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This phase 2b study will evaluate safety, tolerability, and immunogenicity of an RSV vaccine when given together with Tdap in approximately 710 healthy nonpregnant women 18 through 49 years of age. This study will evaluate non-inferiority of RSV vaccine when given with Tdap and vice-versa.
This Phase 2b study will evaluate safety, tolerability, and immunogenicity of an RSV vaccine when given together with Tdap in approximately 710 healthy nonpregnant women 18 through 49 years of age.
The participants will be equally split into 5 treatment groups: One of a possible two dose levels of RSV vaccine (the higher dose level will be formulated with an aluminum hydroxide adjuvant) with either the Tdap or Placebo, or a Tdap and placebo combination.
This study will evaluate non-inferiority of the Tdap when co-administered with RSV vaccine candidate and vice-versa by measuring participants' immune response through appropriate antibody and component levels 1 month after vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lower RSV vaccine dose and Tdap | Experimental | Lower RSV vaccine dose and Tdap |
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| Lower RSV vaccine dose and Placebo | Experimental | Lower RSV vaccine dose and Placebo |
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| Higher RSV vaccine dose with Aluminum Hydroxide and Tdap | Experimental | Higher RSV vaccine dose with Aluminum Hydroxide and Tdap |
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| Higher RSV vaccine dose with Aluminum Hydroxide and Placebo | Experimental | Higher RSV vaccine dose with Aluminum Hydroxide and Placebo |
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| Placebo and Tdap | Placebo Comparator | Normal saline solution for injection (0.9% sodium chloride injection) and Tdap |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSV Vaccine | Biological | RSV vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Anti-Tetanus Toxoid (TTd) Antibody Concentrations of Greater Than or Equal to (>=) 0.1 International Units Per Milliliter (IU/mL) at 1 Month After Vaccination | Percentage of participants achieving Anti-TTd antibody concentrations of >= 0.1 IU/mL at 1 month after vaccination were reported. The lower limit of quantitation (LLOQ) values for Anti-TTd was 0.05 IU/mL. Assay results below the LLOQ were set to 0.5*LLOQ. Data for this outcome measure was planned to be collected and analyzed only for combined population of participants reported under two RSV vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) along with placebo/Tdap arm and not planned to be collected and analyzed for two RSV vaccine arms: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo), as pre-specified in protocol. | 1 month after vaccination |
| Percentage of Participants Achieving Anti-Diphtheria Toxoid (DTd) Antibody Concentrations of >= 0.1 IU/mL at 1 Month After Vaccination | Percentage of participants achieving Anti-DTd antibody concentrations of >= 0.1 IU/mL at 1 month after vaccination were reported. The LLOQ values for Anti- DTd= 0.037 IU/mL. Assay results below the LLOQ were set to 0.5*LLOQ. Data for this outcome measure was planned to be collected and analyzed only for combined population of participants reported under two RSV vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) along with placebo/Tdap arm and not planned to be collected and analyzed for two RSV vaccine arms: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo), as pre-specified in protocol. | 1 month after vaccination |
| Geometric Mean Concentration (GMC) and Geometric Mean Ratio (GMR) of Anti-Pertussis Antibodies 1 Month After Vaccination | GMCs of anti-pertussis components: anti pertussis (anti-PT) toxin, anti filamentous hemagglutinin (FHA) and anti- pertactin (PRN) was measured and reported in descriptive section. LLOQ values for each component was: Anti-PT=0.9 endotoxin units per milliliter (EU/mL), Anti-FHA=2.9 EU/mL, and Anti-PRN=3.0 EU/mL. Assay results below LLOQ were set to 0.5*LLOQ. Descriptive data for this outcome measure was planned to be collected and analyzed only for combined population of participants reported under two RSV vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) along with placebo/Tdap arm and not planned to be collected and analyzed for two RSV vaccine arms: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo), as pre-specified in protocol. GMRs were reported in statistical analysis section and calculated by dividing GMC of RSV vaccine with aluminum hydroxide with Tdap arm by GMC of placebo/Tdap arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Respiratory Syncytial Virus Subgroup A (RSV A) Neutralizing Antibodies 1 Month After Vaccination Using 1.5 Fold Margin | Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution. Descriptive data for this outcome measure was planned to be collected and analyzed for combined population of participants reported under two RSV and Tdap vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) and two RSV and placebo arm: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo) and not planned to be collected and analyzed for Placebo/Tdap arm, as pre-specified in protocol. GMRs were reported in statistical analysis section and calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Anti-TTd Antibody Concentrations of >= 0.1 IU/mL Before Vaccination | Percentage of participants achieving Anti-TTd antibody concentrations of >= 0.1 IU/mL 1 month before vaccination were reported. The LLOQ values for Anti-TTd = 0.05 IU/mL. Assay results below the LLOQ were set to 0.5*LLOQ. Data for this outcome measure was not planned to be collected and analyzed for RSV 120 mcg with placebo arm and RSV 240 mcg with aluminum hydroxide/placebo arm. |
Inclusion Criteria:
Exclusion Criteria:
Healthy, non-pregnant women 18 to 49 years of age, who are of childbearing potential or not of childbearing potential.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States | ||
| East-West Medical Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34637519 | Derived | Peterson JT, Zareba AM, Fitz-Patrick D, Essink BJ, Scott DA, Swanson KA, Chelani D, Radley D, Cooper D, Jansen KU, Dormitzer PR, Gruber WC, Gurtman A. Safety and Immunogenicity of a Respiratory Syncytial Virus Prefusion F Vaccine When Coadministered With a Tetanus, Diphtheria, and Acellular Pertussis Vaccine. J Infect Dis. 2022 Jun 15;225(12):2077-2086. doi: 10.1093/infdis/jiab505. |
| 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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| ID | Title | Description |
|---|---|---|
| FG000 | Respiratory Syncytial Virus (RSV) Vaccine 120 Microgram (mcg) With Placebo | Participants received 0.5 milliliter (mL), intramuscular injections of RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination. |
| FG001 |
| 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 | Sep 17, 2019 | Dec 7, 2020 |
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This is an observer-blinded study. Study staff dispensing and administering the vaccine will be unblinded, but the participant and all other study personnel, including the principal investigator, will be blinded.
| Tdap | Biological | Tetanus, Diphtheria, and Acellular Pertussis Vaccine |
|
| Placebo | Biological | Normal saline solution for injection (0.9% sodium chloride injection) |
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| 1 month after vaccination |
| Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Respiratory Syncytial Virus Subgroup A (RSV A) Neutralizing Antibodies 1 Month After Vaccination Using 2.0 Fold Margin | Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution. Descriptive data for this outcome measure was planned to be collected and analyzed for combined population of participants reported under two RSV and Tdap vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) and two RSV and placebo arm: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo) and not planned to be collected and analyzed for Placebo/Tdap arm, as pre-specified in protocol. GMRs were reported in statistical analysis section and calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm. | 1 month after vaccination |
| Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies 1 Month After Vaccination Using 2.0 Fold Margin | Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution. Descriptive data for this outcome measure was planned to be collected and analyzed for combined population of participants reported under two RSV and Tdap vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) and two RSV and placebo arm: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo) and not planned to be collected and analyzed for Placebo/Tdap arm, as pre-specified in protocol. GMRs were reported in statistical analysis section and calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm. | 1 month after vaccination |
| Percentage of Participants With Prespecified Local Reactions Within 7 Days After Vaccination | Local reactions included pain at injection site, redness and swelling 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 daily activity, moderate: interfered with daily activity and severe: prevented daily activity. | Within 7 days after vaccination |
| Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination | Systemic reactions included fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever was categorized as: >=38.0 degrees (deg) Celsius (C), mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg 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: requires 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. | Within 7 days after vaccination |
| Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Within 1 month after vaccination (up to 35 days) |
| Percentage of Participants With Medically Attended Adverse Events (MAE) and Serious Adverse Events (SAE) | An medically attended adverse events (MAE) was defined as a non-serious AE that results in an evaluation at a medical facility. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Within 1 month after vaccination (up to 35 days) |
| 1 month after vaccination |
| Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies 1 Month After Vaccination Using 1.5 Fold Margin | Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution. Descriptive data for this outcome measure was planned to be collected and analyzed for combined population of participants reported under two RSV and Tdap vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) and two RSV and placebo arm: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo) and not planned to be collected and analyzed for Placebo/Tdap arm, as pre-specified in protocol. GMRs were reported in statistical analysis section and calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm. | 1 month after vaccination |
| Before vaccination on Day 1 |
| Percentage of Participants Achieving Anti- DTd Antibody Concentrations of >= 0.1 IU/mL Before Vaccination | Percentage of participants achieving Anti-DTd antibody concentrations of >= 0.1 IU/mL before vaccination were reported. The LLOQ values for Anti-DTd= 0.037 IU/mL. Assay results below the LLOQ were set to 0.5*LLOQ. Data for this outcome measure was not planned to be collected and analyzed for RSV 120 mcg with placebo arm and RSV 240 mcg with aluminum hydroxide/placebo arm. | Before vaccination on Day 1 |
| Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) Neutralizing Antibodies Before Vaccination | Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution. Data for this outcome measure was planned to be collected and analyzed for combined population of participants reported under two RSV and Tdap vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) and two RSV and placebo arm: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo) and not planned to be collected and analyzed for Placebo/Tdap arm, as pre-specified in protocol. | Before vaccination on Day 1 |
| Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before Vaccination | Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution. Data for this outcome measure was planned to be collected and analyzed for combined population of participants reported under two RSV and Tdap vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) and two RSV and placebo arm: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo) and not planned to be collected and analyzed for Placebo/Tdap arm, as pre-specified in protocol. | Before vaccination on Day 1 |
| Honolulu |
| Hawaii |
| 96814 |
| United States |
| Alliance for multispecialty research | Wichita | Kansas | 67207 | United States |
| Sundance Clinical Research | St Louis | Missouri | 63141 | United States |
| Meridian Clinical Research | Omaha | Nebraska | 68134 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Omega Medical Research | Warwick | Rhode Island | 02886 | United States |
| Meridian Clinical Research, LLC | Dakota Dunes | South Dakota | 57049 | United States |
| Benchmark Research | Austin | Texas | 78705 | United States |
| Ventavia Research Group | Fort Worth | Texas | 76104 | United States |
| Texas Center for Drug Development | Houston | Texas | 77081 | United States |
| Clinical Trials of Texas, Inc. | San Antonio | Texas | 78229 | United States |
| Martin Diagnostic Clinic | 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 |
| J. Lewis Research, Inc / Jordan River Family Medicine | South Jordan | Utah | 84095 | United States |
| RSV Vaccine 120 mcg With Tdap |
Participants received 0.5 mL, intramuscular injections of RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed (Tdap) on Day 1. Participants were followed up to 1 month after vaccination. |
| FG002 | RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo | Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination. |
| FG003 | RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap | Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination. |
| FG004 | Placebo/Tdap | Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination. |
| Treated |
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| Safety Population | Safety analysis set included all randomized participants who received investigational product. Participants were analyzed according to the investigational product they actually received. |
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| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set included all randomized participants who received investigational product. Participants were analyzed according to the investigational product they actually received.
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| ID | Title | Description |
|---|---|---|
| BG000 | RSV Vaccine 120 mcg With Placebo | Participants received 0.5 mL, intramuscular injections of RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination. |
| BG001 | RSV Vaccine 120 mcg With Tdap | Participants received 0.5 mL, intramuscular injections of RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with Tdap on Day 1. Participants were followed up to 1 month after vaccination. |
| BG002 | RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo | Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination. |
| BG003 | RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap | Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination. |
| BG004 | Placebo/Tdap | Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants Achieving Anti-Tetanus Toxoid (TTd) Antibody Concentrations of Greater Than or Equal to (>=) 0.1 International Units Per Milliliter (IU/mL) at 1 Month After Vaccination | Percentage of participants achieving Anti-TTd antibody concentrations of >= 0.1 IU/mL at 1 month after vaccination were reported. The lower limit of quantitation (LLOQ) values for Anti-TTd was 0.05 IU/mL. Assay results below the LLOQ were set to 0.5*LLOQ. Data for this outcome measure was planned to be collected and analyzed only for combined population of participants reported under two RSV vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) along with placebo/Tdap arm and not planned to be collected and analyzed for two RSV vaccine arms: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo), as pre-specified in protocol. | Evaluable immunogenicity population(EIP): participants who were eligible, received all doses of investigational product to which they were randomized, had blood drawn for assay testing within specified time frame for 1 month after vaccination, had >=1 valid, determinate assay result at 1-month-postvaccination visit and no major protocol violations. | Posted | Number | 95% Confidence Interval | Percentage of participants | 1 month after vaccination |
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| Primary | Percentage of Participants Achieving Anti-Diphtheria Toxoid (DTd) Antibody Concentrations of >= 0.1 IU/mL at 1 Month After Vaccination | Percentage of participants achieving Anti-DTd antibody concentrations of >= 0.1 IU/mL at 1 month after vaccination were reported. The LLOQ values for Anti- DTd= 0.037 IU/mL. Assay results below the LLOQ were set to 0.5*LLOQ. Data for this outcome measure was planned to be collected and analyzed only for combined population of participants reported under two RSV vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) along with placebo/Tdap arm and not planned to be collected and analyzed for two RSV vaccine arms: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo), as pre-specified in protocol. | EIP: participants who were eligible, received all doses of investigational product to which they were randomized, have blood drawn for assay testing within the specified time frame for 1 month after vaccination, had at least 1 valid and determinate assay result at the 1-month-postvaccination visit and had no major protocol violations. | Posted | Number | 95% Confidence Interval | Percentage of participants | 1 month after vaccination |
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| Primary | Geometric Mean Concentration (GMC) and Geometric Mean Ratio (GMR) of Anti-Pertussis Antibodies 1 Month After Vaccination | GMCs of anti-pertussis components: anti pertussis (anti-PT) toxin, anti filamentous hemagglutinin (FHA) and anti- pertactin (PRN) was measured and reported in descriptive section. LLOQ values for each component was: Anti-PT=0.9 endotoxin units per milliliter (EU/mL), Anti-FHA=2.9 EU/mL, and Anti-PRN=3.0 EU/mL. Assay results below LLOQ were set to 0.5*LLOQ. Descriptive data for this outcome measure was planned to be collected and analyzed only for combined population of participants reported under two RSV vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) along with placebo/Tdap arm and not planned to be collected and analyzed for two RSV vaccine arms: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo), as pre-specified in protocol. GMRs were reported in statistical analysis section and calculated by dividing GMC of RSV vaccine with aluminum hydroxide with Tdap arm by GMC of placebo/Tdap arm. | EIP: participants who were eligible, received all doses of investigational product to which they were randomized, have blood drawn for assay testing within the specified time frame for 1 month after vaccination, had at least 1 valid and determinate assay result at the 1-month-postvaccination visit and had no major protocol violations. | Posted | Geometric Mean | 95% Confidence Interval | Endotoxin unit per milliliter (EU/mL) | 1 month after vaccination |
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| Primary | Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Respiratory Syncytial Virus Subgroup A (RSV A) Neutralizing Antibodies 1 Month After Vaccination Using 2.0 Fold Margin | Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution. Descriptive data for this outcome measure was planned to be collected and analyzed for combined population of participants reported under two RSV and Tdap vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) and two RSV and placebo arm: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo) and not planned to be collected and analyzed for Placebo/Tdap arm, as pre-specified in protocol. GMRs were reported in statistical analysis section and calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm. | EIP: participants who were eligible, received all doses of investigational product to which they were randomized, have blood drawn for assay testing within the specified time frame for 1 month after vaccination, had at least 1 valid and determinate assay result at the 1-month-postvaccination visit and had no major protocol violations. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 1 month after vaccination |
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| Primary | Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies 1 Month After Vaccination Using 2.0 Fold Margin | Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution. Descriptive data for this outcome measure was planned to be collected and analyzed for combined population of participants reported under two RSV and Tdap vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) and two RSV and placebo arm: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo) and not planned to be collected and analyzed for Placebo/Tdap arm, as pre-specified in protocol. GMRs were reported in statistical analysis section and calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm. | EIP: participants who were eligible, received all doses of investigational product to which they were randomized, have blood drawn for assay testing within the specified time frame for 1 month after vaccination, had at least 1 valid and determinate assay result at the 1-month-postvaccination visit and had no major protocol violations. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 1 month after vaccination |
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| Primary | Percentage of Participants With Prespecified Local Reactions Within 7 Days After Vaccination | Local reactions included pain at injection site, redness and swelling 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 daily activity, moderate: interfered with daily activity and severe: prevented daily activity. | Safety analysis set included all randomized participants who received investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 days after vaccination |
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| Primary | Percentage of Participants With Prespecified Systemic Reactions Within 7 Days After Vaccination | Systemic reactions included fever, fatigue/tiredness, headache, nausea, muscle pain, joint pain, vomiting, diarrhea and any systemic event recorded by participants in an e-diary. Fever was categorized as: >=38.0 degrees (deg) Celsius (C), mild (>=38.0 to 38.4 deg C, >38.4 to 38.9 deg C), moderate (>38.9 to 40.0 deg C and >40.0 deg C), severe (>38.9 deg C to 40.0 deg C) and grade 4 (>40.0 deg 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: requires 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. | Safety analysis set included all randomized participants who received investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 days after vaccination |
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| Primary | Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. AEs included both serious and non-serious adverse events. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Safety analysis set included all randomized participants who received investigational product. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 1 month after vaccination (up to 35 days) |
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| Primary | Percentage of Participants With Medically Attended Adverse Events (MAE) and Serious Adverse Events (SAE) | An medically attended adverse events (MAE) was defined as a non-serious AE that results in an evaluation at a medical facility. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Safety analysis set included all randomized participants who received investigational product. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 1 month after vaccination (up to 35 days) |
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| Secondary | Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Respiratory Syncytial Virus Subgroup A (RSV A) Neutralizing Antibodies 1 Month After Vaccination Using 1.5 Fold Margin | Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution. Descriptive data for this outcome measure was planned to be collected and analyzed for combined population of participants reported under two RSV and Tdap vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) and two RSV and placebo arm: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo) and not planned to be collected and analyzed for Placebo/Tdap arm, as pre-specified in protocol. GMRs were reported in statistical analysis section and calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm. | EIP: participants who were eligible, received all doses of investigational product to which they were randomized, have blood drawn for assay testing within the specified time frame for 1 month after vaccination, had at least 1 valid and determinate assay result at the 1-month-postvaccination visit and had no major protocol violations. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 1 month after vaccination |
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| Secondary | Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies 1 Month After Vaccination Using 1.5 Fold Margin | Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution. Descriptive data for this outcome measure was planned to be collected and analyzed for combined population of participants reported under two RSV and Tdap vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) and two RSV and placebo arm: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo) and not planned to be collected and analyzed for Placebo/Tdap arm, as pre-specified in protocol. GMRs were reported in statistical analysis section and calculated by dividing GMT of RSV vaccine with aluminum hydroxide with Tdap arm by GMT of RSV vaccine with aluminum hydroxide with placebo arm. | EIP: participants who were eligible, received all doses of investigational product to which they were randomized, have blood drawn for assay testing within the specified time frame for 1 month after vaccination, had at least 1 valid and determinate assay result at the 1-month-postvaccination visit and had no major protocol violations. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 1 month after vaccination |
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| Other Pre-specified | Percentage of Participants Achieving Anti-TTd Antibody Concentrations of >= 0.1 IU/mL Before Vaccination | Percentage of participants achieving Anti-TTd antibody concentrations of >= 0.1 IU/mL 1 month before vaccination were reported. The LLOQ values for Anti-TTd = 0.05 IU/mL. Assay results below the LLOQ were set to 0.5*LLOQ. Data for this outcome measure was not planned to be collected and analyzed for RSV 120 mcg with placebo arm and RSV 240 mcg with aluminum hydroxide/placebo arm. | EIP: participants who were eligible, received all doses of investigational product to which they were randomized, have blood drawn for assay testing within the specified time frame for 1 month after vaccination, had at least 1 valid and determinate assay result at the 1-month-postvaccination visit and had no major protocol violations. | Posted | Number | 95% Confidence Interval | Percentage of participants | Before vaccination on Day 1 |
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| Other Pre-specified | Percentage of Participants Achieving Anti- DTd Antibody Concentrations of >= 0.1 IU/mL Before Vaccination | Percentage of participants achieving Anti-DTd antibody concentrations of >= 0.1 IU/mL before vaccination were reported. The LLOQ values for Anti-DTd= 0.037 IU/mL. Assay results below the LLOQ were set to 0.5*LLOQ. Data for this outcome measure was not planned to be collected and analyzed for RSV 120 mcg with placebo arm and RSV 240 mcg with aluminum hydroxide/placebo arm. | EIP: participants who were eligible, received all doses of investigational product to which they were randomized, have blood drawn for assay testing within the specified time frame for 1 month after vaccination, had at least 1 valid and determinate assay result at the 1-month-postvaccination visit and had no major protocol violations. | Posted | Number | 95% Confidence Interval | Percentage of participants | Before vaccination on Day 1 |
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| Other Pre-specified | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup A (RSV A) Neutralizing Antibodies Before Vaccination | Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution. Data for this outcome measure was planned to be collected and analyzed for combined population of participants reported under two RSV and Tdap vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) and two RSV and placebo arm: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo) and not planned to be collected and analyzed for Placebo/Tdap arm, as pre-specified in protocol. | EIP: participants who were eligible, received all doses of investigational product to which they were randomized, have blood drawn for assay testing within the specified time frame for 1 month after vaccination, had at least 1 valid and determinate assay result at the 1-month-postvaccination visit and had no major protocol violations. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Before vaccination on Day 1 |
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| Other Pre-specified | Geometric Mean Titer (GMT) of Respiratory Syncytial Virus Subgroup B (RSV B) Neutralizing Antibodies Before Vaccination | Assay results below the LLOQ were set to 0.5*LLOQ. Titers were expressed in terms of 1/dilution. Data for this outcome measure was planned to be collected and analyzed for combined population of participants reported under two RSV and Tdap vaccine arms: (RSV vaccine 120 mcg with Tdap and RSV vaccine 240 mcg with aluminum hydroxide/Tdap) and two RSV and placebo arm: (RSV vaccine 120 mcg with placebo and RSV vaccine 240 mcg with aluminum hydroxide with placebo) and not planned to be collected and analyzed for Placebo/Tdap arm, as pre-specified in protocol. | EIP: participants who were eligible, received all doses of investigational product to which they were randomized, have blood drawn for assay testing within the specified time frame for 1 month after vaccination, had at least 1 valid and determinate assay result at the 1-month-postvaccination visit and had no major protocol violations. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Before vaccination on Day 1 |
|
Local reactions and systematic reactions: within 7 days after vaccination. AEs: Baseline up to 35 days
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RSV Vaccine 120 mcg With Placebo | Participants received 0.5 mL, intramuscular injections of RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination. | 0 | 141 | 0 | 141 | 103 | 141 |
| EG001 | RSV Vaccine 120 mcg With Tdap | Participants received 0.5 mL, intramuscular injections of RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with Tdap on Day 1. Participants were followed up to 1 month after vaccination. | 0 | 141 | 0 | 141 | 114 | 141 |
| EG002 | RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo | Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination. | 0 | 142 | 1 | 142 | 118 | 142 |
| EG003 | RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap | Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination. | 0 | 144 | 0 | 144 | 119 | 144 |
| EG004 | Placebo/Tdap | Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination. | 0 | 141 | 0 | 141 | 106 | 141 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA v22.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v22.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v22.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Tooth impacted | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v22.1 | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v22.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA v22.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA v22.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA v22.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v22.1 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Sinusitis bacterial | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v22.1 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA v22.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v22.1 | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA v22.1 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA v22.1 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA v22.1 | Non-systematic Assessment |
| |
| Venomous sting | Injury, poisoning and procedural complications | MedDRA v22.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v22.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Pharyngeal mass | Respiratory, thoracic and mediastinal disorders | MedDRA v22.1 | Non-systematic Assessment |
| |
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA v22.1 | 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 | Nov 8, 2019 | Dec 7, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D013742 | Tetanus |
| D004165 | Diphtheria |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D022261 | Respiratory Syncytial Virus Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Male |
|
| 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 |
|
| OG001 |
| Placebo/Tdap |
Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination. |
|
|
|
| OG001 | Placebo/Tdap | Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination. |
|
|
|
| OG001 | RSV Vaccine With Aluminum Hydroxide With Placebo | This arm included all participants who received 0.5 mL intramuscular injection of either RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with matching placebo or RSV vaccine 240 mcg with aluminum hydroxide with matching placebo on Day 1. Participants were followed up to 1 month after vaccination. |
|
|
|
| OG001 | RSV Vaccine With Aluminum Hydroxide With Placebo | This arm included all participants who received 0.5 mL intramuscular injection of either RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with matching placebo or RSV vaccine 240 mcg with aluminum hydroxide with matching placebo on Day 1. Participants were followed up to 1 month after vaccination. |
|
|
|
| OG002 | RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo | Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination. |
| OG003 | RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap | Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination. |
| OG004 | Placebo/Tdap | Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination. |
|
|
| RSV Vaccine 120 mcg With Tdap |
Participants received 0.5 mL, intramuscular injections of RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with Tdap on Day 1. Participants were followed up to 1 month after vaccination. |
| OG002 | RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo | Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination. |
| OG003 | RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap | Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination. |
| OG004 | Placebo/Tdap | Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination. |
|
|
| OG002 |
| RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo |
Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination. |
| OG003 | RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap | Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination. |
| OG004 | Placebo/Tdap | Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination. |
|
|
| RSV Vaccine 240 mcg With Aluminum Hydroxide With Placebo |
Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with matching placebo (normal saline) on Day 1. Participants were followed up to 1 month after vaccination. |
| OG003 | RSV Vaccine 240 mcg With Aluminum Hydroxide With Tdap | Participants received 0.5 mL, intramuscular injections of RSV vaccine 240 mcg with aluminum hydroxide with Tdap on Day 1. Participants were followed up to 1 month after vaccination. |
| OG004 | Placebo/Tdap | Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination. |
|
|
| OG001 | RSV Vaccine With Aluminum Hydroxide With Placebo | This arm included all participants who received 0.5 mL intramuscular injection of either RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with matching placebo or RSV vaccine 240 mcg with aluminum hydroxide with matching placebo on Day 1. Participants were followed up to 1 month after vaccination. |
|
|
|
| OG001 | RSV Vaccine With Aluminum Hydroxide With Placebo | This arm included all participants who received 0.5 mL intramuscular injection of either RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with matching placebo or RSV vaccine 240 mcg with aluminum hydroxide with matching placebo on Day 1. Participants were followed up to 1 month after vaccination. |
|
|
|
| OG002 | Placebo/Tdap | Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination. |
|
|
| OG002 | Placebo/Tdap | Participants received 0.5 mL, intramuscular injection of matching placebo to RSV vaccine and Tdap on Day 1. Participants were followed up to 1 month after vaccination. |
|
|
This arm included all participants who received 0.5 mL intramuscular injection of either RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with matching placebo or RSV vaccine 240 mcg with aluminum hydroxide with matching placebo on Day 1. Participants were followed up to 1 month after vaccination. |
|
|
This arm included all participants who received 0.5 mL intramuscular injection of either RSV vaccine 120 mcg (reconstituted with sterile water for injection) along with matching placebo or RSV vaccine 240 mcg with aluminum hydroxide with matching placebo on Day 1. Participants were followed up to 1 month after vaccination. |
|
|