Infection, Viral, EnterovirusPhase 2NCT01421121
Safety and Immunogenicity of an Inactivated EV71 Vaccine in Infants
A Phase 2 study testing 100U EV71 vaccine with adjuvant, 200 U EV71 vaccine with adjuvant and 400U EV71 vaccine with adjuvant in people with Infection, Viral, Enterovirus, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
A randomized, placebo-controlled, double-blind clinical trial is to evaluate the safety and immunogenicity of a new inactivated EV71 vaccine developed by Sinovac Biotech CO., LTD. Read more about this study
- Who is it for?
- Ages 6 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Infection, Viral, Enterovirus
- What is being tested?
- 100U EV71 vaccine with adjuvant, 200 U EV71 vaccine with adjuvant and 400U EV71 vaccine with adjuvant
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 540 participants
- Where
- 1 siteChina
- Study dates
- Jun 2011to Dec 2011
- Phase
- Phase 2
- 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
- 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
- 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 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
A randomized, placebo-controlled, double-blind clinical trial is to evaluate the safety and immunogenicity of a new inactivated EV71 vaccine developed by Sinovac Biotech CO., LTD.
- Conditions
- Infection, Viral, Enterovirus
- Being tested
- 100U EV71 vaccine with adjuvant, 200 U EV71 vaccine with adjuvant, 400U EV71 vaccine with adjuvant, 200U EV71 vaccine without adjuvant, Placebo
- Medical subject headings
- Infections, Enterovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100U EV71 vaccine with adjuvantBiological
Also called EV71 vaccine
inactivated vaccine (vero cell) against EV71 of 100U /0.5ml, two doses, 28 days interval
200 U EV71 vaccine with adjuvantBiological
Also called EV71 vaccine
inactivated vaccine (vero cell) against EV71 of 200U /0.5ml, two doses, 28 days interval
400U EV71 vaccine with adjuvantBiological
Also called EV71 vaccine
inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
200U EV71 vaccine without adjuvantBiological
Also called EV71 vaccine
inactivated vaccine (vero cell) against EV71 without adjuvant of 200U /0.5ml, two doses, 28 days interval
PlaceboBiological
0.5ml placebo, two doses, 28 days interval
| Study group | Role | What they receive |
|---|---|---|
| 100U EV71 vaccine with adjuvant | Experimental | 120 infants received 2 doses of 100U EV71 vaccine with aluminium hydroxide adjuvant 28 days apart Receives: Biological: 100U EV71 vaccine with adjuvant |
| 200 U EV71 vaccine with adjuvant | Experimental | 120 infants received 2 doses of 200U EV71 vaccine with aluminium hydroxide adjuvant 28 days apart Receives: Biological: 200 U EV71 vaccine with adjuvant |
| 400U EV71 vaccine with adjuvant | Experimental | 120 infants received 2 doses of 400U EV71 vaccine with aluminium hydroxide adjuvant 28 days apart Receives: Biological: 400U EV71 vaccine with adjuvant |
| 200U EV71 vaccine without adjuvant | Experimental | 60 infants received 2 doses of 200U EV71 vaccine without adjuvant 28 days apart Receives: Biological: 200U EV71 vaccine without adjuvant |
| Placebo | Placebo comparator | 120 infants received 2 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.
Neutralization antibody geometric mean titer in infants 28 days after immunization with EV71 vaccine with or without aluminium hydroxide adjuvant
Primary immunogenicity end point were geometric mean titer of neutralization antibody againt EV71 virus >= 1:8
Measured: 6 month
Secondary outcomes (1)
The rates and severity of solicited adverse events in infants following immunization as a Measure of Safety and Tolerability
solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site.
solicited general adverse events include Fever, Nausea, Vomiting, Diareahhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy
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 posted22 Aug 2011 (estimated)
- Study startJun 2011
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, Viral, EnterovirusStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 540 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
- NCT01421121
- Sponsor's protocol ID
- EV71-1001-II
- Status last verified
- Nov 2012
- First submitted
- 22 Jul 2011
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of an Inactivated EV71 Vaccine in Infants
- ClinicalTrials.gov ID
- NCT01421121
- Acronym / sponsor ID
- EV71-1001-II
- Conditions
- Infection, Viral, Enterovirus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 22 Aug 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 randomized, placebo-controlled, double-blind clinical trial is to evaluate the safety and immunogenicity of a new inactivated EV71 vaccine developed by Sinovac Biotech CO., LTD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 100U EV71 vaccine with adjuvant | Experimental | Biological: 100U EV71 vaccine with adjuvant120 infants received 2 doses of 100U EV71 vaccine with aluminium hydroxide adjuvant 28 days apart |
| 200 U EV71 vaccine with adjuvant | Experimental | Biological: 200 U EV71 vaccine with adjuvant120 infants received 2 doses of 200U EV71 vaccine with aluminium hydroxide adjuvant 28 days apart |
| 400U EV71 vaccine with adjuvant | Experimental | Biological: 400U EV71 vaccine with adjuvant120 infants received 2 doses of 400U EV71 vaccine with aluminium hydroxide adjuvant 28 days apart |
| 200U EV71 vaccine without adjuvant | Experimental | Biological: 200U EV71 vaccine without adjuvant60 infants received 2 doses of 200U EV71 vaccine without adjuvant 28 days apart |
| Placebo | Placebo comparator | Biological: Placebo120 infants received 2 doses of placebo 28 days apart. |
Who may qualify
- Ages
- 6 to 35 months
- 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)
- 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 |
|---|---|---|
| 100U EV71 vaccine with adjuvantAlso: EV71 vaccineinactivated vaccine (vero cell) against EV71 of 100U /0.5ml, two doses, 28 days interval | Biological | 100U EV71 vaccine with adjuvant |
| 200 U EV71 vaccine with adjuvantAlso: EV71 vaccineinactivated vaccine (vero cell) against EV71 of 200U /0.5ml, two doses, 28 days interval | Biological | 200 U EV71 vaccine with adjuvant |
| 400U EV71 vaccine with adjuvantAlso: EV71 vaccineinactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval | Biological | 400U EV71 vaccine with adjuvant |
| 200U EV71 vaccine without adjuvantAlso: EV71 vaccineinactivated vaccine (vero cell) against EV71 without adjuvant of 200U /0.5ml, two doses, 28 days interval | Biological | 200U EV71 vaccine without adjuvant |
| Placebo0.5ml placebo, two doses, 28 days interval | Biological | Placebo |
Primary outcome
Neutralization antibody geometric mean titer in infants 28 days after immunization with EV71 vaccine with or without aluminium hydroxide adjuvant
Time frame: 6 month
Primary immunogenicity end point were geometric mean titer of neutralization antibody againt EV71 virus >= 1:8
1 secondary outcome
The rates and severity of solicited adverse events in infants following immunization as a Measure of Safety and Tolerability
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 27 Nov 2012.
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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 2 study testing 100U EV71 vaccine with adjuvant, 200 U EV71 vaccine with adjuvant and 400U EV71 vaccine with adjuvant in people with 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 27 Nov 2012. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Neutralization antibody geometric mean titer in infants 28 days after immunization with EV71 vaccine with or without aluminium hydroxide adjuvant (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2012.