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

October 29, 2011
December 30, 2011
May 2010
September 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01502969 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Safety and Immunogenicity Assessment of Rotavin-M1 in Vietnamese Children
A Phase 2b Study of Rotavin-M1 Vaccine in Vietnamese Children

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.

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).

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
  • Diarrhea
  • Fever
  • Nausea
  • Vomit
  • Irritability
  • Biological: Rotavin-M1
    liquid, 10e6ffu/dose, 2 doses, 2 month interval
    Other Names:
    • KH0118
    • POLYVAC
    • G1P[8]
  • Biological: cell culture medium in absence of virus
    Placebo
  • Placebo Comparator: Placebo
    Children receiving placebo (cell culture medium in absence of virus)
    Intervention: Biological: cell culture medium in absence of virus
  • Active Comparator: Rotavirus vaccine
    Rotavin-M1, 10e6.3ffu/dose, 2 doses
    Intervention: Biological: Rotavin-M1

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
799
October 2011
September 2011   (final data collection date for primary outcome measure)

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.
Both
6 Weeks to 12 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
Vietnam
 
NCT01502969
Rotavin-M1-2b
Yes
Dang Duc Anh, National Institute of Hygiene and Epidemiology, Vietnam
National Institute of Hygiene and Epidemiology, Vietnam
Not Provided
Principal Investigator: Dang D Anh, PhD The National Institute of Hygiene and Epidemiology
National Institute of Hygiene and Epidemiology, Vietnam
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP