Monovalent group C meningococcal vaccine
Trade name: Menomune-C
Vaccineapproved
Approved
Apr 2, 1974
Clinical trial activity
24 trials · 18 clinical orgs · 1 marketing orgs
Phase 1
1
Phase 2
16
Phase 3
14
Phase 4
6
Earliest trial started Sep 1, 2003 (NCT00352963)
Timeline
1970s
- Apr 2, 1974
Earliest FDA Approval
1990s
- Dec 9, 1999
Sanofi-Aventis — First NDA Organization
- Dec 9, 1999
Sanofi-Aventis — NDA Secondary Org
- Dec 9, 1999
Sanofi-Aventis — NDA Organization
2010s
- Jan 1, 2016
Earliest Phase 1 Sponsor(trial)
Indications
Approved for
Studied for
- Bacterial Infections · Phase 3
- BCG Vaccine · Phase 4
- Diphtheria · Phase 3
- Diphtheria-Tetanus-acellular Pertussis Vaccines · Phase 2
- Diphtheria-Tetanus-Pertussis Vaccine · Phase 4
- Haemophilus influenzae · Phase 4
- Haemophilus influenzae type b · Phase 3
- Healthy Volunteers · Phase 3
- Hepatitis B · Phase 4
- Immunity · Phase 4
- Meningitis · Phase 3
- Meningitis, Meningococcal · Phase 3
- Meningococcal Infections · Phase 4
- Meningococcal Vaccines · Phase 3
- Neisseria meningitidis · Phase 3
- Pertussis Vaccine · Phase 3
- Pneumococcal Infections · Phase 4
- Pneumonia, Staphylococcal · Phase 3
- Poliomyelitis · Phase 3
- Rotavirus Infections · Phase 3
- Tetanus · Phase 3
- Vaccines · Phase 4
- Virus Diseases · Phase 3
Mechanism of action
- Neisseria meningitidisImmunity, active
Neisseria meningitidis immunity, active
Approval history
- approvedApr 2, 1974
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Also known as
- conjugated polysaccharide menc vaccine
- menc
- menc
- mencc-bio
- mencc-bio vaccine
- menc-crm197
- menc-crm conjugate vaccine
- menc vaccine
- meningococcal polysaccharide vaccine, group c
- neisvac
- neisvac-c
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT03890367 | Phase 3 | Jul 19, 2019 | Sanofi-Aventis |
| NCT02858570 | Phase 2/Phase 3 (Phase 3) | Nov 1, 2016 | Oswaldo Cruz Foundation |
| NCT02639351 | Phase 1 | Mar 1, 2016 | GlaxoSmithKline |
| NCT02002156 | Phase 4 | Jun 1, 2014 | University of Oxford |
| NCT01896596 | Phase 4 | Jul 1, 2013 | Department of Health, United Kingdom, Public Health England, University of London |
| NCT01839188 | Phase 3 | May 1, 2013 | Merck, Sanofi-Aventis |
| NCT01839175 | Phase 3 | Apr 1, 2013 | Sanofi-Aventis |
| NCT01553279 | Phase 3 | Mar 1, 2012 | Sanofi-Aventis |
| NCT01359449 | Phase 3 | May 1, 2011 | Sanofi, Sanofi-Aventis |
| NCT01218451 | Phase 3 | Sep 1, 2010 | Baxalta, Pfizer |
| NCT01171989 | Phase 2 | Aug 1, 2010 | GlaxoSmithKline |
| NCT01144663 | Phase 3 | Jul 1, 2010 | GlaxoSmithKline |
| NCT01129518 | Phase 4 | Jun 1, 2010 | GlaxoSmithKline, University of Oxford |
| NCT00936962 | Phase 4 | Jul 1, 2009 | Canadian Institutes of Health Research (CIHR), Dalhousie University, University of British Columbia, University of Calgary |
| NCT00891176 | Phase 3 | May 1, 2009 | GlaxoSmithKline |
| NCT00625677 | Phase 4 | Feb 1, 2008 | National Institutes of Health (NIH), Public Health England |
| NCT00463437 | Phase 3 | Apr 1, 2007 | GlaxoSmithKline |
| NCT00443846 | Phase 3 | Feb 1, 2007 | Merck, Sanofi-Aventis |
| NCT00392808 | Phase 4 | Jan 1, 2007 | Centro Superior de Investigación en Salud Publica |
| NCT00381615 | Phase 2 | Sep 1, 2006 | Novartis |
Showing 20 of 24 trials
Page 1 / 2
Organizations
Research & Development (18)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| GlaxoSmithKline | For profit | 9 | 8 | 4 | 2003 |
| Sanofi-Aventis | For profit | 6 | 4 | 1 | 2007 |
| Merck | For profit | 2 | 1 | 1 | 2007 |
| Novartis | For profit | 2 | 2 | 1 | 2005 |
| Public Health England | Government | 2 | 2 | 1 | 2008 |
| University of Oxford | Academic/Hospital | 2 | 2 | 1 | 2010 |
| Baxalta | For profit | 1 | 0 | 1 | 2010 |
| Canadian Institutes of Health Research (CIHR) | Academic/Hospital | 1 | 0 | 1 | 2009 |
| Centro Superior de Investigación en Salud Publica | Academic/Hospital | 1 | 1 | 1 | 2007 |
| Dalhousie University | Academic/Hospital | 1 | 0 | 1 | 2009 |
| Department of Health, United Kingdom | Government | 1 | 0 | 1 | 2013 |
| National Institutes of Health (NIH) | Government | 1 | 0 | 1 | 2008 |
| Oswaldo Cruz Foundation | Academic/Hospital | 1 | 1 | 1 | 2016 |
| Pfizer | For profit | 1 | 1 | 1 | 2010 |
| Sanofi | For profit | 1 | 1 | 1 | 2011 |
| University of British Columbia | Academic/Hospital | 1 | 1 | 1 | 2009 |
| University of Calgary | Academic/Hospital | 1 | 0 | 1 | 2009 |
| University of London | Academic/Hospital | 1 | 0 | 1 | 2013 |
18 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Sanofi-Aventis | For profit | NDA2 | Dec 9, 1999 |
| Sanofi-Aventis | For profit | NDA | Dec 9, 1999 |