RSVPreF3 OA investigational vaccine
Biological1 dose of RSVPreF3 OA investigational vaccine administered intramuscularly on Day 1 to participants in OA-RSV and Adults-AIR-RSV groups.
NCT Number: NCT06614725
The purpose of the study is to evaluate the immunogenicity and safety of a single dose of investigational RSVPreF3 OA vaccine in Indian older adults 60 years of age (YOA) and above and Indian adults 50-59 YOA at increased risk of RSV-LRTD.
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Notify Me50 year and older
All sexes
Interventional
Phase 3
GSK Investigational Site, Kanpur, Uttar Pradesh, India
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Specific inclusion criteria for all participants in Cohort 1 (Older adults)
Specific inclusion criteria for all participants in Cohort 2 (Adults-AIR)
Other diseases at increased risk for RSV-LRTD disease:
Exclusion criteria
Medical Conditions
Prior/Concomitant Therapy
Prior/Concurrent Clinical Study Experience
Other Exclusion Criteria for all participants
Other Exclusion Criteria for cohort 2 (Adults-AIR)
1 dose of RSVPreF3 OA investigational vaccine administered intramuscularly on Day 1 to participants in OA-RSV and Adults-AIR-RSV groups.
1 dose of placebo (saline solution) administered intramuscularly on Day 1 to participants in OA-Placebo and Adults-AIR-Placebo groups.
Time frame: At Day 1 (pre-study intervention administration)
RSV-A neutralizing titers are given as GMTs and are expressed as Estimated Dilution 60 (ED60).
Time frame: At Day 31 (1 month post-study intervention administration)
RSV-A neutralizing titers are given as GMTs and are expressed as ED60.
Time frame: At Day 1 (pre-study intervention administration)
RSV-B neutralizing titers are given as GMTs and are expressed as ED60.
Time frame: At Day 31 (1 month post-study intervention administration)
RSV-B neutralizing titers are given as GMTs and are expressed as ED60.
Time frame: From Day 1 (day of administration) to Day 4
Assessed solicited administration site adverse events (AEs) were redness (erythema), pain and swelling at administration site. Any = occurrence of the AE regardless of intensity grade or relationship to the study interventions.
Time frame: From Day 1 (day of administration) to Day 4
Assessed solicited systemic events were arthralgia (joint pain), fatigue (tiredness), fever (pyrexia), headache, and myalgia (muscle pain). Fever was defined as temperature ≥38.0 degrees Celsius (°C), regardless of the location of measurement. The route for measuring temperature could be oral or axillary. Any = occurrence of the symptom regardless of intensity grade or relationship to the study interventions.
Time frame: From Day 1 (day of administration) to Day 30
An unsolicited AE was an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs included both serious and non-serious AEs, and potential immune-mediated diseases (pIMDs). Any = occurrence of the event regardless of intensity grade or relation to the study intervention.
Time frame: From Day 1 (day of administration) to Month 6 (throughout the study period)
An SAE was any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, was considered or defined as an important medical event, or abnormal pregnancy outcomes. Any = occurrence of the event regardless of the intensity grade or relation to the study intervention.
Time frame: From Day 1 (day of administration) to Month 6 (throughout the study period)
pIMDs were a subset of adverse events of special interest (AESIs) that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune etiology. Any = occurrence of the event regardless of the intensity grade or relation to the study intervention.
GlaxoSmithKline
Industry
A Phase 3, Randomized, Placebo-controlled, Observer-blind Study in India to Evaluate Immune Response, Reactogenicity and Safety of a Single Intramuscular Dose of RSVPreF3 OA Investigational Vaccine When Administered to Older Adults >=60 Years of Age and Adults 50-59 Years of Age at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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