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

ABSTRACT

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 < .0001). For all 13 serotypes except type 7 F, the GMCs in Group T were significantly higher than Group C. The GMC for type 7 F in Group T (P < .0009) was significantly lower than Group C. The frequencies of overall adverse events (P = .0064) and solicited adverse reactions (P = .0019) in Group T were significantly lower than Group C. Post booster vaccination, seropositive rates for all serotypes in Group T were 100.00%. For all serotypes except type 23 F, IgG GMCs in Group T were significantly higher than Group C. Totally, 21 subjects reported SAEs and all but one were considered irrelevant or probably irrelevant to vaccination. In conclusion, the tested PCV13 showed non-inferior immunogenicity and had a good safety profile compared with control vaccine.

KEYWORDS:

• Immunogenicity
• safety
• PCV
• 13-valent pneumococcal conjugate vaccine
• infants

Abbreviations

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Disclosure statement

Guifan Li is an employee of Beijing Minhai Biotechnology Co., LTD. All other authors have no conflicts.

Author contributions

Y.H. and G.L. designed the trial and the study protocol, Q.L. and G.L. contributed to the critical review and revision of the report. W.W., Q.L., J.Z., J.Z., J.C., S.X., H.M. led and participated in the site work, including the recruitment, follow-up. W.W. and Q.L. contributed to the data collection, data management, and statistical analysis and wrote the paper.

Supplementary material

Supplemental data for this article can be accessed on the publisher’s website at https://doi.org/10.1080/21645515.2021.2019498.

Additional information

Funding

This project was funded by Beijing Minhai Biotechnology Co., LTD.