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

A Phase III, Double Blind, Parallel-controlled, Randomised Study to Evaluate the Safety and Immunogenicity of Haemophilus Influenzae Type b Conjugate Vaccine in Healthy Children 2 Months to 5 Years of Age

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.

Study Overview

• Status: Unknown
• Conditions: Haemophilus Influenzae Type b Infections
• Intervention / Treatment: Biological: Minhai-HIB; Biological: Act-HIB®

• Study Type: Interventional
• Enrollment (Anticipated): 1560
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Guifan Li; Phone Number: 86-10-59613591; Email: guifan@sohu.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • Henan Provincial Center for Disease Control and Prevention
      • Contact: shengli xia; Phone Number: 86-371-68089128; Email: xiasl@hncdc.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 5 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Biological: Minhai-HIB; 0.5ml, intramuscular
ACTIVE_COMPARATOR: 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.	Biological: Act-HIB®; 0.5ml, intramuscular

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Beijing Minhai Biotechnology Co., Ltd

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (ANTICIPATED): December 1, 2015
• Study Completion (ANTICIPATED): June 1, 2016

Study Registration Dates

• First Submitted: September 19, 2015
• First Submitted That Met QC Criteria: September 24, 2015
• First Posted (ESTIMATE): September 25, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): September 25, 2015
• Last Update Submitted That Met QC Criteria: September 24, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: vaccine; haemophilus influenzae type b
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Orthomyxoviridae Infections; Pasteurellaceae Infections; Influenza, Human; Haemophilus Infections
• Other Study ID Numbers: 2014L00216