Haemophilus influenzae Type b Conjugate and Hepatitis B (Recombinant)

Trade name: Comvax

Vaccineapproved

Approved

Oct 2, 1996

Haemophilus B and hepatitis B vaccine is a combination vaccine whose generic name is Haemophilus b conjugate and hepatitis B recombinant vaccine. It protects against the infectious diseases Haemophilus influenzae type B and hepatitis B. — Wikipedia

Clinical trial activity

3 trials · 3 clinical orgs · 1 marketing orgs

Phase 1
0
Phase 2
3
Phase 3
3
Phase 4
0

Earliest trial started Jun 1, 2000 (NCT00984295)

Timeline

1990s

  1. Oct 2, 1996

    Merck — Earliest FDA Approval

  2. Oct 2, 1996

    Merck — NDA Secondary Org

  3. Oct 2, 1996

    Merck — NDA Organization

2000s

  1. Jan 1, 2000

    Merck — Earliest Phase 3 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedOct 2, 1996

Chemistry & pharmacology

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • comvax
  • hepb-hib
  • hib/hep b vaccine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT02584816Phase 3Nov 1, 2015PATH, Serum Institute of India Pvt. Ltd.
NCT00441012Phase 3Dec 1, 2006Merck
NCT00984295Phase 3Jun 1, 2000Merck
Showing 3 of 3 trials
Page 1 / 1

Organizations

Research & Development (3)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MerckFor profit2212000
PATHAcademic/Hospital1012015
Serum Institute of India Pvt. Ltd.For profit1112015
3 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
MerckFor profitNDA2Oct 2, 1996
MerckFor profitNDAOct 2, 1996