Drugs / VLA15
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT04801420 | Mar 2021 → Mar 2022 | Lyme disease | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT03970733 | Jul 2019 → Apr 2020 | Lyme disease | Pfizer | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT07500506 | Apr → Dec 2026 expected | Lyme disease | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT07226882 | Nov 2025 → Jan 2028 expected | Lyme disease | Pfizer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05634811 | Dec 2022 → Jul 2025 | Lyme disease | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT05477524 | Aug 2022 → Jan 2026 | Lyme disease | Pfizer | Completed | Mixed |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT03010228 Comparator | Jan → Sep 2017 | Lyme disease | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT03769194 Comparator | Dec 2018 → Dec 2019 | Lyme disease | Pfizer | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 26
| Date | Issuer | Release |
|---|---|---|
| 2026-08-14 | Pfizer | Regulatory Pfizer and Valneva’s Lyme Disease Vaccine Candidate Marketing Authorization Application Validated by European Medicines Agency pfizer.com ↗
Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for PF-07307405, the companies’ 6-valent outer surface protein A (OspA)-based Lyme disease vaccine candidate and will begin its assessment of the application. |
| 2026-08-14 | Valneva Austria GmbH | Regulatory Pfizer and Valneva’s Lyme Disease Vaccine Candidate Marketing Authorization Application Validated by European Medicines Agency valneva.com ↗
The application is based on encouraging efficacy of more than 70% observed in the Phase 3 VALOR “Vaccine Against Lyme for Outdoor Recreationists” clinical trial (NCT05477524), which investigated whether the vaccine candidate, PF-07307405, prevented Lyme disease cases in individuals aged five years and older. |
| 2026-03-23 | Pfizer | Results Pfizer and Valneva Announce Lyme Disease Vaccine Candidate Demonstrates Strong Efficacy in Phase 3 VALOR Trial pfizer.com ↗
Vaccine candidate PF-07307405 (LB6V) demonstrated more than 70% efficacy in preventing Lyme disease in individuals aged five years and above |
| 2026-03-23 | Valneva Austria GmbH | Results Pfizer and Valneva Announce Lyme Disease Vaccine Candidate Demonstrates Strong Efficacy in Phase 3 VALOR Trial valneva.com ↗
Efficacy of 73.2% from 28 days post-dose 4 (season 2) in reducing the rate of confirmed Lyme disease cases compared to the placebo arm (95% CI 15.8, 93.5) |
| 2025-11-26 | Valneva Austria GmbH | Results Valneva Announces Positive Final Phase 2 Results for Lyme Disease Vaccine Candidate valneva.com ↗ |
| 2025-09-03 | Valneva Austria GmbH | Results Valneva Reports Further Positive Phase 2 Safety and Immunogenicity Results for Lyme Disease Vaccine Candidate valneva.com ↗
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) announced positive immunogenicity and safety data from the ongoing Phase 2 study of Lyme disease vaccine candidate, VLA15. |
| 2024-09-03 | Valneva Austria GmbH | Results Valneva and Pfizer Report Further Positive Phase 2 Booster Results for Lyme Disease Vaccine Candidate valneva.com ↗ |
| 2024-06-03 | Valneva Austria GmbH | Results Valneva Announces Publication of Lyme Disease Phase 2 Trials in the Lancet Infectious Diseases valneva.com ↗ |
| 2023-09-07 | Valneva Austria GmbH | Results Valneva and Pfizer Report Positive Pediatric and Adolescent Phase 2 Booster Results for Lyme Disease Vaccine Candidate valneva.com ↗ |
| 2022-12-01 | Pfizer | Results Valneva and Pfizer Report Six-Month Antibody Persistence Data in Children and Adults for Lyme Disease Vaccine Candidate pfizer.com ↗
Pfizer Inc . (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today reported antibody persistence data six months after the completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination schedule with their Lyme disease vaccine candidate, VLA15, in both children and adults. |
| 2022-12-01 | Valneva Austria GmbH | Results Valneva and Pfizer Report Six-Month Antibody Persistence Data in Children and Adults for Lyme Disease Vaccine Candidate valneva.com ↗
Pfizer Inc. (NYSE: PFE) und Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) haben heute Daten zur Persistenz von Antikörpern sechs Monate nach Abschluss eines Impfschemas mit drei Dosen (Monat 0-2-6) oder mit zwei Dosen (Monat 0-6) mit dem Borreliose-Impfstoffkandidaten VLA15 bei Kindern und Erwachsenen veröffentlicht. |
| 2022-04-26 | Pfizer | Results Valneva and Pfizer Report Positive Phase 2 Pediatric Data for Lyme Disease Vaccine Candidate pfizer.com ↗ |
| 2022-04-26 | Valneva Austria GmbH | Results Valneva and Pfizer Report Positive Phase 2 Pediatric Data for Lyme Disease Vaccine Candidate valneva.com ↗ |
| 2022-02-04 | Pfizer | Results Valneva and Pfizer Report Further Positive Phase 2 Data for Lyme Disease Vaccine Candidate pfizer.com ↗ |
| 2022-02-04 | Valneva Austria GmbH | Results Valneva and Pfizer Report Further Positive Phase 2 Data for Lyme Disease Vaccine Candidate valneva.com ↗ |
| 2021-09-28 | Pfizer | Results Valneva and Pfizer Report Further Positive Phase 2 Results, Including Booster Response, for Lyme Disease Vaccine Candidate pfizer.com ↗
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. (NYSE: PFE), today announced further positive Phase 2 results, including booster response, for Lyme disease vaccine candidate VLA15. |
| 2021-09-28 | Valneva Austria GmbH | Results Valneva and Pfizer Report Further Positive Phase 2 Results, Including Booster Response, for Lyme Disease Vaccine Candidate valneva.com ↗ |
| 2020-10-20 | Valneva Austria GmbH | Results Valneva Announces Positive Initial Results for Second Phase 2 Study of Lyme Disease Vaccine Candidate VLA15 valneva.com ↗ |
| 2020-07-22 | Valneva Austria GmbH | Results Valneva Announces Positive Initial Results for Phase 2 Study of Lyme Disease Vaccine Candidate valneva.com ↗
Valneva SE (“Valneva”), a specialty vaccine company focused on prevention of diseases with major unmet needs , today announced positive initial results for its first Phase 2 study (VLA15-201) of Lyme disease vaccine candidate VLA15. |
| 2020-06-08 | Valneva Austria GmbH | Regulatory Valneva announces HSR clearance for Lyme vaccine collaboration with Pfizer valneva.com ↗ |
| 2020-04-20 | Pfizer | Regulatory Valneva Receives FDA Fast Track Designation for its Lyme Disease Vaccine Candidate VLA15 pfizer.com ↗
the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its Lyme disease vaccine candidate VLA15. |
| 2019-06-12 | Valneva Austria GmbH | Results Valneva Reports Successful Outcome of Phase 2 Run-In for its Lyme Disease Vaccine Candidate valneva.com ↗
The DSMB has reviewed safety data from those subjects and has cleared the 135µg and 180µg dosage levels for further investigation in the main study phase. |
| 2019-01-31 | Valneva Austria GmbH | Results Valneva Reports Positive Initial Booster Data and Final Phase 1 Data for its Lyme Disease Vaccine Candidate valneva.com ↗
Valneva Reports Positive Initial Booster Data and Final Phase 1 Data for its Lyme Disease Vaccine Candidate |
| 2018-03-19 | Valneva Austria GmbH | Results Valneva Reports Positive Phase I Interim Results for Its Lyme Vaccine Candidate VLA15 valneva.com ↗
Valneva SE (“Valneva” or “the Company”), a fully integrated, commercial stage biotech company focused on developing innovative lifesaving vaccines, today announced positive Phase I interim results for its Lyme vaccine candidate, VLA15. |
| 2017-07-24 | Valneva Austria GmbH | Regulatory Valneva Receives FDA Fast Track Designation for its Lyme Disease Vaccine Candidate VLA15 valneva.com ↗
the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its Lyme disease vaccine candidate VLA15. |
| 2016-12-09 | Valneva Austria GmbH | Regulatory Valneva Receives FDA and European Approvals to Start Clinical Testing of Lyme Disease Vaccine Candidate valneva.com ↗
Valneva SE (“Valneva” or “the Company”), a fully integrated, commercial stage biotech company focuse d on developing innovative life -saving vaccines, today announced that its vaccine candidate VLA15 against Lyme disease is now progressing into clinical testing (Phase I ) following the Investigational New Drug application (IND) clearance from the Food & Drug Administration (FDA) and the approval of the Clinical Trial Application (CTA) in Europe (Belgium). |
All press releases naming this drug 37 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | VLA15 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03010228 ↗ |
| Modality | Vaccine | “We investigated a novel Lyme borreliosis vaccine candidate (VLA15) targeting the six most common outer surface protein A (OspA) serotypes 1-6 to prevent infection with...” PMID 37419129 ↗ Jul 2023 |
| Route | Intramuscular | “vaccinations will be given I.M.(intramuscular) into the deltoid region on Days 0, 28 and 56.” NCT03010228 ↗ |