None listed
Conditions
Interventions
Intervention1: Rotavirus Vaccine: Single oral dose in Part I of the study and three doses in Part II of the study
Control Intervention1: Placebo: Schedule matching with Rotavirus vaccine
Sponsors
Serum Institute of India Pune India
Eligibility
Inclusion criteria
Inclusion criteria: The subjects will be enrolled in the study, if they meet all the following criteria: (1) Healthy adult male and 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 (for Group I); (2) Healthy toddlers male and female subjects aged between 2-5 years and normal weight for age (for Group II); (3) Healthy infants male and female subjects aged between 8-10 weeks of age at the time of vaccination and are born with more than 37 week gestation and birth weight 2500 gm or above (for Group III); (4) Normal health as determined by medical history, clinical examination and laboratory assessment; (5) Subjects or parent/guardian of subjects willing to adhere to the protocol requirements and to provide written informed consent; (6) Subjects or parent/guardian of subjects will be available for the follow-up throughout the study period; (7) Has Access to telephone at home or in the immediate neighbourhood; (8) Normal 12-lead electrocardiogram (ECG) and chest X-Ray (PA view) (for Group I); (9) Female subjects who are either currently using reliable methods of birth control, have a negative pregnancy test during screening & prior to vaccine administration and agree to avoid pregnancy during participation in the study (for Group I); (10) Negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine) (for Group I).
Exclusion criteria
Exclusion criteria: The subjects will not be enrolled in the study, if they meet any of the following criteria: (1) Prior receipt of any rotavirus vaccine; (2) Fever at time of immunisation; (3) History of diarrhoea or blood in stool or abnormal stool pattern in past one week; (4) A known sensitivity or allergy to any components of the study medication; (5) History or presence of asthma, urticaria or other allergic reaction; (6) History of chronic gastrointestinal disease, intussusceptions, gastrointestinal malformation or abdominal surgery; (7) Presence of any significant systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) which would endanger the subjects health or is likely to result in non conformance to the protocol; (8) Major congenital or genetic defect; (9) Has received immunosuppressant for more than 14 days or other immune-modifying drugs; (10) Has any confirmed or suspected immunosuppressive or immunodeficiency condition; (11) Household contact with an immunosuppressed individual or pregnant woman; (12) Has received any immunoglobulin therapy or blood products prior to start of study; (13) 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; (14) Subjects participating in any other clinical trial; (15) Participation in a drug research study within past 3 months; (16) Subject is not suitable for inclusion in the study in the opinion of the investigator; (17) 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; (18) Blood donation within the last 3 months (for Group I); (19) History or presence of significant alcoholism or drug abuse in the past one year (applicable to adults) (for Group I); (20) Subject have received any other vaccine within the past 7 days preceding the study vaccine administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Occurrence of any solicited symptom within 7-day solicited follow-up period.Timepoint: Post-dose 7 days;1. Occurrence of any solicited symptom within 7-day solicited follow-up period.Timepoint: Post-dose 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rotavirus-specific IgA antibody titre.Timepoint: Screening and Day 28;2. Presence of rotavirus antigen in any diarrhoeal stools during the 7-day solicited follow-up period.Timepoint: Post-dose | — |
Countries
India
Contacts
Public ContactDr Sajjad Desai
Deputy Medical Director
Outcome results
None listed