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

Beijing Zhifei Lvzhu Biopharmaceutical

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Meningitis; Meningococcal Meningitis; Meningococcal Infections

Treatments: Biological: Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine(adjuvant); Biological: Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine (adjuvant-free)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02919293

085201602

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 2 to 5 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 2 patient groups

Adjuvant-Free MenAC-Hib Conjugate Vaccine Group

Experimental group

Description:

Participants randomized to receive adjuvant-free MenAC-Hib conjugate vaccine.

Treatment:

Biological: Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine (adjuvant-free)

Adjuvant MenAC-Hib Conjugate Vaccine Group

Active Comparator group

Description:

Participants randomized to receive adjuvant MenAC-Hib conjugate vaccine.

Treatment:

Biological: Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine(adjuvant)