The immunogenicity and safety of a Hib-MenAC vaccine: a non-inferiority randomized, observer-blind trial in infants aged 3-5 months
| Autor: | Fengcai Zhu, Wei-Ming Dai, Hong Tao, Wen-Yu Liu, Pei Liu, Jinfang Sun, Jingxin Li, Jie Tang, Yuxiao Wang, Jian-li Hu |
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| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Male Pediatrics medicine.medical_specialty China Drug-Related Side Effects and Adverse Reactions 030106 microbiology Immunology Meningococcal Vaccines Neisseria meningitidis Serogroup C medicine.disease_cause complex mixtures Placebos 03 medical and health sciences 0302 clinical medicine Conjugate vaccine Neisseria meningitidis Serogroup A Drug Discovery Tetanus Toxoid Medicine Humans Single-Blind Method 030212 general & internal medicine Vaccines Combined Seroconversion Haemophilus Vaccines Pharmacology Vaccines Conjugate business.industry Immunogenicity Neisseria meningitidis Toxoid Antibody titer Haemophilus influenzae type b Infant bacterial infections and mycoses Antibodies Bacterial Clinical trial Treatment Outcome Hib vaccine Molecular Medicine Female business |
| Zdroj: | Expert review of vaccines. 16(5) |
| ISSN: | 1744-8395 |
| Popis: | The objective of this study was to evaluate the immunogenicity and safety of the novel combined Haemophilus influenzae type b-Neisseria meningitidis serogroup A and C-tetanus toxoid conjugate vaccine (Hib-MenAC).We conducted a non-inferiority, randomized, observer-blind, positive control clinical trial in 900 healthy infants aged between 3-5 months in Funing County, Jiangsu Province, China. Participants were randomly allocated, in a ratio of 2:1 (block = 6), to receive experimental combined Hib-MenAC vaccines co-administrated with placebo or the co-administration of licensed Hib vaccine and MenAC vaccine, according to a three-dose immunization schedule. The seroconversion of antibody titer against meningococcal serogroups A, C and Hib was the primary endpoint.The experimental vaccines was non-inferior to the licensed two control vaccines. Participants receiving experimental Hib-MenAC vaccines showed a seroconversion rate of 99.0%, 96.1% and 97.7% for rSBA-MenA, rSBA-MenC and anti-PRP antibodies, respectively. The Hib-MenAC vaccine did not result in an increase in adverse reaction, and no serious adverse event was judged to be related to the vaccination.The novel combined Hib-MenAC conjugate vaccine was safe and highly immunogenic in infants aged between 3 to 5 months. |
| Databáze: | OpenAIRE |
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