Immunogenicity, Safety
Conditions
Keywords
immunogenicity, safety, inactivated EV71 vaccine
Brief 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 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.
Interventions
BIOLOGICAL160U /0.5ml EV71 Vaccine
inactivated vaccine (vero cell) against EV71 of 160U /0.5ml, two doses, 28 days interval
BIOLOGICAL320U /0.5ml EV71 vaccine
inactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, 28 days interval
BIOLOGICAL640U /0.5ml EV71 vaccine
inactivated vaccine (vero cell) against EV71 of 640U /0.5ml, two doses, 28 days interval
BIOLOGICAL(without adjuvant) 640U /0.5ml
inactivated vaccine (vero cell) against EV71 of (without adjuvant) 640U /0.5ml, two doses, 28 days interval
BIOLOGICAL0/0.5ml placebo
0/0.5ml placebo, two doses, 28 days interval
Sponsors
Bejing Vigoo Biological Co., LTD
Jiangsu Province Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 36 Months
Healthy volunteers
No
Inclusion criteria
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 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
Exclusion criteria
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of systemic and local adverse reactions after the first vaccination | 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 | 28 days after the second vaccination | Frequency of systemic and local adverse reactions in healthy Children and infants following second doses of EV71 vaccine |
| The GMT of anti-EV71 antibodies in serum after first vaccination | 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 | 28 days after second vaccination | to evaluate the GMT of anti-EV71 antibodies in serum 28 days after second vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The clinical abnormality of hematological examination, blood biochemical test and urinalysis after first vaccination in children | 3 days after first vaccination | to evaluate the clinical abnormality of hematological examination, blood biochemical test and urinalysis 3 days after first vaccination in children |
| The seroconversion rate of anti-EV71 antibodies in serum after first vaccination | 28 days after first vaccination | to evaluate the seroconversion rate of anti-EV71 antibodies in serum 28 days after first vaccination |
| The persistence of immunogenicity of the EV71vaccine after two doses in children and infants | 6 months after blood collection at day 56 | to evaluate the persistence of immunogenicity of the EV71vaccine after two doses in children and infants 6 months after blood collection at day 56 |
| The clinical abnormality of hematological examination, blood biochemical test and urinalysis after second vaccination in children | 3 days after second vaccination | to evaluate the clinical abnormality of hematological examination, blood biochemical test and urinalysis 3 days after second vaccination in children |
| The seroconversion rate of anti-EV71 antibodies in serum after second vaccination | 28 days after second vaccination | to evaluate the seroconversion rate of anti-EV71 antibodies in serum 28 days after second vaccination |
| Frequency of adverse events and any SAE after the first vaccination | 28 days after the first vaccination | Frequency of adverse events and any SAE in healthy Children and infants following first doses of EV71 vaccine |
| Frequency of adverse events and any SAE after the second vaccination | 28 days after the second vaccination | Frequency of adverse events and any SAE in healthy Children and infants following second doses of EV71 vaccine |
Countries
China
Outcome results
None listed