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

A Randomized, Positive-controlled, Non-inferiority Phase III Clinical Trial of a Haemophilus Influenzae Type b (Hib) Conjugate Vaccine in Healthy Infants and Children

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.

Study Overview

• Status: Completed
• Conditions: Haemophilus Influenza
• Intervention / Treatment: Biological: Hib conjugate vaccine

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 1992
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.); Hib conjugate vaccine	Biological: 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
Active Comparator: Vaccine (Walvax Biotechnology Co., LTD.); Hib conjugate vaccine	Biological: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Solicited Adverse Reactions	Number of Participants with Solicited Adverse Reactions	0-7 days after each dose
Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations ≥1.0μg/ml		28 days after full course of vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of Unsolicited Adverse Reactions	0-28 days after each dose
Incidence of Serious Adverse Event (SAE) During the Whole Study Period	0-84 days for children aged 3-5 months, 0-56 days for children aged 6-11 months and 0-28 days for children aged 1-5 y
Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations ≥0.15μg/ml	28 days after full course of vaccination
the Anti-PRP Geometric Mean Concentrations (GMCs)	28 days after full course of vaccination
the Anti-PRP Geometric Mean Fold Increase (GMFI)	28 days after full course of vaccination

Collaborators and Investigators

• Sponsor: Jiangsu Province Centers for Disease Control and Prevention
• Collaborators: Chengdu Olymvax Biopharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: February 24, 2016
• First Submitted That Met QC Criteria: February 24, 2016
• First Posted (Estimate): February 26, 2016

Study Record Updates

• Last Update Posted (Actual): September 20, 2017
• Last Update Submitted That Met QC Criteria: August 22, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• 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: PRO-201301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No