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DiarrheaPhase 2/3Rotavin-M1NCT01502969

Safety and Immunogenicity Assessment of Rotavin-M1 in Vietnamese Children

A Phase 2/3 study testing Rotavin-M1 and cell culture medium in absence of virus in people with Diarrhea and Fever, run by National Institute of Hygiene and Epidemiology, Vietnam at 2 sites in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 to 12 weeksHealthy volunteers can take part
Conditions the study is for
Diarrhea, Fever, Nausea
What is being tested?
Rotavin-M1 and cell culture medium in absence of virus
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
799 participants
Where
2 sitesVietnam
Study dates
May 2010to Oct 2011
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • At dose 2
  • Acute disease at the time of 2nd dose.
  • 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).
  • History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.
  • Fever (axillary temperature >38oC) within 3 days before or on the day of vaccination.
  • 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 during the study period.

Trial locations and contacts

2 sites in 1 country.

Vietnam2 sites

  • Thai Binh Preventive Medicine Center

    Thái Bình, Thai Binh

  • Preventive Medicine Center

    Thanh Sơn, Phu Tho

Other trials in Vietnam

About this study

Official title: 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.

Read the 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).

Being tested
Rotavin-M1, cell culture medium in absence of virus
Keywords
diarrhea, fever, nausea, vomit, irritability
Medical subject headings
Diarrhea, Fever, Nausea, Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rotavin-M1Biological

    Also called KH0118, POLYVAC, G1P[8]

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

  • cell culture medium in absence of virusBiological

    Placebo

Study groups in NCT01502969
Study groupRoleWhat they receive
PlaceboPlacebo comparatorChildren receiving placebo (cell culture medium in absence of virus)
Receives: Biological: cell culture medium in absence of virus
Rotavirus vaccineActive comparatorRotavin-M1, 10e6.3ffu/dose, 2 doses
Receives: Biological: Rotavin-M1

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (4)

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

    to assess RV-IgA antibody responses 9 months after the last dose (i.e. 12 months after the 1st dose)

    Measured: 12 year

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

    to assess the anti-rotavirus IgG responses 1 month after completing 2 doses of Rotavin-M1

    Measured: 12 months

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

    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

    Measured: 12 months

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

    To assess anti-RV IgG antibody responses 1 year after the 1st dose of Rotavin-M1 (9 months after the 2nd dose)

    Measured: 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2012 (estimated)
  2. Study startMay 2010
  3. Primary completionSep 2011
  4. Study completionOct 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
799 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01502969
Sponsor's protocol ID
Rotavin-M1-2b
Acronym
Rotavin-M1
Status last verified
Dec 2011
First submitted
29 Oct 2011
Last updated
2 Jan 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 16395100

  • 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.

    PubMed 17385670

  • 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.

    PubMed 19931725

  • 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.

    PubMed 16088796

  • 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.

    PubMed 19159483

  • 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.

    PubMed 19931712

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Rotavin-M1 and cell culture medium in absence of virus in people with Diarrhea and Fever, run by National Institute of Hygiene and Epidemiology, Vietnam at 2 sites in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anti-rotavirus IgA antibody responses 1 month after vaccination (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01502969, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2012.

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