Safety and Immunogenicity of Haemophilus Influenzae Type b Conjugate Vaccine，Freeze-dried

Beijing Minhai Biotechnology

Status and phase: Unknown; Phase 3

Conditions: Haemophilus Influenzae Type b Infections

Treatments: Biological: Act-HIB®; Biological: Minhai-HIB

Study type: Interventional

Funder types: Industry

Identifiers

NCT02560272

2014L00216

Details and patient eligibility

About

The study will evaluate the safety and immunogenicity of a haemophilus influenzae type b conjugate vaccine (Hib) in Healthy Children 2 Months to 5 Years of Age who have not been previously immunized with a Hib vaccine. Children 2 to 5 months of age will receive 3 doses of Hib vaccine, Children 6 to 11 months of age will receive 2 doses of Hib vaccine, Children 1 to 5 years of age will receive 1 dose of Hib vaccine, with each dose given approximately 1 month apart.

Enrollment: 1,560 estimated patients

Sex: All

Ages: 2 months to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy permanent residence 2 months to 5 years old.
• Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
• Subjects and parent/guardian able to attend all scheduled visits and comply with all study procedures.
• Axillary temperature ≤37.0 ℃.

Exclusion criteria

• History of Haemophilus influenzae type b infection or vaccination of Haemophilus influenzae type b conjugate vaccine.
• Allergic history or any SAE after vaccination, such as allergy, urticaria, dyspnea, angioedema, celialgia.
• Receipt of blood or blood-derived products in the 3 months preceding vaccination
• Participation in another clinical study investigating a vaccine, drug in the 30 days preceding vaccination.
• Receipt of any live virus vaccine in the 15 days preceding vaccination.
• Receipt of any subunit vaccine and inactivated vaccine in the 7 days before vaccination.
• Febrile illness (temperature ≥ 38°C) in the 3 days or any acute illness/infection in the 7 days preceding vaccination.
• Thrombocytopenia.
• History of treatment for thyroid gland disease.
• Functional or anatomic asplenia.
• History of eclampsia, epilepsy, encephalopathy and mental disease or family disease.
• Any condition that, in the judgment of investigator, may affect trial assessment.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,560 participants in 2 patient groups

Minhai-HIB

Experimental group

Description:

Participants at age 1 to 5 years of enrollment will receive one dose on Hib vaccine. Participants at age 6 to 11 months of enrollment will receive 2 doses on Hib vaccine at one months apart. Participants at age 2 to 5 months of enrollment will receive 3 doses on Hib vaccine at one months apart.

Treatment:

Biological: Minhai-HIB

Act-HIB®

Active Comparator group

Description:

Participants at age 1 to 5 years of enrollment will receive one dose on Hib vaccine. Participants at age 6 to 11 months of enrollment will receive 2 doses on Hib vaccine at one months apart. Participants at age 2 to 5 months of enrollment will receive 3 doses on Hib vaccine at one months apart.

Treatment:

Biological: Act-HIB®