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Virus Therapy

RSV LD Group for Respiratory Syncytial Virus

Phase 1 & 2
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at pre-vaccination (screening), day 31, day 61 and day 366
Awards & highlights

Study Summary

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of the respiratory syncytial virus (RSV) candidate vaccine when first administered via intramuscular (IM) injection according to a 0, 1-month schedule to RSV-seropositive infants aged 12 to 23 months.

Eligible Conditions
  • Respiratory Syncytial Virus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at pre-vaccination (screening), day 31, day 61 and day 366
This trial's timeline: 3 weeks for screening, Varies for treatment, and at pre-vaccination (screening), day 31, day 61 and day 366 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Subjects With Any Serious Adverse Events (SAEs) From Day 1 up to Day 61
Number of Subjects With Any Solicited General AEs
Number of Subjects With Any Solicited Local Adverse Events (AEs)
+10 more
Secondary outcome measures
Anti-RSV-A Neutralizing Antibody Titers
Anti-RSV-F Antibody Concentrations
Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools
+7 more

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: RSV MD GroupExperimental Treatment1 Intervention
RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.
Group II: RSV LD GroupExperimental Treatment1 Intervention
RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.
Group III: RSV HD GroupExperimental Treatment1 Intervention
RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.
Group IV: Placebo LD groupPlacebo Group1 Intervention
RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Group V: Placebo MD groupPlacebo Group1 Intervention
RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Group VI: Placebo HD groupPlacebo Group1 Intervention
RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RSV (GSK3389245A) low dose formulation vaccine
2017
Completed Phase 2
~110
RSV (GSK3389245A) middle dose formulation vaccine
2017
Completed Phase 2
~110
RSV (GSK3389245A) high dose formulation vaccine
2017
Completed Phase 2
~110

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,763 Previous Clinical Trials
8,104,660 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,596 Previous Clinical Trials
6,144,232 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in RSV-seropositive Infants
2017. "A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in RSV-seropositive Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02927873.
~13 spots leftby May 2025
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