A Phase 1 interventional study of Rotavin in Diarrhea, Vomit and Fever, sponsored by National Institute of Hygiene and Epidemiology, Vietnam. Completed at 1 site in Vietnam. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-04.
Sponsored by National Institute of Hygiene and Epidemiology, Vietnam · Phase 1 and Interventional
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.
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
877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.
This study's enrollment of 29 is below the median of 137 across 738 interventional studies indexed under Diarrhea.
Browse Diarrhea studies →National Institute of Hygiene and Epidemiology, Vietnam is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
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At dose 1
Exclusion Criteria:
At dose 1
At dose 2
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Rotavin-M1 vaccine, 10e6.3FFU/dose, 2 doses, 1 month between doses
Drug: Rotavin
Rotavin-M1, 10e6.3FFU/dose, 2 doses, 1-month between doses
Also known as: Rotavin-M1
Safety of Rotavin-M1 vaccine in healthy adult volunteers
To evaluate the safety of 2 doses Rotavin-M1 vaccine (10e6.3FFU/dose, 1-month interval between doses) in healthy adult volunteers.
Time frame: 3 months
Reactogenicity of Rotavin-M1 in healthy adult volunteer
To evaluate immediate reactions (30 minutes) after administration of each dose
Time frame: 3 months
Change in blood cell counts, serum transaminase and urea nitrogen concentration in adults after vaccination with Rotavin-M1
to assess change in blood cell counts (red blood cells, white blood cells, platelets), blood urea nitrogen concentration, serum transaminase levels (AST, ALT) in adult volunteer after each dose of Rotavin-M1 10e6.3FFU/dose
Time frame: 3 months
The record gives a start of Aug 2009, a primary completion of Oct 2009 and a completion of Oct 2009. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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National Institute of Hygiene and Epidemiology, Vietnam