A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine IN006 … (NCT06645665) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to Describe the Safety and Immunogenicity of a Respiratory Syncytial Virus Vaccine IN006 in Healthy Adult Aged 18 Years and Above
China240 participantsStarted 2024-11-11
Plain-language summary
The study will evaluate the safety, tolerability, and immunogenicity of 3 dose levels of IN006 in healthy adults aged 18 Years and Above; of a revaccination of IN006 given approximately 12 months after the initial vaccination in older adults (aged ≥60 years).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Healthy people aged 18-59 (Part 1) or ≥60 (Part 2), male or female.
✓. Body mass index (BMI) in the range of 18 to 29 kg/m\^2.
✓. Laboratory tests, 12-lead electrocardiogram, chest radiograph, vital signs and physical examination results are normal during the screening period, or abnormal results assessed by the investigator had no clinical significance; Subjects ≥60 years old with stable medical conditions, whose risk was considered controllable by the investigator, could also be enrolled.
✓. Women of childbearing age took effective contraception within 2 weeks before joining the study, and the pregnancy test results before vaccination are negative. All male and female subjects of reproductive age voluntarily agree to use effective contraception from the signing of informed consent until 6 months after vaccination.
Exclusion criteria
✕. The results of vital signs show: for subjects with no history of hypertension or hypotension, systolic blood pressure ≥140mmHg or \< 90mmHg, and/or diastolic blood pressure ≥90mmHg or \< 50mmHg; for subject with a history of hypertension not appropriately controlled via pharmaceutical treatment, systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg in those aged 40-59, and systolic blood pressure ≥150mmHg or diastolic blood pressure ≥90mmHg in those aged 60 and above. Pulse rate \> 100 beats/min or \< 50 beats/min; Ear temperature/oral temperature \> 37.5°C (or axillary temperature \> 37.0°C).
✕. Laboratory tests, 12-lead electrocardiogram, chest radiography (orthographic) and physical examination results: For subjects aged 18-59 years old, abnormal results judged to be clinically significant by the investigator, or for subjects ≥60 years old, abnormal results judged to be \> Grade 1 criteria by the investigator; For laboratory tests, a retest may be conducted at the discretion of investigators to determine subjects eligibility.
What they're measuring
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 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 2 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 day 3 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 day 3 post initial vaccination
7
Percentage of Abnormal Results of Coagulation On Day 3 After Initial Vaccination Compared with Baseline
✕. Those with tattoos, scars and ecchymosis at the injection site.
✕. Known allergy to the experimental vaccine or its excipient, or history of severe allergy to other vaccines, foods, drugs, etc.
✕. The subject has received any previous investigational or marketed RSV vaccine, or has received investigational or marketed RSV prophylactic monoclonal antibody within the last 6 months.
✕. Received inactivated, subunit, or recombinant influenza vaccine within 14 days prior to enrollment, or received any live vaccine, nucleic acid vaccine, or adenovirus vector vaccine within 28 days prior to enrollment; Or plan to receive other vaccines within 28 days of vaccination.
✕. Used antipyretic, analgesic or anti-allergic drugs within 3 days before enrollment.
✕. Have received blood or blood-related products (including immunoglobulins) within 3 months prior to enrollment, or had planned to use them during the study period.
Timeframe: From initial vaccination up to day 3 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 2 years at most