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Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine manufactured with and without polysorbate 80 given to healthy infants at 2, 3, 4 and 12 months of age.

Author: BakerSherryl A, CzajkaHanna, EminiEmilio A, GadzinowskiJanusz, GiardinaPeter C, GruberWilliam C, KopińskaElzbieta, KorbalPiotr, Majda-StanisławskaEwa, PietrzykJacek J, ScottDaniel A, TanseySusan P, WysockiJacek

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Overview

Polysorbate 80 (P80) is a nonionic detergent used to solubilize proteins and is used in both oral and injectable medications, including vaccines. This study investigated the immunogenicity and safety of 13-valent pneumococcal conjugate vaccine (PCV13) with and without P80 before adding P80 to the formulation.
Paper Details　
Original Abstract of the Article :
Polysorbate 80 (P80), a nonionic detergent used to solubilize proteins, is used in both oral and injectable medications including vaccines. Development studies with 13-valent pneumococcal conjugate vaccine (PCV13) showed that adding P80 resulted in a more robust manufacturing process. Before adding ...See full text at original site
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引用元：
https://doi.org/10.1097/INF.0000000000000511

データ提供：米国国立医学図書館（NLM）

Pneumococcal Conjugate Vaccine: A Safe and Effective Option for Infants

Pneumococcal conjugate vaccine (PCV13), a crucial tool in preventing serious bacterial infections in infants, has undergone significant improvements in its formulation. Researchers, like explorers seeking to refine their tools for navigating the vast desert, are constantly striving to enhance the safety and effectiveness of vaccines.

This study investigated the immunogenicity and safety of PCV13 manufactured with and without polysorbate 80 (P80), a substance used to stabilize vaccines. The study found that PCV13 with P80 was just as safe and effective as the formulation without P80. This discovery, like a camel's ability to adapt to different water sources in the desert, confirms the safety and efficacy of the newly improved vaccine formulation.

PCV13: A Key Weapon in Protecting Infants

PCV13 is a vital tool in safeguarding infants from potentially life-threatening pneumococcal infections. This study provides reassuring evidence for the safety and efficacy of the newly improved formulation, ensuring that infants continue to receive robust protection from these serious infections. This development, like a camel's ability to traverse harsh terrain with ease, strengthens our arsenal against pneumococcal disease.

A Commitment to Safe and Effective Vaccines

The development of safe and effective vaccines is a testament to scientific progress and a commitment to public health. This study highlights the ongoing efforts to enhance vaccine formulations, ensuring that infants receive the best possible protection against preventable diseases. Just as a camel's adaptations enable it to thrive in the desert, vaccines are a powerful tool in our fight against infectious diseases.

Dr.Camel's Conclusion

This study confirms the safety and effectiveness of the improved formulation of PCV13, a crucial vaccine for protecting infants. Like a camel's ability to navigate the desert with its unique adaptations, PCV13 empowers us to safeguard young lives from the threat of pneumococcal infections.

Date :
  1. Date Completed 2015-11-13
  2. Date Revised 2015-03-09
Further Info :

Pubmed ID

25126854

DOI: Digital Object Identifier

10.1097/INF.0000000000000511

SNS
PICO Info
in preparation
Languages

English

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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