Drugs / ProQuad

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) ProQuad 2006-04-05 europa.eu

Trials 12 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT02687763 Dec 2015 → Nov 2016 acute liver failure, chronic kidney disease, heart disorder Medical University of South Carolina Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT00258726 Oct 2005 → Jul 2007 chickenpox, measles, mumps infectious disease, rubella National Institute of Allergy and Infectious Diseases (NIAID) Terminated No outcome recorded
Phase 310 trials
Phase 3 NCT01341639 May 2011 → Mar 2013 bacterial infectious disease, viral infectious disease MCM Vaccines B.V. Completed No outcome recorded
Phase 3 NCT00839917 Feb → May 2008 chickenpox, measles, mumps infectious disease, rubella Merck Sharp & Dohme LLC Terminated No outcome recorded
Phase 3 NCT00566527 Nov 2007 → Dec 2008 measles, mumps infectious disease, rubella, varicella zoster infection Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT00560755 Oct 2007 → Nov 2008 measles, mumps infectious disease, rubella, varicella zoster infection Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT00432042 Jan 2007 → Mar 2008 chickenpox, diphtheria, haemophilus infectious disease, hepatitis B virus infection +6 Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT00402831 Oct 2006 → May 2007 chickenpox, measles, mumps infectious disease, rubella Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT00109343 Mar 2006 → Sep 2007 measles, mumps infectious disease, rubella, varicella zoster infection Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT00092430 Sep 2002 → Jun 2003 chickenpox, measles, mumps infectious disease, rubella Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT00985166 Aug 2000 → May 2002 measles, mumps infectious disease, rubella, varicella zoster infection Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 3 NCT00975507 Mar 1998 → Jan 1999 measles, mumps infectious disease, rubella, varicella zoster infection Merck Sharp & Dohme LLC Completed No outcome recorded
Also used as a comparator or background therapy in 6 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials
Phase 2 NCT05630846 Comparator Dec 2022 → Jun 2024 measles GlaxoSmithKline Completed No outcome recorded
Phase 2 NCT00578175 Comparator Nov 2007 → Feb 2009 chickenpox, measles, mumps infectious disease, rubella GlaxoSmithKline Completed No outcome recorded
Phase 32 trials
Phase 3 NCT01621802 Background Jun 2012 → Jul 2015 viral infectious disease GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT01536405 Comparator Jun 2012 → Jul 2013 chickenpox, measles, mumps infectious disease, rubella Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 42 trials
Phase 4 NCT00326183 Comparator Mar 2007 → Jan 2008 chickenpox, hepatitis A virus infection, measles, mumps infectious disease +1 Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 4 NCT00312858 Comparator Apr 2006 → Mar 2008 hepatitis A virus infection Merck Sharp & Dohme LLC Completed No outcome recorded

Evidence & citations 8 cited values

Every value below carries the sentence it was read from. 22 sources stand behind the page.

FieldValueCited text
Known as ProQuad “This study is designed to evaluate the immunogenicity and safety of the investigational measles, mumps, rubella, varicella vaccine (referred to as the MMRVNS vaccine) compared...” NCT05630846
17

“This study will test the safety and how well the body's immune system responds to a live, but weakened varicella (chickenpox) vaccine, known as Varivax, given with and without...” NCT00258726

“frozen formulation of ProQuad (measles, mumps, rubella, and varicella virus vaccine live).” PMID 17502347 May 2007

ProQuad™” NCT00109343

NCT01621802

NCT00839917

NCT00566527

NCT00326183

NCT00258726

NCT00312858

NCT02687763

NCT00402831

NCT00560755

NCT00578175

NCT00985166

NCT00432042

NCT00109343

NCT01341639

Known as Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad) “Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™)” NCT00839917
Known as MMRV “This open-label, multicenter, randomized, comparative study evaluated immunogenicity, safety and tolerability of concomitant (Group 1; n=330) vs. non-concomitant (Group 2;...” PMID 23744509 Jun 2013
2

“Healthy children 12-to-23 months of age at 71 US sites were randomized (1:1) to receive MMRV manufactured using an alternative process (MMRVAMP) or the currently licensed MMRV.” PMID 27149048 May 2016

“Both groups received concomitantly Prevnar 13 (PCV13) and Rotateq (RV5) at 2, 3 and 4 months of age and ProqQad (MMRV) at 12 months of age.” PMID 27846055 Feb 2017

Known as MMRV (2006 process) ClinicalTrials.gov intervention name — accepted as the source's own label NCT01536405
Known as ProqQad “Both groups received concomitantly Prevnar 13 (PCV13) and Rotateq (RV5) at 2, 3 and 4 months of age and ProqQad (MMRV) at 12 months of age.” PMID 27846055 Feb 2017
Known as V221 “This study will compare Measles, Mumps, Rubella, and Varicella Vaccine (V221) and concomitant administration of Varivax and M-M-R II vaccines in healthy children.” NCT00975507
2

“Comparator: ProQuad™ (V221)” NCT00109343

NCT00092430

Modality Vaccine “virus vaccine live” NCT00092430
Route Subcutaneous “0.5-mL subcutaneous injection” NCT00109343