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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06473519 | Registry Identifier | ClinicalTrials.gov |
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Respiratory Syncytial Virus (RSV) is a common type of virus (germ) that can cause severe illness, where medical help is needed. RSV can lead to airway diseases in all ages. Vaccines help your body make antibodies. These antibodies help fight against diseases. This is called an immune response.
The purpose of this study is to learn about the safety, tolerability, and immunogenicity of a RSV vaccine called RSVpreF. RSVpreF comes either as:
a single dose in a container (called a vial),
or in a vial that holds multiple doses. A multidose vial contains more than one dose of RSVpreF.
2-Phenoxyethanol (2-PE) is a preservative to help prevent the growth of bacteria (germs). This study will compare RSVpreF with an added preservative called 2-phenoxyethanol (2-PE) from a multidose vial, to RSVpreF without an added preservative, from a single-dose vial.
This study is looking to enroll nonpregnant, nonbreastfeeding, healthy female participants.
Participants will need to visit the study clinic two times during the study. Participants will also have a final safety telephone call at the end of the study. All participants will receive a single shot of the study vaccine either from:
Blood samples will be taken at the two study clinic visits. Each participant will take part in the study for around 6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSVpreF multidose vial (MDV) | Experimental | RSVpreF with 2-PE formulated in an MDV |
|
| RSVpreF single-dose vial (SDV) | Experimental | RSVpreF without 2-PE formulated in an SDV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSVpreF MDV | Biological | RSVpreF with 2-PE formulated in an MDV |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) of Serum Neutralizing Titers (NTs) for Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Before Vaccination | GMTs and corresponding 2-sided 95% confidence intervals (CIs) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). | Before vaccination on Day 1 |
| GMT and Geometric Mean Ratio (GMR) of Serum NTs for RSV A and RSV B at 1 Month After Vaccination | GMTs and corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV A and B were reported in the descriptive data section of this outcome measure. GMR each for RSV A and RSV B was calculated as ratio of NTs of RSVpreF (MDV) to RSVpreF (SDV) and was reported in the statistical analysis section of this outcome measure. | 1 month after Vaccination on Day 1 |
| Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Local reactions included redness, swelling and pain at injection site, reported in the electronic diary (e-diary) and the participant-reported reactogenicity (PARREACT) case report form (CRF). Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit= 0.5 centimeter (cm) and graded as mild: >2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm, severe: >10.0 cm, Grade 4: necrosis (redness and swelling) or exfoliative dermatitis (redness). Pain at injection site was graded as mild: did not interfere with activity, moderate: interfered with activity, severe: prevented daily activity, Grade 4: emergency room visit or hospitalization for severe pain at injection site. | Day 1 through Day 7 after Vaccination |
| Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Systemic events included fever, fatigue, headache, vomiting, nausea, diarrhea, muscle pain and joint pain, recorded in the e-diary and PARREACT CRF. Fever measured in degree Celsius and ranged: mild (38.0 - 38.4); moderate (38.5 - 38.9); severe (39.0 - 40.0); Grade 4: >40.0. Fatigue, headache, nausea, muscle and joint pain graded as: mild (didn't interfere with activity); moderate (some interference with activity); severe (prevented daily routine activity); Grade 4 [emergency room (ER) visit or hospitalization). Vomiting graded as: mild (1-2 times in 24 hours[h]); moderate (>2 times in 24h); severe (required intravenous hydration); Grade 4 (ER visit or hospitalization). Diarrhea graded as: mild (2-3 loose stools in 24h); moderate (4-5 loose stools in 24h); severe (6 or more loose stools in 24h); Grade 4 (ER visit or hospitalization).](streamdown:incomplete-link) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Seroresponse for RSV A and RSV B of Serum NTs at 1 Month After Vaccination | Seroresponse was defined as achieving a >=4-fold rise from baseline (before vaccination) if the baseline measurement was above the lower limit of quantification (LLOQ). If the baseline measurement was below the LLOQ, a postvaccination assay result >=4*LLOQ was considered a seroresponse. |
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Inclusion Criteria:
Exclusion Criteria:
Nonpregnant, nonbreastfeeding females
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qps-Mra, Llc | South Miami | Florida | 33143 | United States | ||
| Clinical Research Atlanta |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41660362 | Derived | Sarwar UN, Baker JB, Pereira L, Pahud BA, Finley J, Strong D, Pagnussat S, Patel S, Liu Y, Shittu E, Anastasiou OE, Kalinina EV, Swanson KA, Anderson AS, Gurtman A, Munjal I. Safety and immunogenicity of bivalent RSVpreF vaccine formulated in a multidose vial in healthy female participants in the USA: a multicentre, randomised, open-label, noninferiority phase 3 study. EClinicalMedicine. 2026 Jan 29;92:103767. doi: 10.1016/j.eclinm.2026.103767. eCollection 2026 Feb. |
| 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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Participants were randomized to receive respiratory syncytial virus stabilized prefusion F subunit vaccine (RSVpreF) either with the preservative formulated in a multiple dose vial (MDV) or without the preservative formulated in a single dose vial (SDV). Preservative used was 2-phenoxyethanol (2-PE).
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| ID | Title | Description |
|---|---|---|
| FG000 | RSVpreF (With Preservative, MDV) | Participants were randomized to receive only a single 0.5 milliliter (mL) dose from MDV of RSVpreF (120 micrograms [mcg]), intramuscularly on Day 1. |
| FG001 | RSVpreF (Without Preservative, SDV) |
| 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 26, 2024 | Sep 5, 2025 |
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Open-label
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| RSVpreF SDV |
| Biological |
RSVpreF without 2-PE formulated in an SDV |
|
| Day 1 through Day 7 after Vaccination |
| Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination | An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention were included in evaluation of this outcome measure. AEs included both serious AEs (SAEs) and all non-SAEs. Events collected by systematic assessment (local reactions and systemic events) were excluded from evaluation. | Within 1 Month after Vaccination |
| Percentage of Participants With SAEs Throughout the Study | An AEs was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and other important medical events per protocol of the study. Events collected by systematic assessment (local reactions and systemic events) were excluded from evaluation. | Within 42 to 49 days after Vaccination on Day 1 (maximum up to 1.6 months) |
| 1 Month after Vaccination |
| Stockbridge |
| Georgia |
| 30281 |
| United States |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | United States |
| Clinical Research Prime Rexburg | Rexburg | Idaho | 83440 | United States |
| Headlands Research - Detroit | Southfield | Michigan | 48034 | United States |
| Clinical Trials of Texas, LLC dba Flourish Research | San Antonio | Texas | 78229 | United States |
Participants were randomized to receive entire content from SDV of RSVpreF (120 mcg), intramuscularly on Day 1.
| Vaccinated (on Day 1) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population consisted of all randomized participants who received study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | RSVpreF (With Preservative, MDV) | Participants were randomized to receive only a single 0.5 mL dose from MDV of RSVpreF (120 mcg), intramuscularly on Day 1. |
| BG001 | RSVpreF (Without Preservative, SDV) | Participants were randomized to receive entire content from SDV of RSVpreF (120 mcg), intramuscularly on Day 1. |
| BG002 | 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 Titer (GMT) of Serum Neutralizing Titers (NTs) for Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Before Vaccination | GMTs and corresponding 2-sided 95% confidence intervals (CIs) were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). | Evaluable immunogenicity population (EIP): all eligible participants who received the study intervention to which they were randomized, had blood drawn for assay testing within the specified time frame (27 to 42 days after vaccination) for 1 month after vaccination, had at least 1 valid and determinate assay result at the 1-month follow-up visit, and had no major protocol violations. Here, "Number Analyzed" signifies participants evaluable for specified rows. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Before vaccination on Day 1 |
|
|
| ||||||||||||||||||||||||||||
| Primary | GMT and Geometric Mean Ratio (GMR) of Serum NTs for RSV A and RSV B at 1 Month After Vaccination | GMTs and corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV A and B were reported in the descriptive data section of this outcome measure. GMR each for RSV A and RSV B was calculated as ratio of NTs of RSVpreF (MDV) to RSVpreF (SDV) and was reported in the statistical analysis section of this outcome measure. | EIP: all eligible participants who received the study intervention to which they were randomized, had blood drawn for assay testing within the specified time frame (27 to 42 days after vaccination) for 1 month after vaccination, had at least 1 valid and determinate assay result at the 1-month follow-up visit, and had no major protocol violations. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 1 month after Vaccination on Day 1 |
| ||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Local Reactions Within 7 Days After Vaccination | Local reactions included redness, swelling and pain at injection site, reported in the electronic diary (e-diary) and the participant-reported reactogenicity (PARREACT) case report form (CRF). Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit= 0.5 centimeter (cm) and graded as mild: >2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm, severe: >10.0 cm, Grade 4: necrosis (redness and swelling) or exfoliative dermatitis (redness). Pain at injection site was graded as mild: did not interfere with activity, moderate: interfered with activity, severe: prevented daily activity, Grade 4: emergency room visit or hospitalization for severe pain at injection site. | Safety population consisted of all randomized participants who received study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 through Day 7 after Vaccination |
| ||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Systemic Events Within 7 Days After Vaccination | Systemic events included fever, fatigue, headache, vomiting, nausea, diarrhea, muscle pain and joint pain, recorded in the e-diary and PARREACT CRF. Fever measured in degree Celsius and ranged: mild (38.0 - 38.4); moderate (38.5 - 38.9); severe (39.0 - 40.0); Grade 4: >40.0. Fatigue, headache, nausea, muscle and joint pain graded as: mild (didn't interfere with activity); moderate (some interference with activity); severe (prevented daily routine activity); Grade 4 [emergency room (ER) visit or hospitalization). Vomiting graded as: mild (1-2 times in 24 hours[h]); moderate (>2 times in 24h); severe (required intravenous hydration); Grade 4 (ER visit or hospitalization). Diarrhea graded as: mild (2-3 loose stools in 24h); moderate (4-5 loose stools in 24h); severe (6 or more loose stools in 24h); Grade 4 (ER visit or hospitalization).](streamdown:incomplete-link) | Safety population consisted of all randomized participants who received study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 through Day 7 after Vaccination |
| ||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination | An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention were included in evaluation of this outcome measure. AEs included both serious AEs (SAEs) and all non-SAEs. Events collected by systematic assessment (local reactions and systemic events) were excluded from evaluation. | Safety population consisted of all randomized participants who received study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 1 Month after Vaccination |
|
| |||||||||||||||||||||||||||||
| Primary | Percentage of Participants With SAEs Throughout the Study | An AEs was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention. An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and other important medical events per protocol of the study. Events collected by systematic assessment (local reactions and systemic events) were excluded from evaluation. | Safety population consisted of all randomized participants who received study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 42 to 49 days after Vaccination on Day 1 (maximum up to 1.6 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Seroresponse for RSV A and RSV B of Serum NTs at 1 Month After Vaccination | Seroresponse was defined as achieving a >=4-fold rise from baseline (before vaccination) if the baseline measurement was above the lower limit of quantification (LLOQ). If the baseline measurement was below the LLOQ, a postvaccination assay result >=4*LLOQ was considered a seroresponse. | EIP was analyzed. Here, "Overall Number of Participants Analyzed" = number of participants evaluable for this outcome measure and "Number Analyzed" = number of participants evaluable for specified rows. | Posted | Number | 95% Confidence Interval | Percentage of participants | 1 Month after Vaccination |
|
|
Systematic assessment (local reactions and systemic events): Day 1 through Day 7 after Vaccination; Non-systematic assessment (serious AEs and all-cause mortality): within 42 to 49 days after Vaccination on Day 1 (maximum up to 1.6 months), Other AEs: within 1 month after Vaccination
Same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. Safety population consisted of 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 | RSVpreF (With Preservative, MDV) | Participants were randomized to receive only a single 0.5 mL dose from MDV of RSVpreF (120 mcg), intramuscularly on Day 1. | 0 | 223 | 1 | 223 | 169 | 223 |
| EG001 | RSVpreF (Without Preservative, SDV) | Participants were randomized to receive entire content from SDV of RSVpreF (120 mcg), intramuscularly on Day 1. | 0 | 227 | 2 | 227 | 174 | 227 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaphylactic reaction | Immune system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Face oedema | General disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Fatigue (FATIGUE) | General disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Injection site pain (PAIN AT INJECTION SITE) | General disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Pyrexia (FEVER) | General disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Swelling (SWELLING) | General disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Diarrhoea (DIARRHEA) | Gastrointestinal disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Eosinophilic oesophagitis | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Nausea (NAUSEA) | Gastrointestinal disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Vomiting (VOMITING) | Gastrointestinal disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Milk allergy | Immune system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA v27.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA v27.1 | Non-systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA v27.1 | Non-systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Arthralgia (JOINT PAIN) | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Myalgia (MUSCLE PAIN) | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Brain fog | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Headache (HEADACHE) | Nervous system disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Attention deficit hyperactivity disorder | Psychiatric disorders | MedDRA v27.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Breast disorder | Reproductive system and breast disorders | MedDRA v27.1 | Non-systematic Assessment |
| |
| Erythema (REDNESS) | Skin and subcutaneous tissue disorders | MedDRA v27.1 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA v27.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication 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 | Mar 19, 2024 | Sep 5, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
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| Unknown or Not Reported |
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| RSV B |
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| Units | Counts |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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