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

Sponsor

Jiangsu Province Centers for Disease Control and Prevention (Other)

Overall Status

Completed

CT.gov ID

NCT01399853

Collaborator

Bejing Vigoo Biological Co., LTD (Industry)

1,200

Enrollment

Location

Arms

Duration (Months)

119.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	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 Design

Study Type:

Interventional

Actual Enrollment :

1200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

The GMT of anti-EV71 antibodies in serum after first vaccination [28 days after first vaccination]
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 [28 days after second vaccination]
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 [28 days after the first vaccination]
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 [28 days after the second vaccination]
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 [28 days after first vaccination]
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 [28 days after second vaccination]
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 [28 days after the first vaccination]
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 [28 days after the second vaccination]
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 [3 days after first vaccination]
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 [3 days after second vaccination]
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 [6 months after blood collection at day 56]
to evaluate the persistence of immunogenicity of the EV71vaccine after two doses in children and infants 6 months after blood collection at day 56

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 36 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jiangsu Province Centers for Disease Control and Prevention

ClinicalTrials.gov Identifier:

NCT01399853

Other Study ID Numbers:

JSVCT005

First Posted:

Jul 22, 2011

Last Update Posted:

May 31, 2012

Last Verified:

May 1, 2012

Keywords provided by Jiangsu Province Centers for Disease Control and Prevention

immunogenicity

safety

inactivated EV71 vaccine

Additional relevant MeSH terms:

Vaccines

Study Results

No Results Posted as of May 31, 2012