An open-label, single treatment, single period, single dose, clinical phase 1 study to assess the safety and tolerability of Measles, Mumps, Rubella & Varicella vaccine (live attenuated, freeze dried) of M/s Cadila Healthcare Ltd., India in healthy, adult, male, human subjects.

开始日期2015-10-30

申办/合作机构-

100 项与 Measles, mumps, rubella and varicella vaccine (Cadila Healthcare) 相关的临床结果

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100 项与 Measles, mumps, rubella and varicella vaccine (Cadila Healthcare) 相关的转化医学

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100 项与 Measles, mumps, rubella and varicella vaccine (Cadila Healthcare) 相关的专利（医药）

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项与 Measles, mumps, rubella and varicella vaccine (Cadila Healthcare) 相关的文献（医药）

2024-06-01·Pediatric Infectious Disease Journal

Phase 3 Safety and Immunogenicity Study of a Three-dose Series of Twenty-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers

Article

作者: Gruber, William ; Wysocki, Jacek ; Watson, Wendy ; Jackowska, Teresa ; Lei, Lanyu ; Korbal, Piotr ; Giardina, Peter C ; Kline, Mary ; Scott, Daniel ; Tamimi, Noor ; Peng, Yahong ; Drozd, Jelena

Background:Global pediatric immunization programs with pneumococcal conjugate vaccines (PCVs) have reduced vaccine-type pneumococcal disease, but a substantial disease burden of non-PCV serotypes remains.Methods:This phase 3, randomized (1:1), double-blind study evaluated safety and immunogenicity of 20-valent PCV (PCV20) relative to 13-valent PCV (PCV13) in healthy infants. Participants received 2 infant doses and a toddler dose of PCV20 or PCV13, with diphtheria-tetanus-acellular pertussis combination vaccine at all doses and measles, mumps, rubella and varicella vaccines at the toddler dose. Primary pneumococcal immunogenicity objectives were to demonstrate noninferiority (NI) of PCV20 to PCV13 for immunoglobulin G geometric mean concentrations after infant and toddler doses and percentages of participants with predefined serotype-specific immunoglobulin G concentrations after infant doses. Safety endpoints included local reactions, systemic events and adverse events.Results:Overall, 1204 participants were vaccinated (PCV20, n = 601; PCV13, n = 603). One month after the toddler dose, 19/20 serotypes met NI for immunoglobulin G geometric mean concentrations; serotype 6B narrowly missed NI [PCV20/PCV13 geometric mean ratio: 0.57 (2-sided 95% confidence interval: 0.48–0.67); NI criterion: lower 2-sided 95% confidence interval >0.5]. Sixteen/twenty serotypes met NI for ≥1 primary objective after 2 infant doses. PCV20 induced robust opsonophagocytic activity, and boosting responses were observed for all vaccine serotypes, including those missing statistical NI. The safety/tolerability profile of PCV20 was like that of PCV13.Conclusions:PCV20 3-dose series in infants was safe and elicited robust immune responses. Based on these results and PCV13 experience, PCV20 3-dose series is expected to be protective for all 20 vaccine serotypes. NCT04546425.

2017-10-01·Vaccine3区 · 医学

Pain caused by measles, mumps, and rubella vaccines: A systematic literature review

3区 · 医学

Review

作者: Baril, Laurence ; Lin, Lan ; Henry, Ouzama ; Willame, Corinne ; Praet, Nicolas ; Vetter, Volker

PURPOSEThe risk of post-vaccination adverse events (AEs) is a primary public health concern. Among the AEs, pain is a significant source of anxiety for both children and their parents. This review describes and assesses the intensity of pain experienced by children post-vaccination with widely used Measles-Mumps-Rubella (MMR) vaccines.METHODSA systematic literature search was conducted in Pubmed, Embase and Cochrane to identify publications describing immediate pain at injection site (primary objective) or pain within days (secondary objective) after 2 specific MMR vaccines. Immediate pain ('acute pain' according to the Brighton Collaboration case definition) was defined as pain occurring at the time or within 5min of injection.RESULTSFour studies, which compared the intensity of immediate injection site pain experienced by children after MMR vaccination, were identified. Various pain assessment tools and methods were used to quantify the intensity of pain, including the median difference in Visual Analog Scale scores between vaccine groups. All four studies showed significantly less immediate pain caused by Priorix (GSK Vaccines) compared with M-M-R II (Merck & Co., Inc.).CONCLUSIONSTo our knowledge, this review summarizes for the first time the available scientific evidence on the intensity of pain following different MMR vaccines. It highlights that MMR vaccines can differ in terms of immediate pain. Further research may be needed to better understand the underlying reason for this observation. In this context, it is very important to understand which physicochemical properties are most relevant for the immediate pain profile of a vaccine to thereby support the development of vaccines with the best possible immediate pain profile.

2017-07-03·Human Vaccines & Immunotherapeutics3区 · 医学

Immunogenicity and safety of a novel MMR vaccine (live, freeze-dried) containing the Edmonston-Zagreb measles strain, the Hoshino mumps strain, and the RA 27/3 rubella strain: Results of a randomized, comparative, active controlled phase III clinical trial

3区 · 医学

Article

作者: Mitra, Monjori ; Nayak, Uma Siddhartha ; Sood, Ashwani ; Sanmukhani, Jayesh ; Gupta, Gaurav ; Babu, T. Ramesh ; Glueck, Reinhard ; Joshi, Himanshu Arvind ; Siddaiah, Prashanth ; Mittal, Ravindra ; Mahapatro, Samarendra

This phase III clinical trial was conducted to evaluate the immunogenicity and safety of the single-dose and multi-dose formulations of a novel MMR vaccine (live, freeze-dried) developed by M/s Cadila Healthcare Limited, India (Cadila MMR vaccine), containing the Hoshino mumps strain, compared to that of an existing MMR vaccine (live, freeze-dried) developed by M/s Serum Institute of India Limited, India (Serum MMR vaccine). These two vaccines have similar measles and rubella strains, but different mumps strains (Hoshino in Cadila MMR vaccine, and L-Zagreb in Serum MMR vaccine). Three hundred and twenty-eight subjects of either sex, aged 15-18 months, were randomized in a 2:1 ratio to receive either the Cadila or Serum MMR vaccine. Immunogenicity assessments (IgG antibodies against measles, mumps, and rubella viruses) were done at baseline and 42 d after vaccination. Solicited (local and systemic) and unsolicited adverse events were recorded for up to 42 d following vaccination. The Cadila MMR vaccine was found to be non-inferior to the Serum MMR vaccine in terms of end-of-study proportion of subjects seropositive for anti-measles antibodies (100.0% in both groups), anti-mumps antibodies (94.5% vs. 94.0%), and anti-rubella antibodies (95.5% vs. 91.0%). Both vaccines were well tolerated by all study participants; the most common adverse event reported in both groups was fever, followed by rash. The results of this phase III clinical trial show that the novel Cadila MMR vaccine is non-inferior to the Serum MMR vaccine.

100 项与 Measles, mumps, rubella and varicella vaccine (Cadila Healthcare) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
麻疹	临床1期	印度	Zydus Lifesciences Ltd.	-
腮腺炎	临床1期	印度	Zydus Lifesciences Ltd.	-
先天性风疹综合征	临床1期	印度	Zydus Lifesciences Ltd.	-
水痘带状疱疹病毒感染	临床1期	印度	Zydus Lifesciences Ltd.	-