A Phase 2 Study to Describe the Safety and Immunogenicity of Respiratory Syncytial Virus Vaccine … (NCT07128121) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Phase 2 Study to Describe the Safety and Immunogenicity of Respiratory Syncytial Virus Vaccine IN006 in Healthy Participants Aged 60 Years and Older
China500 participantsStarted 2025-08-13
Plain-language 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.
Who can participate
Age range60 Years
SexALL
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Inclusion criteria
✓. Healthy participants aged ≥60 years, male or female.
✓. 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.
✓. 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.
✓. Participants must be capable of performing self-care and routine activities of daily living.
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.
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 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
. 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.
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