Back to resultsImmunogenicity and Safety of Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age
Primary Purpose
Meningitis, Meningococcal Meningitis, Meningococcal Infections
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine (adjuvant-free)
Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine(adjuvant)
Sponsored by
About this trial
This is an interventional prevention trial for Meningitis
Eligibility Criteria
Inclusion Criteria:
- Health infants aged 2 to 5 months.
- Legal guardian has signed written informed consent.
- Guardian may finish the whole visit in the judgment of investigator.
- 2-5 months health infants who haven't immuned with any Meningococcal A and C Conjugate Vaccine or Haemophilus b Conjugate Vaccine.
- Subject who did't vaccinated with any live vaccine within 14 days or inactivated vaccine within 10 days before vaccination.
Exclusion Criteria:
- Fever, body temperature ≥37.1℃.
- History of severe allergic reaction that needs medical intervention including throat swelling, dyspnea, hypotension or shock; History of allergic reaction to vaccine or to any of the vaccine components especially to tetanus toxoid or history of other severe adverse reaction to vaccine.
- Clear diagnosis of thrombocytopenia or history of other coagulation disorders that may cause contraindications of intramuscular injection.
- Subject with history of abnormal labor, asphyxia rescue history,congenital malformations,eccyliosis or severe chronic disease.
- Severe cardiovascular or liver and kidney disease, active tuberculosis and HIV infection.
- Subject with encephalopathy, uncontrolled epilepsy and other progressive nervous system disease.
- Subject suffer from acute disease, severe chronic disease, acute episode of chronic disease and febrile illness (temperature ≥ 38°C) within 3 days.
- Any condition that, in the judgment of investigator, subject is not suitable for participation in this clinical trial.
Sites / Locations
- Gaozhou Center for Disease Control and PreventionRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Adjuvant-Free MenAC-Hib Conjugate Vaccine Group
Adjuvant MenAC-Hib Conjugate Vaccine Group
Arm Description
Participants randomized to receive adjuvant-free MenAC-Hib conjugate vaccine.
Participants randomized to receive adjuvant MenAC-Hib conjugate vaccine.
Outcomes
Primary Outcome Measures
Percentage of participants with seroresponse to meningococcal serogroups A,C and Haemophilus b post-vaccination with 3 doses of MenAC-Hib conjugate vaccine
Occurrence of adverse events during a 30 day follow-up period after each vaccination
Secondary Outcome Measures
Occurrence of severe adverse events within six months post-vaccination
Geometric mean titer （GMT）of antibodies against meningococcal serogroups A, C and Haemophilus b post-vaccination with 3 doses of MenAC-Hib conjugate vaccine
Full Information
NCT ID
NCT02919293
First Posted
September 27, 2016
Last Updated
September 27, 2016
Sponsor
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Collaborators
Guangdong Center for Disease Prevention and Control, Guizhou Center for Disease Control and Prevention, National Institutes for Food and Drug Control, China, Air Force Military Medical University, China, Simoon Record Pharma Information Consulting Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02919293
Brief Title
Immunogenicity and Safety of Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age
Official Title
Immunogenicity and Safety of Adjuvant and Adjuvant-Free Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Collaborators
Guangdong Center for Disease Prevention and Control, Guizhou Center for Disease Control and Prevention, National Institutes for Food and Drug Control, China, Air Force Military Medical University, China, Simoon Record Pharma Information Consulting Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate Immunogenicity and Safety of Adjuvant and Adjuvant-Free Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age.
Primary objective:
To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C and Haemophilus influenzae type b following the administration of adjuvant-free MenAC-Hib conjugate vaccine compared to those observed following the administration of adjuvant MenAC-Hib conjugate vaccine.
To describe the safety profile of adjuvant-free MenAC-Hib conjugate vaccine compared to that of adjuvant MenAC-Hib conjugate vaccine.
Secondary objective:
•To compare the antibody level of meningococcal serogroups A, C and Haemophilus influenzae type b following the administration of adjuvant-free MenAC-Hib conjugate vaccine to those observed following the administration of adjuvant MenAC-Hib conjugate vaccine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningitis, Meningococcal Meningitis, Meningococcal Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adjuvant-Free MenAC-Hib Conjugate Vaccine Group
Arm Type
Experimental
Arm Description
Participants randomized to receive adjuvant-free MenAC-Hib conjugate vaccine.
Arm Title
Adjuvant MenAC-Hib Conjugate Vaccine Group
Arm Type
Active Comparator
Arm Description
Participants randomized to receive adjuvant MenAC-Hib conjugate vaccine.
Intervention Type
Biological
Intervention Name(s)
Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine (adjuvant-free)
Other Intervention Name(s)
HibACon, MenAC-Hib
Intervention Description
30μg /dose, Intramuscular
Intervention Type
Biological
Intervention Name(s)
Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine(adjuvant)
Other Intervention Name(s)
HibACon, MenAC-Hib
Intervention Description
0.5ml /dose, Intramuscular
Primary Outcome Measure Information:
Title
Percentage of participants with seroresponse to meningococcal serogroups A,C and Haemophilus b post-vaccination with 3 doses of MenAC-Hib conjugate vaccine
Time Frame
Day 30 post-vaccination
Title
Occurrence of adverse events during a 30 day follow-up period after each vaccination
Time Frame
30 day after each vaccination
Secondary Outcome Measure Information:
Title
Occurrence of severe adverse events within six months post-vaccination
Time Frame
six months post-vaccination
Title
Geometric mean titer （GMT）of antibodies against meningococcal serogroups A, C and Haemophilus b post-vaccination with 3 doses of MenAC-Hib conjugate vaccine
Time Frame
Day 30 post-vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
5 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Health infants aged 2 to 5 months.
Legal guardian has signed written informed consent.
Guardian may finish the whole visit in the judgment of investigator.
2-5 months health infants who haven't immuned with any Meningococcal A and C Conjugate Vaccine or Haemophilus b Conjugate Vaccine.
Subject who did't vaccinated with any live vaccine within 14 days or inactivated vaccine within 10 days before vaccination.
Exclusion Criteria:
Fever, body temperature ≥37.1℃.
History of severe allergic reaction that needs medical intervention including throat swelling, dyspnea, hypotension or shock; History of allergic reaction to vaccine or to any of the vaccine components especially to tetanus toxoid or history of other severe adverse reaction to vaccine.
Clear diagnosis of thrombocytopenia or history of other coagulation disorders that may cause contraindications of intramuscular injection.
Subject with history of abnormal labor, asphyxia rescue history,congenital malformations,eccyliosis or severe chronic disease.
Severe cardiovascular or liver and kidney disease, active tuberculosis and HIV infection.
Subject with encephalopathy, uncontrolled epilepsy and other progressive nervous system disease.
Subject suffer from acute disease, severe chronic disease, acute episode of chronic disease and febrile illness (temperature ≥ 38°C) within 3 days.
Any condition that, in the judgment of investigator, subject is not suitable for participation in this clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zeng peiyu, Bachelor
Phone
86-668-6578613
Email
gzcdc6578613@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Du lin, Master
Organizational Affiliation
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Official's Role
Study Chair
Facility Information:
Facility Name
Gaozhou Center for Disease Control and Prevention
City
Gaozhou
State/Province
Guangdong
ZIP/Postal Code
525200
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zeng peiyu, Bachelor
Phone
86-668-6578613
Email
gzcdc6578613@163.com
12. IPD Sharing Statement
Learn more about this trial
Immunogenicity and Safety of Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age
We'll reach out to this number within 24 hrs