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 10

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 38 trials · 4 met primary
Phase 3 NCT01341639 May 2011 → Mar 2013 bacterial infectious disease, viral infectious disease MCM Vaccines B.V. Completed Met primary
Phase 3 NCT00839917 Feb → May 2008 chickenpox, measles, mumps infectious disease, rubella Merck Sharp & Dohme LLC Terminated No outcome recorded Stop: Enrollment
Phase 3 NCT00566527 Nov 2007 → Dec 2008 measles, mumps infectious disease, rubella, varicella zoster infection Merck Sharp & Dohme LLC Completed Mixed
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 Met primary
Phase 3 NCT00402831 Oct 2006 → May 2007 chickenpox, measles, mumps infectious disease, rubella Merck Sharp & Dohme LLC Completed Met primary
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 NCT00985166 Aug 2000 → May 2002 measles, mumps infectious disease, rubella, varicella zoster infection Merck Sharp & Dohme LLC Completed Met primary
Comparator or background therapy5 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 3 NCT01621802 Background Jun 2012 → Jul 2015 viral infectious disease GlaxoSmithKline Completed No outcome recorded
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

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2023-03-06 Merck Sharp & Dohme LLC Regulatory US FDA Approves Intramuscular Administration for Merck’s MMRV Family of Vaccines: M-M-RII (Measles, Mumps, and Rubella Virus Vaccine Live), VARIVAX (Varicella Virus Vaccine Live), and ProQuad (Measles, Mumps, Rubella and Varicella Virus Vaccine Live) merck.com ↗
With these approvals, healthcare professionals now have the option to choose to administer all routinely recommended injectable pediatric vaccinations included in the CDC immunization schedule, via the same IM route.

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 18 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 ↗
16

“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 ↗

“ProQuad™” NCT00109343 ↗

NCT00560755 ↗

NCT00109343 ↗

NCT00402831 ↗

NCT02687763 ↗

NCT00985166 ↗

NCT00566527 ↗

NCT00839917 ↗

NCT00258726 ↗

Show 6 more sources

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
1

“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 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 “Comparator: ProQuad™ (V221)” NCT00109343 ↗
Modality Vaccine “combination measles, mump, rubella, and varicella vaccine (MMRV)” PMID 22123890 ↗ Nov 2011
Route Subcutaneous “0.5-mL subcutaneous injection” NCT00109343 ↗