A Phase 2 interventional study of Rotarix in Diarrhea, Fever and Nausea, sponsored by National Institute of Hygiene and Epidemiology, Vietnam. Completed at 1 site in Vietnam. Open to participants aged 6 Weeks to 12 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-04.
Sponsored by National Institute of Hygiene and Epidemiology, Vietnam · Phase 2 and Interventional
The purpose of this study is to evaluate the safety and immunogenicity of Rotavin-M1 produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in infants in Vietnam. In addition, we evaluate different dosages and schedules to determine the best regimen to test in a clinical trial.
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 passages and plaque purification in qualified Vero cells under GLP conditions.
877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.
This study's enrollment of 200 is above 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
At dose 2
At dose 3
Exclusion Criteria:
At dose 1
At dose 2
At dose 3
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.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
2 doses of Rotavin-M1 vaccine, 106.3FFU/dose, 2-month separation between doses
Biological: Rotarix
2 doses of Rotavin-M1 vaccine, 106.0FFU/dose, 2-month interval between doses
Biological: Rotarix
3 doses of Rotavin-M1 vaccine, 106.3FFU/dose, 1-month interval between doses
Biological: Rotarix
3 doses of Rotavin-M1, 106.0FFU/dose, 1-month interval between doses
Biological: Rotarix
2 doses of Rotarix vaccine, 106.5CID/dose, 1-month interval between doses
Also known as: RotarixTM, GSK biologicals
To assess immunogenicity of a new rotavirus vaccine Rotavin-M1 in terms of anti-rotavirus IgA antibody seroconversion 1 month after complete the vaccination schedule
To assess immunogenicity of Rotavin-M1 of 2 titers (10e6.0 and 10e6.3FFU/dose) and 2 schedules (3 doses and 1-month interval between vs 2 doses and 2-month interval between doses), compared with 2 doses GSK's lyophilized Rotarix (10e6.5 CID50/dose).
Time frame: up to 7 months
To assess immunogenicity of Rotavin-M1 vaccine versus GSK Biologicals' HRV vaccine in terms of anti-rotavirus IgA antibody seroconversion at Month 2 in the group receiving the vaccines.
To assess immunogenicity of Rotavin-M1 vaccine (of different dosages and schedules) versus GSK Biologicals' HRV vaccine in terms of anti-rotavirus IgA antibody seroconversion at Month 2 in the group receiving the vaccines.
Time frame: up to 7 months
To assess immunogenicity of Rotavin-M1 vaccine versus GSK Biologicals' HRV vaccine in terms of anti-rotavirus IgA antibody GMT at Month 2 in the group receiving the vaccines.
To assess immunogenicity of Rotavin-M1 vaccine (of different dosages and schedules) versus GSK Biologicals' HRV vaccine in terms of anti-rotavirus IgA antibody GMT at Month 2 in the group receiving the vaccines.
Time frame: up to 7 months
To assess immunogenicity of Rotavin-M1 vaccine versus GSK Biologicals' HRV vaccine in terms of anti-rotavirus IgA antibody GMT at Month 3 in the group receiving the vaccines.
To assess immunogenicity of Rotavin-M1 vaccine (of different dosages and schedules) versus GSK Biologicals' HRV vaccine in terms of anti-rotavirus IgA antibody GMT at Month 3 in the group receiving the vaccines.
Time frame: up to 7 months
To assess the safety and reactogenicity of each dose of Rotavin-M1 versus GSK's biologicals Rotarix
To assess immediate reactions (30minutes) after administration of each dose To assess adverse events 30 days after each dose To assess change in blood cell counts (red blood cells, white blood cells, platelets), blood urea nitrogen concentration, transaminase concentration (ALT, AST)
Time frame: up to 7 months
To assess the presence of rotavirus (RV) in GE stools collected after administration of first dose of the study vaccine up to 1 month after the last dose.
To assess the presence of rotavirus (RV) in GE stools collected after administration of the first dose of the study vaccine up to 1 month after the last dose.
Time frame: up to 7 months
To assess the shedding of rotavirus (RV) in stools collected daily for 7 days after administration of each dose of the study vaccine.
To assess the shedding of rotavirus (RV) in stools collected daily for 7 days after administration of each dose of the study vaccine
Time frame: up to 7 months
To compare the RV antibody titers 1 year after the first doses between one Rotavin-M1 group and Rotarix
To assess the RV antibody titers 1 year after the 1st dose between Rotavin-M1 group (106.3FFU/dose, 2 doses, 2-month interval) and Rotarix group (106.0CID/dose, 2 doses, 1-month interval between doses).
Time frame: up to 15 months
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: RIX4414 vaccine
National Institute of Hygiene and Epidemiology, Vietnam