Immunogenicity and Safety of Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine in Infants 2 to 5 Months of Age

Phase 1

• Conditions: Meningococcal Meningitis; Meningitis; Meningococcal Infections
• Interventions: Biological: Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine (adjuvant-free); Biological: Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine(adjuvant)

• Registration Number: NCT02919293
• Lead Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-08
• Study Start: 2016-08
• Study First Submitted: 2016-09-27
• Study First Submitted QC: 2016-09-27
• Last Update Submitted: 2016-09-27
• Study First Posted: 2016-09-29
• Last Update Posted: 2016-09-29
• Primary Completion: 2017-03
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adjuvant-Free MenAC-Hib Conjugate Vaccine Group	Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine (adjuvant-free)	Participants randomized to receive adjuvant-free MenAC-Hib conjugate vaccine.
Adjuvant MenAC-Hib Conjugate Vaccine Group	Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine(adjuvant)	Participants randomized to receive adjuvant MenAC-Hib conjugate vaccine.

Primary Outcome Measures

Name	Time	Method
Percentage of participants with seroresponse to meningococcal serogroups A,C and Haemophilus b post-vaccination with 3 doses of MenAC-Hib conjugate vaccine	Day 30 post-vaccination
Occurrence of adverse events during a 30 day follow-up period after each vaccination	30 day after each vaccination

Secondary Outcome Measures

Name	Time	Method
Geometric mean titer （GMT）of antibodies against meningococcal serogroups A, C and Haemophilus b post-vaccination with 3 doses of MenAC-Hib conjugate vaccine	Day 30 post-vaccination
Occurrence of severe adverse events within six months post-vaccination	six months post-vaccination

Trial Locations

Locations (1)

Gaozhou Center for Disease Control and Prevention; 🇨🇳 Gaozhou, Guangdong, China