Hand-foot-mouth DiseasePhase 1NCT01273246
Safety of an Inactivated Enterovirus Type 71 Vaccines in Healthy Children
A Phase 1 study testing 100U inactivated Enterovirus Type 71 Vaccine, 200U inactivated Enterovirus Type 71 Vaccine and 400U inactivated Enterovirus Type 71 Vaccine in people with Hand-foot-mouth Disease and Infection; Viral, Enterovirus, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
A Phase I clinical trialto evaluate the safety of an Inactivated Enterovirus Type 71 Vaccine in healthy children (3-11y) and infants (6-35m). Read more about this study
- Who is it for?
- Ages 6 months to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Hand-foot-mouth Disease, Infection; Viral, Enterovirus
- What is being tested?
- 100U inactivated Enterovirus Type 71 Vaccine, 200U inactivated Enterovirus Type 71 Vaccine and 400U inactivated Enterovirus Type 71 Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Jul 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 11 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.
- Birth weight more than 2500 grams
Who cannot join
- Histroy 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 28 days
- Administration of subunit or inactivated vaccines ,e.g., pneumococcal vaccine, or allergy treatment within 14 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: A Blind, Randomized and Placebo-controlled Clinical Trial With Inactivated Enterovirus Type 71 Vaccines in Healthy Children.
A Phase I clinical trialto evaluate the safety of an Inactivated Enterovirus Type 71 Vaccine in healthy children (3-11y) and infants (6-35m).
Read the detailed description
36 eligible children aged from 3 to 11 years and 96 eligible infants aged from 6 to 35 months will be enrolled in the study, they will be randomized to receive different dosage of vaccine candidate or placebo to evaluate the safety of this vaccine
- Being tested
- 100U inactivated Enterovirus Type 71 Vaccine, 200U inactivated Enterovirus Type 71 Vaccine, 400U inactivated Enterovirus Type 71 Vaccine, Placebo
- Medical subject headings
- Hand, Foot and Mouth Disease, Infections, Enterovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100U inactivated Enterovirus Type 71 VaccineBiological
Also called EV71 vaccine
Inactivated Enterovirus Type 71 Vaccine, 100U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
200U inactivated Enterovirus Type 71 VaccineBiological
Also called EV71 vaccine
Inactivated Enterovirus Type 71 Vaccine, 200U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
400U inactivated Enterovirus Type 71 VaccineBiological
Also called EV71 vaccine
Inactivated Enterovirus Type 71 Vaccine, 400U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
PlaceboBiological
Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose. Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
| Study group | Role | What they receive |
|---|---|---|
| Children Group 1: 200U EV71 vaccine | Experimental | 12 children received 3 doses of 200U EV71 vaccine 28 days apart Receives: Biological: 200U inactivated Enterovirus Type 71 Vaccine |
| Children Group 1: Placebo | Placebo comparator | 6 children received 3 doses of placebo 28 days apart Receives: Biological: Placebo |
| Children Group 2: 400U EV71 vaccine | Experimental | 12 children received 3 doses of 400U EV71 vaccine 28 days apart Receives: Biological: 400U inactivated Enterovirus Type 71 Vaccine |
| Children Group 2: Placebo | Placebo comparator | 6 children received 3 doses of placebo 28 days apart Receives: Biological: Placebo |
| Infants Group 1: 100U EV71 vaccine | Experimental | 24 infants received 3 doses of 100U EV71 vaccine 28 days apart Receives: Biological: 100U inactivated Enterovirus Type 71 Vaccine |
| Infants Group 1: Placebo | Placebo comparator | 8 infants received 3 doses of placebo 28 days apart Receives: Biological: Placebo |
| Infants Group 2: 200U EV71 vaccine | Experimental | 24 infants received 3 doses of 200U EV71 vaccine 28 days apart Receives: Biological: 200U inactivated Enterovirus Type 71 Vaccine |
| Infants Group 2: Placebo | Placebo comparator | 8 infants received 3 doses of placebo 28 days apart Receives: Biological: Placebo |
| Infants Group 3: 400U EV71 vaccine | Experimental | 24 infants received 3 doses of 400U EV71 vaccine 28 days apart Receives: Biological: 400U inactivated Enterovirus Type 71 Vaccine |
| Infants Group 3: Placebo | Placebo comparator | 8 infants received 3 doses of placebo 28 days apart Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of the inactivated Enterovirus Type 71 Vaccine
All adverse events were records. Blood cell and biochemistry were performed.
Measured: 6 months
Secondary outcomes (1)
To evaluate the immunogenicity of the inactivated Enterovirus Type 71 Vaccine
virus neutralization assays were performed.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2011
- Study completionJul 2011
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-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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yan-pin Li, MD, Principal investigator, Guangxi Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273246
- Sponsor's protocol ID
- EV71-1001-Ib
- Status last verified
- Jul 2011
- First submitted
- 7 Jan 2011
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mao Q, Cheng T, Zhu F, Li J, Wang Y, Li Y, Gao F, Yang L, Yao X, Shao J, Xia N, Liang Z, Wang J. The cross-neutralizing activity of enterovirus 71 subgenotype c4 vaccines in healthy chinese infants and children. PLoS One. 2013 Nov 19;8(11):e79599. doi: 10.1371/journal.pone.0079599. eCollection 2013.
PubMed 24260259Li YP, Liang ZL, Gao Q, Huang LR, Mao QY, Wen SQ, Liu Y, Yin WD, Li RC, Wang JZ. Safety and immunogenicity of a novel human Enterovirus 71 (EV71) vaccine: a randomized, placebo-controlled, double-blind, Phase I clinical trial. Vaccine. 2012 May 9;30(22):3295-303. doi: 10.1016/j.vaccine.2012.03.010. Epub 2012 Mar 15.
PubMed 22426327
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blind, Randomized and Placebo-controlled Clinical Trial With Inactivated Enterovirus Type 71 Vaccines in Healthy Children.
- ClinicalTrials.gov ID
- NCT01273246
- Acronym / sponsor ID
- EV71-1001-Ib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 10 Jan 2011 (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.
A Phase I clinical trialto evaluate the safety of an Inactivated Enterovirus Type 71 Vaccine in healthy children (3-11y) and infants (6-35m).
Detailed description
36 eligible children aged from 3 to 11 years and 96 eligible infants aged from 6 to 35 months will be enrolled in the study, they will be randomized to receive different dosage of vaccine candidate or placebo to evaluate the safety of this vaccine
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Children Group 1: 200U EV71 vaccine | Experimental | Biological: 200U inactivated Enterovirus Type 71 Vaccine12 children received 3 doses of 200U EV71 vaccine 28 days apart |
| Children Group 1: Placebo | Placebo comparator | Biological: Placebo6 children received 3 doses of placebo 28 days apart |
| Children Group 2: 400U EV71 vaccine | Experimental | Biological: 400U inactivated Enterovirus Type 71 Vaccine12 children received 3 doses of 400U EV71 vaccine 28 days apart |
| Children Group 2: Placebo | Placebo comparator | Biological: Placebo6 children received 3 doses of placebo 28 days apart |
| Infants Group 1: 100U EV71 vaccine | Experimental | Biological: 100U inactivated Enterovirus Type 71 Vaccine24 infants received 3 doses of 100U EV71 vaccine 28 days apart |
| Infants Group 1: Placebo | Placebo comparator | Biological: Placebo8 infants received 3 doses of placebo 28 days apart |
| Infants Group 2: 200U EV71 vaccine | Experimental | Biological: 200U inactivated Enterovirus Type 71 Vaccine24 infants received 3 doses of 200U EV71 vaccine 28 days apart |
| Infants Group 2: Placebo | Placebo comparator | Biological: Placebo8 infants received 3 doses of placebo 28 days apart |
| Infants Group 3: 400U EV71 vaccine | Experimental | Biological: 400U inactivated Enterovirus Type 71 Vaccine24 infants received 3 doses of 400U EV71 vaccine 28 days apart |
| Infants Group 3: Placebo | Placebo comparator | Biological: Placebo8 infants received 3 doses of placebo 28 days apart |
Who may qualify
- Ages
- 6 months to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 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.
- Birth weight more than 2500 grams
Key exclusion criteria (18 listed)
- Histroy 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 |
|---|---|---|
| 100U inactivated Enterovirus Type 71 VaccineAlso: EV71 vaccineInactivated Enterovirus Type 71 Vaccine, 100U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm | Biological | Infants Group 1: 100U EV71 vaccine |
| 200U inactivated Enterovirus Type 71 VaccineAlso: EV71 vaccineInactivated Enterovirus Type 71 Vaccine, 200U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm | Biological | Children Group 1: 200U EV71 vaccine, Infants Group 2: 200U EV71 vaccine |
| 400U inactivated Enterovirus Type 71 VaccineAlso: EV71 vaccineInactivated Enterovirus Type 71 Vaccine, 400U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm | Biological | Children Group 2: 400U EV71 vaccine, Infants Group 3: 400U EV71 vaccine |
| PlaceboPlacebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose. Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm | Biological | Children Group 1: Placebo, Children Group 2: Placebo, Infants Group 1: Placebo, Infants Group 2: Placebo, Infants Group 3: Placebo |
Primary outcome
To evaluate the safety of the inactivated Enterovirus Type 71 Vaccine
Time frame: 6 months
All adverse events were records. Blood cell and biochemistry were performed.
1 secondary outcome
To evaluate the immunogenicity of the inactivated Enterovirus Type 71 Vaccine
Time frame: 6 months
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 28 Jul 2021.
- Derived from this study: PubMed 24260259Mao Q, Cheng T, Zhu F, Li J, Wang Y, Li Y, Gao F, Yang L, Yao X, Shao J, Xia N, Liang Z, Wang J. The cross-neutralizing activity of enterovirus 71 subgenotype c4 vaccines in healthy chinese infants and children. PLoS One. 2013 Nov 19;8(11):e79599. doi: 10.1371/journal.pone.0079599. eCollection 2013.
- Derived from this study: PubMed 22426327Li YP, Liang ZL, Gao Q, Huang LR, Mao QY, Wen SQ, Liu Y, Yin WD, Li RC, Wang JZ. Safety and immunogenicity of a novel human Enterovirus 71 (EV71) vaccine: a randomized, placebo-controlled, double-blind, Phase I clinical trial. Vaccine. 2012 May 9;30(22):3295-303. doi: 10.1016/j.vaccine.2012.03.010. Epub 2012 Mar 15.
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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.
Yan-pin Li, MD principal investigator
Guangxi Centers for Disease 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 1 study testing 100U inactivated Enterovirus Type 71 Vaccine, 200U inactivated Enterovirus Type 71 Vaccine and 400U inactivated Enterovirus Type 71 Vaccine in people with Hand-foot-mouth Disease and Infection; Viral, Enterovirus, 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 4 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 28 Jul 2021. 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?
To evaluate the safety of the inactivated Enterovirus Type 71 Vaccine (time frame: 6 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 NCT01273246, 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 28 Jul 2021.