Safety and Immunogenicity Assessment of Rotavin-M1 in Vietnamese Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

799 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-10-31

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.

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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).

Conditions

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Diarrhea Fever Nausea Vomit Irritability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Placebo

Children receiving placebo (cell culture medium in absence of virus)

Group Type PLACEBO_COMPARATOR

cell culture medium in absence of virus

Intervention Type BIOLOGICAL

Placebo

Rotavirus vaccine

Rotavin-M1, 10e6.3ffu/dose, 2 doses

Group Type ACTIVE_COMPARATOR

Rotavin-M1

Intervention Type BIOLOGICAL

liquid, 10e6ffu/dose, 2 doses, 2 month interval

Interventions

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Rotavin-M1

liquid, 10e6ffu/dose, 2 doses, 2 month interval

Intervention Type BIOLOGICAL

cell culture medium in absence of virus

Placebo

Intervention Type BIOLOGICAL

Other Intervention Names

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KH0118 POLYVAC G1P[8]

Eligibility Criteria

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Inclusion Criteria

At study entry

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

At dose 2

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

Exclusion Criteria

At study entry

1. Has a chronic disease (cardiovascular, liver, kidney disease).
2. Acute disease at the time of enrolment.
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. Family has immunosuppressive or immunodeficient condition medical history.
7. History of high fever convulsion.
8. Allergic or reaction with any component of vaccine, includes anaphylactic shock with any antibiotic.
9. Preterm of gestation delivery (gestation period \< 37 weeks).
10. Low birth weight (\<2.5 kg).
11. Fever (axillary temperature \>38oC) within 3 days before or on the day of vaccination.
12. Malnutrition.
13. Has any type of blood disorder, leukemia, or malignant tumor which can affect the bone marrow or lymph system.
14. 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

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

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes