Safety Study of a Rotavirus Vaccine (Rotavin-M1) Among Healthy Adults

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety of Rotavin-M1 produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in adult volunteers in Vietnam.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Hygiene and Epidemiology, Vietnam
• Collaborator: Center for Research and Production of Vaccines and Biologicals
• Treatments: Vaccines

Criteria

Inclusion Criteria:

At dose 1

• Healthy male or female, 18 to 40 years of age,

• Free of disease,

• Written informed consent obtained from subjects. At dose 2

• Received dose 1.

• Oral informed consent obtained from subject for continuing participate the study.

Exclusion Criteria:

At dose 1

1. Pregnant woman or planning to be pregnant during the study period.

2. Has a chronic disease (cardiovascular, liver, kidney disease).

3. Acute disease at the time of enrolment.

4. Administering corticosteroids (> 1mg/kg/day).

5. Received any immunosuppressive therapy within 4 week before vaccination (Administration of immunoglobulins and/or any blood product or corticosteroids for >2 weeks).

6. Immunosuppressive or immunodeficient condition.

7. Allergic or reaction with any component of vaccine, includes anaphylactic and shock with any antibiotic.

8. Fever (axillary temperature >38oC) within 3 days before or on the day of vaccination.

9. Has any type of blood disorder, leukemia, or malignant tumor which can affect the bone marrow or lymph system.

10. Use of any investigational or non-registered product (unlicensed drug or vaccine) other than the study vaccine during the study period.

At dose 2

1. Pregnant woman or planning to be pregnant in next 1 month.

2. Acute disease at the time of 2nd dose.

3. Administering corticosteroids (> 1mg/kg/day).

4. Received any immunosuppressive therapy within 4 week before vaccination (administration of immunoglobulins and/or any blood product or corticosteroids for >2 weeks).

5. Immunosuppressive or immunodeficient condition.

6. History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.

7. Fever (axillary temperature >38oC) within 3 days before or on the day of vaccination.

8. Has any type of blood disorder, leukemia, or malignant tumor which can affect the bone marrow or lymph system.

9. Use of any investigational or non-registered product (unlicensed drug or vaccine) other than the study vaccine during the study period.