None listed
Conditions
Interventions
Intervention1: ROTAVAC 5CM: Rotavac 5CM is a attenuated Rotavirus (116E strain) Vaccine. It has a modified formulation and can be stored at +2 to +8 degree centigrade.
Intervention2: ROTAVAC®-20 degr
Sponsors
Bharat Biotech International Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Healthy male or female full term (>=36 weeks gestation) babies weighing at least 2500g at birth. Healthiness established by medical history and clinical examination 2 Resident of a state in India where ROTAVAC® is not introduced as a part of UIP 3 Subjects whose either of parent or guardian is able to understand planned study procedures and demonstrate comprehension of the protocol procedures prior to vaccination. 4 Subjects whose parent or guardian, in the opinion of the investigator, can and will comply with the requirements of the protocol (eg completion of the diary cards, return for follow-up visits). 5 Written informed consent obtained from the subjects parent or guardian prior to performance of any study specific procedure. 6 Generally healthy subjects without acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination. 7 Infants receiving vaccines as per Universal Immunization Program of India 8 Subjects with no history of rotavirus vaccination prior to study enrolment and whose parent or guardian is willing to forego any outside rotavirus vaccination during the entire study period. 9 Subjects with a minor illness [such as low-grade fever between 36.5°C (97.7°F) and 37.5°C (99.5°F) and mild upper respiratory infection] may be enrolled at the discretion of the investigator.
Exclusion criteria
Exclusion criteria: 1 Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines 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 Administration of long-acting immune-modifying drugs (e.g. infliximab, rituximab) since birth or planned administration any time during the study period. 4 Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (e.g. Severe Combined Immunodeficiency Disease). 5 Neonates born to mother Infected with Human Immunodeficiency Virus (HIV) regardless of clinical stage of immunodeficiency. 6 History of or current autoimmune disease. 7 Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period 8 History of uncorrected congenital malformation of the gastrointestinal tract. 9 History of intussusception. 10 History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. 11 Hypersensitivity to latex. 12 Presence of significant malnutrition or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the childâ??s health or is likely to result in non-conformance to the protocol. 13 Acute disease and/or fever at the time of enrolment. a Fever is defined as temperature >=38.0°C/100.4°F. The preferred location for measuring temperature in this study will be underarm (axillary) temperature first. If that reading is >99ï?°F, take rectal temperature for a more precise and accurate result b Subjects with acute diarrhea and/or vomiting within last 24 hours 14 Have signs or symptoms that could confound or confuse assessment of study vaccine reactogenicity 15 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 |
|---|---|
| To evaluate the safety and tolerabilityTimepoint: Neonatal Schedule- Day 0 (Cord blood), Week 14-16 (Before 4th dose) and Week 18-20. Infant Schedule- Week 6-8 (Before 1st dose and Week 18-20) | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate vaccine immunogenicity â?? anti-rotavirus immunoglobulin A(GMT, seroconversion, and seroresponse) of ROTAVAC® -20ï?°C and Rotavac 5CM administered at birth (neonatal schedule) and an additional dose (Group 1) compared with infant schedule (Group 2) during routine immunisation at specified timepointsTimepoint: For Neonates: Immunogenicity will be assessed at Day 0-5, week 14-16 and week 18-20. For Infants: Immunogenicity will be assessed at week 6-8 and week 18-20. | — |
Countries
India
Contacts
Public ContactDr Krishna Mohan
Bharat Biotech International Limited
Outcome results
None listed