NCT01377571

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of Rotavin-M1 produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in infants in Vietnam. In addition, we evaluate different dosages and schedules to determine the best regimen to test in a clinical trial.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 21, 2011

Completed
Last Updated

July 4, 2016

Status Verified

June 1, 2016

Enrollment Period

5 months

First QC Date

May 19, 2011

Last Update Submit

June 30, 2016

Conditions

DiarrheaFeverNauseaVomitIrritability

Keywords

diarrheafevernauseavomitirritability

Outcome Measures

Primary Outcomes (1)

  • To assess immunogenicity of a new rotavirus vaccine Rotavin-M1 in terms of anti-rotavirus IgA antibody seroconversion 1 month after complete the vaccination schedule

    To assess immunogenicity of Rotavin-M1 of 2 titers (10e6.0 and 10e6.3FFU/dose) and 2 schedules (3 doses and 1-month interval between vs 2 doses and 2-month interval between doses), compared with 2 doses GSK's lyophilized Rotarix (10e6.5 CID50/dose).

    up to 7 months

Secondary Outcomes (7)

  • To assess immunogenicity of Rotavin-M1 vaccine versus GSK Biologicals' HRV vaccine in terms of anti-rotavirus IgA antibody seroconversion at Month 2 in the group receiving the vaccines.

    up to 7 months

  • To assess immunogenicity of Rotavin-M1 vaccine versus GSK Biologicals' HRV vaccine in terms of anti-rotavirus IgA antibody GMT at Month 2 in the group receiving the vaccines.

    up to 7 months

  • To assess immunogenicity of Rotavin-M1 vaccine versus GSK Biologicals' HRV vaccine in terms of anti-rotavirus IgA antibody GMT at Month 3 in the group receiving the vaccines.

    up to 7 months

  • To assess the safety and reactogenicity of each dose of Rotavin-M1 versus GSK's biologicals Rotarix

    up to 7 months

  • To assess the presence of rotavirus (RV) in GE stools collected after administration of first dose of the study vaccine up to 1 month after the last dose.

    up to 7 months

  • +2 more secondary outcomes

Study Arms (4)

Rotavin2H

EXPERIMENTAL

2 doses of Rotavin-M1 vaccine, 106.3FFU/dose, 2-month separation between doses

Biological: Rotarix

Rotavin2L

EXPERIMENTAL

2 doses of Rotavin-M1 vaccine, 106.0FFU/dose, 2-month interval between doses

Biological: Rotarix

Rotavin3H

EXPERIMENTAL

3 doses of Rotavin-M1 vaccine, 106.3FFU/dose, 1-month interval between doses

Biological: Rotarix

Rotavin3L

EXPERIMENTAL

3 doses of Rotavin-M1, 106.0FFU/dose, 1-month interval between doses

Biological: Rotarix

Interventions

RotarixBIOLOGICAL

2 doses of Rotarix vaccine, 106.5CID/dose, 1-month interval between doses

Also known as: RotarixTM, GSK biologicals
Rotavin2HRotavin2LRotavin3HRotavin3L

Eligibility Criteria

Age6 Weeks - 12 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • At dose 1
  • 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.
  • At dose 3
  • Received both dose 1 and dose 2.
  • Oral informed consent obtained from the parent or guardian of the subject for continuing participate the study.

You may not qualify if:

  • At dose 1
  • 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.
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Preventive Medicine center

Thanh Sơn, Phu Tho, Vietnam

Location

Related Publications (7)

  • 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.

    PMID: 16395100BACKGROUND

  • 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.

    PMID: 16088796BACKGROUND

  • 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.

    PMID: 19931725BACKGROUND

  • 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.

    PMID: 17385670BACKGROUND

  • 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.

    PMID: 19159483BACKGROUND

  • 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.

    PMID: 19931712BACKGROUND

  • Dang DA, Nguyen VT, Vu DT, Nguyen TH, Nguyen DM, Yuhuan W, Baoming J, Nguyen DH, Le TL; Rotavin-M1 Vaccine Trial Group. A dose-escalation safety and immunogenicity study of a new live attenuated human rotavirus vaccine (Rotavin-M1) in Vietnamese children. Vaccine. 2012 Apr 27;30 Suppl 1:A114-21. doi: 10.1016/j.vaccine.2011.07.118.

    PMID: 22520120DERIVED

MeSH Terms

Conditions

DiarrheaFeverNauseaVomiting

Interventions

RIX4414 vaccine

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBody Temperature Changes

Study Officials

  • Anh D Dang, PhD.

    The National Institute of Hygiene and Epidemiology

    PRINCIPAL INVESTIGATOR

  • Thiem D Vu, MD., PhD.

    The National Institute of Hygiene and Epidemiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

May 19, 2011

First Posted

June 21, 2011

Study Start

October 1, 2009

Primary Completion

March 1, 2010

Study Completion

April 1, 2010

Last Updated

July 4, 2016

Record last verified: 2016-06

Locations

VN(1)