Safety and Immunogenicity Assessment of Rotavin-M1 in Vietnamese Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dang Duc Anh, National Institute of Hygiene and Epidemiology, Vietnam
ClinicalTrials.gov Identifier:
NCT01502969
First received: October 29, 2011
Last updated: December 30, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Diarrhea
Fever
Nausea
Vomit
Irritability
Biological: Rotavin-M1
Biological: cell culture medium in absence of virus
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 2b Study of Rotavin-M1 Vaccine in Vietnamese Children

Resource links provided by NLM:


Further study details as provided by National Institute of Hygiene and Epidemiology, Vietnam:

Primary Outcome Measures:
  • Anti-rotavirus IgA antibody responses 1 month after vaccination [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 12 year ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
    To assess anti-RV IgG antibody responses 1 year after the 1st dose of Rotavin-M1 (9 months after the 2nd dose)


Enrollment: 799
Study Start Date: May 2010
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Children receiving placebo (cell culture medium in absence of virus)
Biological: cell culture medium in absence of virus
Placebo
Active Comparator: Rotavirus vaccine
Rotavin-M1, 10e6.3ffu/dose, 2 doses
Biological: Rotavin-M1
liquid, 10e6ffu/dose, 2 doses, 2 month interval
Other Names:
  • KH0118
  • POLYVAC
  • G1P[8]

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

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01502969

Locations
Vietnam
Preventive Medicine Center
Thanh Son, Phu Tho, Vietnam
Thai Binh Preventive Medicine Center
Thai Binh, Vietnam
Sponsors and Collaborators
National Institute of Hygiene and Epidemiology, Vietnam
Investigators
Principal Investigator: Dang D Anh, PhD The National Institute of Hygiene and Epidemiology
  More Information

Publications:

Responsible Party: Dang Duc Anh, Deputy Director, National Institute of Hygiene and Epidemiology, Vietnam
ClinicalTrials.gov Identifier: NCT01502969     History of Changes
Other Study ID Numbers: Rotavin-M1-2b
Study First Received: October 29, 2011
Last Updated: December 30, 2011
Health Authority: Vietnam: Ministry of Health

Keywords provided by National Institute of Hygiene and Epidemiology, Vietnam:
diarrhea
fever
nausea
vomit
irritability

Additional relevant MeSH terms:
Diarrhea
Fever
Nausea
Signs and Symptoms, Digestive
Signs and Symptoms
Body Temperature Changes

ClinicalTrials.gov processed this record on April 20, 2014