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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001340-62 | EudraCT Number |
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The purpose of this study is to evaluate different dose levels of the investigational RSV maternal vaccine (GSK3888550A) based on safety/reactogenicity and immune response data.
As this is the first time the investigational RSV maternal vaccine (GSK3888550A) is being been used in humans, this study will be performed in healthy non-pregnant women 18-45 years of age before testing in pregnant women.
Healthy non-pregnant women 18-45 years of age will be randomized in a 1:1:1:1 ratio to receive one of three dose levels (30, 60, 120 micrograms [µg]) of the investigational RSV maternal vaccine (GSK3888550A) or placebo, administered as a single intramuscular injection (IM).
There will be a screening visit and five study visits scheduled at Day 1 (study vaccination), Day 8, Day 31, Day 61, and Day 91 to evaluate the primary and secondary objectives of safety/reactogenicity and immunogenicity profiles of the 3 dose levels. Subjects will also be contacted at Day 181. During this contact, the investigator (or delegate) will ask the subject if she has experienced any serious adverse events (SAEs) and or any adverse events (AEs) leading to study withdrawal since the last study visit (Day 360), as well as if she has become pregnant during the post-vaccination period. The investigator (or delegate) will also ask the subject about concomitant vaccinations/products/medications that she has received since the last study visit (D91). Contact should be performed preferably via telephone. Other means of contact (email/other) may be acceptable provided the required information can be fully collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSV MAT formulation 1 Group | Experimental | Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
|
| RSV MAT formulation 2 Group | Experimental | Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
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| RSV MAT formulation 3 Group | Experimental | Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
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| Control Group | Placebo Comparator | Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK3888550A RSV Maternal vaccine formulation 1 | Biological | Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period | Assessed solicited local symptoms include pain, redness and swelling, at the injection site. Any = occurrence of the AE regardless of intensity grade. Any Redness and swelling symptom = symptom reported with a surface diameter greater than 20 millimeters. Grade 3 pain = significant pain at rest, pain that prevented normal every day activity. Grade 3 redness/swelling = symptom reported with a surface diameter greater than 100 millimeters. | During a 7-day follow-up period (i.e., on the day of vaccination and 6 subsequent days) |
| Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Assessed solicited general symptoms include fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhea and/or abdominal pain), headache and fever. Any Fatigue, gastrointestinal symptoms and headache = occurrence of the symptom regardless of intensity grade and relationship. Any Fever = temperature higher than or equal to 38.0 degrees Celsius (°C), or 100.4 degrees Fahrenheit (°F). Grade 3 Fatigue, gastrointestinal symptoms and headache = symptoms that prevented normal activities. Grade 3 Fever = temperature higher than 39.0 degrees Celsius (°C), or 102.2 degrees Fahrenheit (°F). Related fatigue, gastrointestinal symptoms, headache and fever(>38°C) = symptoms assessed by the investigator as related to the vaccination. | During a 7-day follow-up period (i.e., on the day of vaccination and 6 subsequent days) |
| Number of Subjects With Any Unsolicited AEs During a 30-day Follow-up Period | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | During a 30-day follow-up period after vaccination (i.e., on the day of vaccination and 29 subsequent days) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With SAEs | Assessed SAEs include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. | From Day 1 (vaccination) up to Day 91 and up to Day 181 |
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Inclusion Criteria:
Subjects who the investigator believes will comply with the requirements of the protocol (e.g. completion of the diary cards/questionnaires, return for follow-up visits, have regular contact to allow evaluation during the study);
Written informed consent obtained from the subject;
Healthy female subjects; as established by medical history and clinical examination, aged 18 to 45 years at the time of the vaccination;
Female subjects of childbearing potential may be enrolled in the study, if the subject:
Exclusion Criteria:
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding vaccination or any planned use during the study period;
Concurrently participating in the active phase of another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product
Chronic administration (defined as more than 14 days in total) of immunosuppressant or other immune-modifying drugs, as well as administration of long acting immune modifying drugs, within 6 months prior to the vaccine dose (for corticosteroids, this will mean prednisone higher than or equal to (≥) 5 milligrams per day (mg/day), or equivalent). Inhaled and topical steroids are allowed;
Administration of immunoglobulins and/or any blood products during the period starting 3 months before the study vaccination, or planned administration until 90 days post-vaccination;
Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after study vaccination, with the exception of any licensed influenza vaccine which may be administered ≥ 15 days before or after study vaccination;
Previous experimental vaccination against RSV;
Presence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports;
Family history of congenital or hereditary immunodeficiency;
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination;
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine;
Any acute or chronic, clinically significant disease, as determined by physical examination, laboratory screening tests, subject personal report and/or health care provider information. The following conditions will be exclusionary:
Diabetes mellitus,
Respiratory diseases, such as:
Significant and/or uncontrolled psychiatric illness:
Major neurological disease including:
Significant cardiovascular disease, including:
Known or suspected Hepatitis B or Hepatitis C infection,
Any other significant uncontrolled medical illness, defined as any illness requiring new medical and/or surgical treatment or significant modification of treatment dose due to uncontrolled symptoms or drug toxicity, within 3 months prior to study vaccination.
History of or current autoimmune disease;
Body mass index (BMI) > 40 Kilograms (kg)/square meters(m^2);
Pregnant or lactating female;
Female planning to become pregnant or planning to discontinue contraceptive precautions;
Hypersensitivity to latex;
Lymphoproliferative disorder or malignancy within previous 5 years;
Acute disease and/or fever at the time of enrolment;
Any clinically significant or any ≥ Grade 2* haematological (haemoglobin level, white blood cell, lymphocyte, neutrophil, eosinophil, and platelets) and biochemical (alanine aminotransferase [ALT] aspartate aminotransferase [AST], creatinine, blood urea nitrogen [BUN]) laboratory abnormality detected at the last screening blood sampling; *Grading of laboratory parameters will be based on the FDA Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials".
For Grade 1 laboratory abnormalities, the investigator should use clinical judgement to decide which ones are clinically relevant.
Subjects with haematological/biochemical values out of normal range at screening which are expected to be temporary, may be re-screened 1 time at a later date.
The vaccine is for use in pregnant women, as such, the study is female only.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Lenexa | Kansas | 66219 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34146100 | Background | Schwarz TF, Johnson C, Grigat C, Apter D, Csonka P, Lindblad N, Nguyen TL, Gao FF, Qian H, Tullio AN, Dieussaert I, Picciolato M, Henry O. Three Dose Levels of a Maternal Respiratory Syncytial Virus Vaccine Candidate Are Well Tolerated and Immunogenic in a Randomized Trial in Nonpregnant Women. J Infect Dis. 2022 Jun 15;225(12):2067-2076. doi: 10.1093/infdis/jiab317. |
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IPD for this study is available via the Clinical Study Data Request site
IPD is available via the Clinical Study Data Request site (copy the URL below to your browser)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Among 579 screened subjects in this study, 77 subjects were screen failure. 502 subjects were enrolled.
The study was conducted at 11 centers in 3 countries: 4 in Finland, 5 in Germany and 2 in the USA.
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| ID | Title | Description |
|---|---|---|
| FG000 | RSV MAT Formulation 1 Group | Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
| FG001 | RSV MAT Formulation 2 Group |
| 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 | Aug 13, 2018 | Mar 17, 2020 |
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Observer-blind In this study, the subject and study site personnel involved in the clinical evaluations of the subjects are blinded while other study personnel may be aware of the treatment assignments.
| GSK3888550A RSV Maternal vaccine formulation 2 | Biological | Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm |
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| GSK3888550A RSV Maternal vaccine formulation 3 | Biological | Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm |
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| Placebo (Normal Saline) | Drug | Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm |
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| Number of Subjects With Serious Adverse Events (SAEs) During a 30-day Follow-up Period | Assessed SAEs include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. | From Day 1 (vaccination) up to Day 30 (i.e., on the day of vaccination and 29 subsequent days) |
| Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes, Neutrophils, Platelets, White blood cells (WBC). Hematological abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR). [e.g. WBC, BELOW(SCR), BELOW = WBC BELOW normal ranges at baseline versus BELOW normal ranges at Day 8]. | At Day 8 |
| Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes, Neutrophils, Platelets, White blood cells (WBC). Hematological abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR) [e.g. WBC, BELOW(SCR), BELOW = WBC BELOW normal ranges at baseline versus BELOW normal ranges at Day 31]. | At Day 31 |
| Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine. Biochemical abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR)[e.g. ALT, BELOW(SCR), BELOW = ALT BELOW normal ranges at baseline versus BELOW normal ranges at Day 8]. | At Day 8 |
| Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine and blood urea nitrogen (BUN). Biochemical abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR) [e.g. ALT, BELOW(SCR), BELOW = ALT BELOW normal ranges at baseline versus BELOW normal ranges at Day 31]. | At Day 31 |
| Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes Decrease, Neutrophils Decrease, Platelets Decrease, WBC Decrease and WBC Increase, as graded by the Food and Drug Administration [FDA] Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline [e.g. WBC decrease-Grade 1(SCR)-Grade 1 = WBC decrease Grade 1 at baseline versus Grade 1 at Day 8]. "Any" corresponding to any grade and "Grade 0" to normal ranges. | At Day 8 |
| Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes Decrease, Neutrophils Decrease, Platelets Decrease, WBC Decrease and WBC Increase, as graded by the Food and Drug Administration [FDA] Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline [e.g. WBC decrease-Grade 1(SCR)-Grade 1 = WBC decrease Grade 1 at baseline versus Grade 1 at Day 31]. "Any" corresponding to any grade and "Grade 0" to normal ranges. | At Day 31 |
| Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine, as graded by the Food and Drug Administration [FDA] Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline [e.g. ALT-Grade 1(SCR)-Grade 1 = ALT Grade 1 at baseline versus Grade 1 at Day 8]. "Any" corresponding to any grade and "Grade 0" to normal ranges. | At Day 8 |
| Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine, as graded by the Food and Drug Administration [FDA] Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline [e.g. ALT-Grade 1(SCR)-Grade 1 = ALT Grade 1 at baseline versus Grade 1 at Day 31]. "Any" corresponding to any grade and "Grade 0" to normal ranges. | At Day 31 |
| Neutralizing Antibody (Nab) Titers Against RSV Serotype A | Anti RSV-A neutralizing antibody titers are given as geometric mean titers (GMTs) and expressed as Estimated Dose: serum dilution giving a 60% reduction of the signal compared to a control without serum (ED60), calculated on subjects with anti-RSV-A neutralizing antibody titer equal to or above the assay cut-off 18 ED60. | At pre-vaccination at screening (PRE), 7 days post vaccination (Day 8), 30 days post vaccination (Day 31), 60 days post vaccination (Day 61) and 90 days post vaccination (Day 91) |
| Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations | Concentrations are presented as geometric mean concentrations (GMCs), expressed in Enzyme Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/mL), calculated on subjects with anti-RSVPreF3 antibody concentration equal to or above the assay cut-off 25 EL.U/mL. | At pre-vaccination at screening (PRE), 7 days post vaccination (Day 8), 30 days post vaccination (Day 31), 60 days post vaccination (Day 61) and 90 days post vaccination (Day 91) |
| Rochester |
| New York |
| 14609 |
| United States |
| GSK Investigational Site | Helsinki | 00260 | Finland |
| GSK Investigational Site | Tampere | FI-33100 | Finland |
| GSK Investigational Site | Turku | 20100 | Finland |
| GSK Investigational Site | Turku | 20540 | Finland |
| GSK Investigational Site | Würzburg | Bavaria | 97070 | Germany |
| GSK Investigational Site | Hanover | Lower Saxony | 30159 | Germany |
| GSK Investigational Site | Goch | North Rhine-Westphalia | 47574 | Germany |
| GSK Investigational Site | Mainz | Rhineland-Palatinate | 55116 | Germany |
| GSK Investigational Site | Hamburg | 22143 | Germany |
Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
| FG002 | RSV MAT Formulation 3 Group | Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
| FG003 | Control Group | Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | RSV MAT Formulation 1 Group | Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
| BG001 | RSV MAT Formulation 2 Group | Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
| BG002 | RSV MAT Formulation 3 Group | Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
| BG003 | Control Group | Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | 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 | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events (AE) During a 7-day Follow-up Period | Assessed solicited local symptoms include pain, redness and swelling, at the injection site. Any = occurrence of the AE regardless of intensity grade. Any Redness and swelling symptom = symptom reported with a surface diameter greater than 20 millimeters. Grade 3 pain = significant pain at rest, pain that prevented normal every day activity. Grade 3 redness/swelling = symptom reported with a surface diameter greater than 100 millimeters. | The analysis was performed on the Exposed Set, which included all subjects with the study vaccine administration documented. | Posted | Count of Participants | Participants | During a 7-day follow-up period (i.e., on the day of vaccination and 6 subsequent days) |
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| Primary | Number of Subjects With Any, Grade 3 and Related Solicited General Adverse Events (AE) During a 7-day Follow-up Period | Assessed solicited general symptoms include fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhea and/or abdominal pain), headache and fever. Any Fatigue, gastrointestinal symptoms and headache = occurrence of the symptom regardless of intensity grade and relationship. Any Fever = temperature higher than or equal to 38.0 degrees Celsius (°C), or 100.4 degrees Fahrenheit (°F). Grade 3 Fatigue, gastrointestinal symptoms and headache = symptoms that prevented normal activities. Grade 3 Fever = temperature higher than 39.0 degrees Celsius (°C), or 102.2 degrees Fahrenheit (°F). Related fatigue, gastrointestinal symptoms, headache and fever(>38°C) = symptoms assessed by the investigator as related to the vaccination. | The analysis was performed on the Exposed Set, which included all subjects with the study vaccine administration documented. | Posted | Count of Participants | Participants | During a 7-day follow-up period (i.e., on the day of vaccination and 6 subsequent days) |
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| Primary | Number of Subjects With Any Unsolicited AEs During a 30-day Follow-up Period | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | The analysis was performed on the Exposed Set, which included all vaccinated subjects. | Posted | Count of Participants | Participants | During a 30-day follow-up period after vaccination (i.e., on the day of vaccination and 29 subsequent days) |
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| Primary | Number of Subjects With Serious Adverse Events (SAEs) During a 30-day Follow-up Period | Assessed SAEs include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. | The analysis was performed on the Exposed Set, which included all vaccinated subjects. | Posted | Count of Participants | Participants | From Day 1 (vaccination) up to Day 30 (i.e., on the day of vaccination and 29 subsequent days) |
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| Primary | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes, Neutrophils, Platelets, White blood cells (WBC). Hematological abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR). [e.g. WBC, BELOW(SCR), BELOW = WBC BELOW normal ranges at baseline versus BELOW normal ranges at Day 8]. | The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point. | Posted | Count of Participants | Participants | At Day 8 |
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| Primary | Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes, Neutrophils, Platelets, White blood cells (WBC). Hematological abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR) [e.g. WBC, BELOW(SCR), BELOW = WBC BELOW normal ranges at baseline versus BELOW normal ranges at Day 31]. | The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point. | Posted | Count of Participants | Participants | At Day 31 |
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| Primary | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 | Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine. Biochemical abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR)[e.g. ALT, BELOW(SCR), BELOW = ALT BELOW normal ranges at baseline versus BELOW normal ranges at Day 8]. | The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point. | Posted | Count of Participants | Participants | At Day 8 |
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| Primary | Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 | Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine and blood urea nitrogen (BUN). Biochemical abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR) [e.g. ALT, BELOW(SCR), BELOW = ALT BELOW normal ranges at baseline versus BELOW normal ranges at Day 31]. | The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point. | Posted | Count of Participants | Participants | At Day 31 |
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| Primary | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes Decrease, Neutrophils Decrease, Platelets Decrease, WBC Decrease and WBC Increase, as graded by the Food and Drug Administration [FDA] Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline [e.g. WBC decrease-Grade 1(SCR)-Grade 1 = WBC decrease Grade 1 at baseline versus Grade 1 at Day 8]. "Any" corresponding to any grade and "Grade 0" to normal ranges. | The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point. | Posted | Count of Participants | Participants | At Day 8 |
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| Primary | Number of Subjects With Hematological Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes Decrease, Neutrophils Decrease, Platelets Decrease, WBC Decrease and WBC Increase, as graded by the Food and Drug Administration [FDA] Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline [e.g. WBC decrease-Grade 1(SCR)-Grade 1 = WBC decrease Grade 1 at baseline versus Grade 1 at Day 31]. "Any" corresponding to any grade and "Grade 0" to normal ranges. | The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point. | Posted | Count of Participants | Participants | At Day 31 |
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| Primary | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 8 | Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine, as graded by the Food and Drug Administration [FDA] Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline [e.g. ALT-Grade 1(SCR)-Grade 1 = ALT Grade 1 at baseline versus Grade 1 at Day 8]. "Any" corresponding to any grade and "Grade 0" to normal ranges. | The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point. | Posted | Count of Participants | Participants | At Day 8 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Biochemical Laboratory Results Versus Baseline, by Maximum Grading, at Day 31 | Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine, as graded by the Food and Drug Administration [FDA] Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline [e.g. ALT-Grade 1(SCR)-Grade 1 = ALT Grade 1 at baseline versus Grade 1 at Day 31]. "Any" corresponding to any grade and "Grade 0" to normal ranges. | The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point. | Posted | Count of Participants | Participants | At Day 31 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Subjects With SAEs | Assessed SAEs include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. | The analysis was performed on the Exposed Set, which included all vaccinated subjects. | Posted | Count of Participants | Participants | From Day 1 (vaccination) up to Day 91 and up to Day 181 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Neutralizing Antibody (Nab) Titers Against RSV Serotype A | Anti RSV-A neutralizing antibody titers are given as geometric mean titers (GMTs) and expressed as Estimated Dose: serum dilution giving a 60% reduction of the signal compared to a control without serum (ED60), calculated on subjects with anti-RSV-A neutralizing antibody titer equal to or above the assay cut-off 18 ED60. | The analysis was performed on the Per-protocol set which included all vaccinated subjects, meeting all protocol requirements and for whom immunogenicity results were available for the specified assay at the corresponding time-point. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At pre-vaccination at screening (PRE), 7 days post vaccination (Day 8), 30 days post vaccination (Day 31), 60 days post vaccination (Day 61) and 90 days post vaccination (Day 91) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Anti-RSVPreF3 Immunoglobulin G (IgG) Antibody Concentrations | Concentrations are presented as geometric mean concentrations (GMCs), expressed in Enzyme Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/mL), calculated on subjects with anti-RSVPreF3 antibody concentration equal to or above the assay cut-off 25 EL.U/mL. | The analysis was performed on the Per-protocol set which included all vaccinated subjects, meeting all protocol requirements and for whom immunogenicity results were available for the specified assay at the corresponding time-point. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At pre-vaccination at screening (PRE), 7 days post vaccination (Day 8), 30 days post vaccination (Day 31), 60 days post vaccination (Day 61) and 90 days post vaccination (Day 91) |
|
Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
Not provided
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 MAT Formulation 1 Group | Subjects received a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm | 0 | 124 | 0 | 124 | 94 | 124 |
| EG001 | RSV MAT Formulation 2 Group | Subjects received a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm | 0 | 126 | 0 | 126 | 96 | 126 |
| EG002 | RSV MAT Formulation 3 Group | Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm | 0 | 126 | 1 | 126 | 105 | 126 |
| EG003 | Control Group | Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm | 0 | 126 | 2 | 126 | 83 | 126 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Injection site inflammation | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Injury associated with device | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vaccination site bruising | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vaccination site haematoma | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nerve compression | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Poor quality sleep | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Thermohyperaesthesia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Bacterial vaginosis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Conjunctivitis bacterial | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Nasal herpes | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Paranasal sinus discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Breast swelling | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Genital pain | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Menstrual disorder | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Perioral dermatitis | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
| |
| External ear pain | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyperacusis | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dental restoration failure | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Peripheral coldness | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 25, 2018 | Mar 17, 2020 | 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
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
|
| BLACK OR AFRICAN AMERICAN |
|
| OTHER |
|
| WHITE |
|
| Grade 3 Pain |
|
| Any Redness |
|
| Grade 3 Redness |
|
| Any Swelling |
|
| Grade 3 Swelling |
|
| OG002 | RSV MAT Formulation 3 Group | Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
| OG003 | Control Group | Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
|
|
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
| OG003 | Control Group | Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
|
|
| OG003 | Control Group | Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
|
|
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
| OG003 | Control Group | Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
|
|
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
| OG003 | Control Group | Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
|
|
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
| OG003 | Control Group | Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
|
|
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
| OG003 | Control Group | Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
|
|
| OG002 | RSV MAT Formulation 3 Group | Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
| OG003 | Control Group | Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
|
|
| OG002 | RSV MAT Formulation 3 Group | Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
| OG003 | Control Group | Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
|
|
| OG002 | RSV MAT Formulation 3 Group | Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
| OG003 | Control Group | Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
|
|
| OG002 | RSV MAT Formulation 3 Group | Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
| OG003 | Control Group | Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
|
|
| OG003 | Control Group | Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
|
|
| RSV MAT Formulation 3 Group |
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
| OG003 | Control Group | Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
|
|
Subjects received a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
| OG003 | Control Group | Subjects received a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm |
|
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