Immunogenicity and Safety of a 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers Given With Routine Vaccines in India

被引：14

作者：

Amdekar, Yeshwant K. ^{[1
]}

Lalwani, Sanjay K. ^{[2
]}

Bavdekar, Ashish ^{[3
]}

Balasubramanian, S. ^{[4
,5
]}

Chhatwal, Jugesh ^{[6
]}

Bhat, Swarna Rekha ^{[7
]}

Verghese, Valsan Philip ^{[8
]}

Tansey, Susan P. ^{[9
]}

Gadgil, Durga ^{[10
]}

Jiang, Qin ^{[11
]}

Pride, Michael ^{[12
]}

Emini, Emilio A. ^{[11
]}

Gruber, William C. ^{[12
]}

Scott, Daniel A. ^{[12
]}

机构：

[1] Jaslok Hosp & Res Ctr, Bombay, Maharashtra, India

[2] Bharati Vidyapeeth Univ, Coll Med, Pune, Maharashtra, India

[3] KEM Hosp Res Ctr, Dept Pediat, Pune, Maharashtra, India

[4] Kanchi Kamakoti CHILDS Trust Hosp, Madras, Tamil Nadu, India

[5] CHILDS Trust Med Res Fdn, Madras, Tamil Nadu, India

[6] Christian Med Coll & Hosp, Ludhiana, Punjab, India

[7] St Johns Med Coll, Dept Pediat, Bangalore, Karnataka, India

[8] Christian Med Coll & Hosp, Dept Child Hlth, Vellore, Tamil Nadu, India

[9] Pfizer Inc, Maidenhead, Berks, England

[10] Pfizer Inc, Pharmaceut India Pvt Ltd, Bombay, Maharashtra, India

[11] Pfizer Inc, Collegeville, PA USA

[12] Pfizer Inc, Pearl River, NY USA

来源：

PEDIATRIC INFECTIOUS DISEASE JOURNAL | 2013年 / 32卷 / 05期

关键词：

immunogenicity; pneumococcal vaccine; pediatric; safety; STREPTOCOCCUS-PNEUMONIAE; PEDIATRIC VACCINATIONS; CROSS-REACTIVITY; CHILDREN YOUNGER; POLYSACCHARIDES; EFFICACY; SERIES; AGE;

D O I：

10.1097/INF.0b013e31827b478d

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Background: The childhood burden of disease attributable to Streptococcus pneumoniae is particularly high in India. The immunogenicity and safety of 13-valent pneumococcal conjugate vaccine (PCV13) were compared with 7-valent pneumococcal conjugate vaccine (PCV7) in a randomized, active-controlled, double-blind trial conducted at 12 sites in India. Methods: Healthy infants received PCV13 or PCV7 at 6, 10, and 14 weeks of age (infant series) and at 12 months of age (toddler dose), along with routine pediatric vaccinations. Immunoglobulin G responses against the 13 pneumococcal serotypes were evaluated 1 month after the infant series and after the toddler dose. Pertussis and poliomyelitis immune responses were assessed 1 month after the infant series. Safety and tolerability also were assessed. Results: The immunogenicity results for the 7 common serotypes and the concomitant vaccines (whole-cell pertussis and oral poliovirus) were similar for subjects receiving PCV13 and subjects receiving PCV7. Immune responses to the 6 additional serotypes were higher in the PCV13 group compared with the PCV7 group. PCV13 and PCV7 had similar safety and tolerability profiles. Conclusions: PCV13 has immunogenicity similar to PCV7 in response to the 7 common serotypes, and has generally higher immunogenicity in response to the 6 additional serotypes. PCV13 may provide added protection against pneumococcal disease caused by the additional 6 serotypes and does not interfere with immune responses to whole-cell pertussis and oral poliovirus vaccines. PCV13 has an acceptable safety profile in both infants and toddlers, comparable with that of PCV7.

引用

页码：509 / 516

页数：8

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