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

December 30, 2011 updated by: Dang Duc Anh, National Institute of Hygiene and Epidemiology, Vietnam

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

799

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Thai Binh, Vietnam
        • Thai Binh Preventive Medicine Center
    • Phu Tho
      • Thanh Son, Phu Tho, Vietnam
        • Preventive Medicine Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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]

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-rotavirus IgA antibody responses 1 month after vaccination
Time Frame: 12 months
To assess IgA antibody responses 1 month after completing 2 doses of Rotavin-M1, 10e6.3ffu/dose
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RV-IgA antibody responses to Rotavin-M1 one year after 1st dose
Time Frame: 12 year
to assess RV-IgA antibody responses 9 months after the last dose (i.e. 12 months after the 1st dose)
12 year
Anti-rotavirus IgG antibody responses 1 month after vaccination with Rotavin-M1
Time Frame: 12 months
to assess the anti-rotavirus IgG responses 1 month after completing 2 doses of Rotavin-M1
12 months
safety and reactogenicity of each doses of Rotavin-M1, 10e6.3ffu/dose
Time Frame: 12 months
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
12 months
anti-RV IgG antibody responses 1 year after the 1st dose
Time Frame: 12 month
To assess anti-RV IgG antibody responses 1 year after the 1st dose of Rotavin-M1 (9 months after the 2nd dose)
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Hygiene and Epidemiology, Vietnam

Investigators

  • Principal Investigator: Dang D Anh, PhD, The National Institute of Hygiene and Epidemiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

September 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

October 29, 2011

First Submitted That Met QC Criteria

December 30, 2011

First Posted (ESTIMATE)

January 2, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 2, 2012

Last Update Submitted That Met QC Criteria

December 30, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rotavin-M1-2b

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.

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