Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine administered in a prime-boost regimen among Chinese infants: a randomized, double blind phase III clinical trial

Autor: Wenjuan Wang, Qi Liang, Jiahong Zhu, Junxia Zhang, Junsheng Chen, Sulan Xie, Yuemei Hu, Guifan Li
Jazyk: angličtina
Rok vydání: 2022
Předmět:
Zdroj: Human Vaccines & Immunotherapeutics, Vol 18, Iss 1 (2022)
Druh dokumentu: article
ISSN: 2164-5515
2164-554X
21645515
DOI: 10.1080/21645515.2021.2019498
Popis: This study aimed to evaluate the immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine (PCV13). In total, 1200 infants were randomized into two groups with a 1:1 allocation and received a three-dose series of tested PCV13 or control PCV13 at ages 2, 4 and 6 months, respectively, and a booster dose at 12–15 months. Blood samples were collected before and 30 days after primary and booster vaccination. Serotype-specific antibodies were measured using ELISA for immunoglobulin G (IgG) and OPA for functional antibodies. Safety data were collected for 30 days after each inoculation. Results showed that post primary vaccination seropositive rates of all 13 serotypes except type 3 were not significantly different between two groups. The seropositive rate for type 3 in Group T was significantly higher than Group C (P
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