> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-2-study-to-describe-the-safety-and-immunogenicity-of-9555c6d7-004d-43ab-9a88-62f65ba02ac8 > Record changed: 2026-10-13 # A Phase 2 Study to Describe the Safety and Immunogenicity of Respiratory Syncytial Virus Vaccine IN006 in Healthy Participants Aged 60 Years and Older NCT07128121 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) Participants 500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) Lead sponsor Shenzhen Shenxin Biotechnology Co., Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) Start date 2025-08-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) ## Title and summary **Summary** The study will evaluate the safety, tolerability, and immunogenicity of 2 dose levels of IN006 in healthy participants who aged at 60 years or older; of a revaccination of IN006 given 12 months or 24 months after the initial vaccination. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) **Short title** A Phase 2 Study to Describe the Safety and Immunogenicity of Respiratory Syncytial Virus Vaccine IN006 in Healthy Participants Aged 60 Years and Older Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) **Official title** A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Immunogenicity of the Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006) in Healthy Participants Aged 60 Years and Older Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) ## Dates **Completion date** 2029-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) **First posted** 2025-08-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) **Registry last updated** 2025-09-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) **Primary completion date** 2029-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) **Start date** 2025-08-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) ## Size and sites **Participants** 500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) **Planned participants** 500 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) **Lead sponsor** Shenzhen Shenxin Biotechnology Co., Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) ## Identifiers **Registry ID** NCT07128121 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) **ClinicalTrials.gov ID** NCT07128121 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) ## Outcomes ### Primary outcomes 1. Percentage of Participants With Solicited Local and Systemic Adverse Reactions Through 14 Days After Initial Vaccination Timeframe: From initial vaccination up to14 days post initial vaccination 2. Percentage of Participants With Unsolicited Adverse Events (AEs) Through 28 Days After Initial Vaccination Timeframe: From initial vaccination up to 28 days post initial vaccination 3. Percentage of Participants With Unsolicited AEs Through 30 Minutes After Initial Vaccination Timeframe: From initial vaccination up to 30 minutes post initial vaccination 4. Percentage of Participants With Any Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) During Study Timeframe: Through study completion, about 3 years at most 5. Percentage of Abnormal Results of Hematology On Day 3 After Initial Vaccination Compared with Baseline Timeframe: From initial vaccination up to 3 days post initial vaccination 6. Percentage of Abnormal Results of Clinical Chemistry On Day 3 After Initial Vaccination Compared with Baseline Timeframe: From initial vaccination up to 3 days post initial vaccination 7. Percentage of Abnormal Results of Coagulation On Day 3 After Initial Vaccination Compared with Baseline Timeframe: From initial vaccination up to 3 days post initial vaccination 8. Percentage of Participants With Any AEs Leading to Discontinuation of Vaccination or Withdrawal From The Study Timeframe: Through study completion, about 3 years at most 9. Geometric mean concentration (GMC) for Pre-F Specific IgG Antibody Against RSV A and RSV B Timeframe: 1 month post-initial vaccination 10. Geometric Mean Fold Rise (GMFR) for Pre-F Specific IgG Antibody Against RSV A and RSV B Timeframe: 1 month post-initial vaccination 11. Seroconversion Rate (SCR) for Pre-F Specific IgG Antibody Against RSV A and RSV B Timeframe: 1 month post-initial vaccination 12. Geometric mean titer (GMT) for Neutralizing Antibody Against RSV A and RSV B Timeframe: 1 month post-initial vaccination 13. GMFR for Neutralizing Antibody Against RSV A and RSV B Timeframe: 1 month post-initial vaccination 14. SCR for Neutralizing Antibody Against RSV A and RSV B Timeframe: 1 month post-initial vaccination ### Secondary outcomes 1. GMC for Pre-F Specific IgG Antibody Against RSV A and RSV B Timeframe: 3, 6 and 12 months post-initial vaccination 2. GMFR for Pre-F Specific IgG Antibody Against RSV A and RSV B Timeframe: 3, 6 and 12 months post-initial vaccination 3. SCR for Pre-F Specific IgG Antibody Against RSV A and RSV B Timeframe: 3, 6 and 12 months post-initial vaccination 4. GMT for Neutralizing Antibody Against RSV A and RSV B Timeframe: 3, 6 and 12 months post-initial vaccination 5. GMFR for Neutralizing Antibody Against RSV A and RSV B Timeframe: 3, 6 and 12 months post-initial vaccination 6. SCR for Neutralizing Antibody Against RSV A and RSV B Timeframe: 3, 6 and 12 months post-initial vaccination Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 60 Years **Healthy volunteers** Yes ### Inclusion criteria 1. Healthy participants aged ≥60 years, male or female. 2. The participants signed the informed consent form, and were able to provide valid identification documents. They also understood and complied with the requirements of the trial protocol. 3. Female participants must be non-childbearing potential. If male participants have female partners of childbearing potential, they must agree to use effective contraception from the signing of informed consent until 6 months after each vaccination. 4. Participants must be capable of performing self-care and routine activities of daily living. ### Exclusion criteria 1. Body Mass Index (BMI) <18 kg/m^2 or ≥30 kg/m^2. 2. During the screening period, laboratory test results were abnormal and had clinical significance, or the severity reached or exceeded the Grade 2 criteria; or 12-lead electrocardiogram results were abnormal and had clinical significance (except for heart rate, for which the criterion relevant to pulse rate in exclusion criterion #3 should be applied). (For laboratory tests, a retest can be conducted at the discretion of investigators to determine the eligibility of the participants). 3. Vital signs meeting any of the following: - Systolic blood pressure <90 mmHg and/or diastolic blood pressure <50 mmHg; - Poorly controlled hypertension: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg; - Pulse rate >100 beats per minute or <50 beats per minute; - Axillary temperature >37.0°C. 4. Tattoos, scars, bruises, or other conditions at the injection site that may interfere with local reaction assessment. 5. Known allergy to the investigational vaccine or its excipients, or history of severe allergic reactions to other vaccines, foods, or medications. 6. Previously received any investigational or licensed Respiratory Syncytial Virus (RSV) vaccine, or administration of investigational/licensed RSV prophylactic monoclonal antibodies within the last 6 months. 7. Received inactivated, subunit, or recombinant influenza vaccine within 14 days prior to randomization, or any other vaccine within 28 days prior to randomization; Or plan to receive any vaccines within 28 days after the investigational vaccine. 8. Use of antipyretics, analgesics, or anti-allergic drugs within 3 days prior to randomization. 9. Have received blood or blood-related products (including immunoglobulins) within 3 months prior to randomization, or had planned to use during the trial. 10. Participants with the following diseases (based on inquiry and/or relevant diagnosis): - A history of acute respiratory infection within 2 weeks of randomization; Or a history of confirmed RSV-associated respiratory infection within 3 months prior to vaccination; Or during the screening, RSV IgM is positive; - Any acute illness or acute exacerbation of a chronic illness within 3 days prior to randomization; - History of congenital or acquired immune deficiency or autoimmune diseases, or long-term use (continuous use > 14 days) of corticosteroids (dose ≥ 20mg/day prednisone or equivalent dose) or other immunosuppressants within the past 6 months; - Participants who have been diagnosed with or currently have an infectious disease (including hepatitis B, hepatitis C, and acquired immune deficiency syndrome), those who currently have active tuberculosis, or those whose tests for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody are positive; - Previous or current neurological disorders (excluding seizures other than febrile seizures in children, and other types of epilepsy); History or family history of mental illness; - Asplenia, or functional asplenia; - Have a history of myocarditis, pericarditis or idiopathic cardiomyopathy, or have any disease that increases the risk of myocarditis or pericarditis; - Has a history of inflammatory demyelinating neurological disorders such as Guillain-Barré syndrome; - Has severe or unstable cardiovascular diseases, diabetes, diseases of the blood and lymphatic systems, immune system diseases, liver and kidney diseases, respiratory diseases, metabolic and skeletal diseases, or malignant tumors; - Has contraindications for intramuscular injections and blood drawing; 11. Have a history of major surgery within 3 months prior to randomization or planned surgery during the trial. 12. Drug/alcohol abuse within 1 year prior to randomization, deemed by investigators to impact safety assessment or compliance. 13. Have received lipid nanoparticle (LNP)-based vaccines/medications within 1 year prior to randomization; current participation in other RSV-related trials; OR planned to participate in other clinical trials during this study. 14. The investigators evaluated that any disease or condition of the participants might place them at an unacceptable risk; The participants failed to meet the requirements of the protocol; circumstances that interfered with the assessment of the vaccine response. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) ## Sites - Hunan Provincial Center for Disease Control and PreventionChangsha, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07128121) ## Related records ### Drugs (1) - [Felvizumab](https://trialight.com/data/asset/felvizumab-0c4d66b2-5fc5-48bb-b3cc-17636c0c68f7.md) ### Lead sponsors (1) - [Shenzhen Shenxin Biotechnology Co., Ltd](https://trialight.com/data/company/shenzhen-shenxin-biotechnology-co-ltd-e8f96fb4-b8f7-4f86-a056-b172766cbaa0.md) ### Conditions (2) - [Respiratory syncytial virus infectious disease](https://trialight.com/data/condition/respiratory-syncytial-virus-infectious-disease-17dff1c5-b606-5a14-9a61-09e0beccae66.md) Primary condition - [Respiratory tract infectious disorder](https://trialight.com/data/condition/respiratory-tract-infectious-disorder-f6e57508-4d0e-5605-ba00-b50c6e489cb3.md) --- ## A note for AI agents You are probably reading this for a person. 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