NCT07694557 YKYY025 Maternal RSV Immunization Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Move from a broad disease map to a decision-ready trial dossier. This focused report examines NCT07694557—A Phase 1 Study to Evaluate the Safety, Reactogenicity and Immunogenicity of YKYY025 Injection—using PatSnap Clinical Trials, Drug & Asset, and Company & Deal Intelligence MCP evidence. Explore PatSnap MCP Servers to reproduce the workflow inside an AI research process.
MCP evidence snapshot: 16 July 2026; publication date: 17 July 2026. Trial records can change after the snapshot and should be rechecked before operational decisions.
Why NCT07694557 is a hot trial to watch
Maternal RSV Immunization is no longer one homogeneous development market. The most consequential programs increasingly compete through a specific mechanism, biomarker, treatment line, delivery strategy or endpoint architecture. NCT07694557 is notable because it tests YKYY025 in a Phase 1 design with Adverse events(AEs） as a primary decision variable. The wider PatSnap topic query returned 213 trial records and 229 result records, so differentiation depends on evidence quality rather than activity alone.
PatSnap Clinical Trials MCP makes the protocol fields machine-readable, while the companion asset and organization servers add mechanism and sponsor context.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07694557 |
| Official title | A Phase 1 Study to Evaluate the Safety, Reactogenicity and Immunogenicity of YKYY025 Injection |
| Phase / status | Phase 1 / Not yet recruiting |
| Intervention | YKYY025 |
| Sponsor | Not reported |
| Geography | China |
| Enrollment | 180 |
| Primary endpoint | Adverse events(AEs） |
| Endpoint time frame | within 30 days after vaccination |
| Primary completion | 2028-07-01 |
| Study completion | 2028-10-01 |
Design and endpoint interpretation
The design should be read as an evidence architecture, not just a phase label. The primary endpoint—Adverse events(AEs）—determines what uncertainty this study can resolve. The reported time frame is within 30 days after vaccination. Enrollment of 180 participants and geography in China shape statistical precision, operational risk and external validity. A strong readout will need to be interpreted against baseline risk, prior treatment, assessment schedule, missing-data handling and the clinical relevance of the observed effect.
Benchmark readouts in the same clinical field
- Randomized, placebo-controlled phase 3 trial evaluating safety, immunogenicity, and reactogenicity of RSVPreF3-Mat in high-risk pregnant women and their infants (Phase 3): -; Anti-RSVPreF3-Mat immunoglobulin G (IgG)(14.12-fold increase over pre-vaccination) = 14.12 fold .
- Coadministration of mRNA-1345 RSV vaccine with high-dose quadrivalent influenza vaccine in adults aged 65 and older: An observer-blinded, placebo-controlled, randomized, phase 3 trial. (Phase 3): death = no deaths .
- A PHASE 3, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN PREGNANT PARTICIPANTS LIVING WITH HIV AND THEIR INFANTS (Phase 3): Redness: Any = 1.8 Percentage of participants (95% Confidence Interval, 0.4 - 5.2); -; -; -; -.
These result records are contextual benchmarks rather than direct head-to-head evidence. Cross-trial comparisons can be distorted by population, line of therapy, endpoint definition, follow-up and analysis set. Their value is to clarify what magnitude and type of evidence the market already recognizes.
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Asset and sponsor context
Drug & Asset context: YKYY025 (Phase 1; RSV F protein).
Company & Deal Intelligence context: Sponsor not reported; no additional normalized organization profile was available..
The sponsor profile matters because a trial's strategic value depends on more than scientific rationale. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes that connect biological activity with function, symptoms, survival or treatment burden.
- Sequencing evidence: randomized data after the most relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world care settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety monitoring or durability.
What to monitor next
Monitor recruitment status, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. The most important inflection point is not always the headline data release; a change in endpoint, population or ownership can alter probability of success months earlier.
Bottom line
NCT07694557 is a focused lens on Maternal RSV Immunization development. Its value will be determined by whether YKYY025 can convert the current design into evidence that is clinically meaningful, operationally credible and differentiated from topic-level benchmark readouts.
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