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

Primary Purpose

Haemophilus Influenzae Type b Infections

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Minhai-HIB
Act-HIB®
Sponsored by
Beijing Minhai Biotechnology Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Haemophilus Influenzae Type b Infections focused on measuring vaccine, haemophilus influenzae type b

Eligibility Criteria

2 Months - 5 Years (Child)All SexesAccepts 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.

Sites / Locations

  • Henan Provincial Center for Disease Control and PreventionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Minhai-HIB

Act-HIB®

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Subjects With Any Solicited Local and General Symptoms
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations

Full Information

First Posted
September 19, 2015
Last Updated
September 24, 2015
Sponsor
Beijing Minhai Biotechnology Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02560272
Brief Title
Safety and Immunogenicity of Haemophilus Influenzae Type b Conjugate Vaccine，Freeze-dried
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Minhai Biotechnology Co., Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemophilus Influenzae Type b Infections
Keywords
vaccine, haemophilus influenzae type b

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1560 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Minhai-HIB
Arm Type
Experimental
Arm 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.
Arm Title
Act-HIB®
Arm Type
Active Comparator
Arm 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.
Intervention Type
Biological
Intervention Name(s)
Minhai-HIB
Intervention Description
0.5ml, intramuscular
Intervention Type
Biological
Intervention Name(s)
Act-HIB®
Intervention Description
0.5ml, intramuscular
Primary Outcome Measure Information:
Title
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
Time Frame
28 days after last dose of primary vaccination
Secondary Outcome Measure Information:
Title
Number of Subjects With Any Solicited Local and General Symptoms
Time Frame
Within 7 days after any vaccination
Title
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time Frame
Within 28 days after any vaccination
Title
Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations
Time Frame
28 days after last dose of primary vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guifan Li
Phone
86-10-59613591
Email
guifan@sohu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
shengli xia
Organizational Affiliation
Henan Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henan Provincial Center for Disease Control and Prevention
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
shengli xia
Phone
86-371-68089128
Email
xiasl@hncdc.com.cn

12. IPD Sharing Statement

Learn more about this trial

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

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