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

Phase 3

• Conditions: Haemophilus Influenzae Type b Infections
• Interventions: Biological: Minhai-HIB; Biological: Act-HIB®

• Registration Number: NCT02560272
• Lead Sponsor: Beijing Minhai Biotechnology Co., Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Status Verified: 2015-09
• Study First Submitted: 2015-09-19
• Study First Submitted QC: 2015-09-24
• Last Update Submitted: 2015-09-24
• Study First Posted: 2015-09-25
• Last Update Posted: 2015-09-25
• Primary Completion: 2015-12
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1560

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Minhai-HIB	Minhai-HIB	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.
Act-HIB®	Act-HIB®	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.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0 µg/mL	28 days after last dose of primary vaccination

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Any Solicited Local and General Symptoms	Within 7 days after any vaccination
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations	28 days after last dose of primary vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs)	Within 28 days after any vaccination

Trial Locations

Locations (1)

Henan Provincial Center for Disease Control and Prevention; 🇨🇳 Zhengzhou, Henan, China