A Phase 2 interventional study of Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006) and Placebo in Respiratory Syncytial Virus (RSV) Infection, sponsored by Shenzhen Shenxin Biotechnology Co., Ltd. Active, not recruiting at 1 site in China. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-09.
Sponsored by Shenzhen Shenxin Biotechnology Co., Ltd · Phase 2, Interventional, and Prevention
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 500 is above the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →Shenzhen Shenxin Biotechnology Co., Ltd is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Vital signs meeting any of the following:
Participants with the following diseases (based on inquiry and/or relevant diagnosis):
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.
Biological: Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006)
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.
Biological: Respiratory Syncytial Virus IN006 Bivalent mRNA Vaccine (IN006)
Placebo On injection of placebo on Day 0.
Biological: Placebo
Formulation for injection
0.9% sodium chloride (normal saline) injection
Percentage of Participants With Solicited Local and Systemic Adverse Reactions Through 14 Days After Initial Vaccination
Time frame: From initial vaccination up to14 days post initial vaccination
Percentage of Participants With Unsolicited Adverse Events (AEs) Through 28 Days After Initial Vaccination
Time frame: From initial vaccination up to 28 days post initial vaccination
Percentage of Participants With Unsolicited AEs Through 30 Minutes After Initial Vaccination
Time frame: 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
Time frame: Through study completion, about 3 years at most
Percentage of Abnormal Results of Hematology On Day 3 After Initial Vaccination Compared with Baseline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through study completion, about 3 years at most
Geometric mean concentration (GMC) for Pre-F Specific IgG Antibody Against RSV A and RSV B
Time frame: 1 month post-initial vaccination
Geometric Mean Fold Rise (GMFR) for Pre-F Specific IgG Antibody Against RSV A and RSV B
Time frame: 1 month post-initial vaccination
Seroconversion Rate (SCR) for Pre-F Specific IgG Antibody Against RSV A and RSV B
Time frame: 1 month post-initial vaccination
Geometric mean titer (GMT) for Neutralizing Antibody Against RSV A and RSV B
Time frame: 1 month post-initial vaccination
GMFR for Neutralizing Antibody Against RSV A and RSV B
Time frame: 1 month post-initial vaccination
SCR for Neutralizing Antibody Against RSV A and RSV B
Time frame: 1 month post-initial vaccination
GMC for Pre-F Specific IgG Antibody Against RSV A and RSV B
Time frame: 3, 6 and 12 months post-initial vaccination
GMFR for Pre-F Specific IgG Antibody Against RSV A and RSV B
Time frame: 3, 6 and 12 months post-initial vaccination
SCR for Pre-F Specific IgG Antibody Against RSV A and RSV B
Time frame: 3, 6 and 12 months post-initial vaccination
GMT for Neutralizing Antibody Against RSV A and RSV B
Time frame: 3, 6 and 12 months post-initial vaccination
GMFR for Neutralizing Antibody Against RSV A and RSV B
Time frame: 3, 6 and 12 months post-initial vaccination
SCR for Neutralizing Antibody Against RSV A and RSV B
Time frame: 3, 6 and 12 months post-initial vaccination
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shenzhen Shenxin Biotechnology Co., Ltd