Hand, Foot and Mouth DiseasePhase 3NCT01636245
Immunogenicity and Safety of Three Consecutive Lots of a New Inactivated Enterovirus Type 71 (EV71) Vaccine
A Phase 3 study testing three consecutive lots of EV71 vaccine in people with Hand, Foot and Mouth Disease, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
The purpose of this study is to evaluate the immunogenicity and safety of three consecutive lots of EV71 Vaccines in healthy infants volunteers aged from 6 months to 5 years old. Read more about this study
- Who is it for?
- Ages 6 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand, Foot and Mouth Disease
- What is being tested?
- three consecutive lots of EV71 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,400 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Feb 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 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy males and females, aged from 6 months to 11 years old Health is determined by medical history, physical examination, laboratory examination and clinical judgment of the investigator
- Provided legal identification for the sake of recruitment
- Subjects and/or parent(s)/legal guardian(s) are able to understand and sign informed consents
Who cannot join
- History of Hand-foot-mouth Disease
- Subject that has allergic history of vaccine, or allergic to any ingredient of vaccine
- Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- Congenital malformations or developmental disorders, genetic defects, or severe malnutrition
- Epilepsy, seizures or convulsions history, or family history of mental illness
- Autoimmune disease or immunodeficiency, or parents, brothers and sisters have autoimmune diseases or immunodeficiency
Show all 18Show fewer
- History of asthma, angioedema, diabetes or malignancy
- History of thyroidectomy or thyroid disease that required medication within the past 12 months
- Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
- Asplenia, functional asplenia or any condition resulting in the absence or removal the spleen
- Acute illness or acute exacerbation of chronic disease within the past 7 days
- Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis)
- History of any blood products within 3 months
- Administration of any live attenuated vaccine within 14 days
- Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 7 days
- Axillary temperature > 37.0 centigrade before vaccination
- Abnormal laboratory parameters before vaccination
- Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity and Safety of Three Consecutive Lots of a New Inactivated Enterovirus Type 71 (EV71) Vaccine: A Double-blind, Randomized and Controlled Trial
The purpose of this study is to evaluate the immunogenicity and safety of three consecutive lots of EV71 Vaccines in healthy infants volunteers aged from 6 months to 5 years old.
Read the detailed description
The data from the phase I and II study suggested that the inactivated EV71 vaccine (vero cell) had a clinically acceptable safety and good immunogenicity for healthy Chinese infants. The phase III study of inactivated vaccine has initiated on Jan 2012 in China. Over 10,000 healthy infants have revieved the vaccines and no unexpected severe adverse reactions were reported. According to the requirement of SFDA (China), the sponsor should also provide the evidence for the consistency of three consecutive lots of EV71 Vaccines before the application for the market. Thus, a clinical trial to evaluate the immunogenicity and safety of three consecutive lots of EV71 Vaccines in healthy infants volunteers is planed to conduct.
- Conditions
- Hand, Foot and Mouth Disease
- Being tested
- three consecutive lots of EV71 vaccine, placebo
- Keywords
- 71 vaccine, HFMD, consistency of three consecutive lots, immunogenicity
- 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.
three consecutive lots of EV71 vaccineBiological
Also called Vaccine groups
inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
placeboBiological
Also called Control group
placebo, two doses, 28 days interval
| Study group | Role | What they receive |
|---|---|---|
| Lot 1 | Experimental | inactivated vaccine (Lot 1) against EV71 of 400U /0.5ml in 350 infants aged 6 months to 5 years old on day 0,28 Receives: Biological: three consecutive lots of EV71 vaccine |
| Lot 2 | Experimental | inactivated vaccine (Lot 2) against EV71 of 400U /0.5ml in 350 infants aged 6 months to 5 years old on day 0,28 Receives: Biological: three consecutive lots of EV71 vaccine |
| Lot 3 | Experimental | inactivated vaccine (Lot 3) against EV71 of 400U /0.5ml in 350 infants aged 6 months to 5 years old on day 0,28 Receives: Biological: three consecutive lots of EV71 vaccine |
| Placebo | Placebo comparator | Placebo in 350 infants aged 6 months to 5 years old on day 0,28 Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The GMT of anti-EV71 antibodies in serum 28 days after the two-dose regimen
to evaluate the immunogenicity of anti-EV71 antibodies in serum 28 days after second vaccination
Measured: 28 days after first vaccination
Secondary outcomes (2)
Frequency of systemic and local adverse reactions after the first vaccination
Frequency of systemic and local adverse reactions in healthy infants following first doses of EV71 vaccine
Measured: 28 days after the first vaccination
Frequency of systemic and local adverse reactions after the second vaccination
Frequency of systemic and local adverse reactions in healthy infants following second doses of EV71 vaccine
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.
- First posted10 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionSep 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hand, Foot and Mouth DiseaseStudies of the same condition, open and under way.
- More trials run by Sinovac Biotech Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yue-Mei Hu, BS, Principal investigator, Jiangsu Center for Diseases Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636245
- Sponsor's protocol ID
- PRO-EV71-3002
- Status last verified
- Mar 2013
- First submitted
- 5 Jul 2012
- Last updated
- 15 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang H, An D, Liu W, Mao Q, Jin J, Xu L, Sun S, Jiang L, Li X, Shao J, Ma H, Huang X, Guo S, Chen H, Cheng T, Yang L, Su W, Kong W, Liang Z, Jiang C. Analysis of cross-reactive neutralizing antibodies in human HFMD serum with an EV71 pseudovirus-based assay. PLoS One. 2014 Jun 25;9(6):e100545. doi: 10.1371/journal.pone.0100545. eCollection 2014.
PubMed 24964084Hu YM, Wang X, Wang JZ, Wang L, Zhang YJ, Chang L, Liang ZL, Xia JL, Dai QG, Hu YL, Mao QY, Zhu FC, Song YF, Gao F, Chen JT. Immunogenicity, safety, and lot consistency of a novel inactivated enterovirus 71 vaccine in Chinese children aged 6 to 59 months. Clin Vaccine Immunol. 2013 Dec;20(12):1805-11. doi: 10.1128/CVI.00491-13. Epub 2013 Oct 9.
PubMed 24108780
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of Three Consecutive Lots of a New Inactivated Enterovirus Type 71 (EV71) Vaccine: A Double-blind, Randomized and Controlled Trial
- ClinicalTrials.gov ID
- NCT01636245
- Acronym / sponsor ID
- PRO-EV71-3002
- Conditions
- Hand, Foot and Mouth Disease
- Keywords
- 71 vaccine, HFMD, consistency of three consecutive lots, immunogenicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 10 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the immunogenicity and safety of three consecutive lots of EV71 Vaccines in healthy infants volunteers aged from 6 months to 5 years old.
Detailed description
The data from the phase I and II study suggested that the inactivated EV71 vaccine (vero cell) had a clinically acceptable safety and good immunogenicity for healthy Chinese infants. The phase III study of inactivated vaccine has initiated on Jan 2012 in China. Over 10,000 healthy infants have revieved the vaccines and no unexpected severe adverse reactions were reported. According to the requirement of SFDA (China), the sponsor should also provide the evidence for the consistency of three consecutive lots of EV71 Vaccines before the application for the market. Thus, a clinical trial to evaluate the immunogenicity and safety of three consecutive lots of EV71 Vaccines in healthy infants volunteers is planed to conduct.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lot 1 | Experimental | Biological: three consecutive lots of EV71 vaccineinactivated vaccine (Lot 1) against EV71 of 400U /0.5ml in 350 infants aged 6 months to 5 years old on day 0,28 |
| Lot 2 | Experimental | Biological: three consecutive lots of EV71 vaccineinactivated vaccine (Lot 2) against EV71 of 400U /0.5ml in 350 infants aged 6 months to 5 years old on day 0,28 |
| Lot 3 | Experimental | Biological: three consecutive lots of EV71 vaccineinactivated vaccine (Lot 3) against EV71 of 400U /0.5ml in 350 infants aged 6 months to 5 years old on day 0,28 |
| Placebo | Placebo comparator | Biological: placeboPlacebo in 350 infants aged 6 months to 5 years old on day 0,28 |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy males and females, aged from 6 months to 11 years old Health is determined by medical history, physical examination, laboratory examination and clinical judgment of the investigator
- Provided legal identification for the sake of recruitment
- Subjects and/or parent(s)/legal guardian(s) are able to understand and sign informed consents
Key exclusion criteria (18 listed)
- History of Hand-foot-mouth Disease
- Subject that has allergic history of vaccine, or allergic to any ingredient of vaccine
- Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- Congenital malformations or developmental disorders, genetic defects, or severe malnutrition
- Epilepsy, seizures or convulsions history, or family history of mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| three consecutive lots of EV71 vaccineAlso: Vaccine groupsinactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval | Biological | Lot 1, Lot 2, Lot 3 |
| placeboAlso: Control groupplacebo, two doses, 28 days interval | Biological | Placebo |
Primary outcome
The GMT of anti-EV71 antibodies in serum 28 days after the two-dose regimen
Time frame: 28 days after first vaccination
to evaluate the immunogenicity of anti-EV71 antibodies in serum 28 days after second vaccination
2 secondary outcomes
Frequency of systemic and local adverse reactions after the first vaccination
Time frame: 28 days after the first vaccination
Frequency of systemic and local adverse reactions after the second vaccination
Time frame: 28 days after the second vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2013.
- Derived from this study: PubMed 24964084Zhang H, An D, Liu W, Mao Q, Jin J, Xu L, Sun S, Jiang L, Li X, Shao J, Ma H, Huang X, Guo S, Chen H, Cheng T, Yang L, Su W, Kong W, Liang Z, Jiang C. Analysis of cross-reactive neutralizing antibodies in human HFMD serum with an EV71 pseudovirus-based assay. PLoS One. 2014 Jun 25;9(6):e100545. doi: 10.1371/journal.pone.0100545. eCollection 2014.
- Derived from this study: PubMed 24108780Hu YM, Wang X, Wang JZ, Wang L, Zhang YJ, Chang L, Liang ZL, Xia JL, Dai QG, Hu YL, Mao QY, Zhu FC, Song YF, Gao F, Chen JT. Immunogenicity, safety, and lot consistency of a novel inactivated enterovirus 71 vaccine in Chinese children aged 6 to 59 months. Clin Vaccine Immunol. 2013 Dec;20(12):1805-11. doi: 10.1128/CVI.00491-13. Epub 2013 Oct 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yue-Mei Hu, BS principal investigator
Jiangsu Center for Diseases Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing three consecutive lots of EV71 vaccine in people with Hand, Foot and Mouth Disease, run by Sinovac Biotech Co., Ltd 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 3 inclusion and 18 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 15 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 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 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 GMT of anti-EV71 antibodies in serum 28 days after the two-dose regimen (time frame: 28 days after first vaccination). 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 NCT01636245, which also lists 2 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 15 Mar 2013.