Weight ≥ 2.5kg at birth.
- Infants received EPI vaccines at birth (i.e., OPV, BCG and/or Hep B)
- 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 (temperature ≥37.5oC) or hypothermia (temperature ≤35.5oC) 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, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the infant'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 medication.
- 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 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.
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.
- Conditions
- Rotavirus Infections
- Being tested
- ROTAVAC®
- Keywords
- Rotavirus, ROTAVAC, Vaccine, Vietnam
- Medical subject headings
- Rotavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROTAVAC®Biological
Rotavac® is in frozen form and is thawed till fully liquid prior to administration.
| Study group | Role | What they receive |
|---|---|---|
| Rotavirus Vaccine | Experimental | 3 dose, interval for each dose is 4 weeks. The first dose will be received at 6-8 weeks of age. Receives: Biological: ROTAVAC® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and rate of the AEs within 30 minutes after vaccination
Frequency and rate of the adverse effects and severity of immediate adverse events (Local and General) within 30 minutes after vaccination
Measured: 30 minutes after vaccination
Frequency and rate of the AEs within 7 days after vaccination
Frequency and rate of adverse effects and severity of solicited adverse events (Local and General) within 7 days after each vaccination
Measured: for 7 days after each vaccination
Frequency and rate of the AEs during 28 days after vaccination
Frequency and rate of adverse effects and severity of unsolicited adverse events (Local and General) during 28 days after each vaccination
Measured: for 28 days after vaccination
Frequency and rate of the SAEs during 28 days after vaccination
Frequency and rate of adverse effects and severity of Serious Adverse Events (Local and General) during 28 days after each vaccination
Measured: for 28 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start8 Feb 2018
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products
- Sponsor type
- University, hospital or other
- Collaborators
- Bharat Biotech International Limited
- Responsible party
- Principal investigator, Pham Ngoc Hung, MD PhD Assoc, Vietnam Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367559
- Sponsor's protocol ID
- VX-2017.01
- Status last verified
- Mar 2019
- First submitted
- 5 Dec 2017
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. 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
- NCT03367559
- Acronym / sponsor ID
- VX-2017.01
- Conditions
- Rotavirus Infections
- Keywords
- Rotavirus, ROTAVAC, Vaccine, Vietnam
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological ProductsUniversity, hospital or other
- Collaborators
- Bharat Biotech International Limited
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 8 Dec 2017 (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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rotavirus Vaccine | Experimental | Biological: ROTAVAC®3 dose, interval for each dose is 4 weeks. The first dose will be received at 6-8 weeks of age. |
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 before entering the study.
- Age: 6-8 weeks
- Weight ≥ 2.5kg at birth.
- Infants received EPI vaccines at birth (i.e., OPV, BCG and/or Hep B)
- 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 (temperature ≥37.5oC) or hypothermia (temperature ≤35.5oC) 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, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the infant'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® is in frozen form and is thawed till fully liquid prior to administration. | Biological | Rotavirus Vaccine |
Primary outcome
Frequency and rate of the AEs within 30 minutes after vaccination
Time frame: 30 minutes after vaccination
Frequency and rate of the adverse effects and severity of immediate adverse events (Local and General) within 30 minutes after vaccination
Frequency and rate of the AEs within 7 days after vaccination
Time frame: for 7 days after each vaccination
Frequency and rate of adverse effects and severity of solicited adverse events (Local and General) within 7 days after each vaccination
Frequency and rate of the AEs during 28 days after vaccination
Time frame: for 28 days after vaccination
Frequency and rate of adverse effects and severity of unsolicited adverse events (Local and General) during 28 days after each vaccination
Frequency and rate of the SAEs during 28 days after vaccination
Time frame: for 28 days after vaccination
Frequency and rate of adverse effects and severity of Serious Adverse Events (Local and General) during 28 days after each vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
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 Infections, run by Institute of Clinical Research and Clinical Trial Support for Vaccine and Biological Products 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: status not confirmed, as of the sponsor's last update on 25 Mar 2019. 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?
Results are not available in the source record.
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?
Frequency and rate of the AEs within 30 minutes after vaccination (time frame: 30 minutes after vaccination). The study lists 4 primary outcomes in all. 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 25 Mar 2019.