Details

Autor(en) / Beteiligte

• Xie, Z Q
• Zhao, D Y
• Huang, H T
• Gou, J B
• Zhang, W
• Yang, Y L
• Huang, L L
• Wang, Y X
• Wang, X
• Xu, L F
• Zhu, T
• Xia, S L

Titel

A phase Ⅲ clinical trial study on the safety and immunogenicity of ACYW135 group meningococcal conjugate vaccine inoculated in 3 month old infants

Ist Teil von

• Zhōnghuá yùfáng-yīxué zázhì, 2020-09, Vol.54 (9), p.947

Ort / Verlag

China

Erscheinungsjahr

2020

Quelle

MEDLINE

Beschreibungen/Notizen

• 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. 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 1∶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). T