NCT01502969

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
799

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

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

May 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 2, 2012

Completed
Last Updated

January 2, 2012

Status Verified

December 1, 2011

Enrollment Period

1.3 years

First QC Date

October 29, 2011

Last Update Submit

December 30, 2011

Conditions

DiarrheaFeverNauseaVomitIrritability

Keywords

diarrheafevernauseavomitirritability

Outcome Measures

Primary Outcomes (1)

  • 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

    12 months

Secondary Outcomes (4)

  • RV-IgA antibody responses to Rotavin-M1 one year after 1st dose

    12 year

  • Anti-rotavirus IgG antibody responses 1 month after vaccination with Rotavin-M1

    12 months

  • safety and reactogenicity of each doses of Rotavin-M1, 10e6.3ffu/dose

    12 months

  • anti-RV IgG antibody responses 1 year after the 1st dose

    12 month

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Biological: cell culture medium in absence of virus

Rotavirus vaccine

ACTIVE COMPARATOR

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

Biological: Rotavin-M1

Interventions

Rotavin-M1BIOLOGICAL

liquid, 10e6ffu/dose, 2 doses, 2 month interval

Also known as: KH0118, POLYVAC, G1P[8]
Rotavirus vaccine
cell culture medium in absence of virusBIOLOGICAL

Placebo

Placebo

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Preventive Medicine Center

Thanh Sơn, Phu Tho, Vietnam

Location

Thai Binh Preventive Medicine Center

Thái Bình, Thai Binh, Vietnam

Location

Related Publications (6)

  • 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

  • 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

  • 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

  • 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

  • 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

MeSH Terms

Conditions

DiarrheaFeverNauseaVomiting

Condition Hierarchy (Ancestors)

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

Study Officials

  • Dang D Anh, PhD

    The National Institute of Hygiene and Epidemiology

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 29, 2011

First Posted

January 2, 2012

Study Start

May 1, 2010

Primary Completion

September 1, 2011

Study Completion

October 1, 2011

Last Updated

January 2, 2012

Record last verified: 2011-12

Locations

VN(2)