[A phase â
¢ clinical trial study on the safety and immunogenicity of ACYW135 group meningococcal conjugate vaccine inoculated in 3 month old infants].
Zhonghua Yu Fang Yi Xue Za Zhi
; 54(9): 947-952, 2020 Sep 06.
Article
en Zh
| MEDLINE
| ID: mdl-32907283
ABSTRACT
Objective:
The aim of this study was to evaluate the safety and immunogenicity of the first domestic ACYW135 meningococcal conjugate vaccine and a control vaccine named AC group meningococcal conjugate vaccine for 3 months (90-119 days) infants.Methods:
From February 2017 to June 2018, a randomized, blinded, and similar vaccine-controlled clinical trial design was adopted at the Henan Vaccine Clinical Research Base. The subjects were 3 months old healthy infants, a total of 720, based on a 1â¶1 ratio. The random allocation table for entry was randomly assigned to the experimental group and the control group. According to the 3, 4, and 5 month-old vaccination procedures, the subjects were vaccinated with test vaccine (ACYW135 group meningococcal conjugate vaccine) and control vaccine (group A group C meningococcal polysaccharide conjugate vaccine), of which 720 were given the first dose, 696 were given the second dose (test group 346; control group 350), and 692 were given the third dose (test group 344; Control group 348).Results:
The overall adverse reaction rate of the test vaccine was 21.90% (230 cases), which was lower than the 32.04% (339 cases) of the control vaccine (P<0.001). The incidence of systemic adverse reactions was 19.52% (205 cases), which was lower than that of the control vaccine (27.69%) (293 cases) (P<0.001). The local adverse reaction rate was 3.04% (32 cases), which was lower than the control group (7.84%) (83 cases) (P<0.001). The graded adverse reaction test vaccine was 0.57% (6 cases), which was lower than the control group of 2.36% (25 cases) (P<0.001). The positive conversion rate of anti-bacterial serum antibodies showed that there was no significant difference between the test vaccine group A (91.42%), C (88.76%) and the control vaccine (92.92%) (87.02%) (P>0.05). Group Y and W135 was 88.17% (298 cases), 99.41% (336 cases), respectively. The GMT results showed that the test vaccine group A was 56.24, the control vaccine was 57.43 (P>0.05); the group C test vaccine (43.53) was higher than the control group (27.28) (P<0.001). The group Y and W135 are 89.22 and 140.66, respectively. Among them, the proportion of the group C GMT antibody ≥ 1â¶128 for test vaccine (31.07%, 105 cases) was higher than the control vaccine (16.22%, 55 cases) (P<0.001).Conclusion:
ACYW135 group meningococcal conjugate vaccine has more safety and immunogenicity after application to 3 month old infants.Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Contexto en salud:
3_ND
/
4_TD
Problema de salud:
3_zoonosis
/
4_meningitis
Asunto principal:
Vacunas Meningococicas
Tipo de estudio:
Clinical_trials
Límite:
Humans
/
Infant
Idioma:
Zh
Revista:
Zhonghua Yu Fang Yi Xue Za Zhi
Año:
2020
Tipo del documento:
Article
País de afiliación:
China