Safety and Immunogenicity Assessment of Rotavin-M1 in Vietnamese Children

Study Overview
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Brief Summary
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This is a multiple-site phase 2b, randomized, placebo control study to evaluate the safety and immunogenicity of Rotavin-M1, produced by the Center for Research and Production of Vaccines and Biologicals, Vietnam.

Detailed Description
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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).

Official Title
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A Phase 2b Study of Rotavin-M1 Vaccine in Vietnamese Children

Conditions
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Diarrhea, Fever, Nausea, Vomit, Irritability

Intervention / Treatment
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* Biological: Rotavin-M1
* Biological: cell culture medium in absence of virus


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Weeks
Maximum Age: 12 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Children receiving placebo (cell culture medium in absence of virus) | Biological: cell culture medium in absence of virus<br>* Placebo<br>|
| Active Comparator: Rotavirus vaccine<br>Rotavin-M1, 10e6.3ffu/dose, 2 doses | Biological: Rotavin-M1<br>* liquid, 10e6ffu/dose, 2 doses, 2 month interval<br>* Other names: G1P[8];|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-rotavirus IgA antibody responses 1 month after vaccination | To assess IgA antibody responses 1 month after completing 2 doses of Rotavin-M1, 10e6.3ffu/dose | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RV-IgA antibody responses to Rotavin-M1 one year after 1st dose | to assess RV-IgA antibody responses 9 months after the last dose (i.e. 12 months after the 1st dose) | 12 year | 
| Anti-rotavirus IgG antibody responses 1 month after vaccination with Rotavin-M1 | to assess the anti-rotavirus IgG responses 1 month after completing 2 doses of Rotavin-M1 | 12 months | 
| safety and reactogenicity of each doses of Rotavin-M1, 10e6.3ffu/dose | to assess immediate reations (30 minutes) after administration of each dose of vaccine compared to placebo . To assess adverse events 30 days after each dose of vaccine and placebo, and serious adverse events 1 year after the 1st dose of vaccine and placebo | 12 months | 
| anti-RV IgG antibody responses 1 year after the 1st dose | To assess anti-RV IgG antibody responses 1 year after the 1st dose of Rotavin-M1 (9 months after the 2nd dose) | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diarrhea, fever, nausea, vomit, irritability