- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01377571
A Dose-escalating Study to Evaluate the Immunogenicity and Safety of Rotavin-M1 Vaccine in Healthy Infants
A Phase II, Randomized, Double-blind, Vaccine-controlled Dose-escalating Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Oral Live Attenuated Human Rotavirus (HRV) Vaccine (Rotavin-M1) in Healthy Infants in Vietnam
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Phu Tho
-
Thanh Son, Phu Tho, Vietnam
- Preventive Medicine Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
At dose 1
- 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.
At dose 3
- Received both dose 1 and dose 2.
- Oral informed consent obtained from the parent or guardian of the subject for continuing participate the study.
Exclusion Criteria:
At dose 1
- 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.
At dose 3
- Acute disease at the time of 3rd 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.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rotavin2H
2 doses of Rotavin-M1 vaccine, 106.3FFU/dose, 2-month separation between doses
|
2 doses of Rotarix vaccine, 106.5CID/dose, 1-month interval between doses
Other Names:
|
Experimental: Rotavin2L
2 doses of Rotavin-M1 vaccine, 106.0FFU/dose, 2-month interval between doses
|
2 doses of Rotarix vaccine, 106.5CID/dose, 1-month interval between doses
Other Names:
|
Experimental: Rotavin3H
3 doses of Rotavin-M1 vaccine, 106.3FFU/dose, 1-month interval between doses
|
2 doses of Rotarix vaccine, 106.5CID/dose, 1-month interval between doses
Other Names:
|
Experimental: Rotavin3L
3 doses of Rotavin-M1, 106.0FFU/dose, 1-month interval between doses
|
2 doses of Rotarix vaccine, 106.5CID/dose, 1-month interval between doses
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: up to 7 months
|
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).
|
up to 7 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: up to 7 months
|
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.
|
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.
Time Frame: up to 7 months
|
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.
|
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.
Time Frame: up to 7 months
|
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.
|
up to 7 months
|
To assess the safety and reactogenicity of each dose of Rotavin-M1 versus GSK's biologicals Rotarix
Time Frame: up to 7 months
|
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)
|
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.
Time Frame: up to 7 months
|
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.
|
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.
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
|
up to 7 months
|
To compare the RV antibody titers 1 year after the first doses between one Rotavin-M1 group and Rotarix
Time Frame: up to 15 months
|
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).
|
up to 15 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Anh D Dang, PhD., The National Institute of Hygiene and Epidemiology
- Principal Investigator: Thiem D Vu, MD., PhD., The National Institute of Hygiene and Epidemiology
Publications and helpful links
General Publications
- Anh DD, Thiem VD, Fischer TK, Canh DG, Minh TT, Tho le H, Van Man N, Luan le T, Kilgore P, von Seidlein L, Glass RI. The burden of rotavirus diarrhea in Khanh Hoa Province, Vietnam: baseline assessment for a rotavirus vaccine trial. Pediatr Infect Dis J. 2006 Jan;25(1):37-40. doi: 10.1097/01.inf.0000195635.05186.52.
- Van Man N, Luan le T, Trach DD, Thanh NT, Van Tu P, Long NT, Anh DD, Fischer TK, Ivanoff B, Gentsch JR, Glass RI; Vietnam Rotavirus Surveillance Network. Epidemiological profile and burden of rotavirus diarrhea in Vietnam: 5 years of sentinel hospital surveillance, 1998-2003. J Infect Dis. 2005 Sep 1;192 Suppl 1:S127-32. doi: 10.1086/431501.
- Ngo TC, Nguyen BM, Dang DA, Nguyen HT, Nguyen TT, Tran VN, Vu TT, Ogino M, Alam MM, Nakagomi T, Nakagomi O, Yamashiro T. Molecular epidemiology of rotavirus diarrhoea among children in Haiphong, Vietnam: the emergence of G3 rotavirus. Vaccine. 2009 Nov 20;27 Suppl 5:F75-80. doi: 10.1016/j.vaccine.2009.08.074.
- Nguyen TA, Yagyu F, Okame M, Phan TG, Trinh QD, Yan H, Hoang KT, Cao AT, Le Hoang P, Okitsu S, Ushijima H. Diversity of viruses associated with acute gastroenteritis in children hospitalized with diarrhea in Ho Chi Minh City, Vietnam. J Med Virol. 2007 May;79(5):582-90. doi: 10.1002/jmv.20857.
- Kim SY, Goldie SJ, Salomon JA. Cost-effectiveness of Rotavirus vaccination in Vietnam. BMC Public Health. 2009 Jan 21;9:29. doi: 10.1186/1471-2458-9-29.
- Luan le T, Trang NV, Phuong NM, Nguyen HT, Ngo HT, Nguyen HT, Tran HB, Dang HN, Dang AD, Gentsch JR, Wang Y, Esona MD, Glass RI, Steele AD, Kilgore PE, Nguyen MV, Jiang B, Nguyen HD. Development and characterization of candidate rotavirus vaccine strains derived from children with diarrhoea in Vietnam. Vaccine. 2009 Nov 20;27 Suppl 5:F130-8. doi: 10.1016/j.vaccine.2009.08.086.
- Dang DA, Nguyen VT, Vu DT, Nguyen TH, Nguyen DM, Yuhuan W, Baoming J, Nguyen DH, Le TL; Rotavin-M1 Vaccine Trial Group. A dose-escalation safety and immunogenicity study of a new live attenuated human rotavirus vaccine (Rotavin-M1) in Vietnamese children. Vaccine. 2012 Apr 27;30 Suppl 1:A114-21. doi: 10.1016/j.vaccine.2011.07.118.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Rotavin02
- KC.10.33/06-10 (Other Grant/Funding Number: The Ministry of Science and Technology, Vietnam)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nausea
-
University of North Carolina, Chapel HillNational Institute of Dental and Craniofacial Research (NIDCR)CompletedPost-operative Nausea | Post-operative Vomiting | Nausea PersistentUnited States
-
Cukurova UniversityTarsus UniversityRecruitingNausea, Postoperative | Vomiting, Postoperative | APFEL RİSK SCORETurkey
-
MonoSol RxCompletedNausea With Vomiting Chemotherapy-Induced | Nausea and Vomiting, PostoperativeIndia
-
GlaxoSmithKlineCompletedPostoperative Nausea and Vomiting | Nausea and Vomiting, PostoperativeUnited States, Spain, Philippines, Israel, Hong Kong, Thailand, United Kingdom, Hungary, Slovenia, Norway, Denmark
-
Hoffmann-La RocheCompletedPost-Operative Nausea and VomitingUnited States
-
Cairo UniversityUnknownPost Operative Nausea and VomitingEgypt
-
Yonsei UniversityCompletedPost Operative Nausea and VomitingKorea, Republic of
-
Lancaster General HospitalCompletedBariatric Surgery Candidate | Nausea, PostoperativeUnited States
-
AccentureCompletedPost-Operative Nausea and Vomiting (PONV)Australia
-
Blokhin's Russian Cancer Research CenterRUSSCO/RakFondUnknownChemotherapy-induced Nausea and Vomiting | Nausea | Vomiting | Emesis | Nausea Post ChemotherapyRussian Federation
Clinical Trials on Rotarix
-
International Centre for Diarrhoeal Disease Research...PATHCompletedRotavirus GastroenteritisBangladesh
-
University of VermontInternational Centre for Diarrhoeal Disease Research, Bangladesh; Thrasher... and other collaboratorsCompletedRotavirus Infection | Vaccine Response Impaired | Vaccine Virus SheddingBangladesh
-
GlaxoSmithKlineCompletedInfections, RotavirusKorea, Republic of
-
Telethon Kids InstituteMenzies School of Health ResearchActive, not recruitingViral Gastroenteritis Due to RotavirusAustralia
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineCompletedInfections, Rotavirus | Rotavirus VaccinesJapan
-
GlaxoSmithKlineCompleted
-
GlaxoSmithKlineCompletedInfections, RotavirusMexico, Colombia, Peru