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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSVpreF vaccine Group 1 | Experimental | RSVpreF |
|
| RSVpreF vaccine Group 2 | Experimental | RSVpreF |
|
| RSVpreF vaccine Group 3 | Experimental | RSVpreF |
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| Placebo dose | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSVpreF (Group 1) | Biological | RSV vaccine (RSVpreF) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Global Health Research Center, Inc. | Miami Lakes | Florida | 33016 | United States | ||
| Precision Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38616438 | Derived | Baker J, Aliabadi N, Munjal I, Jiang Q, Feng Y, Brock LG, Cooper D, Anderson AS, Swanson KA, Gruber WC, Gurtman A. Equivalent immunogenicity across three RSVpreF vaccine lots in healthy adults 18-49 years of age: Results of a randomized phase 3 study. Vaccine. 2024 May 10;42(13):3172-3179. doi: 10.1016/j.vaccine.2024.03.070. Epub 2024 Apr 16. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 1028 participants signed the informed consent form (ICF) and were enrolled. Out of which, 35 participants were not eligible for randomization and 993 participants were randomized into the study. Only 992 participants were vaccinated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants were randomized to receive a single intramuscular injection of placebo reconstituted with sterile water for injection, once only on Day 1. |
| FG001 | Group 1: RSVpreF Lot 1 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 8, 2022 | Mar 17, 2023 |
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This is a double-blinded, placebo controlled study
| RSVpreF (Group 2) |
| Biological |
RSV vaccine (RSVpreF) |
|
| RSVpreF (Group 3) | Biological | RSV vaccine (RSVpreF) |
|
| Placebo | Biological | Placebo |
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| 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. | Day of consent (Day 1) through study completion (approximately 1 Month) |
| Sunrise |
| Florida |
| 33351 |
| United States |
| Clinical Site Partners, Inc | Winter Park | Florida | 32789 | United States |
| Clinical Site Partners | Winter Park | Florida | 32789 | United States |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | United States |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | United States |
| Kentucky Pediatric/ Adult Research | Bardstown | Kentucky | 40004 | United States |
| Sundance Clinical Research | St Louis | Missouri | 63141 | United States |
| Meridian Clinical Research, LLC | Omaha | Nebraska | 68134 | United States |
| Accellacare - Wilmington | Wilmington | North Carolina | 28401 | United States |
| Aventiv Research Inc | Columbus | Ohio | 43213 | United States |
| Velocity Clinical Research, Providence | East Greenwich | Rhode Island | 02818 | United States |
| Benchmark Research | Austin | Texas | 78705 | United States |
| Texas Center for Drug Development, Inc. | Houston | Texas | 77081 | United States |
| DM Clinical Research | Tomball | Texas | 77375 | United States |
| J. Lewis Research, Inc. / Foothill Family Clinic | Salt Lake City | Utah | 84109 | United States |
| J. Lewis Research, Inc. / Foothill Family Clinic South | Salt Lake City | Utah | 84121 | United States |
Participants were randomized to receive a single intramuscular injection of 120 microgram (mcg) Respiratory Syncytial Virus prefusion F subunit vaccine (RSVpreF) Lot 1 reconstituted with sterile water for injection, once only on Day 1.
| FG002 | Group 2: RSVpreF Lot 2 | Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 2 reconstituted with sterile water for injection, once only on Day 1. |
| FG003 | Group 3: RSVpreF Lot 3 | Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 3 reconstituted with sterile water for injection, once only on Day 1. |
| Vaccinated |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Safety population included all randomized participants who received study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants were randomized to receive a single intramuscular injection of placebo reconstituted with sterile water for injection, once only on Day 1. |
| BG001 | Group 1: RSVpreF Lot 1 | Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 1 reconstituted with sterile water for injection, once only on Day 1. |
| BG002 | Group 2: RSVpreF Lot 2 | Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 2 reconstituted with sterile water for injection, once only on Day 1. |
| BG003 | Group 3: RSVpreF Lot 3 | Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 3 reconstituted with sterile water for injection, once only on Day 1. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Evaluable immunogenicity population included all eligible participants who received vaccine to which they were randomized at visit 1, had a valid and determinate immunogenicity result from the blood sample collected within 27 to 42 days after vaccination and had no other major protocol deviations. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 1 month (27 to 42 days window) after vaccination on Day 1 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | Safety population included all randomized participants who received study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was planned to be analyzed for placebo and pooled RSVpreF lots (Groups 1, 2, and 3). | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 days after vaccination on Day 1 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | 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. | Safety population included all randomized participants who received study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was planned to be analyzed for placebo and pooled RSVpreF lots (Groups 1, 2, and 3). | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 days after vaccination on Day 1 |
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| Primary | 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. | Safety population included all randomized participants who received study intervention. Data for this outcome measure was planned to be analyzed for placebo and pooled RSVpreF lots (Groups 1, 2, and 3). | Posted | Number | 95% Confidence Interval | Percentage of participants | Day of consent (Day 1) through study completion (approximately 1 Month) |
|
Local reactions and systemic events (systematic assessment): within 7 days after vaccination on Day 1; AEs and SAEs (non-systematic assessment) and all-cause mortality: Day of consent (Day 1) through study completion (approximately 1 Month)
Safety population included all randomized participants who received study intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants were randomized to receive a single intramuscular injection of placebo reconstituted with sterile water for injection, once only on Day 1. | 0 | 247 | 0 | 247 | 130 | 247 |
| EG001 | Group 1: RSVpreF Lot 1 | Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 1 reconstituted with sterile water for injection, once only on Day 1. | 0 | 249 | 0 | 249 | 170 | 249 |
| EG002 | Group 2: RSVpreF Lot 2 | Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 2 reconstituted with sterile water for injection, once only on Day 1. | 0 | 247 | 0 | 247 | 172 | 247 |
| EG003 | Group 3: RSVpreF Lot 3 | Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF Lot 3 reconstituted with sterile water for injection, once only on Day 1. | 0 | 249 | 0 | 249 | 166 | 249 |
| EG004 | RSVpreF Pooled Lots (Groups 1, 2 and 3) | Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF lots 1, 2 or 3 reconstituted with sterile water for injection, once only on Day 1. | 0 | 745 | 0 | 745 | 508 | 745 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Diarrhoea (DIARRHEA) | Gastrointestinal disorders | MedDRA v24.1 | Systematic Assessment |
| |
| Nausea (NAUSEA) | Gastrointestinal disorders | MedDRA v24.1 | Systematic Assessment |
| |
| Vomiting (VOMITING) | Gastrointestinal disorders | MedDRA v24.1 | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Fatigue (FATIGUE) | General disorders | MedDRA v24.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Injection site pain (PAIN AT INJECTION SITE) | General disorders | MedDRA v24.1 | Systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pyrexia (FEVER) | General disorders | MedDRA v24.1 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Swelling (SWELLING) | General disorders | MedDRA v24.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Arthralgia (JOINT PAIN) | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Joint hyperextension | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Myalgia (MUSCLE PAIN) | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Systematic Assessment |
| |
| Neck mass | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Headache (HEADACHE) | Nervous system disorders | MedDRA v24.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Erythema (REDNESS) | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 22, 2022 | Mar 17, 2023 | SAP_001.pdf |
| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| RSV B |
|
| RSV A | Geometric Mean Ratio | 1.05 | 2-Sided | 95 | 0.900 | 1.215 | GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model. | Equivalence | Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously. |
| RSV A | Geometric Mean Ratio | 1.04 | 2-Sided | 95 | 0.886 | 1.232 | GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model. | Equivalence | Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously. |
| RSV B | Geometric Mean Ratio | 1.07 | 2-Sided | 95 | 0.905 | 1.261 | GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model. | Equivalence | Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously. |
| RSV B | Geometric Mean Ratio | 1.13 | 2-Sided | 95 | 0.953 | 1.336 | GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model. | Equivalence | Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously. |
| RSV B | Geometric Mean Ratio | 1.06 | 2-Sided | 95 | 0.884 | 1.262 | GMRs and 2-sided CIs were calculated by exponentiating the difference in LS means and corresponding CIs based on analysis of logarithmically transformed assay results using a linear regression model. | Equivalence | Equivalence was established if the 2-sided 95% CI for the ratio of neutralizing GMTs for each pair of individual vaccine lots (RSVpreF Lot 1/RSVpreF Lot 2, RSVpreF Lot 1/RSVpreF Lot 3 and RSVpreF Lot 2/RSVpreF Lot 3) was within the interval (0.667, 1.5), for both antigens simultaneously. |
|
|
| RSVpreF Pooled Lots (Groups 1, 2 and 3) |
Participants were randomized to receive a single intramuscular injection of 120 mcg RSVpreF lots 1, 2 or 3 reconstituted with sterile water for injection, once only on Day 1. |
|
|
|
|