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

An Open Label Clinical Trial To Assess The Safety And Tolerability Of A Liquid Bovine Rotavirus Pentavalent Vaccine (LBRV-PV) Formulation In Healthy Adults

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/11/006384

Enrollment

Registered

2015-11-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Liquid formulation of live Attenuated pentavalent rotavirus vaccine (LBRV- PV): Liquid formulation of live Attenuated pentavalent rotavirus vaccine (LBRV-PV). Dose of 2.0 ml Control Int

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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. 2. Normal health as determined by medical history, clinical examination and laboratory assessment. 3. 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

Exclusion criteria: 1. Investigator site personnel directly affiliated with this study and their immediate families. 2. Fever or any acute infection at time of immunization. 3. History of diarrhea or blood in stool or abnormal stool pattern in past one week. 4. 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. 5. History or presence of asthma, urticaria or other allergic reaction. 6. History of chronic gastrointestinal disease, intussusceptions, gastrointestinal malformation or abdominal surgery.

Design outcomes

Primary

Measure	Time frame
1. Occurrence of immediate adverse events within 60 minutes. 2. Occurrence of solicited reactions within 7-day post-vaccination follow-up period. 3. Occurrence of unsolicited adverse events, including serious adverse events within 28 days after vaccination.Timepoint: within 60 minutes; within 7-day post-vaccination follow-up period; within 28 days after vaccination.	—

Secondary

Measure	Time frame
Occurrence of unsolicited adverse events, including serious adverse events within 28 days after vaccination.Timepoint: 28 days after vaccination	—

Countries

India

Contacts

Public ContactDr Sajjad Desai

Serum Institute of India Limited

drpsk@seruminstitute.com020-26602384

Outcome results