Pawaskar, Manjiri Schmidt, Elvira Marshall, Gary S Fergie, Jaime Richardson, Elizabeth Saldutti, Louise Parks Li, Se Neumann, Monika Koller, Linnea Kuter, Barbara
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Published in
Human vaccines & immunotherapeutics
M-M-R®II (M-M-R II) is routinely used in many countries at 12-15 months with a second dose at 4 to 6 years of age. However, the vaccine may need to be administered at other ages due to delays in the immunization schedule or in certain situations such as outbreaks or international travel. A systematic literature review was conducted to evaluate effi...
Reddy, Raghu Reddy, Bhargav Sarangi, Vamshi Reddy, Siddharth Ella, Raches Vadrevu, Krishna Mohan
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Human vaccines & immunotherapeutics
A typhoid Vi capsular-polysaccharide tetanus toxoid conjugate vaccine (Typbar-TCV®) was recommended by the World Health Organization for use in children >6 months of age. The present post-marketing surveillance study was intended to assess the clinical safety of approximately 11 million doses of TCV sold till 2019 in a diverse age range Indian popu...
Nwoji, Ugo
Published in
Human vaccines & immunotherapeutics
PLAIN LANGUAGE SUMMARYWhat is the context?The pneumococcus bacterium can cause infections of the meninges, blood, lung, middle ear and sinuses.Two vaccins, Synflorix (GSK) and Prevnar 13 (Pfizer Inc.), are widely used to protect young children against these infections.The vaccines’ compositions differ: Synflorix includes antigens from 10 pneumococc...
Basu, Indraneel Agarwal, Manish Shah, Viral Shukla, Vijay Naik, Sunil Supe, Pravin Dinkar Srivastava, Manoj Kumar Giriraja, Kanakapura Vrushabaiah Pinjar, Peersab Mishra, Pradeep Kumar
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Published in
Human vaccines & immunotherapeutics
This study was conducted to compare the immunogenicity and safety profile of two quadrivalent influenza vaccines (QIVs) in healthy adults (18-60 years) and elderly (>61 years) participants. This phase III study was conducted from March 2018 to April 2018 across 12 sites in India. In this randomized, observer-blind, active-controlled study, 480 part...
Shi, Li Sun, Mingbo
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Human vaccines & immunotherapeutics
As one of the powerful vaccines for completely eradicating all types of poliovirus in the polio endgame period, the novel IPV, which is prepared from attenuated polio Sabin strains (sIPV) and is expected to reduce the overall biosafety risk, was licensed in Japan (sIPV-containing diphtheria-tetanus-acellular pertussis combination vaccines, DTP-sIPV...
Russell, Kevin L Rupp, Richard E Morales-Ramirez, Javier O Diaz-Perez, Clemente Andrews, Charles P Lee, Andrew W Finn, Tyler S Cox, Kara S Falk Russell, Amy Schaller, Margaret M
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Human vaccines & immunotherapeutics
Dengue (DENV) is a mosquito-borne virus with four serotypes causing substantial morbidity in tropical and subtropical areas worldwide. V181 is an investigational, live, attenuated, quadrivalent dengue vaccine. In this phase 1 double-blind, placebo-controlled study, the safety, tolerability, and immunogenicity of V181 in baseline flavivirus-naïve (B...
Gao, Shuyu Wei, Mingwei Chu, Kai Li, Jingxin Zhu, Fengcai
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Human vaccines & immunotherapeutics
The presence of maternal poliovirus antibodies may interfere with the immune response to inactivated polio vaccine (IPV), and its influence on the safety of vaccination is not yet understood. A total of 1146 eligible infants were randomly assigned (1:1) to the IPV and Sabin IPV (SIPV) groups to compare and analyze the efficacy of the two vaccines i...
Siegel, Jerry Kappeler, Karl
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Human vaccines & immunotherapeutics
The FDA strongly encourages rigorous safety and efficacy studies in all age groups for which vaccines and treatments for pervasive and severe diseases are intended. Until recently, there had been no safety and efficacy studies conducted in children for human rabies immune globulins. The publication," Safety, and efficacy of rabies immunoglobulin in...
Huang, Xiaoyuan Fan, Ting Li, Li Nian, Xuanxuan Zhang, Jiayou Gao, Xuefen Zhao, Wei Chen, Wei Zhang, Zhaoqing Yao, Zhihao
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Published in
Human vaccines & immunotherapeutics
A quadrivalent split influenza vaccine IIV4-W against both influenza A and B viruses is urgently needed. To evaluate the safety and immunogenicity of IIV4-W in people aged 3-60 years, 2400 participants recruited in a double-blind phase III trial and were randomly assigned to the IIV4-W, TIV1 and TIV2 groups. The immunogenicity indicators were measu...
Kishino, Hiroyuki Sawata, Miyuki Igarashi, Rie Shirakawa, Masayoshi Pedley, Alison Musey, Luwy Platt, Heather Loryn Buchwald, Ulrike Kirsten
Published in
Japanese journal of infectious diseases
The safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine (PCV), were assessed in a pivotal phase III trial conducted in healthy adults ≥50 years of age (NCT03950622, Japic-CTI 194845). We performed a subgroup analysis of 245 Japanese participants (all ≥65 years of age). The participants were randomized 1:1 to receive a sing...
