Safety and Immunogenicity Assessment of Rotavin-M1 in Vietnamese Children

The investigators evaluate the vaccine schedule consisting of 2 doses of Rotavin-M1, 10e6.3ffu/dose at 2 month interval in children in two study sites, Thanh Son- Phu Tho and Thai Binh city-Thai Binh provinces.

This vaccine dose and schedule was chosen based on results from the previous dose-escalating study (NCT01377571).

Inclusion criteria

At study entry

• A healthy male or female, 6 to 12 weeks of age (42 days to 84 days of age).
• Full term gestation (>=37 weeks).
• Birth weight of the subject should be >=2.5 kg.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Did not use any dose of Rota virus vaccine.
• Written informed consent obtained from the parent or guardian of the subject.

At dose 2

• Received dose 1.
• Oral informed consent obtained from the parent or guardian of the subject for continuing participate the study.

Exclusion criteria

At study entry

• Has a chronic disease (cardiovascular, liver, kidney disease).
• Acute disease at the time of enrolment.
• Administering corticosteroids (> 1mg/kg/day).
• Received any immunosuppressive therapy within 4 week before vaccination (Administration of immunoglobulins and/or any blood product or corticosteroids for >2 weeks).
• Immunosuppressive or immunodeficient condition.
• Family has immunosuppressive or immunodeficient condition medical history.
• History of high fever convulsion.
• Allergic or reaction with any component of vaccine, includes anaphylactic shock with any antibiotic.
• Preterm of gestation delivery (gestation period < 37 weeks).
• Low birth weight (<2.5 kg).
• Fever (axillary temperature >38oC) within 3 days before or on the day of vaccination.
• Malnutrition.
• Has any type of blood disorder, leukemia, or malignant tumor which can affect the bone marrow or lymph system.
• Use of any investigational or non-registered product (unlicensed drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.

At dose 2

• Acute disease at the time of 2nd dose.
• Administering corticosteroids (> 1mg/kg/day).
• Received any immunosuppressive therapy within 4 week before vaccination (Administration of immunoglobulins and/or any blood product or corticosteroids for >2 weeks).
• History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.
• Fever (axillary temperature >38oC) within 3 days before or on the day of vaccination.
• Has any type of blood disorder, leukemia, or malignant tumor which can affect the bone marrow or lymph system.
• Use of any investigational or non-registered product (unlicensed drug or vaccine) other than the study vaccine during the study period.