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

NCT03893747 | Completed Phase 4

• 1 other identifier: JSVCT048-2
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Hand, Foot and Mouth Disease

Outcome Measures

Primary Outcomes (2)

• 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

  56 days 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

  1 month after each dose

Secondary Outcomes (7)

• Incidence of sever adverse events after vaccination

  13 months after vaccination

• GMTof EV-A71 neutralizing antibody on day 56 after vaccination

  56 days after vaccination

• Positive rate of EV-A71 neutralizing antibody on day 56 after vaccination

  56 days after vaccination

• Seroconversion rate of EV-A71 neutralizing antibody on day 56 after vaccination

  56 days after vaccination

• Geometric Mean Fold Increase(GMFI) of EV-A71 neutralizing antibody on day 56 after vaccination

  56 days after vaccination

Study Arms (6)

the first batch vaccine producted by 40 L reactor

EXPERIMENTAL

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

Biological: The first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor

the second batch vaccine producted by 40 L reactor

EXPERIMENTAL

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

Biological: The second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor

the third batch vaccine producted by 40 L reactor

EXPERIMENTAL

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

Biological: The third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor

the first batch vaccine producted by 150 L reactor

EXPERIMENTAL

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

Biological: The first batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor

the second batch vaccine producted by 150 L reactor

EXPERIMENTAL

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

Biological: The second batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor

the third batch vaccine proudected by 150 L reactor

EXPERIMENTAL

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

Biological: The third batch of inactivated EV-A71 vaccine (vero cell) proudected by 150 L reactor

Interventions

The first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor BIOLOGICAL

500 subjects will be randomized to receive the first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor

the first batch vaccine producted by 40 L reactor

The second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor BIOLOGICAL

500 subjects will be randomized to receive the second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor

the second batch vaccine producted by 40 L reactor

The third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor BIOLOGICAL

500 subjects will be randomized to receive the third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor

the third batch vaccine producted by 40 L reactor

The first batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor BIOLOGICAL

500 subjects will be randomized to receive the first batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor

the first batch vaccine producted by 150 L reactor

The second batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor BIOLOGICAL

500 subjects will be randomized to receive the second batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor

the second batch vaccine producted by 150 L reactor

The third batch of inactivated EV-A71 vaccine (vero cell) proudected by 150 L reactor BIOLOGICAL

500 subjects will be randomized to receive the third batch of inactivated EV-A71 vaccine (vero cell) proudected by 150 L reactor

the third batch vaccine proudected by 150 L reactor

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead
• Wuhan Institute of Biological Products Co., Ltd: collaborator

Study Sites (1)

Fengcai Zhu

Nanjing, China

Location

MeSH Terms

Conditions

Hand, Foot and Mouth Disease

Condition Hierarchy (Ancestors)

Coxsackievirus Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 28, 2019
• Study Start: April 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: May 24, 2021

Record last verified: 2021-05

Locations

CN (1)