Clinical trial NCT02919293: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Meningitis
Meningococcal Meningitis
Meningococcal Infections
Lead sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Guangdong Center for Disease Prevention and Control
name: Guizhou Center for Disease Control and Prevention
name: National Institutes for Food and Drug Control, China
name: Air Force Military Medical University, China
name: Simoon Record Pharma Information Consulting Co., Ltd.
First posted: 2016-09-29
Enrollment: 360
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Percentage of participants with seroresponse to meningococcal serogroups A,C and Haemophilus b post-vaccination with 3 doses of MenAC-Hib conjugate vaccine
timeFrame: Day 30 post-vaccination
measure: Occurrence of adverse events during a 30 day follow-up period after each vaccination
timeFrame: 30 day after each vaccination
Secondary outcomes:
measure: Occurrence of severe adverse events within six months post-vaccination
timeFrame: six months post-vaccination
measure: Geometric mean titer （GMT）of antibodies against meningococcal serogroups A, C and Haemophilus b post-vaccination with 3 doses of MenAC-Hib conjugate vaccine
timeFrame: Day 30 post-vaccination
Other outcomes:
Locations:
city: Gaozhou
country: China
facility: Gaozhou Center for Disease Control and Prevention
state: Guangdong
Study officials:
affiliation: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
name: Du lin, Master
role: STUDY_CHAIR
References: