Immunogenicity and Safety of Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age
NCT ID: NCT02919293
Last Updated: 2016-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1/PHASE2
360 participants
INTERVENTIONAL
2016-08-31
2017-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Immunogenicity and Safety of Meningococcal (A, C, Y and W135) Conjugate Vaccine
NCT02003495
Safety Study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months
NCT02878291
Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Infants
NCT00262002
A Phase III Clinical Trial of the Group A and C Meningococcal Polysaccharide Vaccine
NCT04689191
A Single-center, Open Trials to Evaluate the Safety of Freeze-dried Group ACYW135 Meningococcal Conjugate Vaccine
NCT02481232
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Adjuvant-Free MenAC-Hib Conjugate Vaccine Group
Participants randomized to receive adjuvant-free MenAC-Hib conjugate vaccine.
Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine (adjuvant-free)
30μg /dose, Intramuscular
Adjuvant MenAC-Hib Conjugate Vaccine Group
Participants randomized to receive adjuvant MenAC-Hib conjugate vaccine.
Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine(adjuvant)
0.5ml /dose, Intramuscular
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine (adjuvant-free)
30μg /dose, Intramuscular
Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine(adjuvant)
0.5ml /dose, Intramuscular
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
2 Months
5 Months
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Guangdong Center for Disease Prevention and Control
OTHER_GOV
Guizhou Center for Disease Control and Prevention
OTHER
National Institutes for Food and Drug Control, China
OTHER
Air Force Military Medical University, China
OTHER
Simoon Record Pharma Information Consulting Co., Ltd.
INDUSTRY
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Du lin, Master
Role: STUDY_CHAIR
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gaozhou Center for Disease Control and Prevention
Gaozhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
085201602
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.