Safety and immunogenicity of a 7-valent pneumococcal conjugate vaccine (Prevenar™): Primary dosing series in healthy Chinese infants

Safety and immunogenicity of a new 13-valent pneumococcal conjugate vaccine versus a licensed 7-valent pneumococcal conjugate vaccine: a study protocol of a randomised non-inferiority trial in China

“…Given the main focus of the research, this study is not designed to involve the assessment of concomitant immunisation with other vaccines specified in paediatric vaccination schedules such as diphtheria, tetanus and acellular pertussis vaccine (DTaP), which might be regarded as a potential limitation. Since the feasibility of PCV7 administered concomitantly with DTaP in mainland Chinese infants has been shown in the research reported by Li RC et al, 30 and the immunogenicity of PCV13 coadministered with DTaP was demonstrated by Togashi T et al, 7 we will not prohibit the usage of vaccines listed in the expanded programme on immunisation, but we will compulsively demand at least a fortnight's interval between two kinds of vaccination.…”

Estimated public health impact of nationwide vaccination of infants with 7-valent pneumococcal conjugate vaccine (PCV7) in China

“…27 In order to estimate the local effectiveness of PCV7 on invasive disease, efficacy data were used from an immunogenicity study of PCV7 that was conducted on healthy infants from Guangxi, China. 28 This randomized, controlled immunogenicity study compared the level of antibody to pneumococcal antigens of children who received PCV7 with DTaP (diphtheria-tetanusacellular pertussis) to a control group who received DTaP only. The proportion of subjects who achieved >0.35 mg of pneumococcal antibody/ml 30-50 days after the primary series by serotype were 4 (99%), 6B (83%), 9 V (98%), 14 (99%), 18C (99%), 19F (99%), and 23F (94%).…”

“…The proportion of subjects who achieved >0.35 mg of pneumococcal antibody/ml 30-50 days after the primary series by serotype were 4 (99%), 6B (83%), 9 V (98%), 14 (99%), 18C (99%), 19F (99%), and 23F (94%). 28 These data were multiplied by the respective serotype prevalence locally to estimate an effectiveness of 96.9% reduction in IPD versus covered serotypes in China.…”

Safety, tolerability, and immunogenicity of 7-valent pneumococcal conjugate vaccine in older infants and young children in China who are naive to pneumococcal vaccination: Results of a phase 4 open-label trial

“…Pneumococcal disease remains a significant cause of morbidity and mortality among children in China [3]. (PCV7) targeting serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in preventing pneumococcal disease [4][5][6][7][8][9]. The most prevalent pneumococcal serotypes among 218 invasive pneumococcal disease strains from 12 hospitals across China, collected from 2005 to 2011, were 19A (22%), 19F (22%), 14 (8%), 3 (7%), and 23F (5%), which accounted for 64% of all strains; the estimated coverage by PCV7 was 41% [10].…”

“…In clinical trials enrolling Chinese infants, PCV7 has been shown to be safe and immunogenic when given either separately or concomitantly with a diphtheria, tetanus, and acellular pertussis vaccine at 3, 4, and 5 months of age [9]. Health outcomes studies support the use of PCV7 administered as primary and booster immunizations to reduce morbidity and mortality related to pneumococcal disease in Chinese children [12].…”