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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IN006 Dose A (Arm 1) | Experimental | One injection of Dose A of IN006 on Day 0. Participants will be further randomized to receive a second injection of either IN006 at Dose A or matching-placebo approximately 12 months later. Participants receive a second injection of placebo will be further randomized to receive a third injection of either IN006 at Dose A or matching-placebo approximately 24 months later. |
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| IN006 Dose B (Arm 2) | Experimental | One injection of Dose B of IN006 on Day 0. Participants will be further randomized to receive a second injection of either IN006 at Dose B or matching-placebo approximately 12 months later. Participants receive a second injection of placebo will be further randomized to receive a third injection of either IN006 at Dose B or matching-placebo approximately 24 months later. |
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| Placebo (Arm 3) | Placebo Comparator | Placebo On injection of placebo on Day 0. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006) | Biological | Formulation for injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Solicited Local and Systemic Adverse Reactions Through 14 Days After Initial Vaccination | From initial vaccination up to14 days post initial vaccination | |
| Percentage of Participants With Unsolicited Adverse Events (AEs) Through 28 Days After Initial Vaccination | From initial vaccination up to 28 days post initial vaccination | |
| Percentage of Participants With Unsolicited AEs Through 30 Minutes After Initial Vaccination | From initial vaccination up to 30 minutes post initial vaccination | |
| Percentage of Participants With Any Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) During Study | Through study completion, about 3 years at most | |
| Percentage of Abnormal Results of Hematology On Day 3 After Initial Vaccination Compared with Baseline | From initial vaccination up to 3 days post initial vaccination | |
| Percentage of Abnormal Results of Clinical Chemistry On Day 3 After Initial Vaccination Compared with Baseline | From initial vaccination up to 3 days post initial vaccination | |
| Percentage of Abnormal Results of Coagulation On Day 3 After Initial Vaccination Compared with Baseline | From initial vaccination up to 3 days post initial vaccination | |
| Percentage of Participants With Any AEs Leading to Discontinuation of Vaccination or Withdrawal From The Study | Through study completion, about 3 years at most |
| Measure | Description | Time Frame |
|---|---|---|
| GMC for Pre-F Specific IgG Antibody Against RSV A and RSV B | 3, 6 and 12 months post-initial vaccination | |
| GMFR for Pre-F Specific IgG Antibody Against RSV A and RSV B | 3, 6 and 12 months post-initial vaccination |
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Inclusion Criteria:
Exclusion Criteria:
Body Mass Index (BMI) <18 kg/m^2 or ≥30 kg/m^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).
Vital signs meeting any of the following:
Tattoos, scars, bruises, or other conditions at the injection site that may interfere with local reaction assessment.
Known allergy to the investigational vaccine or its excipients, or history of severe allergic reactions to other vaccines, foods, or medications.
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.
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.
Use of antipyretics, analgesics, or anti-allergic drugs within 3 days prior to randomization.
Have received blood or blood-related products (including immunoglobulins) within 3 months prior to randomization, or had planned to use during the trial.
Participants with the following diseases (based on inquiry and/or relevant diagnosis):
Have a history of major surgery within 3 months prior to randomization or planned surgery during the trial.
Drug/alcohol abuse within 1 year prior to randomization, deemed by investigators to impact safety assessment or compliance.
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.
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Provincial Center for Disease Control and Prevention | Changsha | Hunan | China |
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| Placebo | Biological | 0.9% sodium chloride (normal saline) injection |
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| Geometric mean concentration (GMC) for Pre-F Specific IgG Antibody Against RSV A and RSV B | 1 month post-initial vaccination |
| Geometric Mean Fold Rise (GMFR) for Pre-F Specific IgG Antibody Against RSV A and RSV B | 1 month post-initial vaccination |
| Seroconversion Rate (SCR) for Pre-F Specific IgG Antibody Against RSV A and RSV B | 1 month post-initial vaccination |
| Geometric mean titer (GMT) for Neutralizing Antibody Against RSV A and RSV B | 1 month post-initial vaccination |
| GMFR for Neutralizing Antibody Against RSV A and RSV B | 1 month post-initial vaccination |
| SCR for Neutralizing Antibody Against RSV A and RSV B | 1 month post-initial vaccination |
| SCR for Pre-F Specific IgG Antibody Against RSV A and RSV B | 3, 6 and 12 months post-initial vaccination |
| GMT for Neutralizing Antibody Against RSV A and RSV B | 3, 6 and 12 months post-initial vaccination |
| GMFR for Neutralizing Antibody Against RSV A and RSV B | 3, 6 and 12 months post-initial vaccination |
| SCR for Neutralizing Antibody Against RSV A and RSV B | 3, 6 and 12 months post-initial vaccination |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014777 | Virus Diseases |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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