The immunogenicity and safety of a Hib-MenAC vaccine: a non-inferiority randomized, observer-blind trial in infants aged 3-5 months.
Expert Rev Vaccines
; 16(5): 515-524, 2017 May.
Article
in En
| MEDLINE
| ID: mdl-28277801
ABSTRACT
BACKGROUND:
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).METHODS:
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 21 (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.RESULTS:
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.CONCLUSIONS:
The novel combined Hib-MenAC conjugate vaccine was safe and highly immunogenic in infants aged between 3 to 5 months.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Haemophilus Vaccines
/
Meningococcal Vaccines
Type of study:
Clinical_trials
Limits:
Female
/
Humans
/
Infant
/
Male
Country/Region as subject:
Asia
Language:
En
Journal:
Expert Rev Vaccines
Journal subject:
ALERGIA E IMUNOLOGIA
Year:
2017
Type:
Article