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Data updated: Nov 8, 2026

Rabavert (rabies vaccine) · Bavarian Nordic

Approved 1997-10-20
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
29
Years on Market

Details

Status
Prescription
First Approved
1997-10-20
Routes
Intramuscular
Dosage Forms
For Injection

Companies

Bavarian Nordic
Active Ingredient: Rabies Vaccine

Rabavert Approval History

1998
1999
2000
2001
2002
2003
2004
2005
2006
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2008
2009
2010
2011
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2026
Original
New Indication
New Form
Label Update
1 FDA actions from 1997 to 1997
Oct 1997 ORIGINAL
Update · CBER biologic (Purple Book)

What Rabavert Treats

1 FDA approvals

Originally approved for its first indication in 1997 .

  • Other (1)
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Clinical Trial Registry

29 trials
Trial Sponsor ID Phase Status Title
NCT07445815 CNBG-CT-0282 Ph 2 not yet recruiting A Phase II Trial of a Recombinant Human Anti-Rabies Virus Monoclonal Antibody
NCT03961555 ARPEP results posted SYN023-004 Ph 2 completed Comparison of SYN023 to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies
NCT07342257 SYN023-007 Ph 1 completed SYN023 With Rabies Vaccine in Healthy Pediatric Subjects
NCT07345208 PR-25035 Ph 2, Ph 3 not yet recruiting Safety and Immunogenicity of ID vs IM Rabies Vaccine
NCT06799234 RVF003 OxTREC 3/24 KEMRI/SERU/CGMRC/314/4960, PACTR202406789723926 Ph 2 active not recruiting Safety and Immunogenicity of a Candidate Rift Valley Fever Vaccine (RVF003)
NCT03896724 VAC076 Ph 1, Ph 2 completed Safety, Immunogenicity and Efficacy of R21 Matrix-M in 5-17 Month Old Children in Nanoro, Burkina Faso
NCT07055893 PRO-PVRV-sf-3002 Ph 3 not yet recruiting Immunogenicity and Safety of Rabies Vaccine (Serum-free Vero Cell) in a Simulated Post-exposure Prophylaxis Regimen
NCT05790889 VAC091 Ph 1, Ph 2 completed A Study to Test Experimental Blood Stage Malaria Vaccine in Burkina Faso.
NCT05846568 GR1801-003 Ph 3 completed Study to Evaluate GR1801's Efficacy and Safety
NCT06048770 RBI-4000-101 Ph 1 terminated A Study of RBI-4000 in Healthy Participants
NCT04019444 results posted 17-0089 Ph 1 completed Dosage-Escalation Study of the Safety and Immunogenicity of a Novel Rabies Vaccine ChAd155-RG vs. the Comparator RABAVERT Vaccine in Healthy Adult Subjects
NCT03276962 results posted 204889 2016-000290-20 Ph 2 completed Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age
NCT05549908 ZY201905001 Ph 3 completed Vaccine Prevention of Rabies Adopts 4-shot Immunization Method
NCT04062669 208608 Ph 1 completed A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Experimental Rabies Vaccine in Healthy Adults
NCT03557008 results posted IRB00101567 Ph 4 completed Responses to Rabies Vaccine in Adults With or Without Antibiotics
NCT04644484 results posted SYN023-006 Ph 3 completed A Phase III Clinical Study to Evaluate SYN023's Efficacy and Safety
NCT02374814 RABVAX results posted 568085 Ph 4 completed Immunogenicity of Rabies Vaccine for Pre Exposure Prophylaxis
NCT04495569 SYN023-005 Ph 1, Ph 2 completed A Bridging Study of the SYN023 on Healthy Adult Subjects
NCT02564471 MALRAB results posted 790117 Ph 4 completed Effect of Antimalarial Drugs to Rabies Vaccine for Post-exposure Prophylaxis.
NCT03264157 results posted RIG01 Ph 2, Ph 3 completed Safety and Effectiveness of BPL HRIG With Active Rabies Vaccine in Healthy Subjects
NCT03435874 VAC070 Ph 1 completed Safety and Immunogenicity of ChAd63 RH5 and MVA RH5 in Adults, Young Children and Infants Living in Tanzania
NCT02956746 RabiesMab results posted SYN023-002 Ph 1, Ph 2 completed A Comparison of the Safety, PD and PK of a Single Dose of SYN023 Administered With Licensed Rabies Vaccines
NCT02177032 results posted V49_30 2013-CT0191 Ph 3 completed Safety and Immunogenicity of Two Intradermal Rabies Vaccine Regimens Administered With and Without Human Rabies Immunoglobulin in Subjects ≥ 1 Years of Age
NCT01635647 VAC050 Ph 1, Ph 2 completed A Phase 1/2b Study of an Investigational Malaria Vaccination Strategy in 5-17 Month Old Infants and Children in Burkina Faso
NCT01827917 BJCDPC-6 Ph 4 completed The Protection Effect of Speeda® Rabies Vaccine for Human Use
NCT01466387 results posted V59_38 2011-000475-14 Ph 3 completed A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults
NCT01658696 VAC047 Ph 2 completed Efficacy of Candidate Malaria Vaccines in Senegalese Adults
NCT01666925 VAC046 Ph 2 completed Efficacy of Malaria Vaccines in Kenyan Adults
NCT07914673 202607188 U19AI181103 Ph 4 recruiting Age-Associated Differences in Germinal Center Responses to Influenza and Rabies Vaccination in Humans
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

Rabavert FDA Label Details

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Data Sources

FDA Approval: BLA103334 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.