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

NCT02919293 | Unknown Phase 1

• 1 other identifier: 085201602
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

Meningitis; Meningococcal Meningitis; Meningococcal Infections

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Occurrence of severe adverse events within six months post-vaccination

  six months post-vaccination

• 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

Study Arms (2)

Adjuvant-Free MenAC-Hib Conjugate Vaccine Group

EXPERIMENTAL

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

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

Adjuvant MenAC-Hib Conjugate Vaccine Group

ACTIVE COMPARATOR

Participants randomized to receive adjuvant MenAC-Hib conjugate vaccine.

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

Interventions

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

30μg /dose, Intramuscular

Also known as: HibACon, MenAC-Hib

Adjuvant-Free MenAC-Hib Conjugate Vaccine Group

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

0.5ml /dose, Intramuscular

Also known as: HibACon, MenAC-Hib

Adjuvant MenAC-Hib Conjugate Vaccine Group

Eligibility Criteria

• Age: 2 Months - 5 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd: lead
• Guangdong Center for Disease Prevention and Control: collaborator
• Guizhou Center for Disease Control and Prevention: collaborator
• National Institutes for Food and Drug Control, China: collaborator
• Air Force Military Medical University, China: collaborator
• Simoon Record Pharma Information Consulting Co., Ltd.: collaborator

Study Sites (1)

Gaozhou Center for Disease Control and Prevention

Gaozhou, Guangdong, 525200, China

RECRUITING

MeSH Terms

Conditions

Meningitis; Meningitis, Meningococcal; Meningococcal Infections

Interventions

HibTITER protein, Haemophilus influenzae

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases

Study Officials

• Du lin, Master

  Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd

  STUDY CHAIR

Central Study Contacts

Zeng peiyu, Bachelor

CONTACT

86-668-6578613; gzcdc6578613@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2016
• First Posted: September 29, 2016
• Study Start: August 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: May 1, 2017
• Last Updated: September 29, 2016

Record last verified: 2016-08

Locations

CN (1)