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Immunity and Safety of Inactivated Enterovirus 71 Vaccine Post-marketing Among Children Aged 6-35 Months in China

Primary Purpose

Hand, Foot and Mouth Disease

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
The first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
The second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
The third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
The first batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor
The second batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor
The third batch of inactivated EV-A71 vaccine (vero cell) proudected by 150 L reactor
Sponsored by
Jiangsu Province Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hand, Foot and Mouth Disease

Eligibility Criteria

6 Months - 35 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy children aged 6-35 months
  • Subjects who have been clinically judged to be healthy by the researcher after being asked about the medical history and related physical examination
  • The subjects' guardians agree the requirements of the protocol and the relevant follow up visits
  • The subjects' guardians agree and sign the informed consent
  • Subjects who have no relocation or long-term travel plan within one year and are able to comply with the requirements of the clinical trial protocol.

Exclusion Criteria:

  • Subject who has a medical history of HFMD caused by EV71 or has been vaccinated with EV71 vaccine
  • Subject that has a history of allergies to vaccines or vaccine ingredients, and has serious side effects on vaccines, such as allergies, urticaria, dyspnea, vascular neuroedema or abdominal pain
  • Subject who has congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
  • Subject who has a history of epilepsy, convulsion or convulsion, or a family history of mental illness
  • Subject who has autoimmune disease or immune deficiency, or whose parents and siblings have autoimmune disease or immune deficiency
  • Subject who has a history of asthma, vascular and neuroedema, diabetes or malignant tumor
  • Subject who has a thyroid resection history, or received treatment due to thyroid disease in the past 12 months
  • Subject who has an abnormal coagulation function (such as coagulation factor deficiency, coagulant disease, platelet abnormality) or obvious bruising or clotting disorder which was diagnosed by doctors.
  • Asplenia, functional asplenia, or splenectomy due to any circumstances
  • Acute onset of various acute or chronic diseases in the last 7 days
  • Immunosuppressant therapy, antiallergic therapy, cytotoxicity therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, surface corticosteroid therapy for acute non-dermatitis) in the past 6 months
  • Any prior administration of blood products in last 3 months
  • Any prior administration of other research medicines or vaccines in last 1 month
  • Any prior administration of attenuated live vaccine in last 15 days
  • Any prior administration of subunit or inactivated vaccines in last 7 days
  • Under the anti-TB prevention or therapy
  • Underarm temperature > 37.0 ℃ for fever before vaccination
  • Other factors that are not suitable for clinical trials according to the judgment of researchers

Exclusion Criteria for the second dose:

  • Have severe allergic reaction after first dose
  • Have severe adverse reactions related to first dose
  • Any situation meet the exclusion criteria stated in the exclusion criteria for first dose
  • Acute infection or illness
  • Other factors that are not suitable for clinical trials according to the judgment of researchers

Sites / Locations

  • Fengcai Zhu

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

the first batch vaccine producted by 40 L reactor

the second batch vaccine producted by 40 L reactor

the third batch vaccine producted by 40 L reactor

the first batch vaccine producted by 150 L reactor

the second batch vaccine producted by 150 L reactor

the third batch vaccine proudected by 150 L reactor

Arm Description

500 subjects will be randomly received the first batch vaccine producted by 40 L reactor

500 subjects will be randomly received the second batch vaccine producted by 40 L reactor

500 subjects will be randomly received the third batch vaccine producted by 40 L reactor

500 subjects will be randomly received the first batch vaccine producted by 150 L reactor

500 subjects will be randomly received the second batch vaccine producted by 150 L reactor

500 subjects will be randomly received the third batch vaccine producted by 150 L reactor

Outcomes

Primary Outcome Measures

Consistency of different batches for geometric mean titre(GMT) after vaccination
Consistency of different batches for GMT of EV-A71 neutralizing antibody on 56 day after vaccination
Incidence and severity of adverse reactions/adverse events after each dose
Incidence and severity of adverse reactions/adverse events within 1 month after each dose

Secondary Outcome Measures

Incidence of sever adverse events after vaccination
Incidence of sever adverse events within 13 months after vaccination
GMTof EV-A71 neutralizing antibody on day 56 after vaccination
GMTof EV-A71 neutralizing antibody on day 56 after vaccination for different batchs
Positive rate of EV-A71 neutralizing antibody on day 56 after vaccination
Positive rate of EV-A71 neutralizing antibody on day 56 after vaccination for different batchs
Seroconversion rate of EV-A71 neutralizing antibody on day 56 after vaccination
Seroconversion rate of EV-A71 neutralizing antibody on day 56 after vaccination for different batchs
Geometric Mean Fold Increase(GMFI) of EV-A71 neutralizing antibody on day 56 after vaccination
Geometric Mean Fold Increase(GMFI) of EV-A71 neutralizing antibody on day 56 after vaccination for different batchs
GMTof EV-A71 neutralizing antibody on month 13 after vaccination
GMTof EV-A71 neutralizing antibody on month 13 after vaccination for different batchs
Positive rate of EV-A71 neutralizing antibody on month 13 after vaccination
Positive rate of EV-A71 neutralizing antibody on month 13 after vaccination for different batchs

Full Information

First Posted
March 26, 2019
Last Updated
May 21, 2021
Sponsor
Jiangsu Province Centers for Disease Control and Prevention
Collaborators
Wuhan Institute of Biological Products Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03893747
Brief Title
Immunity and Safety of Inactivated Enterovirus 71 Vaccine Post-marketing Among Children Aged 6-35 Months in China
Official Title
Three Batches Consistency, Immunity Duration and Safety of Inactivated Enterovirus 71 Vaccine Post-marketing Among Children Aged 6-35 Months in China
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
May 1, 2020 (Actual)
Study Completion Date
May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Province Centers for Disease Control and Prevention
Collaborators
Wuhan Institute of Biological Products Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates three batches consistency, immunity duration and safety of inactivated Enterovirus 71(EV-A71) vaccine(vero cell) post-marketing among children aged 6-35months in China.3000 subjects will be recruited in this study, of who 1500 subjects will be randomly assigned in a ratio of 1:1:1 to receive one of the three batches of EV-A71 vaccines manufactured by 40L capacity reactor, other 1500 subjects will be randomly assigned in a ratio of 1:1:1 to receive one of the three batches of EV-A71 vaccines manufactured by 150L capacity reactor. Vaccine wil be administrated according to a two doses of schedule given at day 0 and 28. Sample will be collected at day 0, day 56 and at month 13 after vaccinaiton.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand, Foot and Mouth Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the first batch vaccine producted by 40 L reactor
Arm Type
Experimental
Arm Description
500 subjects will be randomly received the first batch vaccine producted by 40 L reactor
Arm Title
the second batch vaccine producted by 40 L reactor
Arm Type
Experimental
Arm Description
500 subjects will be randomly received the second batch vaccine producted by 40 L reactor
Arm Title
the third batch vaccine producted by 40 L reactor
Arm Type
Experimental
Arm Description
500 subjects will be randomly received the third batch vaccine producted by 40 L reactor
Arm Title
the first batch vaccine producted by 150 L reactor
Arm Type
Experimental
Arm Description
500 subjects will be randomly received the first batch vaccine producted by 150 L reactor
Arm Title
the second batch vaccine producted by 150 L reactor
Arm Type
Experimental
Arm Description
500 subjects will be randomly received the second batch vaccine producted by 150 L reactor
Arm Title
the third batch vaccine proudected by 150 L reactor
Arm Type
Experimental
Arm Description
500 subjects will be randomly received the third batch vaccine producted by 150 L reactor
Intervention Type
Biological
Intervention Name(s)
The first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
Intervention Description
500 subjects will be randomized to receive the first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
Intervention Type
Biological
Intervention Name(s)
The second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
Intervention Description
500 subjects will be randomized to receive the second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
Intervention Type
Biological
Intervention Name(s)
The third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
Intervention Description
500 subjects will be randomized to receive the third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
Intervention Type
Biological
Intervention Name(s)
The first batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor
Intervention Description
500 subjects will be randomized to receive the first batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor
Intervention Type
Biological
Intervention Name(s)
The second batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor
Intervention Description
500 subjects will be randomized to receive the second batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor
Intervention Type
Biological
Intervention Name(s)
The third batch of inactivated EV-A71 vaccine (vero cell) proudected by 150 L reactor
Intervention Description
500 subjects will be randomized to receive the third batch of inactivated EV-A71 vaccine (vero cell) proudected by 150 L reactor
Primary Outcome Measure Information:
Title
Consistency of different batches for geometric mean titre(GMT) after vaccination
Description
Consistency of different batches for GMT of EV-A71 neutralizing antibody on 56 day after vaccination
Time Frame
56 days after vaccination
Title
Incidence and severity of adverse reactions/adverse events after each dose
Description
Incidence and severity of adverse reactions/adverse events within 1 month after each dose
Time Frame
1 month after each dose
Secondary Outcome Measure Information:
Title
Incidence of sever adverse events after vaccination
Description
Incidence of sever adverse events within 13 months after vaccination
Time Frame
13 months after vaccination
Title
GMTof EV-A71 neutralizing antibody on day 56 after vaccination
Description
GMTof EV-A71 neutralizing antibody on day 56 after vaccination for different batchs
Time Frame
56 days after vaccination
Title
Positive rate of EV-A71 neutralizing antibody on day 56 after vaccination
Description
Positive rate of EV-A71 neutralizing antibody on day 56 after vaccination for different batchs
Time Frame
56 days after vaccination
Title
Seroconversion rate of EV-A71 neutralizing antibody on day 56 after vaccination
Description
Seroconversion rate of EV-A71 neutralizing antibody on day 56 after vaccination for different batchs
Time Frame
56 days after vaccination
Title
Geometric Mean Fold Increase(GMFI) of EV-A71 neutralizing antibody on day 56 after vaccination
Description
Geometric Mean Fold Increase(GMFI) of EV-A71 neutralizing antibody on day 56 after vaccination for different batchs
Time Frame
56 days after vaccination
Title
GMTof EV-A71 neutralizing antibody on month 13 after vaccination
Description
GMTof EV-A71 neutralizing antibody on month 13 after vaccination for different batchs
Time Frame
13 months after vaccination
Title
Positive rate of EV-A71 neutralizing antibody on month 13 after vaccination
Description
Positive rate of EV-A71 neutralizing antibody on month 13 after vaccination for different batchs
Time Frame
13 months after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
35 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy children aged 6-35 months Subjects who have been clinically judged to be healthy by the researcher after being asked about the medical history and related physical examination The subjects' guardians agree the requirements of the protocol and the relevant follow up visits The subjects' guardians agree and sign the informed consent Subjects who have no relocation or long-term travel plan within one year and are able to comply with the requirements of the clinical trial protocol. Exclusion Criteria: Subject who has a medical history of HFMD caused by EV71 or has been vaccinated with EV71 vaccine Subject that has a history of allergies to vaccines or vaccine ingredients, and has serious side effects on vaccines, such as allergies, urticaria, dyspnea, vascular neuroedema or abdominal pain Subject who has congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc. Subject who has a history of epilepsy, convulsion or convulsion, or a family history of mental illness Subject who has autoimmune disease or immune deficiency, or whose parents and siblings have autoimmune disease or immune deficiency Subject who has a history of asthma, vascular and neuroedema, diabetes or malignant tumor Subject who has a thyroid resection history, or received treatment due to thyroid disease in the past 12 months Subject who has an abnormal coagulation function (such as coagulation factor deficiency, coagulant disease, platelet abnormality) or obvious bruising or clotting disorder which was diagnosed by doctors. Asplenia, functional asplenia, or splenectomy due to any circumstances Acute onset of various acute or chronic diseases in the last 7 days Immunosuppressant therapy, antiallergic therapy, cytotoxicity therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, surface corticosteroid therapy for acute non-dermatitis) in the past 6 months Any prior administration of blood products in last 3 months Any prior administration of other research medicines or vaccines in last 1 month Any prior administration of attenuated live vaccine in last 15 days Any prior administration of subunit or inactivated vaccines in last 7 days Under the anti-TB prevention or therapy Underarm temperature > 37.0 ℃ for fever before vaccination Other factors that are not suitable for clinical trials according to the judgment of researchers Exclusion Criteria for the second dose: Have severe allergic reaction after first dose Have severe adverse reactions related to first dose Any situation meet the exclusion criteria stated in the exclusion criteria for first dose Acute infection or illness Other factors that are not suitable for clinical trials according to the judgment of researchers
Facility Information:
Facility Name
Fengcai Zhu
City
Nanjing
Country
China

12. IPD Sharing Statement

Learn more about this trial

Immunity and Safety of Inactivated Enterovirus 71 Vaccine Post-marketing Among Children Aged 6-35 Months in China

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