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This phase 2B, placebo-controlled, randomized, observer-blinded trial will evaluate the safety, tolerability, and immunogenicity of the investigational multivalent group B streptococcus vaccine administered concomitantly with Tdap in healthy nonpregnant women 18 through 49 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GBS6 and Tdap | Experimental | Multivalent group B streptococcus vaccine and Tetanus, diphtheria, and acellular pertussis vaccine (Tdap) |
|
| GBS6 and Placebo | Experimental | Multivalent group B streptococcus vaccine and Placebo |
|
| Placebo and Tdap | Experimental | Placebo and Tetanus, diphtheria, and acellular pertussis vaccine (Tdap) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multivalent Group B streptococcus vaccine | Biological | Multivalent Group B streptococcus vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination | Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 centimeter [cm]). Grading: Grade 1/mild (greater than [>] 2.0 to 5.0 cm), Grade 2/moderate (>5.0 to 10.0 cm), Grade 3/severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (emergency room [ER] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. | Day 1 (day of vaccination) to Day 7 |
| Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination | Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (>=) 38.0 degree Celsius (deg C) and categorized as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 hours [h]), Grade 2/moderate: (>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, chills, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person. | Day 1 (day of vaccination) to Day 7 |
| Percentage of Participants Reporting Adverse Events (AEs) Through 1 Month After Vaccination | 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. In this outcome measure results excluded data for local reactions and systemic events. |
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Inclusion Criteria:
Exclusion Criteria:
Healthy women ≥18 and ≤49 years of age.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alliance for Multispecialty Research, LLC | Newton | Kansas | 67114 | United States | ||
| Quality Clinical Research, Inc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40036340 | Derived | Smith WB, Seger W, Chawana R, Skogeby Z, Silmon de Monerri NC, Feng Y, Gaylord M, Jongihlati B, Beeslaar J, Skinner JM, Bickham K, Anderson AS. A Phase 2b Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 6-Valent Group B Streptococcus Vaccine Administered Concomitantly With Tetanus, Diphtheria, and Acellular Pertussis Vaccine in Healthy Nonpregnant Female Individuals. J Infect Dis. 2025 Jul 11;231(6):e1065-e1074. doi: 10.1093/infdis/jiaf096. |
| 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 306 participants were enrolled and randomized in the study, of whom 304 were vaccinated.
Healthy non-pregnant female participants aged 18-49 years, were randomized to receive multivalent group B streptococcus 6-valent polysaccharide conjugate vaccine (GBS6) and tetanus toxoid, diphtheria toxoid, and acellular pertussis vaccine (Tdap), or GBS6 and placebo, or placebo and Tdap.
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| ID | Title | Description |
|---|---|---|
| FG000 | GBS6 + Tdap | Participants were randomized to receive GBS6 120 microgram (mcg) (0.5 milliliter [mL]) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1. |
| FG001 | GBS6 + Placebo |
| 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 | Oct 4, 2022 | Apr 25, 2024 |
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This is an observer-blinded study. Study staff dispensing and administering the vaccine will be unblinded, but all other study personnel, including the principal investigator, and the subject, will be blinded.
| Tetanus, diphtheria, and acellular pertussis vaccine | Biological | Tetanus, diphtheria, and acellular pertussis vaccine |
|
|
| Placebo | Biological | Saline control |
|
| Day 1 (day of vaccination) through 1 Month post-vaccination |
| Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 6 Months After Vaccination | A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event. | Day 1 (day of vaccination) through 6 Months post-vaccination |
| Percentage of Participants Achieving Anti-tetanus Toxoid (Anti-TTd) and Anti-diphtheria Toxoid (Anti-DTd) Antibody Concentration >=0.1 IU/mL at 1 Month After Vaccination: GBS6 + Tdap and Placebo + Tdap Groups | IU/mL stands for international units per milliliter. | 1 Month after Vaccination (Day 1, day of vaccination) |
| Geometric Mean Concentration (GMC) of Anti-Pertussis Toxin (PT), Anti-Filamentous Hemagglutinin (FHA), and Anti-Pertactin (PRN) Antibodies; GMR of Anti-PT, Anti-FHA, and Anti-PRN for GBS6 + Tdap to Placebo + Tdap at 1 Month After Vaccination | GMCs of anti-PT, anti-FHA, and anti-PRN was reported as descriptive data for the GBS6 +Tdap and placebo + Tdap groups, along with associated 2-sided 95% confidence interval. GMR for anti-PT, anti-FHA and anti-PRN antibodies were estimated from the GBS6 + Tdap group to the placebo + Tdap group and reported as statistical data. | 1 Month after Vaccination (Day 1, day of vaccination) |
| GMC of GBS Capsular Polysaccharide (CPS) Serotype-Specific Immunoglobulin G (IgG) Antibodies; GMR of GBS CPS Serotype-specific IgG Antibodies for GBS6 + Tdap to Placebo + Tdap at 1 Month After Vaccination | GBS CPS serotype-specific IgG GMCs (Ia, Ib, II, III, IV, V) were reported as descriptive data for the GBS6+Tdap and GBS6+placebo groups, along with associated 2-sided 95% confidence interval. GMR of GBS CPS serotype-specific IgG antibodies were estimated from the GBS6 + Tdap group to the placebo + Tdap group and reported as statistical data. | 1 Month after Vaccination (Day 1, day of vaccination) |
| Omaha |
| Nebraska |
| 68114 |
| United States |
| Alliance for Multispecialty Research, LLC | Las Vegas | Nevada | 89119 | United States |
| Accellacare - Raleigh | Raleigh | North Carolina | 27609 | United States |
| Accellacare - Wilmington | Wilmington | North Carolina | 28401 | United States |
| PriMED Clinical Research | Dayton | Ohio | 45419 | United States |
| PriMed Clinical Research | Dayton | Ohio | 45429 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Alliance for Multispecialty Research, LLC | Knoxville | Tennessee | 37909 | United States |
| Benchmark Research | Fort Worth | Texas | 76135 | United States |
| DM Clinical Research - Brookline | Houston | Texas | 77081 | United States |
| J. Lewis Research, Inc. / Foothill Family Clinic South | Salt Lake City | Utah | 84121 | United States |
Participants were randomized to receive GBS6 120 mcg (0.5 mL) and placebo (0.5 mL, normal saline) intramuscularly in the left and right deltoid muscle respectively on Day 1.
| FG002 | Placebo + Tdap | Participants were randomized to receive placebo (0.5 mL normal saline) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1. |
| Vaccinated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety set included all participants who received at least 1 dose of the study interventions and had at least 1 valid post dose safety assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | GBS6 + Tdap | Participants were randomized to receive GBS6 120 microgram (mcg) (0.5 milliliter [mL]) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1. |
| BG001 | GBS6 + Placebo | Participants were randomized to receive GBS6 120 mcg (0.5 mL) and placebo (0.5 mL, normal saline) intramuscularly in the left and right deltoid muscle respectively on Day 1. |
| BG002 | Placebo + Tdap | Participants were randomized to receive placebo (0.5 mL normal saline) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1. |
| BG003 | 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 | Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination | Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 centimeter [cm]). Grading: Grade 1/mild (greater than [>] 2.0 to 5.0 cm), Grade 2/moderate (>5.0 to 10.0 cm), Grade 3/severe (>10.0 cm) and Grade 4 (necrosis [swelling] or necrosis or exfoliative dermatitis [redness]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (emergency room [ER] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. | Safety set included all participants who received at least 1 dose of the study interventions and had at least 1 valid post dose safety assessment. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 (day of vaccination) to Day 7 |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination | Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (>=) 38.0 degree Celsius (deg C) and categorized as >=38.0-38.4 deg C, >38.4-38.9 deg C, >38.9-40.0 deg C and >40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 hours [h]), Grade 2/moderate: (>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, chills, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person. | Safety set included all participants who received at least 1 dose of the study interventions and had at least 1 valid post dose safety assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 (day of vaccination) to Day 7 |
| ||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Reporting Adverse Events (AEs) Through 1 Month After Vaccination | 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. In this outcome measure results excluded data for local reactions and systemic events. | Safety set included all participants who received at least 1 dose of the study interventions and had at least 1 valid post dose safety assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 (day of vaccination) through 1 Month post-vaccination |
| ||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 6 Months After Vaccination | A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event. | Safety set included all participants who received at least 1 dose of the study interventions and had at least 1 valid post dose safety assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 (day of vaccination) through 6 Months post-vaccination |
| ||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Achieving Anti-tetanus Toxoid (Anti-TTd) and Anti-diphtheria Toxoid (Anti-DTd) Antibody Concentration >=0.1 IU/mL at 1 Month After Vaccination: GBS6 + Tdap and Placebo + Tdap Groups | IU/mL stands for international units per milliliter. | Evaluable immunogenicity population included all participants who were eligible, received all doses of the investigational products to which they were randomized, had 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 (Day 1, day of vaccination) |
|
| |||||||||||||||||||||||||||||||||
| Primary | Geometric Mean Concentration (GMC) of Anti-Pertussis Toxin (PT), Anti-Filamentous Hemagglutinin (FHA), and Anti-Pertactin (PRN) Antibodies; GMR of Anti-PT, Anti-FHA, and Anti-PRN for GBS6 + Tdap to Placebo + Tdap at 1 Month After Vaccination | GMCs of anti-PT, anti-FHA, and anti-PRN was reported as descriptive data for the GBS6 +Tdap and placebo + Tdap groups, along with associated 2-sided 95% confidence interval. GMR for anti-PT, anti-FHA and anti-PRN antibodies were estimated from the GBS6 + Tdap group to the placebo + Tdap group and reported as statistical data. | Evaluable immunogenicity population included all participants who were eligible, received all doses of the investigational products to which they were randomized, had 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 units per milliliter (EU/mL) | 1 Month after Vaccination (Day 1, day of vaccination) |
| ||||||||||||||||||||||||||||||||||
| Primary | GMC of GBS Capsular Polysaccharide (CPS) Serotype-Specific Immunoglobulin G (IgG) Antibodies; GMR of GBS CPS Serotype-specific IgG Antibodies for GBS6 + Tdap to Placebo + Tdap at 1 Month After Vaccination | GBS CPS serotype-specific IgG GMCs (Ia, Ib, II, III, IV, V) were reported as descriptive data for the GBS6+Tdap and GBS6+placebo groups, along with associated 2-sided 95% confidence interval. GMR of GBS CPS serotype-specific IgG antibodies were estimated from the GBS6 + Tdap group to the placebo + Tdap group and reported as statistical data. | Evaluable immunogenicity population evaluated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Here, "Number analyzed" signifies number of participants with valid and determinate assay results for the serotype at the specified time point. | Posted | Geometric Mean | 95% Confidence Interval | mcg/mL | 1 Month after Vaccination (Day 1, day of vaccination) |
|
Local reaction and systemic events (systematic assessment): up to 7 days post-vaccination; All-cause mortality, SAEs, MAEs (non-systematic assessment): up to 6 months post-vaccination; Other AEs (non-systematic assessment): up to 1-month post-vaccination [vaccination was on Day 1]
All participants who receive at least 1 dose of the investigational products and have at least 1 valid post dose assessment.
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 | GBS6 + Tdap | Participants were randomized to receive GBS6 120 microgram (mcg) (0.5 milliliter [mL]) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1. | 0 | 102 | 0 | 102 | 81 | 102 |
| EG001 | GBS6 + Placebo | Participants were randomized to receive GBS6 120 mcg (0.5 mL) and placebo (0.5 mL, normal saline) intramuscularly in the left and right deltoid muscle respectively on Day 1. | 0 | 99 | 0 | 99 | 71 | 99 |
| EG002 | Placebo + Tdap | Participants were randomized to receive placebo (0.5 mL normal saline) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1. | 0 | 103 | 1 | 103 | 79 | 103 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bile duct stone | Hepatobiliary disorders | MedDRA v26.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Developmental hip dysplasia | Congenital, familial and genetic disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Autoimmune thyroiditis | Endocrine disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Tooth impacted | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
| |
| Abnormal weight gain | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Tenosynovitis stenosans | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Nerve compression | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Attention deficit hyperactivity disorder | Psychiatric disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v26.0 | Non-systematic Assessment |
| |
| Diarrhoea (DIARRHEA) | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Vomiting (NAUSEA/VOMITING) | Gastrointestinal disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Fatigue (FATIGUE) | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Injection site erythema (REDNESS) | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Injection site pain (PAIN) | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Injection site swelling (SWELLING) | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Pyrexia (FEVER) | General disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Arthralgia (JOINT PAIN) | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Myalgia (MUSCLE PAIN) | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Systematic Assessment |
| |
| Headache (HEADACHE) | Nervous system disorders | MedDRA v26.0 | 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_Inquires@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 14, 2022 | Apr 25, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D022681 | Diphtheria-Tetanus-acellular Pertussis Vaccines |
| ID | Term |
|---|---|
| D010567 | Pertussis Vaccine |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D004168 | Diphtheria Toxoid |
| D014121 | Toxoids |
| D013745 | Tetanus Toxoid |
| D017778 | Vaccines, Combined |
| D022282 | Vaccines, Acellular |
| D022223 | Vaccines, Subunit |
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 |
|
|
| Pain at injection site: Moderate |
|
| Pain at injection site: Severe |
|
| Pain at injection site: Grade 4 |
|
| Erythema/redness: Any |
|
| Erythema/redness: Mild |
|
| Erythema/redness: Moderate |
|
| Erythema/redness: Severe |
|
| Erythema/redness: Grade 4 |
|
| Induration/swelling: Any |
|
| Induration/swelling: Mild |
|
| Induration/swelling: Moderate |
|
| Induration/swelling: Severe |
|
| Induration/swelling: Grade 4 |
|
| GBS6 + Placebo |
Participants were randomized to receive GBS6 120 mcg (0.5 mL) and placebo (0.5 mL, normal saline) intramuscularly in the left and right deltoid muscle respectively on Day 1. |
| OG002 | Placebo + Tdap | Participants were randomized to receive placebo (0.5 mL normal saline) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1. |
|
|
|
|
| OG002 |
| Placebo + Tdap |
Participants were randomized to receive placebo (0.5 mL normal saline) and Tdap (0.5 mL) intramuscularly in the left and right deltoid muscle respectively on Day 1. |
|
|
| Participants |
|
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|