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

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ClinicalTrials.gov Identifier: NCT02919293
Recruitment Status : Unknown
Verified August 2016 by Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd.
Recruitment status was:  Recruiting
First Posted : September 29, 2016
Last Update Posted : September 29, 2016
Sponsor:
Collaborators:
Guangdong Center for Disease Prevention and Control
Gaozhou Center for Disease Control and Prevention
National Institutes for Food and Drug Control, China
Fourth Military Medical University
Simoon Record Pharma Information Consulting Co., Ltd
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Meningitis Meningococcal Meningitis Meningococcal Infections 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) Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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 Start Date : August 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adjuvant-Free MenAC-Hib Conjugate Vaccine Group
Participants randomized to receive adjuvant-free MenAC-Hib conjugate vaccine.
Biological: Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine (adjuvant-free)
30μg /dose, Intramuscular
Other Names:
  • HibACon
  • MenAC-Hib

Active Comparator: Adjuvant MenAC-Hib Conjugate Vaccine Group
Participants randomized to receive adjuvant MenAC-Hib conjugate vaccine.
Biological: Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine(adjuvant)
0.5ml /dose, Intramuscular
Other Names:
  • HibACon
  • MenAC-Hib




Primary Outcome Measures :
  1. Percentage of participants with seroresponse to meningococcal serogroups A,C and Haemophilus b post-vaccination with 3 doses of MenAC-Hib conjugate vaccine [ Time Frame: Day 30 post-vaccination ]
  2. Occurrence of adverse events during a 30 day follow-up period after each vaccination [ Time Frame: 30 day after each vaccination ]

Secondary Outcome Measures :
  1. Occurrence of severe adverse events within six months post-vaccination [ Time Frame: six months post-vaccination ]
  2. Geometric mean titer (GMT)of antibodies against meningococcal serogroups A, C and Haemophilus b post-vaccination with 3 doses of MenAC-Hib conjugate vaccine [ Time Frame: Day 30 post-vaccination ]


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Ages Eligible for Study:   2 Months to 5 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02919293


Contacts
Contact: Zeng peiyu, Bachelor 86-668-6578613 gzcdc6578613@163.com

Locations
China, Guangdong
Gaozhou Center for Disease Control and Prevention Recruiting
Gaozhou, Guangdong, China, 525200
Contact: Zeng peiyu, Bachelor    86-668-6578613    gzcdc6578613@163.com   
Sponsors and Collaborators
Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Guangdong Center for Disease Prevention and Control
Gaozhou Center for Disease Control and Prevention
National Institutes for Food and Drug Control, China
Fourth Military Medical University
Simoon Record Pharma Information Consulting Co., Ltd
Investigators
Study Chair: Du lin, Master Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

Responsible Party: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT02919293     History of Changes
Other Study ID Numbers: 085201602
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Meningococcal Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs