A Phase 3 interventional study of ROTAVAC 5D and Placebo in Rotavirus Infection of Children, sponsored by Bharat Biotech International Limited. Active, not recruiting at 16 sites in Chile. Open to participants aged 6 Weeks to 8 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by Bharat Biotech International Limited · Phase 3, Interventional, and Prevention
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.
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.
104 studies on the registry are indexed under Rotavirus Infections; 3 are open to participants now.
This study's planned enrollment of 5,800 is above the median of 403 across 69 interventional studies indexed under Rotavirus Infections.
Browse Rotavirus Infections studies →Bharat Biotech International Limited is the lead sponsor of 20 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: ROTAVAC 5D
Placebo administered as a three-dose regimen, 4 weeks apart.
Other: Placebo
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.
Placebo is administered as three doses 4 weeks apart
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
Time frame: 14 days following the 3rd dose till the age of 1 year (12 months) + up to 14 days].
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
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
Any severity of gastroenteritis caused by non vaccine rotavirus from 14 days following the 3rd dose
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)
All primary and secondary endpoints indicated above for episodes that result positive only for rotavirus, and no other co-pathogen.
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
Any severity of gastroenteritis irrespective of etiology from 14 days following the 3rd dose
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
Severe (\>11 on the 20 point Vesikari scoring scale) gastroenteritis irrespective of etiology f
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
Severe rotavirus gastroenteritis (≥11 on the 20 point Vesikari scoring scale) caused by non vaccine rotavirus in the intent-to-treat population
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
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.
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
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
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
SAEs with a special focus on Intussusception events in comparison to a placebo will be assessed in all subjects throughout the study period.
Time frame: 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.
Time frame: Day 28 (+) 5 days after the third dose in comparison to baseline levels
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2023 to primary completion in Jan 2025, 17 months.
Of 14 phase 3 interventional studies under Rotavirus Infections, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 20. This study's 17 months is above that.
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This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Bharat Biotech International Limited