Rotavirus Infection of ChildrenPhase 3Rota5DCHILENCT06200844
The Efficacy of Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants
A Phase 3 study testing ROTAVAC 5D in people with Rotavirus Infection of Children, run by Bharat Biotech International Limited at 16 sites in Chile.
Trial summary
This is a randomized, double-blind, phase 3 study to evaluate the Efficacy,Safety, and Immunogenicity of ROTAVAC 5D, a live attenuated rotavirus vaccine in healthy infants aged 6-8 weeks. Read more about this study
- Who is it for?
- Ages 6 to 8 weeksHealthy volunteers can take part
- Conditions the study is for
- Rotavirus Infection of Children
- What is being tested?
- ROTAVAC 5D
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5,800 participants
- Where
- 16 sitesChile
- Study dates
- 7 Jul 2023to Jul 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- At least one parent(s) or legally acceptable representative's consent for participation and are able to understand study procedures
- Subjects aged 6 to 8 weeks at recruitment
- No plans to move in the next 12 months
Who cannot join
- Administration of rotavirus vaccine in the past
- Presence of any illness requiring hospital referral (temporary exclusion)
- Known case of immunodeficiency disease, known HIV positive
- Known case of chronic gastroenteritis disease, chronic pulmonary disease, chronic renal disease, congenital heart disease
- Any other conditions which in the judgment of the investigator warrant exclusion (e.g. no exclusion criteria but seems 'ill', investigators suspects neglect)
- Diarrhea on the day of enrollment (temporary exclusion)
Show all 10Show fewer
- A known sensitivity or allergy to any components of the study vaccines.
- Major congenital or genetic defect.
- 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, at the discretion of the principal investigator.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Chile16 sites
Vacunatorio Mediped
Antofagasta, 1240000
Vacunatorio Kinewen
Concepción, 4070118
CESFAM Dr. Alejandro Gutierrez
Coyhaique, 5950000
Hospital de Puerto Montt
Los Lagos, 5480000
Hospital Base Osorno ,Av. Guillermo Buhler 1765
Osorno, 5290000
CESFAM Puerto Aysen
Puerto Aisén, 6000594
Centro de Salud Familiar CESFAM Rosita Renard
Santiago, 7500539
Hospital de Carabineros
Santiago, 7770201
Consultorio Dr. Alejandro del Rio
Santiago, 8210269
Hospital de ninos Roberto del Rio
Santiago, 8380418
CESFAM Esmeralda
Santiago, 9340000
CESFAM Colina
Santiago, 9350079
CESFAM Lo Barnechea
Santiago
Hospital Exequiel Gónzalez Cortés
Santiago
CESFAM Jean y Marie Thierry de Valparaíso
Valparaíso, 2340319
Hospital Gustavo Fricke
Viña del Mar, 2520000
About this study
Official title: The Efficacy of Three Doses of Live Attenuated, Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants.
This is a randomized, double-blind, phase 3 study to evaluate the Efficacy,Safety, and Immunogenicity of ROTAVAC 5D, a live attenuated rotavirus vaccine in healthy infants aged 6-8 weeks.
A total of 5800 healthy Chilean infants will be recruited in this study and randomized to receive either vaccine or placebo in 1:1 ratio. Among these participants 300 will be categorized to immunogenicity cohort, 150 from each group, and blood samples will be collected to assess the immune response.
Read the detailed description
The Efficacy of Three Doses of Live Attenuated, Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants.
This is a randomized, double-blind, phase 3 study to evaluate the Efficacy, Safety, and Immunogenicity of ROTAVAC 5D, a live attenuated rotavirus vaccine in healthy infants aged 6-8 weeks.
A total of 5800 healthy Chilean infants will be recruited in this study and randomized to receive either vaccine or placebo in 1:1 ratio. Among these participants 300 will be categorized to immunogenicity cohort, 150 from each group, and blood samples will be collected to assess the immune response. Inclusion At least one parent(s) or legally acceptable representative's consent for participation and are able to understand study procedures Subjects aged 6 to 8 weeks at recruitment No plans to move in the next 12 months Exclusion Administration of rotavirus vaccine in the past Presence of any illness requiring hospital referral (temporary exclusion) Known case of immunodeficiency disease, known HIV positive Known case of chronic gastroenteritis disease, chronic pulmonary disease, chronic renal disease, congenital heart disease Any other conditions which in the judgment of the investigator warrant exclusion (e.g. no exclusion criteria but seems 'ill', investigators suspects neglect) Diarrhea on the day of enrollment (temporary exclusion) A known sensitivity or allergy to any components of the study vaccines. Major congenital or genetic defect. 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, at the discretion of the principal investigator. Blood samples: In the "Immunogenicity Subset", 3 ml blood specimens will be collected at baseline and 28 (+) 5 days after the third dose of the Test Article/placebo to assess the anti rotavirus IgA antibody titer. Stool Specimens: The study team will attempt to collect a stool specimen for every GE episode, preferably within the first 2 days after episode onset. The stool specimen may be collected up to 7 days after the last day of diarrhea. The stool specimens will be sent to the laboratory. If the episode is a suspected intussusception or vaccine associated gastroenteritis that has occurred within four weeks after each dose of the Test Article/placebo, the specimen will be sent to the laboratory immediately for rotavirus testing and typing. For all ELISA RV positive samples, an aliquot of the stool specimen will be assessed for 20 enteropathogens by multiplex-PCR panel and to identify the genotype of the virus.
- Conditions
- Rotavirus Infection of Children
- Being tested
- ROTAVAC 5D, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROTAVAC 5DBiological
Rotavirus Vaccine (ROTAVAC 5D), is a monovalent vaccine containing suspension of live attenuated rotavirus 116E prepared in Vero cells, containing NLT 105.0 FFU and administered as a three-dose regimen, 4 weeks apart.
PlaceboOther
Placebo is administered as three doses 4 weeks apart
| Study group | Role | What they receive |
|---|---|---|
| Rotavac 5D | Experimental | Rotavirus Vaccine (ROTAVAC 5D), is a monovalent vaccine containing suspension of live attenuated rotavirus 116E prepared in Vero cells, containing NLT 10 power 5.0 FFU and administered as a three-dose regimen, 4 weeks apart. Receives: Biological: ROTAVAC 5D |
| Placebo | Placebo comparator | Placebo administered as a three-dose regimen, 4 weeks apart. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of ROTAVAC5D
Efficacy of ORV 116E in comparison to a placebo against moderate-severe rotavirus gastroenteritis defined as: episode of diarrhea (the passage of three or more loose or watery stools within a 24-hour period), with or without vomiting, that requires overnight hospitalization or rehydration therapy equivalent to World Health Organization (WHO) plan B (oral rehydration therapy) or plan C (intravenous rehydration therapy) in a medical facility such as a hospital, clinic, or supervised rural health care center
Measured: 14 days following the 3rd dose till the age of 1 year (12 months) + up to 14 days].
Secondary outcomes (10)
Efficacy of Severe rotavirus gastroenteritis (>11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus occurring at least 14 days following the third dose
Severe rotavirus gastroenteritis (>11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus occurring at least 14 days following the third dose
Measured: Till the age of 12 months + up to 14 days
To evaluate the efficacy of a ROTAVAC 5D against any severity of rotavirusgastroenteritis
Any severity of gastroenteritis caused by non vaccine rotavirus from 14 days following the 3rd dose
Measured: Till the age of 1 year (12 months) + up to 14 days
To evaluate the efficacy of ROTAVAC 5D for rotavirus only gastroenteritis (absence of co-pathogens)
All primary and secondary endpoints indicated above for episodes that result positive only for rotavirus, and no other co-pathogen.
Measured: Throughout study period i.e.,30 months
To evaluate the efficacy of a ROTAVAC 5D against any severity of gastroenteritis irrespective of etiology
Any severity of gastroenteritis irrespective of etiology from 14 days following the 3rd dose
Measured: till the age of 1 year (12 months) + up to 14 days
To evaluate the efficacy of ROTAVAC 5D against severe (>11 on the 20 point Vesikari scoring scale) gastroenteritis irrespective of etiology
Severe (>11 on the 20 point Vesikari scoring scale) gastroenteritis irrespective of etiology f
Measured: From 14 days following the 3rd dose till the age of 1 year (12months) + up to 14 days
To evaluate the intent to treat efficacy of ROTAVAC 5D against severe rotavirus gastroenteritis
Severe rotavirus gastroenteritis (≥11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus in the intent-to-treat population
Measured: till the age of 1 year (12 months) + up to 14 days
Safety of the subjects during study period To assess the safety of ROTAVAC 5D for immediate and seven day adverse events, after all the 3 doses
During this period, will be solicited adverse events till 30 minutes after each vaccination (immediate solicited adverse events) and adverse events occurring within 7 days after each vaccination.
Measured: From the day of vaccine administration to 7 days for all the three doses.
To assess the safety of ROTAVAC 5D for adverse events in the 4-week period following administration of each of the three doses of the vaccine/placebo
Unsolicited adverse events assessed from day 0 to 28 following each dose in comparison to a placebo will be assessed in a subset of subjects
Measured: day 0 to 28 following each dose
To assess the safety of ROTAVAC 5D for SAEs,especially intussusception events occurring during the study period in all subjects
SAEs with a special focus on Intussusception events in comparison to a placebo will be assessed in all subjects throughout the study period.
Measured: from day of 1st dose till the age of 1 year (12 months) + up to 14 days
Secondary Objectives (Immunogenicity)
Immunogenicity rates after three doses of the ROTAVAC 5D in comparison to a placebo will be ascertained in approximately 150 subjects in each group assessed by fourfold rise in rotavirus-specific serum IgA antibody titers.
Measured: Day 28 (+) 5 days after the third dose in comparison to baseline levels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start7 Jul 2023
- Primary completion4 Jan 2025
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotavirus Infection of ChildrenStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bharat Biotech International Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr.V.Krishna Mohan, PhD, Study director, Bharat Biotech International Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200844
- Sponsor's protocol ID
- BBIL/Rotavac 5D-CHILE /2022
- Acronym
- Rota5DCHILE
- Status last verified
- May 2025
- First submitted
- 11 Dec 2023
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Three Doses of Live Attenuated, Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants.
- ClinicalTrials.gov ID
- NCT06200844
- Acronym / sponsor ID
- Rota5DCHILE / BBIL/Rotavac 5D-CHILE /2022
- Conditions
- Rotavirus Infection of Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5,800 participants (estimated)
- Lead sponsor
- Bharat Biotech International LimitedIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2023 (actual)
- Primary completion
- 4 Jan 2025 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 11 Jan 2024 (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.
This is a randomized, double-blind, phase 3 study to evaluate the Efficacy,Safety, and Immunogenicity of ROTAVAC 5D, a live attenuated rotavirus vaccine in healthy infants aged 6-8 weeks.
A total of 5800 healthy Chilean infants will be recruited in this study and randomized to receive either vaccine or placebo in 1:1 ratio. Among these participants 300 will be categorized to immunogenicity cohort, 150 from each group, and blood samples will be collected to assess the immune response.
Detailed description
The Efficacy of Three Doses of Live Attenuated, Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants.
This is a randomized, double-blind, phase 3 study to evaluate the Efficacy, Safety, and Immunogenicity of ROTAVAC 5D, a live attenuated rotavirus vaccine in healthy infants aged 6-8 weeks.
A total of 5800 healthy Chilean infants will be recruited in this study and randomized to receive either vaccine or placebo in 1:1 ratio. Among these participants 300 will be categorized to immunogenicity cohort, 150 from each group, and blood samples will be collected to assess the immune response. Inclusion At least one parent(s) or legally acceptable representative's consent for participation and are able to understand study procedures Subjects aged 6 to 8 weeks at recruitment No plans to move in the next 12 months Exclusion Administration of rotavirus vaccine in the past Presence of any illness requiring hospital referral (temporary exclusion) Known case of immunodeficiency disease, known HIV positive Known case of chronic gastroenteritis disease, chronic pulmonary disease, chronic renal disease, congenital heart disease Any other conditions which in the judgment of the investigator warrant exclusion (e.g. no exclusion criteria but seems 'ill', investigators suspects neglect) Diarrhea on the day of enrollment (temporary exclusion) A known sensitivity or allergy to any components of the study vaccines. Major congenital or genetic defect. 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, at the discretion of the principal investigator. Blood samples: In the "Immunogenicity Subset", 3 ml blood specimens will be collected at baseline and 28 (+) 5 days after the third dose of the Test Article/placebo to assess the anti rotavirus IgA antibody titer. Stool Specimens: The study team will attempt to collect a stool specimen for every GE episode, preferably within the first 2 days after episode onset. The stool specimen may be collected up to 7 days after the last day of diarrhea. The stool specimens will be sent to the laboratory. If the episode is a suspected intussusception or vaccine associated gastroenteritis that has occurred within four weeks after each dose of the Test Article/placebo, the specimen will be sent to the laboratory immediately for rotavirus testing and typing. For all ELISA RV positive samples, an aliquot of the stool specimen will be assessed for 20 enteropathogens by multiplex-PCR panel and to identify the genotype of the virus.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotavac 5D | Experimental | Biological: ROTAVAC 5DRotavirus Vaccine (ROTAVAC 5D), is a monovalent vaccine containing suspension of live attenuated rotavirus 116E prepared in Vero cells, containing NLT 10 power 5.0 FFU and administered as a three-dose regimen, 4 weeks apart. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo administered as a three-dose regimen, 4 weeks apart. |
Who may qualify
- Ages
- 6 to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- At least one parent(s) or legally acceptable representative's consent for participation and are able to understand study procedures
- Subjects aged 6 to 8 weeks at recruitment
- No plans to move in the next 12 months
Key exclusion criteria (10 listed)
- Administration of rotavirus vaccine in the past
- Presence of any illness requiring hospital referral (temporary exclusion)
- Known case of immunodeficiency disease, known HIV positive
- Known case of chronic gastroenteritis disease, chronic pulmonary disease, chronic renal disease, congenital heart disease
- Any other conditions which in the judgment of the investigator warrant exclusion (e.g. no exclusion criteria but seems 'ill', investigators suspects neglect)
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 5DRotavirus Vaccine (ROTAVAC 5D), is a monovalent vaccine containing suspension of live attenuated rotavirus 116E prepared in Vero cells, containing NLT 105.0 FFU and administered as a three-dose regimen, 4 weeks apart. | Biological | Rotavac 5D |
| PlaceboPlacebo is administered as three doses 4 weeks apart | Other | Placebo |
Primary outcome
To evaluate the efficacy of ROTAVAC5D
Time frame: 14 days following the 3rd dose till the age of 1 year (12 months) + up to 14 days].
Efficacy of ORV 116E in comparison to a placebo against moderate-severe rotavirus gastroenteritis defined as: episode of diarrhea (the passage of three or more loose or watery stools within a 24-hour period), with or without vomiting, that requires overnight hospitalization or rehydration therapy equivalent to World Health Organization (WHO) plan B (oral rehydration therapy) or plan C (intravenous rehydration therapy) in a medical facility such as a hospital, clinic, or supervised rural health care center
10 secondary outcomes
Efficacy of Severe rotavirus gastroenteritis (>11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus occurring at least 14 days following the third dose
Time frame: Till the age of 12 months + up to 14 days
To evaluate the efficacy of a ROTAVAC 5D against any severity of rotavirusgastroenteritis
Time frame: Till the age of 1 year (12 months) + up to 14 days
To evaluate the efficacy of ROTAVAC 5D for rotavirus only gastroenteritis (absence of co-pathogens)
Time frame: Throughout study period i.e.,30 months
To evaluate the efficacy of a ROTAVAC 5D against any severity of gastroenteritis irrespective of etiology
Time frame: till the age of 1 year (12 months) + up to 14 days
To evaluate the efficacy of ROTAVAC 5D against severe (>11 on the 20 point Vesikari scoring scale) gastroenteritis irrespective of etiology
Time frame: From 14 days following the 3rd dose till the age of 1 year (12months) + up to 14 days
To evaluate the intent to treat efficacy of ROTAVAC 5D against severe rotavirus gastroenteritis
Time frame: till the age of 1 year (12 months) + up to 14 days
Safety of the subjects during study period To assess the safety of ROTAVAC 5D for immediate and seven day adverse events, after all the 3 doses
Time frame: From the day of vaccine administration to 7 days for all the three doses.
To assess the safety of ROTAVAC 5D for adverse events in the 4-week period following administration of each of the three doses of the vaccine/placebo
Time frame: day 0 to 28 following each dose
To assess the safety of ROTAVAC 5D for SAEs,especially intussusception events occurring during the study period in all subjects
Time frame: from day of 1st dose till the age of 1 year (12 months) + up to 14 days
Secondary Objectives (Immunogenicity)
Time frame: Day 28 (+) 5 days after the third dose in comparison to baseline levels
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No
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.V.Krishna Mohan, PhD study director
Bharat Biotech International Limited
16 sites 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 5D in people with Rotavirus Infection of Children, run by Bharat Biotech International Limited at 16 sites in Chile.
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 3 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Chile. 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 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?
This study is still under way. Results are not available in the source record yet.
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 efficacy of ROTAVAC5D (time frame: 14 days following the 3rd dose till the age of 1 year (12 months) + up to 14 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 22 May 2025.