Safety and Immunogenicity of Recombinant RSV Vaccine (CHO Cell) in Healthy Subjects Aged 18 Years and Above
Condition(s) studied
Investigational drug(s) / intervention(s)
Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(low dose): 0.25 mL per dose.
Recombinant Respiratory Syncytial Virus Vaccine (CHO Cells)(high dose): 0.5 mL per dose
Placebo (Saline solution): 0.5 mL per dose
Study summary
The purpose of this study is to assess the safety and immunogenicity of two dose levels of the single dose Recombinant RSV vaccine(CHO cells), when administered intramuscularly (IM) in healthy adults aged 18 years and older.
Eligibility
Primary outcome measure(s)
- Incidence, Intensity and Causality of adverse events(AE) — Within 30 days after vaccination
An AE includes any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a investigational product, whether or not related to the investigational product. - Incidence, Intensity and Causality of solicited AEs — Within 14 days after vaccination
Solicited AEs include solicited local and general symptoms; Assessed solicited local AEs at injection site are pain, erythema, swelling, induration and itching; Assessed solicited general symptoms include fever, fatigue, headache, myalgia, nausea, vomiting, diarrhea, arthralgia and hypersensitivity. - Incidence, Intensity and Causality of unsolicited AEs — Within 30 days after vaccination
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. - Incidence, Intensity and Causality of Severe adverse events(SAEs) — Within 30 days after vaccination
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in persistent or significant disability/incapacity or are congenital anomaly/birth defect. - Incidence, Intensity and Causality of Adverse events of special interest(AESI) — Within 30 days after vaccination
Adverse events of special interest include potential immune-mediated diseases and atrial fibrillation. - Incidence of abnormal and clinically significant laboratory test results - only for phase 1 — The 3rd day after vaccination
Laboratory test includes hematology, blood biochemistry, coagulation test, urine analysis and Electrocardiograph. - Geometric Mean Titer (GMT) of Neutralizing Antibody against RSV-serotype A — 30 days after vaccination
Measured by Virus Neutralization Test. - GMT of Neutralizing Antibody against RSV-serotype B — 30 days after vaccination
Measured by Virus Neutralization Test. - Geometric Mean Fold Rise (GMFR) of Neutralizing Antibody against RSV-serotype A — 30 days after vaccination
Compared with the baseline Titer(Day 0). - GMFR of Neutralizing Antibody against RSV-serotype B — 30 days after vaccination
Compared with the baseline Titer(Day 0). - Geometric Mean Concentration (GMC) of RSV-Prefusion F protein(RSV-PreF) specific Immunoglobulin G (IgG) Antibody against RSV-serotype A — 30 days after vaccination
Measured by ELISA. - GMC of RSV-PreF specific IgG Antibody against RSV-serotype B — 30 days after vaccination
Measured by ELISA. - GMFR of RSV-PreF specific IgG Antibody against RSV-serotype A — 30 days after vaccination
Compared with the baseline concentration(Day 0). - GMFR of RSV-PreF specific IgG Antibody against RSV-serotype B — 30 days after vaccination
Compared with the baseline concentration(Day 0).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Liangyuan District Center for Disease Prevention and Control | Shangqiu | Henan |
More MAXVAX Biotechnology Limited Liability Company trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06642558 on ClinicalTrials.gov ↗ ← All trials in China