None listed
Conditions
Interventions
Intervention1: Rotavirus vaccine: 3 Oral doses with 28 days interval between each doses
Control Intervention1: Placebo: Schedule matching with Rotavirus vaccine
Sponsors
Serum Institute of India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Healthy male or female infant 8-10 weeks of age at the time of first dose of vaccination and born after 37 weeks of gestation and birth weight of 2500g Written informed consent is obtained from the parent or legal guardian of the subject after nature of the study has been explained Subject along with their parent or legal guardian will be available for the follow-up throughout the study period. Access to telephone at home or in the immediate neighbourhood. Free of obvious health problems as established by medical history, clinical examination and laboratory tests before entering into the study The subjects will receive other childhood vaccines such as DTP, OPV, Hepatitis B vaccine, Haemophilus influenzae type b (Hib), BCG with at least 7 days separation from the first and subsequent dose of the study vaccine.
Exclusion criteria
Exclusion criteria: Subjects participating in any other clinical trial. Prior receipt of any rotavirus vaccine Fever at time of immunization. History of diarrhoea or blood in stool or abnormal stool pattern in past one week. A known sensitivity or allergy to any components of the study medication. History of chronic gastrointestinal disease, intussusceptions, gastrointestinal malformation or abdominal surgery. Presence of any significant systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) which would endanger the subject?s health or is likely to result in non conformance to the protocol. Major congenital or genetic defect. Has received immunosuppressant for more than 14 days or other immune-modifying drugs prior to the first vaccine dose. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection based on medical history and physical examination (no laboratory testing is required). Household contact with an immunosuppressed individual or pregnant woman. Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period. Subject is not suitable for inclusion in the study in the opinion of the investigator. Investigator site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted. Use of any investigational or non-registered drug other than the study vaccine(s) within 30 days preceding the first dose of the study vaccine or placebo, or planned use during the study period.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Rotavirus-specific IgA antibody titre [ At about 28 days after second and third doses of vaccine/ placebo ] Viral Shedding [ After each of the three doses of the vaccine/placebo ]Timepoint: At about 28 days after second and third doses of vaccine/ placebo After each of the three doses of the vaccine/placebo | — |
Primary
| Measure | Time frame |
|---|---|
| Occurrence of unsolicited and serious adverse eventsTimepoint: Post-dose 28 days after each of the three doses of study drug;Occurrence of unsolicited and serious adverse eventsTimepoint: Post-dose 28 days after each of the three doses of study drug | — |
Countries
India
Contacts
Public ContactDr Sajjad Desai
Outcome results
None listed