NCT02919293

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 2 Months – 5 Months
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine (adjuvant-free)	30μg /dose, Intramuscular
BIOLOGICAL	Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine(adjuvant)	0.5ml /dose, Intramuscular

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-03-01
• Completion: 2017-05-01
• First posted: 2016-09-29
• Last updated: 2016-09-29

Locations

1 site across 1 country: China