The Efficacy of Three Doses of Live Attenuated, Oral Rotavirus Vaccine 116E
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ClinicalTrials.gov Identifier: NCT05958771 |
Recruitment Status :
Recruiting
First Posted : July 25, 2023
Last Update Posted : July 25, 2023
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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.
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.
Condition or disease | Intervention/treatment | Phase |
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Rotavirus Gastroenteritis | Drug: ROTAVAC 5D Drug: Placebo | Phase 3 |
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Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 5800 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Prevention |
Official Title: | The Efficacy of Three Doses of Live Attenuated, Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants. |
Actual Study Start Date : | July 6, 2023 |
Estimated Primary Completion Date : | June 1, 2025 |
Estimated Study Completion Date : | June 1, 2025 |
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Arm | Intervention/treatment |
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Active Comparator: Children who receive the IP
The Test Article/placebo will be co-administered with the childhood vaccines that are scheduled at the regular National Program of Immunization vaccination visits around 2 months, 4 months and 6 months of age. Test article: ROTAVAC 5D, 3 doses. Each dose of 0.5 mL. Administered orally. |
Drug: ROTAVAC 5D
monovalent vaccine containing suspension of live attenuated rotavirus 116E prepared in Vero cells. Each dose contains NLT 10 e 5.0 FFU |
Placebo Comparator: Children who receive placebo
The Test Article/placebo will be co-administered with the childhood vaccines that are scheduled at the regular National Program of Immunization vaccination visits around 2 months, 4 months and 6 months of age. Placebo: 3 doses. Each dose of 0.5 mL. Administered orally. |
Drug: Placebo
Placebo contains all the excipients of ROTAVAC 5D but without the suspension of live attenuated rotavirus |
- Percentage of subject who suffer a moderate-severe rotavirus gastroenteritis in vaccine arm as compared to placebo arm [ Time Frame: till 8 months +14 days after administering the third dose ]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
- Percentage of subject who suffer a severe rotavirus gastroenteritis according to the Vesikari Score in vaccine arm as compared to placebo [ Time Frame: till 8 months +14 days after administering the third dose ]Severe rotavirus gastroenteritis: >11 on the 20 point Vesikari scoring scale, caused by non-vaccine rotavirus
- Percentage of subject who suffer any severity of rotavirus gastroenteritis according to the Vesikari score in vaccine arm as compared to placebo arm [ Time Frame: till 8 months +14 days after administering the third dose ]Any severity of gastroenteritis caused by non vaccine rotavirus
- Percentage of subject who suffer moderate-severe rotavirus-only gastroenteritis (absence of co-pathogens) in vaccine arm as compared to placebo arm [ Time Frame: till 8 months +14 days after administering the third dose ]
Efficacy of ORV 116E in comparison to a placebo against 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. Moderate-severe will be defined by the requirement of 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.
Rotavirus-only gastroenteritis will be defined as absence of co-pathogens according to Filmarray ® Gastrointestinal Panel.
- Percentage of subject who suffer severe (according to Vesikari score) rotavirus-only gastroenteritis (absence of co-pathogens) in vaccine arm as compared to placebo arm [ Time Frame: till 8 months +14 days after administering the third dose ]Efficacy of ORV 116E in comparison to a placebo against severe (>11 on the 20 point Vesikari scoring scale) rotavirus-only gastroenteritis (absence of co-pathogens according to Filmarray ® Gastrointestinal Panel )Rotavirus-only gastroenteritis will be defined as absence of co-pathogens according to Filmarray ® Gastrointestinal Panel.
- Percentage of subject who suffer any severity (according to Vesikari score) of rotavirus-only gastroenteritis (absence of co-pathogens) in vaccine arm as compared to placebo arm [ Time Frame: till 8 months +14 days after administering the third dose ]Efficacy of ORV 116E in comparison to a placebo against any severity (any score on the 20 point Vesikari scoring scale) of rotavirus only gastroenteritis (absence of co-pathogens
- Percentage of subject who suffer severe (>11 on the 20 point Vesikari scoring scale) gastroenteritis irrespective of etiology in vaccine arm as compared to placebo arm [ Time Frame: till 8 months +14 days after administering the third dose ]Efficacy of ORV 116E in comparison to a placebo against Severe (>11 on the 20 point Vesikari scoring scale) gastroenteritis irrespective of etiology
- Intent to treat efficacy of ROTAVAC 5D against severe rotavirus gastroenteritis [ Time Frame: till 8 months +14 days after administering the third dose ]
Severe rotavirus gastroenteritis (≥11 on the 20 point Vesikari scoring scale) caused by non-vaccine rotavirus in the intent-to-treat population till 8 months
+14 days after administering the third dose
- Percentage of subject who suffer solicited immediate adverse events after each dose in vaccine arm as compared to placebo arm [ Time Frame: 0 to 30 minutes after each vaccination. ]Safety of ROTAVAC 5D solicited adverse events till 30 minutes after each vaccination (immediate solicited adverse events)
- Percentage of subject who suffer solicited adverse events till 7 days after each dose in vaccine arm as compared to placebo arm [ Time Frame: 30 minutes to 7 days after each vaccination. ]Solicited adverse events occurring within 7 days after each vaccination
- Percentage of subject who suffer any adverse event in the 4-week period following each dose in vaccine arm as compared to placebo arm [ Time Frame: from day 0 to end of the study ( till 1 year (12 months) + up to 14 days) ]Unsolicited adverse events assessed from day 0 to end of the study in comparison to a placebo will be assessed in a subset of subjects Unsolicited adverse events from day 0 to 28 following each dose in comparison to a placebo will be assessed in a subset of subjects
- Percentage of subject who suffer any severe adverse event during the study period in vaccine arm as compared to placebo arm [ Time Frame: from day 0 to end of the study ( till 1 year (12 months) + up to 14 days) ]Any severe adverse event will be assessed in all subjects throughout the study period.
- b. Percentage of subject who suffer intussusception during the study period in vaccine arm as compared to placebo arm [ Time Frame: from day 0 to end of the study ( till 1 year (12 months) + up to 14 days) ]Intussusception will be assessed in all subjects throughout the study period.
- Immunogenicity rates after 3 doses of vaccine as compared to placebo arm. [ Time Frame: 28 (+) 5 days after the third dose in comparison to baseline levels ]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 four-fold rise in rotavirus-specific serum IgA antibody titers.(Time Frame: 28 (+) 5 days after the third dose in comparison to baseline levels)
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 60 Days to 89 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- At least one parent(s) or legally acceptable representative's consent for participation and are able to understand study procedures
- Subjects aged at least 2 months at recruitment
- No plans to move in the next 12 months
Exclusion Criteria:
- Administration of rotavirus vaccine in the past
- Participants vaccinated with a dose of vaccine from the National Immunization Program corresponding to their current age, in which more than 48 hours have passed since the last dose received
- 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 (Stable with no on-going medication).
- 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.
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05958771
Contact: Veronica De la Maza, Licence | 56 9 77647257 | vdelamaza@uchile.cl |
Chile | |
Vacunatorio Mediped | Recruiting |
Antofagasta, Antofagasta Region, Chile, 124 3817 | |
Contact: . Daniza Jaldin, MD +56968638015 djaldin2010@gmail.com | |
Hospital Base de Osorno | Recruiting |
Osorno, Los Lagos Region, Chile | |
Contact: Stephania Passalacqua, MD +569 78620320 steph.passalacqua@gmail.com | |
Hospital de Puerto Montt | Recruiting |
Puerto Montt, Los Lagos Region, Chile | |
Contact: Loreto Twele, MD +56 9 8721 3886. loreto.twele@gmail.com | |
Hospital Roberto del Rio | Recruiting |
Santiago, Metropolitan Region, Chile | |
Contact: Yalda Lucero, MD, PhD + 56 9 97330860 ylucero@uchile.cl | |
Hospital Dr. Gustavo Fricke | Recruiting |
Viña Del Mar, Chile | |
Contact: Karen Ducasse, MD +56 22 5756103 karenducasse.c@gmail.com |
Responsible Party: | Miguel O'Ryan Gallardo, Titular Professor, University of Chile |
ClinicalTrials.gov Identifier: | NCT05958771 |
Other Study ID Numbers: |
BBIL/Rotavac 5D-CHILE /2022 |
First Posted: | July 25, 2023 Key Record Dates |
Last Update Posted: | July 25, 2023 |
Last Verified: | July 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |