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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Dose-escalating Study to Evaluate the Immunogenicity and Safety of Rotavin-M1 Vaccine in Healthy Infants

NCT01377571

Diarrhea Fever Nausea +2 more

COMPLETED PHASE2

Safety and Immunogenicity Assessment of Rotavin-M1 in Vietnamese Children

NCT01502969

Diarrhea Fever Nausea +2 more

COMPLETED PHASE2/PHASE3

Phase III Study of Liquid Formulation of ROTAVIN

NCT03703336

Diarrhea Diarrhea Rotavirus

COMPLETED PHASE3

Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac® in Healthy Infants Aged Between 6-8 Weeks in Vietnam

NCT03367559

Rotavirus Infections

UNKNOWN PHASE3

Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac in Healthy Infants in Vietnam

NCT04596696

Rotavirus Gastroenteritis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Rotavirus (RV) is the most important cause of acute gastroenteritis in children worldwide. In Vietnam rotavirus causes an estimated 122,000-140,000 hospitalizations and 2900-5400 deaths per year among children under 5 years of age (1). Over the past 13 years, sentinel hospital surveillance identified rotavirus in 44%-62% of children admitted for the treatment of acute diarrhea in Vietnam (2-4). Such a high burden of disease justified accelerated development of a new and locally manufactured vaccine against rotavirus in Vietnam. It is estimated that if a vaccine was introduced in the current childhood immunization schedule, it could reduce severe rotavirus disease by about 60% or more given current vaccine efficacies and coverage (5).

The Government of Vietnam has pursued a policy to encourage local vaccine production so the country could be self-reliant with affordable vaccines for its population (6). Over the past decades, several locally produced vaccines for poliomyelitis, cholera, Japanese encephalitis, and Diphtheria-Pertussis-Tetanus have contributed to the reduction in the prevalence of these diseases and to the eradication of polio over the past decade. While two commercial rotavirus vaccines, RotarixTM (GSK, Belgium) and RotaTeq® (Merck), have both been tested in Vietnam, neither is currently available at an affordable cost for the national program. Therefore, the candidate vaccine, Rotavin-M1, was developed in order to fill this need for a more affordable vaccine for Vietnamese children (6). This vaccine is similar to RotarixTM, and was developed by selecting a common G1P\[8\] strain and attenuating it through serial

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diarrhea Vomit Fever Nausea Irritability

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rotavin

Rotavin-M1 vaccine, 10e6.3FFU/dose, 2 doses, 1 month between doses

Group Type EXPERIMENTAL

Rotavin

Intervention Type DRUG

Rotavin-M1, 10e6.3FFU/dose, 2 doses, 1-month between doses

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rotavin

Rotavin-M1, 10e6.3FFU/dose, 2 doses, 1-month between doses

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Rotavin-M1

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes