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

Jiangsu Provincial Center for Disease Control and Prevention

Status and phase

Completed

Phase 3

Conditions

Haemophilus Influenza

Treatments

Biological: Hib conjugate vaccine

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT02692859

PRO-201301

Details and patient eligibility

About

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.

Full description

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.

Enrollment

1,992 patients

Sex

All

Ages

3 months to 5 years old

Volunteers

Accepts Healthy Volunteers

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