This is phase one study with healthy adult participants to be enrolled to receive study product to check the safety and tolerability of liquid rotavirus vaccine in healthy adults

Phase 1

Completed

Brief Summary: This is a phase I, open labelled study to assess the safety and tolerability of a Liquid formulation of Bovine Rotavirus Pentavalent Vaccine (LBRV-PV), in healthy adults.

A total of 20 subjects will be enrolled in the study at single site to receive LBRV-PV. Active surveillance for vaccine reactogenicity (solicited reactions) over the 7-day period after vaccination will be conducted on all subjects. In addition, surveillance for unsolicited AEs and SAEs will be carried out over the period between enrollment and four weeks after vaccination on all subjects.

Recruitment & Eligibility

Inclusion Criteria

Healthy adult male or non-pregnant female subjects aged between 18-45 years and normal Body Mass Index (18.5 to 24.9 kg/m2) with minimum of 50 kg weight.
Normal health as determined by medical history, clinical examination and laboratory assessment.
Subjects willing to adhere to the protocol requirements and to provide written informed consent 4.
Availability for clinical follow up through period of the study.

Exclusion Criteria

Investigator site personnel directly affiliated with this study and their immediate families.
Fever or any acute infection at time of immunization.
History of diarrhea or blood in stool or abnormal stool pattern in past one week.
A known hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the study vaccine or a vaccine containing the same substances.
History or presence of asthma, urticaria or other allergic reaction.
History of chronic gastrointestinal disease, intussusceptions, gastrointestinal malformation or abdominal surgery.

Primary Outcome Measures

Name	Time	Method
1. Occurrence of immediate adverse events within 60 minutes.	within 60 minutes; \| within 7-day post-vaccination follow-up period; \| within 28 days after vaccination.
2. Occurrence of solicited reactions within 7-day post-vaccination follow-up	within 60 minutes; \| within 7-day post-vaccination follow-up period; \| within 28 days after vaccination.
period.	within 60 minutes; \| within 7-day post-vaccination follow-up period; \| within 28 days after vaccination.
3. Occurrence of unsolicited adverse events, including serious adverse events	within 60 minutes; \| within 7-day post-vaccination follow-up period; \| within 28 days after vaccination.
within 28 days after vaccination.	within 60 minutes; \| within 7-day post-vaccination follow-up period; \| within 28 days after vaccination.

Secondary Outcome Measures

Name	Time	Method
Occurrence of unsolicited adverse events, including serious adverse	events within 28 days after vaccination.

Locations (1): Syngene International Limited
🇮🇳
Bangalore, KARNATAKA, India
Syngene International Limited
🇮🇳Bangalore, KARNATAKA, India
Dr Anil K
Principal investigator
080-28082780
Anil.Dr@syngeneintl.com