Long-term Persistence of Rotavac@birth phase 3 study in neonates and infants

To Evaluate the Long-term Persistence of Rotavirus Antibody Responses in Children Previously Vaccinated With a 3-Dose Infant Schedule or 4-Dose Neonatal Schedule with ROTAVACÂ® -20ï?°C or ROTAVAC 5DÂ® (BBIL/ROTAVAC/III/2018). - Rotavac@Birth phase 3 extension study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/10/028458

Enrollment

416

Registered

2020-10-19

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: ROTAVAC 5DÂ®: ROTAVAC 5DÂ® is a attenuated Rotavirus (116E strain) Vaccine. Dose 0.5ml, Oral(ROA), duration of therapy 3 months Intervention2: ROTAVACÂ®-20 degree C: ROTAVACÂ® -20 degre

Eligibility

Inclusion criteria

Inclusion criteria: Subjects who previously participated in the main study Subjects whose either of parent or guardian is able to understand planned study procedures and demonstrate comprehension of the protocol procedures Subjects whose parent or guardian, in the opinion of the investigator can and will comply with the requirements of the protocol Written informed consent obtained from the subjects parent or guardian prior to performance of any study specific procedure

Exclusion criteria

Exclusion criteria: Any of the following criteria will preclude the participant from being enrolled in the study: 1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines (apart from BBIL/ROTAVAC/III/2018 study) during the study period. 2. Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device). 3. Acute disease and/or fever at the time of enrolment. a. Fever is defined as temperature >=38.0Â°C/100.4Â°F. The preferred location for measuring temperature in this study will be underarm (axillary) temperature. b. Subjects with acute diarrhea and/or vomiting within last 24 hours. 4. Any medical condition in the parents/infant which, in the judgment of the Investigator, would interfere with or serves as a contraindication to protocol adherence.

Design outcomes

Primary

Measure	Time frame
Evaluation of persistence of anti-rotavirus IgA and IgG antibodies (in terms of GMT) of ROTAVACÂ® -20ï?°C and ROTAVAC 5DÂ®Timepoint: There will be 1 study visit i.e. Visit 1/Day 0.	—

Secondary

Measure	Time frame
Not applicableTimepoint: Not applicable	—

Countries

India

Contacts

Public ContactDr V Krishna Mohan

Bharat Biotech International Limited

kmohan@bharatbiotech.com04023480567

Outcome results