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Hand, Foot and Mouth DiseasePhase 3NCT01508247

A Clinical Trial to Assess the Efficacy and Safety of an Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children Aged 6-35 Months

A Phase 3 study testing inactivated vaccine (Vero Cell) against EV71 in people with Hand, Foot and Mouth Disease and Herpangina, run by Jiangsu Province Centers for Disease Control and Prevention at 4 sites in China.

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

Since its discovery in 1969, enterovirus 71 (EV71) has been recognised as a frequent cause of epidemics of hand-foot-mouth disease (HFMD) associated with severe neurological sequelae in a small proportion of cases. Read more about this study

Who is it for?
Ages 6 to 35 months
What is being tested?
inactivated vaccine (Vero Cell) against EV71
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10,245 participants
Where
4 sitesChina
Study dates
Jan 2012to Mar 2013
Phase
Phase 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 35 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Only subjects fulfilling all of the following criteria will be eligible for the study:
  • Healthy children aged from 6 to 35 months old
  • General good health as established by medical history and physical examination
  • The subjects' guardians are able to understand and sign the informed consent
  • Had never received the vaccine against EV71
  • The subjects' guardians allow to comply with the requirements of the protocol
  • Available for all visits scheduled in this study
  • Subjects with temperature <=37.0°C on axillary setting

Who cannot join

  • Subjects will not be eligible for the study if any of the following criteria is met:
  • Subject who has a medical history of HFMD
  • Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
  • Family history of seizures or progressive neurological disease
  • Family history of congenital or hereditary immunodeficiency
  • Severe malnutrition or hypogenesis
Show all 27Show fewer
  • Major congenital defects or serious chronic illness, including perinatal brain damage
  • Autoimmune disease
  • Bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with IM injections or blood draws
  • Asplenia, functional asplenia, or splenic excision
  • History of asthma, angioneurotic edema, diabetes or malignant tumour
  • History of thyroidectomy, or thyroid disease in last 12 months
  • Any acute infections in last 7 days
  • Any prior administration of immunodepressant or corticosteroids in last 6 months
  • Any prior administration of blood products in last 3 months
  • Any prior administration of other research vaccines or medicines in last 1 month
  • Any prior administration of attenuated live vaccine in last 15 days
  • Any prior administration of subunit or inactivated vaccines in last 7 days
  • Under the anti-TB prevention or therapy
  • Subjects with temperature >37.0°C on axillary setting
  • Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
  • Subjects will not be eligible for the second dose if any of following adverse events happened after the first dose. They can continue other process of the study without the second dose vaccination according to the opinion of the investigator.
  • Had any serious adverse events related to the first dose of inactivated vaccine (vero cell) against EV71 within 7 days
  • Hypersensitivity reactions after vaccination (including urticaria/rashes that occur within 30 minutes after inoculation)
  • Anaphylaxis after vaccination
  • Any confirmed or suspected autoimmune disease or immune deficiency diseases, including human immunodeficiency virus (HIV) infection
  • Any condition that in the opinion of the investigator, or IRB

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Chaoyang Distinct Center for Disease Control and Prevention

    Beijing

  • Donghai County Center for Disease Control and Prevention

    Lianyungang, Jiangsu

  • Pizhou County-Level City Center for Disease Control and Prevention

    Xuzhou, Jiangsu

  • Baoying County Center for Disease Control and Prevention

    Yangzhou, Jiangsu

Other trials in China

About this study

Official title: A Multiple-center Randomized Double-blind Placebo-controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of an Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children Aged 6-35 Months

Since its discovery in 1969, enterovirus 71 (EV71) has been recognised as a frequent cause of epidemics of hand-foot-mouth disease (HFMD) associated with severe neurological sequelae in a small proportion of cases. There has been a significant increase in EV71 epidemic activity throughout the Asia-Pacific region since 1997. Recent HFMD epidemics in this region have heen associated with a severe from of brainstem encephalitis associated with pulmonary oedema and high case-fatality rates.

The data from the phase 1 and 2 trials suggested that the inactivated EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese children and infants. According to the immunogenicity and safety results, the 320U with adjuvant with immunizing schedule of two doses (per 28 day) will be applied in phase 3 clinical trial.

Being tested
inactivated vaccine (Vero Cell) against EV71, 0/0.5ml placebo
Keywords
efficacy, safety, inactivated vaccine (Vero Cell) against EV71, EV71-associated diseases
Medical subject headings
Hand, Foot and Mouth Disease, Herpangina

What participants receive

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

  • inactivated vaccine (Vero Cell) against EV71Biological

    inactivated vaccine (vero cell) against EV71, 320U /0.5ml, two doses, on day0, 28

  • 0/0.5ml placeboBiological

    0/0.5ml placebo, two doses, on day0, 28

Study groups in NCT01508247
Study groupRoleWhat they receive
vaccine against EV71ExperimentalInactivated vaccine (Vero Cell) against EV71 of 320U /0.5ml in 5000 children aged 6-35 months on day0, 28
Receives: Biological: inactivated vaccine (Vero Cell) against EV71
placeboPlacebo comparator0/0.5ml placebo in 5000 children aged 6-35 months on day0, 28
Receives: Biological: 0/0.5ml placebo

What is being measured

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

  1. the incidence density of the EV71-associated diseases in the vaccine group and placebo group.

    compare the incidence density of the EV71-associated diseases between the vaccine group and placebo group in Chinese children aged 6-35 months.

    Measured: begin at day 56 up to 14 months

Secondary outcomes (11)

  1. the frequency of all the adverse events in vaccine group and placebo group.

    compare frequency of all the solicited events, unsolicited adverse events and serious adverse events between vaccine group and placebo group.

    Measured: up to 14 months

  2. Seropositive rate of the vaccine group

    calculate the seropositive rate of the vaccine group in Chinese children aged 6-35 months at month 8 after first vaccination.

    Measured: 8 months after first vaccination

  3. Seroconversion rate of the vaccine group

    calculate the seroconversion rate of the vaccine group in Chinese children aged 6-35 months at month 8 after first vaccination.

    Measured: 8 months after first vaccination

  4. GMT of the vaccine group

    calculate the geometric mean titre (GMT) of the vaccine group in Chinese children aged 6-35 months at month 8 after first vaccination.

    Measured: 8 months after first vaccination

  5. Seropositive rate of the vaccine group

    calculate the seropositive rate of the vaccine group in Chinese children aged 6-35 months at month 14 after first vaccination.

    Measured: 14 months after first vaccination

  6. Seroconversion rate of the vaccine group

    calculate the seroconversion rate of the vaccine group in Chinese children aged 6-35 months at month 14 after first vaccination.

    Measured: 14 months after first vaccination

  7. GMT of the vaccine group

    calculate the geometric mean titre (GMT) of the vaccine group in Chinese children aged 6-35 months at month 14 after first vaccination.

    Measured: 14 months after first vaccination

  8. Seropositive rate of the vaccine group and placebo group

    compare the seropositive rate of the vaccine group and placebo group in healthy children aged 6-35 months.

    Measured: 28 days after the second vaccination

  9. Seroconversion rate of the vaccine group and placebo group

    compare the Seroconversion rate of the vaccine group and placebo group in healthy children aged 6-35 months.

    Measured: 28 days after the second vaccination

  10. GMT of the vaccine group and placebo group

    compare the geometric mean titre (GMT) of the vaccine group and placebo group in healthy children aged 6-35 months.

    Measured: 28 days after the second vaccination

  11. GMI of the vaccine group and placebo group

    compare the geometric mean fold increase (GMFI) of the vaccine group and placebo group in healthy children aged 6-35 months.

    Measured: 28 days after the second vaccination

Timeline

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

  1. First posted11 Jan 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionMar 2013
  4. Study completionMar 2013

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
10,245 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01508247
Sponsor's protocol ID
JSVCT010
Status last verified
Mar 2013
First submitted
4 Jan 2012
Last updated
29 Mar 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Zhu W, Jin P, Li JX, Zhu FC, Liu P. Correlates of protection for inactivated enterovirus 71 vaccine: the analysis of immunological surrogate endpoints. Expert Rev Vaccines. 2017 Sep;16(9):945-949. doi: 10.1080/14760584.2017.1335603. Epub 2017 Jun 12.

    PubMed 28548626

  • Wei M, Meng F, Wang S, Li J, Zhang Y, Mao Q, Hu Y, Liu P, Shi N, Tao H, Chu K, Wang Y, Liang Z, Li X, Zhu F. 2-Year Efficacy, Immunogenicity, and Safety of Vigoo Enterovirus 71 Vaccine in Healthy Chinese Children: A Randomized Open-Label Study. J Infect Dis. 2017 Jan 1;215(1):56-63. doi: 10.1093/infdis/jiw502. Epub 2016 Oct 17.

    PubMed 28077584

  • Zhu FC, Meng FY, Li JX, Li XL, Mao QY, Tao H, Zhang YT, Yao X, Chu K, Chen QH, Hu YM, Wu X, Liu P, Zhu LY, Gao F, Jin H, Chen YJ, Dong YY, Liang YC, Shi NM, Ge HM, Liu L, Chen SG, Ai X, Zhang ZY, Ji YG, Luo FJ, Chen XQ, Zhang Y, Zhu LW, Liang ZL, Shen XL. Efficacy, safety, and immunology of an inactivated alum-adjuvant enterovirus 71 vaccine in children in China: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2013 Jun 8;381(9882):2024-32. doi: 10.1016/S0140-6736(13)61049-1. Epub 2013 May 29.

    PubMed 23726161

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing inactivated vaccine (Vero Cell) against EV71 in people with Hand, Foot and Mouth Disease and Herpangina, run by Jiangsu Province Centers for Disease Control and Prevention at 4 sites in China.

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 8 inclusion and 27 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 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. 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 phase mean?

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?

the incidence density of the EV71-associated diseases in the vaccine group and placebo group. (time frame: begin at day 56 up to 14 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 NCT01508247, which also lists 3 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 29 Mar 2013.

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