This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the safety, tolerability, and immunogenicity of 3 lots of RSVpreF in healthy adults.
This randomized, double-blinded, placebo-controlled Phase 3 study will examine the immune response and the safety and tolerability profiles across 3 manufactured lots of RSVpreF when administered as a single 120 µg dose to healthy adults to demonstrate lot equivalence in manufacturing of RSVpreF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,028
RSV vaccine (RSVpreF)
RSV vaccine (RSVpreF)
RSV vaccine (RSVpreF)
Global Health Research Center, Inc.
Miami Lakes, Florida, United States
Precision Clinical Research
Sunrise, Florida, United States
Geometric Mean Ratios (GMRs) of Respiratory Syncytial Virus Subgroup A (RSV A) and B (RSV B) Neutralizing Antibodies at 1 Month After Vaccination for Every Pair of RSVpreF Lots
Geometric mean titer (GMT) of RSV A and RSV B neutralizing antibodies were calculated by exponentiating the mean logarithm of the titers and the corresponding 95% confidence interval (CI) was based on the Student t distribution. GMTs were reported in the descriptive section. Geometric mean ratios (GMRs) for each RSV vaccine lot comparison (Group 1/Group 2, Group 1/Group 3, and Group 2/Group 3) for RSV A and RSV B neutralizing antibody titers was calculated and reported in statistical analysis.
Time frame: 1 month (27 to 42 days window) after vaccination on Day 1
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (\>) 2.0 to 5.0 cm, moderate: \>5.0 to 10.0 cm and severe: \>10.0 cm. Pain at injection site was graded as mild: did not interfere with activity, moderate: interfered with activity and severe: prevented daily activity. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Time frame: Within 7 days after vaccination on Day 1
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Systemic events included fever, fatigue, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and were recorded by participants in an e-diary. Fever was defined as temperature greater than or equal to (\>=)38.0 degrees Celsius (C) and categorized as mild (\>=38.0 to 38.4 degrees C), moderate (\>38.4 to 38.9 degrees C) and severe (\>38.9 to 40.0 degrees C). Fatigue, headache, nausea, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours (h), moderate: \>2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
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Placebo
Clinical Site Partners, Inc
Winter Park, Florida, United States
Clinical Site Partners
Winter Park, Florida, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, United States
Sundance Clinical Research
St Louis, Missouri, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, United States
...and 8 more locations
Time frame: Within 7 days after vaccination on Day 1
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. AEs included both serious and all non-serious adverse events excluding local reactions and systemic events. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; required inpatient hospitalization or prolongation of existing hospitalization; life-threatening ; persistent or significant disability/incapacity; congenital anomaly/birth defect and suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI was based on the Clopper and Pearson method.
Time frame: Day of consent (Day 1) through study completion (approximately 1 Month)