Safety Clinical Trial
Official title:
A Phase II Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants
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.
Status | Completed |
Enrollment | 1200 |
Est. completion date | May 2012 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Months to 36 Months |
Eligibility |
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 Exclusion Criteria for the second dose: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
China | Jiangsu Provincial Center for Diseases Control and Prevention | Nanjing | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Jiangsu Province Centers for Disease Control and Prevention | Bejing Vigoo Biological Co., LTD |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 28 days after first vaccination | No |
Primary | 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 | 28 days after second vaccination | No |
Primary | 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 | 28 days after the first vaccination | Yes |
Primary | 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 | 28 days after the second vaccination | Yes |
Secondary | 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 | 28 days after first vaccination | No |
Secondary | 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 | 28 days after second vaccination | No |
Secondary | 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 | 28 days after the first vaccination | Yes |
Secondary | 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 | 28 days after the second vaccination | Yes |
Secondary | 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 | 3 days after first vaccination | Yes |
Secondary | 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 | 3 days after second vaccination | Yes |
Secondary | 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 | 6 months after blood collection at day 56 | No |
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