Safety and tolerability of 13-valent pneumococcal conjugate vaccine in healthy Chinese adults, children and infants

Abstract

Objective: Pneumococcal disease is a global problem, including in China. The objective of this study was to provide safety data for single-dose 13-valent pneumococcal conjugate vaccine (PCV13) in Chinese subjects, needed to begin a phase III safety and immunogenicity study in Chinese infants.

Methods: Healthy Chinese adults (18-55 years), children (3-5 years), and infants (42-98 days) received a single dose of PCV13 in this open-label safety study. Local reactions and systemic events were collected for 7 days via an electronic diary; adverse events were recorded for 1 month after vaccination.

Results: All 72 (24 per group) screened subjects (58.3% males; mean ± standard deviation [SD] age: 43.3 ± 9.1 years [adults], 4.5 ± 0.7 years [children], and 79.6 ± 15.2 days [infants]) were enrolled, received vaccine, and completed the study. The most frequently reported local reactions per group were pain at the injection site (n = 23 adults [95.8%]), tenderness (n = 18 children [75%]), and swelling (n = 6 infants [25%]), none of which were severe. The mean duration of each local reaction was ⩽2.0 days in infants and ⩽2.4 days in children but in adults was 3.3 days for pain at the injection site and 9 days each for redness and swelling. Systemic events in adults were muscle pain (n = 5), fatigue (n = 3), and headache and joint pain (n = 1 each). One child and seven infants had disturbed sleep (increased or decreased). One adult and one child had mild fever (37.7-38.5°C, as per China Food and Drug Administration guidelines). No subject used antipyretic medication. One adverse event (bronchopneumonia in an infant) was reported, which was serious, severe, and unrelated to vaccination. There were no deaths.

Conclusions: A single dose of PCV13 was safe and well tolerated in healthy Chinese adults, children, and infants. This study provided the safety data to enable a phase III safety and immunogenicity registration trial in Chinese infants to proceed.

Trial registration: ClinicalTrials.gov NCT01531322.

Keywords: 13-valent pneumococcal conjugate vaccine; pneumococcal infections; safety.

Conflict of interest statement

Conflict of interest statement: Dr Zhu’s and Dr Hu’s institution received research funding for the study. Dr Liang declares no potential conflicts with the content of this manuscript. Dr Young, Dr Zhou, Dr Chen, Dr Liang, Dr Gruber, and Dr Scott are employees and shareholders of Pfizer Inc.

Figures

Figure 1.

Percentage of subjects having local reactions within 7 days of PCV13 vaccination. The worst severity is reported for each subject. No severe reactions were reported. For redness and swelling in adults, mild is 2.5−5.0 cm, moderate is >5.0−10.0 cm, and severe is >10.0 cm; in children and infants, mild is 0.5−2.0 cm, moderate is >2.0−7.0 cm, and severe is >7.0 cm. For injection site pain, mild does not interfere with activity, moderate interferes with activity, and severe prevents activity. For tenderness, mild is the presence of tenderness and severe interferes with limb movement. PCV13, 13-valent pneumococcal conjugate vaccine.