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A Phase III Clinical Trial of a Haemophilus Influenzae Type b (Hib) Conjugate Vaccine

NCT ID: NCT02692859

Last Updated: 2017-09-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1992 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-08-31

Brief Summary

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Haemophilus influenza type b (Hib) remains a serious global health threat associated with high mortality and morbidity in young children. In China, The overall impact of Hib-related infections and the extent of coverage of Hib conjugate vaccines are unclear.Generally, vaccination has been considered the most effective way to prevent infection against Hib.In order to evaluate safety and immunogenicity of a haemophilus influenzae type b (Hib) conjugate vaccine developped by Chengdu Olymvax Biopharmaceuticals Inc. a phase III clinical trial is planned to conduct in healthy infants and children in China.

Detailed Description

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Haemophilus influenza type b (Hib) remains a serious global health threat associated with high mortality and morbidity in young children. In China, The overall impact of Hib-related infections and the extent of coverage of Hib conjugate vaccines are unclear.Generally, vaccination has been considered the most effective way to prevent infection against Hib.In order to evaluate safety and immunogenicity of a haemophilus influenzae type b (Hib) conjugate vaccine developped by Chengdu Olymvax Biopharmaceuticals Inc. a randomized, positive-controlled, non-inferiority phase III clinical trial is planned to conduct in healthy infants and children in China.

Conditions

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Haemophilus Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.)

Hib conjugate vaccine

Group Type EXPERIMENTAL

Hib conjugate vaccine

Intervention Type BIOLOGICAL

Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 years:one dose(0 d), 0.5ml for each dose

Vaccine (Walvax Biotechnology Co., LTD.)

Hib conjugate vaccine

Group Type ACTIVE_COMPARATOR

Hib conjugate vaccine

Intervention Type BIOLOGICAL

Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 years:one dose(0 d), 0.5ml for each dose

Interventions

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Hib conjugate vaccine

Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 years:one dose(0 d), 0.5ml for each dose

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy children aged 3-5 months/ 6-11 months/ 1-5 y for each age group
* Without vaccination history of Hib conjugate vaccine
* One of his/her guardians is able to understand and sign the informed consent
* Subjects' guardian can and will comply with the requirements of the protocol
* Subjects with temperature \<=37.0°C on axillary setting

Exclusion Criteria

* Subject who has a medical or family history of any of the following: allergic history, seizure, epilepsy, brain or mental disease
* Subject who is allergic to any ingredient of the vaccines
* Subject with damaged or low immune function which has already been known
* Subject who had a Hib disease medical history
* Subject with acute febrile illness or infectious disease
* Major congenital defects, developmental disorders or serious chronic illness
* Thrombocytopenia, blood coagulation disorder or bleeding difficulties with intramuscular injection
* Subject who has serious allergic history
* Subject with other medical history not suitable for vaccination such as difficulty for blood collection
* Any prior administration of immunodepressant or corticosteroids in last 6 months
* Any prior administration of blood products in last 3 months
* Any prior administration of other research medicine/vaccine in last 30 days
* Any prior administration of any attenuated live vaccine in last 14 days
* Any prior administration of subunit or inactivated vaccines in last 7 days, such as pneumococcal vaccine
* Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or his/her guardian's signature on informed consent
Minimum Eligible Age

3 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chengdu Olymvax Biopharmaceuticals Inc.

INDUSTRY

Sponsor Role collaborator

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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PRO-201301

Identifier Type: -

Identifier Source: org_study_id