A Phase II Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants

This study has been completed.
Sponsor:
Collaborator:
Bejing Vigoo Biological Co., LTD
Information provided by (Responsible Party):
Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01399853
First received: July 19, 2011
Last updated: May 29, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Immunogenicity
Safety
Biological: 160U /0.5ml EV71 Vaccine
Biological: 320U /0.5ml EV71 vaccine
Biological: 640U /0.5ml EV71 vaccine
Biological: (without adjuvant) 640U /0.5ml
Biological: 0/0.5ml placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: A Phase II Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants

Further study details as provided by Jiangsu Province Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • The GMT of anti-EV71 antibodies in serum after first vaccination [ Time Frame: 28 days after first vaccination ] [ Designated as safety issue: No ]
    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 [ Time Frame: 28 days after second vaccination ] [ Designated as safety issue: No ]
    to evaluate the GMT of anti-EV71 antibodies in serum 28 days after second vaccination

  • Frequency of systemic and local adverse reactions after the first vaccination [ Time Frame: 28 days after the first vaccination ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 28 days after the second vaccination ] [ Designated as safety issue: Yes ]
    Frequency of systemic and local adverse reactions in healthy Children and infants following second doses of EV71 vaccine


Secondary Outcome Measures:
  • The seroconversion rate of anti-EV71 antibodies in serum after first vaccination [ Time Frame: 28 days after first vaccination ] [ Designated as safety issue: No ]
    to evaluate the seroconversion rate of anti-EV71 antibodies in serum 28 days after first vaccination

  • The seroconversion rate of anti-EV71 antibodies in serum after second vaccination [ Time Frame: 28 days after second vaccination ] [ Designated as safety issue: No ]
    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 [ Time Frame: 28 days after the first vaccination ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 28 days after the second vaccination ] [ Designated as safety issue: Yes ]
    Frequency of adverse events and any SAE in healthy Children and infants following second doses of EV71 vaccine

  • The clinical abnormality of hematological examination, blood biochemical test and urinalysis after first vaccination in children [ Time Frame: 3 days after first vaccination ] [ Designated as safety issue: Yes ]
    to evaluate the clinical abnormality of hematological examination, blood biochemical test and urinalysis 3 days after first vaccination in children

  • The clinical abnormality of hematological examination, blood biochemical test and urinalysis after second vaccination in children [ Time Frame: 3 days after second vaccination ] [ Designated as safety issue: Yes ]
    to evaluate the clinical abnormality of hematological examination, blood biochemical test and urinalysis 3 days after second vaccination in children

  • The persistence of immunogenicity of the EV71vaccine after two doses in children and infants [ Time Frame: 6 months after blood collection at day 56 ] [ Designated as safety issue: No ]
    to evaluate the persistence of immunogenicity of the EV71vaccine after two doses in children and infants 6 months after blood collection at day 56


Enrollment: 1200
Study Start Date: July 2011
Study Completion Date: May 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 160U /0.5ml in children (from 12 to 36 months old)
inactivated vaccine(vero cell) against EV71 of 160U /0.5ml in 120 children aged 12-36 months old on day0,28
Biological: 160U /0.5ml EV71 Vaccine
inactivated vaccine (vero cell) against EV71 of 160U /0.5ml, two doses, 28 days interval
Experimental: 320U /0.5ml in children (from 12 to 36 months old)
inactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 120 children aged 12-36 months old on day0,28
Biological: 320U /0.5ml EV71 vaccine
inactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, 28 days interval
Experimental: 640U /0.5ml in children (from 12 to 36 months old)
inactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 120 children aged 12-36 months old on day0,28
Biological: 640U /0.5ml EV71 vaccine
inactivated vaccine (vero cell) against EV71 of 640U /0.5ml, two doses, 28 days interval
Experimental: (without adjuvant) 640U /0.5ml in children (12-36months)
inactivated vaccine(vero cell) against EV71 of (without adjuvant) 640U /0.5ml in 120 children aged 12-36 months old on day0,28
Biological: (without adjuvant) 640U /0.5ml
inactivated vaccine (vero cell) against EV71 of (without adjuvant) 640U /0.5ml, two doses, 28 days interval
Experimental: 160U /0.5ml in infants (from 6 to 11 months old)
inactivated vaccine(vero cell) against EV71 of 160U /0.5ml in 120 infants aged 6-11 months old on day0,28
Biological: 160U /0.5ml EV71 Vaccine
inactivated vaccine (vero cell) against EV71 of 160U /0.5ml, two doses, 28 days interval
Experimental: 320U /0.5ml in infants (from 6 to 11 months old)
inactivated vaccine(vero cell) against EV71 of 320U /0.5ml in 120 infants aged 6-11 months old on day0,28
Biological: 320U /0.5ml EV71 vaccine
inactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, 28 days interval
Experimental: 640U /0.5ml in infants (from 6 to 11 months old)
inactivated vaccine(vero cell) against EV71 of 640U /0.5ml in 120 infants aged 6-11 months old on day0,28
Biological: 640U /0.5ml EV71 vaccine
inactivated vaccine (vero cell) against EV71 of 640U /0.5ml, two doses, 28 days interval
Experimental: (without adjuvant) 640U /0.5ml in infants (from 6 to 11 months
inactivated vaccine(vero cell) against EV71 of (without adjuvant) 640U /0.5ml in 120 infants aged 6-11 months old on day0,28
Biological: (without adjuvant) 640U /0.5ml
inactivated vaccine (vero cell) against EV71 of (without adjuvant) 640U /0.5ml, two doses, 28 days interval
Placebo Comparator: 0/0.5ml placebo in children (from 12 to 36 months old)
0/0.5ml placebo in 120 children aged 12-36 months old on day0,28
Biological: 0/0.5ml placebo
0/0.5ml placebo, two doses, 28 days interval
Placebo Comparator: 0/0.5ml placebo in infants (from 6 to 11 months old)
0/0.5ml placebo in 120 infants aged 6-11 months old on day0,28
Biological: 0/0.5ml placebo
0/0.5ml placebo, two doses, 28 days interval

  Eligibility

Ages Eligible for Study:   6 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01399853

Locations
China, Jiangsu
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China, 210009
Sponsors and Collaborators
Jiangsu Province Centers for Disease Control and Prevention
Bejing Vigoo Biological Co., LTD
  More Information

No publications provided by Jiangsu Province Centers for Disease Control and Prevention

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01399853     History of Changes
Other Study ID Numbers: JSVCT005
Study First Received: July 19, 2011
Last Updated: May 29, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Jiangsu Province Centers for Disease Control and Prevention:
immunogenicity
safety
inactivated EV71 vaccine

ClinicalTrials.gov processed this record on August 26, 2014