Clinical trial NCT01502969: Safety and Immunogenicity Assessment of Rotavin-M1 in Vietnamese Children
Official title: A Phase 2b Study of Rotavin-M1 Vaccine in Vietnamese Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diarrhea
Fever
Nausea
Vomit
Irritability
Keywords: diarrhea
fever
nausea
vomit
irritability
Lead sponsor: National Institute of Hygiene and Epidemiology, Vietnam
Sponsor class: OTHER
First posted: 2012-01-02
Enrollment: 799
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Anti-rotavirus IgA antibody responses 1 month after vaccination
timeFrame: 12 months
Secondary outcomes:
measure: RV-IgA antibody responses to Rotavin-M1 one year after 1st dose
timeFrame: 12 year
measure: Anti-rotavirus IgG antibody responses 1 month after vaccination with Rotavin-M1
timeFrame: 12 months
measure: safety and reactogenicity of each doses of Rotavin-M1, 10e6.3ffu/dose
timeFrame: 12 months
measure: anti-RV IgG antibody responses 1 year after the 1st dose
timeFrame: 12 month
Other outcomes:
Locations:
city: Thanh Son
country: Vietnam
facility: Preventive Medicine Center
state: Phu Tho
city: Thai Binh
country: Vietnam
facility: Thai Binh Preventive Medicine Center
Study officials:
affiliation: The National Institute of Hygiene and Epidemiology
name: Dang D Anh, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.