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

Primary Purpose

Haemophilus Influenza

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Hib conjugate vaccine
Sponsored by
Jiangsu Province Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Haemophilus Influenza

Eligibility Criteria

3 Months - 5 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.)

    Vaccine (Walvax Biotechnology Co., LTD.)

    Arm Description

    Hib conjugate vaccine

    Hib conjugate vaccine

    Outcomes

    Primary Outcome Measures

    Number of Participants With Solicited Adverse Reactions
    Number of Participants with Solicited Adverse Reactions
    Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations ≥1.0μg/ml

    Secondary Outcome Measures

    Incidence of Unsolicited Adverse Reactions
    Incidence of Serious Adverse Event (SAE) During the Whole Study Period
    Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations ≥0.15μg/ml
    the Anti-PRP Geometric Mean Concentrations (GMCs)
    the Anti-PRP Geometric Mean Fold Increase (GMFI)

    Full Information

    First Posted
    February 24, 2016
    Last Updated
    August 22, 2017
    Sponsor
    Jiangsu Province Centers for Disease Control and Prevention
    Collaborators
    Chengdu Olymvax Biopharmaceuticals Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02692859
    Brief Title
    A Phase III Clinical Trial of a Haemophilus Influenzae Type b (Hib) Conjugate Vaccine
    Official Title
    A Randomized, Positive-controlled, Non-inferiority Phase III Clinical Trial of a Haemophilus Influenzae Type b (Hib) Conjugate Vaccine in Healthy Infants and Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2013 (undefined)
    Primary Completion Date
    August 2014 (Actual)
    Study Completion Date
    August 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Jiangsu Province Centers for Disease Control and Prevention
    Collaborators
    Chengdu Olymvax Biopharmaceuticals Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Haemophilus Influenza

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    1992 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vaccine(Chengdu Olymvax Biopharmaceuticals Inc.)
    Arm Type
    Experimental
    Arm Description
    Hib conjugate vaccine
    Arm Title
    Vaccine (Walvax Biotechnology Co., LTD.)
    Arm Type
    Active Comparator
    Arm Description
    Hib conjugate vaccine
    Intervention Type
    Biological
    Intervention Name(s)
    Hib conjugate vaccine
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Number of Participants With Solicited Adverse Reactions
    Description
    Number of Participants with Solicited Adverse Reactions
    Time Frame
    0-7 days after each dose
    Title
    Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations ≥1.0μg/ml
    Time Frame
    28 days after full course of vaccination
    Secondary Outcome Measure Information:
    Title
    Incidence of Unsolicited Adverse Reactions
    Time Frame
    0-28 days after each dose
    Title
    Incidence of Serious Adverse Event (SAE) During the Whole Study Period
    Time Frame
    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
    Title
    Proportion of Vaccinees With Anti-polyribosylribitol Phosphate (PRP) Concentrations ≥0.15μg/ml
    Time Frame
    28 days after full course of vaccination
    Title
    the Anti-PRP Geometric Mean Concentrations (GMCs)
    Time Frame
    28 days after full course of vaccination
    Title
    the Anti-PRP Geometric Mean Fold Increase (GMFI)
    Time Frame
    28 days after full course of vaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Months
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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