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

NCT02919293 Phase 1/Phase 2 UNKNOWN

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.

Details

Lead sponsor	Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Phase	Phase 1/Phase 2
Status	UNKNOWN
Enrolment	360
Start date	2016-08
Completion	2017-05

Conditions

• Meningitis
• Meningococcal Meningitis
• Meningococcal Infections

Interventions

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

Primary outcomes

• 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

Countries

China