ImmunogenicityPhase 2NCT01399853
A Phase II Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants
A Phase 2 study testing 160U /0.5ml EV71 Vaccine, 320U /0.5ml EV71 vaccine and 640U /0.5ml EV71 vaccine in people with Immunogenicity and Safety, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial summary
Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children caused by viruses that belong to the enterovirus genus of the picornavirus family. Although most HFMD cases do not result in serious complications, outbreaks of HFMD caused by enterovirus 71 (EV71) can present with a high rate of… Read more about this study
- Who is it for?
- Ages 6 to 36 months
- Conditions the study is for
- Immunogenicity, Safety
- What is being tested?
- 160U /0.5ml EV71 Vaccine, 320U /0.5ml EV71 vaccine and 640U /0.5ml EV71 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- Jul 2011to May 2012
- 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 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- For children group (aged from 12-36 months):
- Healthy children aged from 12 to 36 months old as established by medical history and clinical examination
- The subjects' guardians are able to understand and sign the informed consent
- Had never received the vaccine against EV71
- Subjects who can and will comply with the requirements of the protocol
- Subjects with temperature <=37.0°C on axillary setting
Show all 12Show fewer
- For infants group (aged from 6-11 months):
- Healthy infants aged from 6 to 11 months old as established by medical history and clinical examination
- The subjects' guardians are able to understand and sign the informed consent
- Had never received the vaccine against EV71
- Subjects who can and will comply with the requirements of the protocol
- Subjects with temperature <=37.0°C on axillary setting
Who cannot join
- For children group (aged from 12-36 months):
- Subject who has a medical history of HFMD
- <= 37 weeks gestation
- Subjects with a birth weight <2.5 kg
- 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
Show all 42Show fewer
- Family history of congenital or hereditary immunodeficiency
- Severe malnutrition or dysgenopathy
- 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
- Any acute infections in last 7 days
- Any prior administration of immunodepressant or corticosteroids in last 6month
- Any prior administration of blood products in last 3 month
- Any prior administration of other research medicines in last 1 month
- Any prior administration of attenuated live vaccine in last 28 days
- Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine
- Under the anti-TB prevention or therapy
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
- For infants group (aged from 6-11 months):
- Subject who has a medical history of HFMD
- <= 37 weeks gestation
- Subjects with a birth weight <2.5 kg
- 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 dysgenopathy
- 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
- Any acute infections in last 7 days
- Any prior administration of immunodepressant or corticosteroids in last 6month
- Any prior administration of blood products in last 3 month
- Any prior administration of other research medicines in last 1 month
- Any prior administration of attenuated live vaccine in last 28 days
- Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine
- Under the anti-TB prevention or therapy
- Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
- Had any Grade 3 or Grade 4 adverse reaction within 7 days after first dose
- Any situation meet the exclusion criteria stated in the exclusion criteria for first dose
- Had any SAE related to first dose during the following-up of first dose
- Any condition that in the opinion of the investigator, or IRB
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, 210009
About this study
Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children caused by viruses that belong to the enterovirus genus of the picornavirus family. Although most HFMD cases do not result in serious complications, outbreaks of HFMD caused by enterovirus 71 (EV71) can present with a high rate of neurological complications, including meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused by EV71 has become a major emerging infectious disease in Asia and the highly pathogenic potential of EV71 clearly requires the attention of world medical community.
The phase I study of inactivated vaccine (vero cell) against EV71 has completed last month in Jiangsu Province in China. The data from the phase I study suggested that the inactivated EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese children and infants. In order to provide more evidence for the immunogenicity of the vaccine, to further explore the probable immunizing dose and the safety profile of this vaccine, a phase II clinical trial is planed to conduct.
- Conditions
- Immunogenicity, Safety
- Being tested
- 160U /0.5ml EV71 Vaccine, 320U /0.5ml EV71 vaccine, 640U /0.5ml EV71 vaccine, (without adjuvant) 640U /0.5ml, 0/0.5ml placebo
- Keywords
- immunogenicity, safety, inactivated EV71 vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
160U /0.5ml EV71 VaccineBiological
inactivated vaccine (vero cell) against EV71 of 160U /0.5ml, two doses, 28 days interval
320U /0.5ml EV71 vaccineBiological
inactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, 28 days interval
640U /0.5ml EV71 vaccineBiological
inactivated vaccine (vero cell) against EV71 of 640U /0.5ml, two doses, 28 days interval
(without adjuvant) 640U /0.5mlBiological
inactivated vaccine (vero cell) against EV71 of (without adjuvant) 640U /0.5ml, two doses, 28 days interval
0/0.5ml placeboBiological
0/0.5ml placebo, two doses, 28 days interval
| Study group | Role | What they receive |
|---|---|---|
| 160U /0.5ml in children (from 12 to 36 months old) | Experimental | inactivated vaccine(vero cell) against EV71 of 160U /0.5ml in 120 children aged 12-36 months old on day0,28 Receives: Biological: 160U /0.5ml EV71 Vaccine |
| 320U /0.5ml in children (from 12 to 36 months old) | Experimental | inactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 120 children aged 12-36 months old on day0,28 Receives: Biological: 320U /0.5ml EV71 vaccine |
| 640U /0.5ml in children (from 12 to 36 months old) | Experimental | inactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 120 children aged 12-36 months old on day0,28 Receives: Biological: 640U /0.5ml EV71 vaccine |
| (without adjuvant) 640U /0.5ml in children (12-36months) | Experimental | inactivated vaccine(vero cell) against EV71 of (without adjuvant) 640U /0.5ml in 120 children aged 12-36 months old on day0,28 Receives: Biological: (without adjuvant) 640U /0.5ml |
| 160U /0.5ml in infants (from 6 to 11 months old) | Experimental | inactivated vaccine(vero cell) against EV71 of 160U /0.5ml in 120 infants aged 6-11 months old on day0,28 Receives: Biological: 160U /0.5ml EV71 Vaccine |
| 320U /0.5ml in infants (from 6 to 11 months old) | Experimental | inactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 120 infants aged 6-11 months old on day0,28 Receives: Biological: 320U /0.5ml EV71 vaccine |
| 640U /0.5ml in infants (from 6 to 11 months old) | Experimental | inactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 120 infants aged 6-11 months old on day0,28 Receives: Biological: 640U /0.5ml EV71 vaccine |
| (without adjuvant) 640U /0.5ml in infants (from 6 to 11 months | Experimental | inactivated vaccine(vero cell) against EV71 of (without adjuvant) 640U /0.5ml in 120 infants aged 6-11 months old on day0,28 Receives: Biological: (without adjuvant) 640U /0.5ml |
| 0/0.5ml placebo in children (from 12 to 36 months old) | Placebo comparator | 0/0.5ml placebo in 120 children aged 12-36 months old on day0,28 Receives: Biological: 0/0.5ml placebo |
| 0/0.5ml placebo in infants (from 6 to 11 months old) | Placebo comparator | 0/0.5ml placebo in 120 infants aged 6-11 months old 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.
The GMT of anti-EV71 antibodies in serum after first vaccination
to evaluate the GMT of anti-EV71 antibodies in serum 28 days after first vaccination
Measured: 28 days after first vaccination
The GMT of anti-EV71 antibodies in serum after second vaccination
to evaluate the GMT of anti-EV71 antibodies in serum 28 days after second vaccination
Measured: 28 days after second vaccination
Frequency of systemic and local adverse reactions after the first vaccination
Frequency of systemic and local adverse reactions in healthy Children and 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 Children and infants following second doses of EV71 vaccine
Measured: 28 days after the second vaccination
Secondary outcomes (7)
The seroconversion rate of anti-EV71 antibodies in serum after first vaccination
to evaluate the seroconversion rate of anti-EV71 antibodies in serum 28 days after first vaccination
Measured: 28 days after first vaccination
The seroconversion rate of anti-EV71 antibodies in serum after second vaccination
to evaluate the seroconversion rate of anti-EV71 antibodies in serum 28 days after second vaccination
Measured: 28 days after second vaccination
Frequency of adverse events and any SAE after the first vaccination
Frequency of adverse events and any SAE in healthy Children and infants following first doses of EV71 vaccine
Measured: 28 days after the first vaccination
Frequency of adverse events and any SAE after the second vaccination
Frequency of adverse events and any SAE in healthy Children and infants following second doses of EV71 vaccine
Measured: 28 days after the second vaccination
The clinical abnormality of hematological examination, blood biochemical test and urinalysis after first vaccination in children
to evaluate the clinical abnormality of hematological examination, blood biochemical test and urinalysis 3 days after first vaccination in children
Measured: 3 days after first vaccination
The clinical abnormality of hematological examination, blood biochemical test and urinalysis after second vaccination in children
to evaluate the clinical abnormality of hematological examination, blood biochemical test and urinalysis 3 days after second vaccination in children
Measured: 3 days after second vaccination
The persistence of immunogenicity of the EV71vaccine after two doses in children and infants
to evaluate the persistence of immunogenicity of the EV71vaccine after two doses in children and infants 6 months after blood collection at day 56
Measured: 6 months after blood collection at day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ImmunogenicityStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Collaborators
- Bejing Vigoo Biological Co., LTD
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399853
- Sponsor's protocol ID
- JSVCT005
- Status last verified
- May 2012
- First submitted
- 19 Jul 2011
- Last updated
- 31 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhu FC, Liang ZL, Li XL, Ge HM, Meng FY, Mao QY, Zhang YT, Hu YM, Zhang ZY, Li JX, Gao F, Chen QH, Zhu QY, Chu K, Wu X, Yao X, Guo HJ, Chen XQ, Liu P, Dong YY, Li FX, Shen XL, Wang JZ. Immunogenicity and safety of an enterovirus 71 vaccine in healthy Chinese children and infants: a randomised, double-blind, placebo-controlled phase 2 clinical trial. Lancet. 2013 Mar 23;381(9871):1037-45. doi: 10.1016/S0140-6736(12)61764-4.
PubMed 23352749
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants
- ClinicalTrials.gov ID
- NCT01399853
- Acronym / sponsor ID
- JSVCT005
- Conditions
- Immunogenicity, Safety
- Keywords
- immunogenicity, safety, inactivated EV71 vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Collaborators
- Bejing Vigoo Biological Co., LTD
- Study start
- Jul 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 22 Jul 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.
Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children caused by viruses that belong to the enterovirus genus of the picornavirus family. Although most HFMD cases do not result in serious complications, outbreaks of HFMD caused by enterovirus 71 (EV71) can present with a high rate of neurological complications, including meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused by EV71 has become a major emerging infectious disease in Asia and the highly pathogenic potential of EV71 clearly requires the attention of world medical community.
The phase I study of inactivated vaccine (vero cell) against EV71 has completed last month in Jiangsu Province in China. The data from the phase I study suggested that the inactivated EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese children and infants. In order to provide more evidence for the immunogenicity of the vaccine, to further explore the probable immunizing dose and the safety profile of this vaccine, a phase II clinical trial is planed to conduct.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| 160U /0.5ml in children (from 12 to 36 months old) | Experimental | Biological: 160U /0.5ml EV71 Vaccineinactivated vaccine(vero cell) against EV71 of 160U /0.5ml in 120 children aged 12-36 months old on day0,28 |
| 320U /0.5ml in children (from 12 to 36 months old) | Experimental | Biological: 320U /0.5ml EV71 vaccineinactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 120 children aged 12-36 months old on day0,28 |
| 640U /0.5ml in children (from 12 to 36 months old) | Experimental | Biological: 640U /0.5ml EV71 vaccineinactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 120 children aged 12-36 months old on day0,28 |
| (without adjuvant) 640U /0.5ml in children (12-36months) | Experimental | Biological: (without adjuvant) 640U /0.5mlinactivated vaccine(vero cell) against EV71 of (without adjuvant) 640U /0.5ml in 120 children aged 12-36 months old on day0,28 |
| 160U /0.5ml in infants (from 6 to 11 months old) | Experimental | Biological: 160U /0.5ml EV71 Vaccineinactivated vaccine(vero cell) against EV71 of 160U /0.5ml in 120 infants aged 6-11 months old on day0,28 |
| 320U /0.5ml in infants (from 6 to 11 months old) | Experimental | Biological: 320U /0.5ml EV71 vaccineinactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 120 infants aged 6-11 months old on day0,28 |
| 640U /0.5ml in infants (from 6 to 11 months old) | Experimental | Biological: 640U /0.5ml EV71 vaccineinactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 120 infants aged 6-11 months old on day0,28 |
| (without adjuvant) 640U /0.5ml in infants (from 6 to 11 months | Experimental | Biological: (without adjuvant) 640U /0.5mlinactivated vaccine(vero cell) against EV71 of (without adjuvant) 640U /0.5ml in 120 infants aged 6-11 months old on day0,28 |
| 0/0.5ml placebo in children (from 12 to 36 months old) | Placebo comparator | Biological: 0/0.5ml placebo0/0.5ml placebo in 120 children aged 12-36 months old on day0,28 |
| 0/0.5ml placebo in infants (from 6 to 11 months old) | Placebo comparator | Biological: 0/0.5ml placebo0/0.5ml placebo in 120 infants aged 6-11 months old on day0,28 |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Healthy children aged from 12 to 36 months old as established by medical history and clinical examination
- The subjects' guardians are able to understand and sign the informed consent
- Had never received the vaccine against EV71
- Subjects who can and will comply with the requirements of the protocol
- Subjects with temperature <=37.0°C on axillary setting
Key exclusion criteria (42 listed)
- Subject who has a medical history of HFMD
- <= 37 weeks gestation
- Subjects with a birth weight <2.5 kg
- 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
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 |
|---|---|---|
| 160U /0.5ml EV71 Vaccineinactivated vaccine (vero cell) against EV71 of 160U /0.5ml, two doses, 28 days interval | Biological | 160U /0.5ml in children (from 12 to 36 months old), 160U /0.5ml in infants (from 6 to 11 months old) |
| 320U /0.5ml EV71 vaccineinactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, 28 days interval | Biological | 320U /0.5ml in children (from 12 to 36 months old), 320U /0.5ml in infants (from 6 to 11 months old) |
| 640U /0.5ml EV71 vaccineinactivated vaccine (vero cell) against EV71 of 640U /0.5ml, two doses, 28 days interval | Biological | 640U /0.5ml in children (from 12 to 36 months old), 640U /0.5ml in infants (from 6 to 11 months old) |
| (without adjuvant) 640U /0.5mlinactivated vaccine (vero cell) against EV71 of (without adjuvant) 640U /0.5ml, two doses, 28 days interval | Biological | (without adjuvant) 640U /0.5ml in children (12-36months), (without adjuvant) 640U /0.5ml in infants (from 6 to 11 months |
| 0/0.5ml placebo0/0.5ml placebo, two doses, 28 days interval | Biological | 0/0.5ml placebo in children (from 12 to 36 months old), 0/0.5ml placebo in infants (from 6 to 11 months old) |
Primary outcome
The GMT of anti-EV71 antibodies in serum after first vaccination
Time frame: 28 days after first vaccination
to evaluate the GMT of anti-EV71 antibodies in serum 28 days after first vaccination
The GMT of anti-EV71 antibodies in serum after second vaccination
Time frame: 28 days after second vaccination
to evaluate the GMT of anti-EV71 antibodies in serum 28 days after second vaccination
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 in healthy Children and infants following first doses of EV71 vaccine
Frequency of systemic and local adverse reactions after the second vaccination
Time frame: 28 days after the second vaccination
Frequency of systemic and local adverse reactions in healthy Children and infants following second doses of EV71 vaccine
7 secondary outcomes
The seroconversion rate of anti-EV71 antibodies in serum after first vaccination
Time frame: 28 days after first vaccination
The seroconversion rate of anti-EV71 antibodies in serum after second vaccination
Time frame: 28 days after second vaccination
Frequency of adverse events and any SAE after the first vaccination
Time frame: 28 days after the first vaccination
Frequency of adverse events and any SAE after the second vaccination
Time frame: 28 days after the second vaccination
The clinical abnormality of hematological examination, blood biochemical test and urinalysis after first vaccination in children
Time frame: 3 days after first vaccination
The clinical abnormality of hematological examination, blood biochemical test and urinalysis after second vaccination in children
Time frame: 3 days after second vaccination
The persistence of immunogenicity of the EV71vaccine after two doses in children and infants
Time frame: 6 months after blood collection at day 56
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 31 May 2012.
- Derived from this study: PubMed 23352749Zhu FC, Liang ZL, Li XL, Ge HM, Meng FY, Mao QY, Zhang YT, Hu YM, Zhang ZY, Li JX, Gao F, Chen QH, Zhu QY, Chu K, Wu X, Yao X, Guo HJ, Chen XQ, Liu P, Dong YY, Li FX, Shen XL, Wang JZ. Immunogenicity and safety of an enterovirus 71 vaccine in healthy Chinese children and infants: a randomised, double-blind, placebo-controlled phase 2 clinical trial. Lancet. 2013 Mar 23;381(9871):1037-45. doi: 10.1016/S0140-6736(12)61764-4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 160U /0.5ml EV71 Vaccine, 320U /0.5ml EV71 vaccine and 640U /0.5ml EV71 vaccine in people with Immunogenicity and Safety, run by Jiangsu Province Centers for Disease Control and Prevention 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 12 inclusion and 42 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 31 May 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?
The GMT of anti-EV71 antibodies in serum after first vaccination (time frame: 28 days after first vaccination). The study lists 4 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 NCT01399853, 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 31 May 2012.