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Safety and Immunogenicity Assessment of Rotavin-M1 in Vietnamese Children (Rotavin-M1)

Primary Purpose

Diarrhea, Fever, Nausea

Status
Completed
Phase
Phase 2
Locations
Vietnam
Study Type
Interventional
Intervention
Rotavin-M1
cell culture medium in absence of virus
Sponsored by
National Institute of Hygiene and Epidemiology, Vietnam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diarrhea focused on measuring diarrhea, fever, nausea, vomit, irritability

Eligibility Criteria

6 Weeks - 12 Weeks (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Preventive Medicine Center
  • Thai Binh Preventive Medicine Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Rotavirus vaccine

Arm Description

Children receiving placebo (cell culture medium in absence of virus)

Rotavin-M1, 10e6.3ffu/dose, 2 doses

Outcomes

Primary Outcome Measures

Anti-rotavirus IgA antibody responses 1 month after vaccination
To assess IgA antibody responses 1 month after completing 2 doses of Rotavin-M1, 10e6.3ffu/dose

Secondary Outcome Measures

RV-IgA antibody responses to Rotavin-M1 one year after 1st dose
to assess RV-IgA antibody responses 9 months after the last dose (i.e. 12 months after the 1st dose)
Anti-rotavirus IgG antibody responses 1 month after vaccination with Rotavin-M1
to assess the anti-rotavirus IgG responses 1 month after completing 2 doses of Rotavin-M1
safety and reactogenicity of each doses of Rotavin-M1, 10e6.3ffu/dose
to assess immediate reations (30 minutes) after administration of each dose of vaccine compared to placebo . To assess adverse events 30 days after each dose of vaccine and placebo, and serious adverse events 1 year after the 1st dose of vaccine and placebo
anti-RV IgG antibody responses 1 year after the 1st dose
To assess anti-RV IgG antibody responses 1 year after the 1st dose of Rotavin-M1 (9 months after the 2nd dose)

Full Information

First Posted
October 29, 2011
Last Updated
December 30, 2011
Sponsor
National Institute of Hygiene and Epidemiology, Vietnam
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1. Study Identification

Unique Protocol Identification Number
NCT01502969
Brief Title
Safety and Immunogenicity Assessment of Rotavin-M1 in Vietnamese Children
Acronym
Rotavin-M1
Official Title
A Phase 2b Study of Rotavin-M1 Vaccine in Vietnamese Children
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Hygiene and Epidemiology, Vietnam

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, Fever, Nausea, Vomit, Irritability
Keywords
diarrhea, fever, nausea, vomit, irritability

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
799 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Children receiving placebo (cell culture medium in absence of virus)
Arm Title
Rotavirus vaccine
Arm Type
Active Comparator
Arm Description
Rotavin-M1, 10e6.3ffu/dose, 2 doses
Intervention Type
Biological
Intervention Name(s)
Rotavin-M1
Other Intervention Name(s)
KH0118, POLYVAC, G1P[8]
Intervention Description
liquid, 10e6ffu/dose, 2 doses, 2 month interval
Intervention Type
Biological
Intervention Name(s)
cell culture medium in absence of virus
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Anti-rotavirus IgA antibody responses 1 month after vaccination
Description
To assess IgA antibody responses 1 month after completing 2 doses of Rotavin-M1, 10e6.3ffu/dose
Time Frame
12 months
Secondary Outcome Measure Information:
Title
RV-IgA antibody responses to Rotavin-M1 one year after 1st dose
Description
to assess RV-IgA antibody responses 9 months after the last dose (i.e. 12 months after the 1st dose)
Time Frame
12 year
Title
Anti-rotavirus IgG antibody responses 1 month after vaccination with Rotavin-M1
Description
to assess the anti-rotavirus IgG responses 1 month after completing 2 doses of Rotavin-M1
Time Frame
12 months
Title
safety and reactogenicity of each doses of Rotavin-M1, 10e6.3ffu/dose
Description
to assess immediate reations (30 minutes) after administration of each dose of vaccine compared to placebo . To assess adverse events 30 days after each dose of vaccine and placebo, and serious adverse events 1 year after the 1st dose of vaccine and placebo
Time Frame
12 months
Title
anti-RV IgG antibody responses 1 year after the 1st dose
Description
To assess anti-RV IgG antibody responses 1 year after the 1st dose of Rotavin-M1 (9 months after the 2nd dose)
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: At study entry 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. Exclusion Criteria: At study entry 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dang D Anh, PhD
Organizational Affiliation
The National Institute of Hygiene and Epidemiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Preventive Medicine Center
City
Thanh Son
State/Province
Phu Tho
Country
Vietnam
Facility Name
Thai Binh Preventive Medicine Center
City
Thai Binh
Country
Vietnam

12. IPD Sharing Statement

Citations:
PubMed Identifier
16395100
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.
Results Reference
background
PubMed Identifier
17385670
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.
Results Reference
background
PubMed Identifier
19931725
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.
Results Reference
background
PubMed Identifier
16088796
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.
Results Reference
background
PubMed Identifier
19159483
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.
Results Reference
background
PubMed Identifier
19931712
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.
Results Reference
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Safety and Immunogenicity Assessment of Rotavin-M1 in Vietnamese Children

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