Clinical trial NCT06200844: The Efficacy of Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants
Official title: The Efficacy of Three Doses of Live Attenuated, Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Rotavirus Infection of Children
Lead sponsor: Bharat Biotech International Limited
Sponsor class: INDUSTRY
First posted: 2024-01-11
Enrollment: 5800
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. At least one parent(s) or legally acceptable representative's consent for participation and are able to understand study procedures
2. Subjects aged 6 to 8 weeks at recruitment
3. No plans to move in the next 12 months

Exclusion Criteria:

1. Administration of rotavirus vaccine in the past
2. Presence of any illness requiring hospital referral (temporary exclusion)
3. Known case of immunodeficiency disease, known HIV positive
4. Known case of chronic gastroenteritis disease, chronic pulmonary disease, chronic renal disease, congenital heart disease
5. Any other conditions which in the judgment of the investigator warrant exclusion (e.g. no exclusion criteria but seems 'ill', investigators suspects neglect)
6. Diarrhea on the day of enrollment (temporary exclusion)
7. A known sensitivity or allergy to any components of the study vaccines.
8. Major congenital or genetic defect.
9. Has received any immunoglobulin therapy and/or blood products since birth.
10. 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.

Primary outcomes:
measure: To evaluate the efficacy of ROTAVAC5D
timeFrame: 14 days following the 3rd dose till the age of 1 year (12 months) + up to 14 days].
Secondary outcomes:
measure: 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
timeFrame: Till the age of 12 months + up to 14 days
measure: To evaluate the efficacy of a ROTAVAC 5D against any severity of rotavirusgastroenteritis
timeFrame: Till the age of 1 year (12 months) + up to 14 days
measure: To evaluate the efficacy of ROTAVAC 5D for rotavirus only gastroenteritis (absence of co-pathogens)
timeFrame: Throughout study period i.e.,30 months
measure: To evaluate the efficacy of a ROTAVAC 5D against any severity of gastroenteritis irrespective of etiology
timeFrame: till the age of 1 year (12 months) + up to 14 days
measure: To evaluate the efficacy of ROTAVAC 5D against severe (>11 on the 20 point Vesikari scoring scale) gastroenteritis irrespective of etiology
timeFrame: From 14 days following the 3rd dose till the age of 1 year (12months) + up to 14 days
measure: To evaluate the intent to treat efficacy of ROTAVAC 5D against severe rotavirus gastroenteritis
timeFrame: till the age of 1 year (12 months) + up to 14 days
measure: 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
timeFrame: From the day of vaccine administration to 7 days for all the three doses.
measure: 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
timeFrame: day 0 to 28 following each dose
measure: To assess the safety of ROTAVAC 5D for SAEs,especially intussusception events occurring during the study period in all subjects
timeFrame: from day of 1st dose till the age of 1 year (12 months) + up to 14 days
measure: Secondary Objectives (Immunogenicity)
timeFrame: Day 28 (+) 5 days after the third dose in comparison to baseline levels
Other outcomes:
Locations:
city: Antofagasta
country: Chile
facility: Vacunatorio Mediped
city: Concepción
country: Chile
facility: Vacunatorio Kinewen
city: Coyhaique
country: Chile
facility: CESFAM Dr. Alejandro Gutierrez
city: Los Lagos
country: Chile
facility: Hospital de Puerto Montt
city: Osorno
country: Chile
facility: Hospital Base Osorno ,Av. Guillermo Buhler 1765
city: Puerto Aysén
country: Chile
facility: CESFAM Puerto Aysen
city: Santiago
country: Chile
facility: Centro de Salud Familiar CESFAM Rosita Renard
city: Santiago
country: Chile
facility: Hospital de Carabineros
city: Santiago
country: Chile
facility: Consultorio Dr. Alejandro del Rio
city: Santiago
country: Chile
facility: Hospital de ninos Roberto del Rio
city: Santiago
country: Chile
facility: CESFAM Esmeralda
city: Santiago
country: Chile
facility: CESFAM Colina
city: Santiago
country: Chile
facility: CESFAM Lo Barnechea
city: Santiago
country: Chile
facility: Hospital Exequiel Gónzalez Cortés
city: Valparaíso
country: Chile
facility: CESFAM Jean y Marie Thierry de Valparaíso
city: Viña Del Mar
country: Chile
facility: Hospital Gustavo Fricke
Study officials:
affiliation: Bharat Biotech International Limited
name: Dr.V.Krishna Mohan, PhD
role: STUDY_DIRECTOR
References: