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

Meningitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02919293
• Other study ID #: 085201602
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: September 27, 2016
• Last updated: September 27, 2016
• Start date: August 2016
• Est. completion date: May 2017

Study information

• Verified date: August 2016
• Source: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
• Contact: Zeng peiyu, Bachelor
• Phone: 86-668-6578613
• Email: gzcdc6578613[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: May 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Months to 5 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningitis
• Meningitis, Meningococcal
• Meningococcal Infections
• Meningococcal Meningitis

Intervention

Biological:
• 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

Locations

Country	Name	City	State
China	Gaozhou Center for Disease Control and Prevention	Gaozhou	Guangdong

Sponsors (6)

Lead Sponsor	Collaborator
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd	Fourth Military Medical University, Gaozhou Center for Disease Control and Prevention, Guangdong Center for Disease Control and Prevention, National Institutes for Food and Drug Control, China, Simoon Record Pharma Information Consulting Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Occurrence of adverse events during a 30 day follow-up period after each vaccination		30 day after each vaccination	Yes
Secondary	Occurrence of severe adverse events within six months post-vaccination		six months post-vaccination	Yes
Secondary	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	No