Background The Ad5-nCoV vaccine is a single-dose adenovirus type 5 (Ad5) vectored vaccine expressing the SARS-CoV-2 spike protein that was well-tolerated and immunogenic in phase 1 and 2 studies. In this study, we report results on the final efficacy and interim safety analyses of the phase 3 trial. Methods This double-blind, randomised, international, placebo-controlled, endpoint-case driven, phase 3, clinical trial enrolled adults aged 18 years older at study centres in Argentina, Chile, Mexico, Pakistan, and Russia. Participants were eligible for the study if they had no unstable or severe underlying medical or psychiatric conditions; had no history of a laboratory-confirmed SARS-CoV-2 infection; were not pregnant or breastfeeding; and had no previous receipt of an adenovirus-vectored, coronavirus, or SARS-CoV-2 vaccine. After informed consent was obtained, 25 mL of whole blood was withdrawn from all eligible participants who were randomised in a 1:1 ratio to receive a single intramuscular dose of 0·5 mL placebo or a 0·5 mL dose of 5 × 10 10 viral particle (vp)/mL Ad5-nCoV vaccine; study staff and participants were blinded to treatment allocation. All participants were contacted weekly by email, telephone, or text message to self-report any symptoms of COVID-19 illness, and laboratory testing for SARS-CoV-2 was done for all participants with any symptoms. The primary efficacy objective evaluated Ad5-nCoV in preventing symptomatic, PCR-confirmed COVID-19 infection occurring at least 28 days after vaccination in all participants who were at least 28 days postvaccination on Jan 15, 2021. The primary safety objective evaluated the incidence of any serious adverse events or medically attended adverse events postvaccination in all participants who received a study injection. This trial is closed for enrolment and is registered with ClinicalTrials.gov ( NCT04526990 ). Findings Study enrolment began on Sept 22, 2020, in Pakistan, Nov 6, 2020, in Mexico, Dec 2, 2020, in Russia and Chile, and Dec 17, 2020, in Argentina; 150 endpoint cases were reached on Jan 15, 2021, triggering the final primary efficacy analysis. One dose of Ad5-nCoV showed a 57·5% (95% CI 39·7–70·0, p=0·0026) efficacy against symptomatic, PCR-confirmed, COVID-19 infection at 28 days or more postvaccination (21 250 participants; 45 days median duration of follow-up [IQR 36–58]). In the primary safety analysis undertaken at the time of the efficacy analysis (36 717 participants), there was no significant difference in the incidence of serious adverse events (14 [0·1%] of 18 363 Ad5-nCoV recipients and 10 [0·1%] of 18 354 placebo recipients, p=0·54) or medically attended adverse events (442 [2·4%] of 18 363 Ad5-nCoV recipients and 411 [2·2%] of 18 354 placebo recipients, p=0·30) between the Ad5-nCoV or placebo groups, or any serious adverse events considered related to the study product (none in bo...
Half of all medicines are prescribed or sold inappropriately and half of all patients fail to take their medicines correctly worldwide. The present study was conducted to evaluate the pattern and practice of drugs within the modern medical system by investigating the prescription pattern, drug use in private and public health care facilities, assessment of the magnitude of the problem, identifying factors responsible for the problem, suggesting measures in Pakistan. There were marked differences between the qualities of consultation indicators between general practitioners (GPs) and public health care providers. The average number of drugs per prescription was 2.92 for all types of health care providers, mean number of drugs dispensed was 2.41 and 50% of the dispensed drugs were adequately labeled. Five categories of drugs comprised around 70% of all drugs prescribed. Injections prescribed per prescription were 0.32, infusions 0.07, capsules/tablets 1.85, syrups/suspensions 0.8. Number of drugs prescribed by GP's was 4.3 and was 2.9 (P = 0.001) for public health care providers and antibiotics prescribed per prescription were 0.9 and 0.8 (P = 0.176) for the GP's and public health care providers. The availability of drugs at public health care facilities influenced prescription in 88% of cases as compared to 57% (P = 0.001) at GPs clinics. Prescribing and dispensing practices are irrational both in public and private sector in Pakistan like many developing countries. Workable and appropriate interventions need to be developed and implemented in countries to improve trends of prescribing. The essential drug list and standard treatment guidelines should be disbursed to all medical, dental and pharmacy students.
Worldwide drug expenditures have been one of the main concerns of health care managers, and its containment is one of the primary goals of health care authorities. The present study was conducted through a cross sectional survey in Pakistan during January to June, 2010 not only to find out the importance and influence of promotional tools used by pharmaceutical industry on prescribing behaviors of doctors/consultants, but to also establish comparison between doctors/consultants versus medical representatives and consultant versus doctors with an auxiliary of difference between local and multinational company's representative. The study revealed that promotional tools are considered vital from doctors and medical representatives' point of view. There exists significant difference in doctors and consultant's perception for sponsorships and low value gifts, but no difference in scientific promotional tools. No significant difference exits in perception of medical representatives of multinational and local company representatives. The companies tried to come up as per expectations of doctors to build its reputation and good image by employing different promotional tools. The study also revealed that marketing managers, product managers, chief executive officers or any decision makers involved in budget allocations and making promotional strategy should not rely heavily on medical representative's feedback as their perception is different from doctors/consultants about relevant importance of each promotional tool. The study will also help product managers and CEOs while allocating promotional budgets and developing promotional mix strategy, to gain maximum return out of investment. Detailed doctors' demographics can further be researched as predictor for preferring any promotional tools.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Copyright © 2025 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.