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

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ClinicalTrials.gov Identifier: NCT03893747
Recruitment Status : Not yet recruiting
First Posted : March 28, 2019
Last Update Posted : March 28, 2019
Sponsor:
Collaborator:
Wuhan Institute of Biological Products Co., Ltd
Information provided by (Responsible Party):
Jiangsu Province Centers for Disease Control and Prevention

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.

Condition or disease Intervention/treatment Phase
Hand, Foot and Mouth Disease Biological: The first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor Biological: The second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor Biological: The third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor Biological: The first batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor Biological: The second batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor Biological: The third batch of inactivated EV-A71 vaccine (vero cell) proudected by 150 L reactor Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Three Batches Consistency, Immunity Duration and Safety of Inactivated Enterovirus 71 Vaccine Post-marketing Among Children Aged 6-35 Months in China
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

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

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

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

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

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

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




Primary Outcome Measures :
  1. Consistency of different batches for geometric mean titre(GMT) after vaccination [ Time Frame: 56 days after vaccination ]
    Consistency of different batches for GMT of EV-A71 neutralizing antibody on 56 day after vaccination

  2. Incidence and severity of adverse reactions/adverse events after each dose [ Time Frame: 1 month after each dose ]
    Incidence and severity of adverse reactions/adverse events within 1 month after each dose


Secondary Outcome Measures :
  1. Incidence of sever adverse events after vaccination [ Time Frame: 13 months after vaccination ]
    Incidence of sever adverse events within 13 months after vaccination

  2. GMTof EV-A71 neutralizing antibody on day 56 after vaccination [ Time Frame: 56 days after vaccination ]
    GMTof EV-A71 neutralizing antibody on day 56 after vaccination for different batchs

  3. Positive rate of EV-A71 neutralizing antibody on day 56 after vaccination [ Time Frame: 56 days after vaccination ]
    Positive rate of EV-A71 neutralizing antibody on day 56 after vaccination for different batchs

  4. Seroconversion rate of EV-A71 neutralizing antibody on day 56 after vaccination [ Time Frame: 56 days after vaccination ]
    Seroconversion rate of EV-A71 neutralizing antibody on day 56 after vaccination for different batchs

  5. Geometric Mean Fold Increase(GMFI) of EV-A71 neutralizing antibody on day 56 after vaccination [ Time Frame: 56 days after vaccination ]
    Geometric Mean Fold Increase(GMFI) of EV-A71 neutralizing antibody on day 56 after vaccination for different batchs

  6. GMTof EV-A71 neutralizing antibody on month 13 after vaccination [ Time Frame: 13 months after vaccination ]
    GMTof EV-A71 neutralizing antibody on month 13 after vaccination for different batchs

  7. Positive rate of EV-A71 neutralizing antibody on month 13 after vaccination [ Time Frame: 13 months after vaccination ]
    Positive rate of EV-A71 neutralizing antibody on month 13 after vaccination for different batchs



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 35 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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Responsible Party: Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT03893747    
Other Study ID Numbers: JSVCT048-2
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Foot-and-Mouth Disease
Hand, Foot and Mouth Disease
Mouth Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Stomatognathic Diseases
Coxsackievirus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs