NCT01144637 is a Phase 3 clinical trial of IMVAMUNE® in Smallpox, sponsored by Bavarian Nordic.

Who is sponsoring NCT01144637?

NCT01144637 is sponsored by Bavarian Nordic.

What drugs are being tested in NCT01144637?

Interventions in NCT01144637: IMVAMUNE®, Placebo.

Is NCT01144637 still recruiting?

NCT01144637 is currently completed. Last updated 7 December 2018.

Are results published for NCT01144637?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-12-07 · How we verify

NCT01144637

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Randomized, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Healthy, Vaccinia-Naïve Subjects

Completed Phase 3 Results posted Last updated 7 December 2018

What this trial tests

Phase 3 trial testing IMVAMUNE® in Smallpox in 4,005 participants. Completed in 1 June 2014.

Timeline

1 February 2013

Primary endpoint
1 November 2013

1 June 2014

Quick facts

Lead sponsor	Bavarian Nordic
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	4,005
Start date	1 February 2013
Primary completion	1 November 2013
Estimated completion	1 June 2014
Sites	34 locations across United States

Drugs / interventions tested

IMVAMUNE®
Placebo

Conditions studied

Smallpox — all drugs for Smallpox →

Sponsor

Bavarian Nordic — full company profile →

Who can join

Adults 18 to 40, any sex, with Smallpox. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

PRNT GMT
Time frame: 2 weeks following the second vaccination
Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'.

Sponsor's own description

A randomized, double-blind, placebo-controlled Phase III trial to evaluate immunogenicity and safety of three consecutive production lots of IMVAMUNE® (MVA-BN®) smallpox vaccine in healthy, vaccinia-naïve subjects.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Monkeypox: epidemiology, pathogenesis, treatment and prevention.
Huang Y, Mu L, Wang W. · · 2022 · cited 166× · PMID 36319633 · DOI 10.1038/s41392-022-01215-4
Vaccinia viruses: vaccines against smallpox and vectors against infectious diseases and tumors.
Walsh SR, Dolin R. · · 2011 · cited 70× · PMID 21854314 · DOI 10.1586/erv.11.79
Immunogenicity and safety of three consecutive production lots of the non replicating smallpox vaccine MVA: A randomised, double blind, placebo controlled phase III trial.
Overton ET, Lawrence SJ, Wagner E, Nopora K, et al · · 2018 · cited 50× · PMID 29652929 · DOI 10.1371/journal.pone.0195897

Verify or expand the search:

Other trials of IMVAMUNE®

Trials testing the same drug.

NCT02038881 — Randomized, Open-label Phase II Trial to Assess the Safety and Immunogenicity of MVA-BN Smallpox Vaccine in Immunocompro · Phase 2 · completed
NCT03472014 — Special Access Program IMVAMUNE® · Phase 4 · completed

Other recruiting trials for Smallpox

Currently open trials in the same condition.

NCT07377175 — Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BSY001 After Single/Multiple Doses. · Phase 1 · recruiting
NCT04957485 — Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS · Phase 2 · active not recruiting

Other Bavarian Nordic trials

Trials by the same sponsor.

NCT07199569 — Comparability Trial of the MVA-BN Vaccine Manufactured in Different Production Cells · Phase 2 · active not recruiting
NCT06549530 — Open-label, Multicenter Immunogenicity and Safety Study of MVA-BN Vaccine in Children From 2 Years to Less Than 12 Years · Phase 2 · active not recruiting
NCT05329220 — ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2 · Phase 3 · completed
NCT05349617 — Safety and Immunogenicity of CHIKV VLP Vaccine PXVX0317 in Adults ≥65 Years · Phase 3 · completed
NCT05238025 — MVA-BN-RSV Vaccine Trial · Phase 3 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01144637 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bavarian Nordic
Last refreshed: 7 December 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01144637.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing