Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of Different Formulations of V114 in Healthy Adults and Infants

Next Previous
Trial Profile

A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of Different Formulations of V114 in Healthy Adults and Infants

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 12 May 2022

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs V 114 (Primary) ; Pneumococcal 13-valent CRM197 vaccine conjugate
  • Indications Pneumococcal infections
  • Focus Adverse reactions; Pharmacodynamics
  • Sponsors Merck Sharp & Dohme

Most Recent Events

  • 30 Jan 2019 According to a Merck & Co media release, the US FDA has granted Breakthrough Therapy designation to V 114 for the treatment of pneumococcal disease caused by the vaccine serotypes in pediatric patients 6 weeks to 18 years of age. The FDA's decision was informed in part by immunogenicity data from the phase I/II 005 trial and phase II 008 trial.
  • 29 Aug 2016 Planned primary completion date changed from 1 Mar 2017 to 1 Jun 2017.
  • 10 Mar 2016 Planned End Date changed from 1 Aug 2017 to 1 Jun 2017, according to ClinicalTrials.gov record.

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top