The purpose of this phase 3 multicenter, double-blinded, placebo-controlled study in India is to learn about the safety and immunogenicity of RSVpreF in adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
540
King George Hospital
Visakhapatnam, Andhra Pradesh, India
RECRUITINGBGS Global Institute of Medical Sciences (BGSGIMS)
Bangalore, Karnataka, India
Proportion of participants reporting local reactions within 7 days following investigational product administration
Describe local reactions following investigational product administration
Time frame: Within 7 days
Percentage of participants reporting systemic events within 7 days following investigational product administration
Describe systemic events following investigational product administration
Time frame: Within 7 days
Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration
Describe AEs occurring through 1 month following administration of investigational product
Time frame: 1 month after vaccination
Percentage of participants reporting serious adverse events (SAEs) throughout the study
Describe SAEs through 3 months following administration of investigational product
Time frame: 3 months after vaccination
Neutralizing Titers (NTs) for RSV A and RSV B expressed as Geometric Mean Titers (GMT)
Time frame: Before vaccination, 1 month after vaccination
NTs for RSV A and RSV B expressed as Geometric Mean Fold Rise (GMFR)
Time frame: Before vaccination, 1 month after vaccination
NTs for RSV A and RSV B expressed as seroresponse rate
Time frame: 1 month after vaccination
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Radhakrishna Multispeciality Hospital and IVF Center
Bangalore, Karnataka, India
RECRUITINGBelagavi Institute of Medical Sciences - Belagavi
Belagavi, Karnataka, India
RECRUITINGSuyog Hospital
Nashik, Maharashtra, India
RECRUITINGBharati Vidyapeeth {Deemed to be University) Medical College Hospital & Research Centre
Pune, Maharashtra, India
RECRUITINGAakash Healthcare Private Limited
Dwarka, National Capital Territory of Delhi, India
RECRUITINGAll India Institute Of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
RECRUITINGSir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, India
RECRUITINGMaharaja Agrasen Superspeciality Hospital
Jaipur, Rajasthan, India
RECRUITING...and 3 more locations