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Hand, Foot and Mouth DiseasePhase 1NCT01391494

A Safety Study of Inactivated EV71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Adults, Children and Infants

A Phase 1 study testing 160Eu/0.5ml in adults, 320Eu/0.5ml in adults and 640Eu/0.5ml in adults in people with Hand, Foot and Mouth Disease, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 1 site in China.

Completed

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

Official record
Search all trials

Trial summary

Enterovirus 71 (EV71), a major pathogen that is responsible for causing hand-foot-and-mouth disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family Picornaviridae. Since the late 1990s, a series of large HFMD epidemics caused by EV71 have been reported in the Asia-Pacific region. Read more about this study

Who is it for?
Ages 6 months to 49 yearsHealthy volunteers can take part
Conditions the study is for
Hand, Foot and Mouth Disease
What is being tested?
160Eu/0.5ml in adults, 320Eu/0.5ml in adults and 640Eu/0.5ml in adults
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
288 participants
Where
1 siteChina
Study dates
Feb 2011to Jun 2011
Phase
Phase 1
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 months to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Healthy subjects (18-49 years old adults) as established by medical history and clinical examination
  • The subjects oneself or their legal guardian must be aware of this vaccines
  • Voluntarily participate in the study and signed Informed Consent Form
  • Subjects with temperature ≤ 37.0℃
  • With the ability and objective to comply with the requirements of the protocol
  • Persist for a 2-month visit and receive blood tests according to program requirements
Show all 20Show fewer
  • Healthy subjects (3-11 years old children) as established by medical history and clinical examination
  • Full-term (37-42 weeks), weight ≥ 2500 g when it was born
  • The subjects' legal guardian must be aware of this vaccines
  • The subjects' legal guardian voluntarily participate in the study and signed Informed Consent Form
  • Subjects with temperature ≤ 37.0℃
  • The subjects' legal guardian with the ability and objective to comply with the requirements of the protocol
  • Persist for a 2-month visit and receive blood tests according to program requirements
  • Healthy subjects (6-35 months infants) as established by medical history and clinical examination
  • Full-term (37-42 weeks), weight ≥ 2500 g when it was born
  • The subjects' legal guardian must be aware of this vaccines
  • The subjects' legal guardian voluntarily participate in the study and signed Informed Consent Form
  • Subjects with temperature ≤ 37.0℃
  • The subjects' legal guardian with the ability and objective to comply with the requirements of the protocol
  • Persist for a 2-month visit and receive blood tests according to program requirements

Who cannot join

  • Subject who has a clinical diagnosis history of Hand, Foot and Mouth Disease (HFMD)
  • Allergy or serious side-effects to a vaccine or any ingredient of vaccine
  • Epilepsy, seizures, convulsions, neurological illness
  • Congenital or hereditary immunodeficiency
  • Autoimmune disease
  • Severe malnutrition or dysgenopathy
Show all 64Show fewer
  • Asthma, thyroidectomy, angioneurotic edema, diabetes or cancer
  • Asplenia, functional asplenia, and any circumstances leading to the asplenia or splenectomy
  • Clinical diagnosis of coagulopathy (such as clotting factor deficiency, coagulation disorders, platelet abnormalities), significant bruising or blood clotting disorder
  • Acute illness or acute exacerbation of chronic disease 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 live-attenuated vaccine in last 28 days or 1 months
  • Any prior administration of subunit or inactivated vaccines in last 14 days
  • Under the anti-TB prevention or therapy
  • Fever before vaccination, axillary temperature ﹥37.0℃
  • The laboratory test abnormalities before vaccination, including blood tests (hemoglobin, total white blood cells, WBC, platelets), blood biochemistry tests (ALT, total bilirubin, direct bilirubin, Cr, BUN) and urine tests (urine protein, urine sugar, blood cells), etc.
  • Hypertension or hypotension. Systolic blood pressure ﹥140mmHg and/or diastolic blood pressure ﹥90mmHg; systolic blood pressure ﹤90mmHg and/or diastolic blood pressure ﹤60mmHg
  • Breast-feeding, pregnant, planning a pregnancy within 60 days or positive pregnancy test women
  • Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
  • For the subjects aged from 3-11 years old children:
  • Subject who has a clinical diagnosis history of Hand, Foot and Mouth Disease (HFMD)
  • ≤37 weeks gestation
  • weight ≤ 2500 g when it was born
  • Allergy or serious side-effects to a vaccine or any ingredient of vaccine
  • Epilepsy, seizures, convulsions, neurological illness
  • Congenital or hereditary immunodeficiency
  • Autoimmune disease
  • Severe malnutrition or dysgenopathy
  • Asthma, thyroidectomy, angioneurotic edema, diabetes or cancer
  • Asplenia, functional asplenia, and any circumstances leading to the asplenia or splenectomy
  • Clinical diagnosis of coagulopathy (such as clotting factor deficiency, coagulation disorders, platelet abnormalities), significant bruising or blood clotting disorder
  • Acute illness or acute exacerbation of chronic disease 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 live-attenuated vaccine in last 28 days or 1 months
  • Any prior administration of subunit or inactivated vaccines in last 14 days
  • Under the anti-TB prevention or therapy
  • Fever before vaccination, axillary temperature ﹥37.0℃
  • The laboratory test abnormalities before vaccination, including blood tests (hemoglobin, total white blood cells, WBC, platelets), blood biochemistry tests (ALT, total bilirubin, direct bilirubin, Cr, BUN) and urine tests (urine protein, urine sugar, blood cells), etc.
  • Hypertension or hypotension. Systolic blood pressure ﹥140mmHg and/or diastolic blood pressure ﹥90mmHg; systolic blood pressure ﹤90mmHg and/or diastolic blood pressure ﹤60mmHg
  • Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
  • For the subjects aged from 6-35 months infants:
  • Subject who has a clinical diagnosis history of Hand, Foot and Mouth Disease (HFMD)
  • ≤37 weeks gestation
  • weight ≤ 2500 g when it was born
  • Allergy or serious side-effects to a vaccine or any ingredient of vaccine
  • Epilepsy, seizures, convulsions, neurological illness
  • Congenital or hereditary immunodeficiency
  • Autoimmune disease
  • Severe malnutrition or dysgenopathy
  • Asthma, thyroidectomy, angioneurotic edema, diabetes or cancer
  • Asplenia, functional asplenia, and any circumstances leading to the asplenia or splenectomy
  • Clinical diagnosis of coagulopathy (such as clotting factor deficiency, coagulation disorders, platelet abnormalities), significant bruising or blood clotting disorder
  • Acute illness or acute exacerbation of chronic disease 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 live-attenuated vaccine in last 28 days or 1 months
  • Any prior administration of subunit or inactivated vaccines in last 14 days
  • Under the anti-TB prevention or therapy
  • Fever before vaccination, axillary temperature ﹥37.0℃
  • The laboratory test abnormalities before vaccination, including blood tests (hemoglobin, total white blood cells, WBC, platelets), blood biochemistry tests (ALT, total bilirubin, direct bilirubin, Cr, BUN) and urine tests (urine protein, urine sugar, blood cells), etc.
  • Hypertension or hypotension. Systolic blood pressure ﹥140mmHg and/or diastolic blood pressure ﹥90mmHg; systolic blood pressure ﹤90mmHg and/or diastolic blood pressure ﹤60mmHg
  • Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives

Trial locations and contacts

1 site in 1 country.

China1 site

  • Guangxi Provincial Center for Diseases Control and Prevention

    Nanning, Guangxi, 530028

Other trials in China

About this study

Official title: A Phase I Clinical Trial for Inactivated Enterovirus Type 71 Vaccine (Human Diploid Cell, KMB-17 Cell) in Chinese Adults, Children and Infants

Enterovirus 71 (EV71), a major pathogen that is responsible for causing hand-foot-and-mouth disease (HFMD) worldwide, is a member of the Human Enterovirus species A, family Picornaviridae.

Since the late 1990s, a series of large HFMD epidemics caused by EV71 have been reported in the Asia-Pacific region. Notably, there is evidence that the most severe cases from these epidemic outbreaks are associated with neurological disorders with CNS involvement caused by EV71 infection. Because of these EV71 infection-related public health issues, the research and development of EV71 vaccine candidates have been heavily promoted.

Read more

Recently, several EV71 vaccine candidates have been evaluated in animals but no final results of clinical trials, including inactivated vaccine, attenuated vaccine, subunit vaccine, DNA vaccine, epitope peptide vaccine, virus-like particles (VLPs).

Basing on the previous studies of elicited protection in mice and rhesus monkeys, a formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been licensed by SFDA in China, Dec. 2010. The phase I clinical trial has been carried out, during four months, in Guangxi Province, China. The purpose of this study is to evaluate the safety, tolerability and immunogenicity of the formalin-inactivated EV71 vaccine in Chinese adults (from 18 to 49 years old), children (from 3 to 11 years old) and infants (from 6 to 35 months old).

Read the detailed description

Hand-foot-and-mouth disease (HFMD) is a significant cause of death, usually characterized by vesicular lesions on the skin and oral mucosa and high morbidity rates in children. Additionally, occasional fatal cases have been reported involving brainstem encephalitis and myelitis associated with cardiopulmonary collapse. Pulmonary edema/hemorrhage and respiratory failure are the major causes of death among children less than five years old.

Enterovirus 71 (EV71), a major pathogen that is responsible for causing HFMD worldwide, is a member of the Human Enterovirus species A, family Picornaviridae. Since the late 1990s, a series of large HFMD epidemics caused by EV71 have been reported in the Asia-Pacific region. Notably, there is evidence that the most severe cases from these epidemic outbreaks are associated with neurological disorders with CNS involvement caused by EV71 infection. Because of these EV71 infection-related public health issues, the research and development of EV71 vaccine candidates have been heavily promoted.

Recently, several EV71 vaccine candidates have been evaluated in animals but no final results of clinical trials, including heat-inactivated or formalin-inactivated vaccine, live-attenuated vaccine, recombinant viral protein 1 (VP1) vaccine, VP1 DNA vaccine, VP1 epitope peptide vaccine, EV71 virus-like particles (VLPs) and bacterial or viral vector expressing VP1. Overall, the inactivated whole-virus vaccines seem to be more immunogenic than recombinant VP1 and DNA vaccines.

Basing on the previous studies of elicited protection in mice and rhesus monkeys (Ying Zhang, et al. Pathogenesis study of Enterovirus 71 Infection in Rhesus Monkeys. Lab Invest, 2011, doi:10.1038/labinest.2011.82; Longding Liu, et al. Neonatal Rhesus Monkey is a Potential Animal Model for Studying Pathogenesis of EV71 Infection. Virology, 2011, 412:91-100; Chenghong Dong, et al. Immunoprotection Elicited by an Enterovirus Type 71 Experimental Inactivated Vaccine in Mice and Rhesus Monkeys. Vaccine, 2011, doi: 10.1016/j.vaccine.2011.06.044.), a formalin-inactivated EV71 vaccine (Human Diploid cell, KMB-17 Cell) has been licensed by SFDA in China, Dec. 2010. The phase I clinical trial has been carried out, during four months, in Guangxi Province, China. The purpose of this study is to evaluate the safety, tolerability and immunogenicity of the formalin-inactivated EV71 vaccine in Chinese adults (from 18 to 49 years old), children (from 3 to 11 years old) and infants (from 6 to 35 months old).

Being tested
160Eu/0.5ml in adults, 320Eu/0.5ml in adults, 640Eu/0.5ml in adults, 1280Eu/0.5ml (without adjuvant) in 12 adults, 0Eu/0.5ml in adults
Keywords
Human Enterovirus 71 (EV71), Hand, Foot and Mouth Disease, Inactivated Vaccine, Human Diploid cell, Safety, Immunogenicity, Adverse reactions associated with vaccine
Medical subject headings
Hand, Foot and Mouth Disease

What participants receive

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

  • 160Eu/0.5ml in adultsBiological

    inactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 12 adults aged 18-49 years old on day 0, 14.

  • 320Eu/0.5ml in adultsBiological

    inactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 12 adults aged 18-49 years old on day 0, 14.

  • 640Eu/0.5ml in adultsBiological

    inactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 12 adults aged 18-49 years old on day 0, 14.

  • 1280Eu/0.5ml (without adjuvant) in 12 adultsBiological

    inactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 12 adults aged 18-49 years old on day 0, 14.

  • 0Eu/0.5ml in adultsBiological

    0Eu/0.5ml placebo in 24 adults aged 18-49 years old on day 0, 14.

  • 160Eu/0.5ml in childrenBiological

    inactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 12 children aged 3-11 years old on day 0, 14.

  • 320Eu/0.5ml in childrenBiological

    inactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 12 children aged 3-11 years old on day 0, 14.

  • 640Eu/0.5ml in childrenBiological

    inactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 12 children aged 3-11 years old on day 0, 14.

  • 1280Eu/0.5ml (without adjuvant) in childrenBiological

    inactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 12 children aged 3-11 years old on day 0, 14.

  • 0Eu/0.5ml in childrenBiological

    0Eu/0.5ml placebo in 24 children aged 3-11 years old on day 0, 14.

  • 160Eu/0.5ml in infantsBiological

    inactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 24 infants aged 6-35 months old on day 0, 28.

  • 320Eu/0.5ml in infantsBiological

    inactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 24 infants aged 6-35 months old on day 0, 28.

  • 640Eu/0.5ml in infantsBiological

    inactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 24 infants aged 6-35 months old on day 0, 28.

  • 1280Eu/0.5ml (without adjuvant) in infantsBiological

    inactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 24 infants aged 6-35 months old on day 0, 28.

  • 0Eu/0.5ml in infantsBiological

    0Eu/0.5ml placebo in 48 infants aged 6-35 months old on day 0, 28.

Study groups in NCT01391494
Study groupRoleWhat they receive
160Eu/0.5ml in adultsExperimentalinactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 12 adults aged 18-49 years old on day 0, 14.
Receives: Biological: 160Eu/0.5ml in adults
320Eu/0.5ml in adultsExperimentalinactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 12 adults aged 18-49 years old on day 0, 14.
Receives: Biological: 320Eu/0.5ml in adults
640Eu/0.5ml in adultsExperimentalinactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 12 adults aged 18-49 years old on day 0, 14.
Receives: Biological: 640Eu/0.5ml in adults
1280Eu/0.5ml (without adjuvant) in adultsExperimentalinactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 12 adults aged 18-49 years old on day 0, 14.
Receives: Biological: 1280Eu/0.5ml (without adjuvant) in 12 adults
0Eu/0.5ml in adultsPlacebo comparator0Eu/0.5ml placebo in 24 adults aged 18-49 years old on day 0, 14.
Receives: Biological: 0Eu/0.5ml in adults
160Eu/0.5ml in childrenExperimentalinactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 12 children aged 3-11 years old on day 0, 14.
Receives: Biological: 160Eu/0.5ml in children
320Eu/0.5ml in childrenExperimentalinactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 12 children aged 3-11 years old on day 0, 14.
Receives: Biological: 320Eu/0.5ml in children
640Eu/0.5ml in childrenExperimentalinactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 12 children aged 3-11 years old on day 0, 14.
Receives: Biological: 640Eu/0.5ml in children
1280Eu/0.5ml (without adjuvant) in childrenExperimentalinactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 12 children aged 3-11 years old on day 0, 14.
Receives: Biological: 1280Eu/0.5ml (without adjuvant) in children
0Eu/0.5ml in childrenPlacebo comparator0Eu/0.5ml placebo in 24 children aged 3-11 years old on day 0, 14.
Receives: Biological: 0Eu/0.5ml in children
160Eu/0.5ml in infantsExperimentalinactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 24 infants aged 6-35 months old on day 0, 28.
Receives: Biological: 160Eu/0.5ml in infants
320Eu/0.5ml in infantsExperimentalinactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 24 infants aged 6-35 months old on day 0, 28.
Receives: Biological: 320Eu/0.5ml in infants
640Eu/0.5ml in infantsExperimentalinactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 24 infants aged 6-35 months old on day 0, 28.
Receives: Biological: 640Eu/0.5ml in infants
1280Eu/0.5ml (without adjuvant) in infantsExperimentalinactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 24 infants aged 6-35 months old on day 0, 28.
Receives: Biological: 1280Eu/0.5ml (without adjuvant) in infants
0Eu/0.5ml in infantsPlacebo comparator0Eu/0.5ml placebo in 48 infants aged 6-35 months old on day 0, 28.
Receives: Biological: 0Eu/0.5ml in infants

What is being measured

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

  1. Evaluate the Safety of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Adults.

    Adverse reactions associated with vaccine were observed in Chinese Adults (from 18 to 49 years old) after the first vaccination.

    Measured: within the first 14 days after the first vaccination

  2. Evaluate the Safety of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Adults.

    Adverse reactions associated with vaccine were observed in Chinese Adults (from 18 to 49 years old) after the second vaccination.

    Measured: within the first 4 days after the second vaccination

  3. Evaluate the Safety of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Children.

    Adverse reactions associated with vaccine were observed in Chinese Children (from 3 to 11 years old) after the first vaccination.

    Measured: within the first 14 days after the first vaccination

  4. Evaluate the Safety of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Children.

    Adverse reactions associated with vaccine were observed in Chinese Children (from 3 to 11 years old) after the second vaccination.

    Measured: within the first 4 days after the second vaccination

  5. Evaluate the safety of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants.

    Adverse reactions associated with vaccine were observed in Chinese Infants (from 6 to 35 months old) after the first vaccination.

    Measured: within the first 28 days after the first vaccination

  6. Evaluate the safety of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants.

    Adverse reactions associated with vaccine were observed in Chinese Infants (from 6 to 35 months old) after the second vaccination.

    Measured: within the first 28 days after the second vaccination

Secondary outcomes (8)

  1. Evaluate the seroconversion rate of anti-EV71 antibodies in serum of adults, children and infant, after first vaccination.

    The seroconversion rate of anti-EV71 antibodies was evaluated in serum of adults within the first 14 days after first vaccination.

    The seroconversion rate of anti-EV71 antibodies was evaluated in serum of children within the first 14 days after first vaccination.

    The seroconversion rate of anti-EV71 antibodies was evaluated in serum of infant, within the first 28 days after first vaccination.

    Measured: within the first 14 or 28 days after the first vaccination

  2. Evaluate the seroconversion rate of anti-EV71 antibodies in serum of adults, children and infant, after second vaccination.

    The seroconversion rate of anti-EV71 antibodies was evaluated in serum of adults within the first 4 days after second vaccination.

    The seroconversion rate of anti-EV71 antibodies was evaluated in serum of children within the first 4 days after second vaccination.

    The seroconversion rate of anti-EV71 antibodies was evaluated in serum of infant, within the first 28 days after second vaccination.

    Measured: within the first 4 or 28 days after the second vaccination

  3. Evaluate the seroconversion rate of antinuclear antibodies in serum of adults, children and infant, after first vaccination.

    The seroconversion rate of antinuclear antibodies was evaluated in serum of adults within the first 14 days after first vaccination.

    The seroconversion rate of antinuclear antibodies was evaluated in serum of children within the first 14 days after first vaccination.

    The seroconversion rate of antinuclear antibodies was evaluated in serum of infant, within the first 28 days after first vaccination.

    Measured: within the first 14 or 28 days after the first vaccination

  4. Evaluate the seroconversion rate of antinuclear antibodies in serum of adults, children and infant, after second vaccination.

    The seroconversion rate of antinuclear antibodies was evaluated in serum of adults within the first 4 days after the second vaccination.

    The seroconversion rate of antinuclear antibodies was evaluated in serum of children within the first 4 days after the second vaccination.

    The seroconversion rate of antinuclear antibodies was evaluated in serum of infant, within the first 28 days after the second vaccination.

    Measured: within the first 4 or 28 days after the second vaccination

  5. Evaluate the abnormity change of live and kidney function indexes in serum of adults, children and infant, after first vaccination.

    The abnormity change of live and kidney function indexes were evaluated in serum of adults within the first 14 days after first vaccination.

    The abnormity change of live and kidney function indexes were evaluated in serum of children within the first 14 days after first vaccination.

    The abnormity change of live and kidney function indexes were evaluated in serum of infant, within the first 28 days after first vaccination.

    Measured: within the first 14 or 28 days after the first vaccination

  6. Evaluate the abnormity change of live and kidney function indexes in serum of adults, children and infant, after second vaccination.

    The abnormity change of live and kidney function indexes were evaluated in serum of adults within the first 4 days after the second vaccination.

    The abnormity change of live and kidney function indexes were evaluated in serum of children within the first 4 days after the second vaccination.

    The abnormity change of live and kidney function indexes were evaluated in serum of infant, within the first 28 days after the second vaccination.

    Measured: within the first 4 or 28 days after the second vaccination

  7. Evaluate the vaccine-induced cellular immune responses in infant after first vaccination.

    The vaccine-induced cellular immune responses were evaluated in serum of infant, within the first 28 days after the first vaccination.

    Measured: within the first 28 days after the first vaccination

  8. Evaluate the vaccine-induced cellular immune responses in infant after second vaccination.

    The vaccine-induced cellular immune responses were evaluated in serum of infant, within the first 28 days after the second vaccination.

    Measured: within the first 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 posted12 Jul 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionJun 2011
  4. Study completionJun 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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
288 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01391494
Sponsor's protocol ID
EV71-KMB17-I-IMB-CAMS
Status last verified
Oct 2023
First submitted
11 Jul 2011
Last updated
11 Oct 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • Liu L, Zhang Y, Wang J, Zhao H, Jiang L, Che Y, Shi H, Li R, Mo Z, Huang T, Liang Z, Mao Q, Wang L, Dong C, Liao Y, Guo L, Yang E, Pu J, Yue L, Zhou Z, Li Q. Study of the integrated immune response induced by an inactivated EV71 vaccine. PLoS One. 2013;8(1):e54451. doi: 10.1371/journal.pone.0054451. Epub 2013 Jan 23.

    PubMed 23372725

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 160Eu/0.5ml in adults, 320Eu/0.5ml in adults and 640Eu/0.5ml in adults in people with Hand, Foot and Mouth Disease, run by Institute of Medical Biology, Chinese Academy of Medical Sciences at 1 site 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 20 inclusion and 64 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 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Evaluate the Safety of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Adults. (time frame: within the first 14 days after the first vaccination). The study lists 6 primary outcomes in all. 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 NCT01391494, which also lists 1 linked publication.

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 11 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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