A Phase 3 interventional study of HZ/su vaccine GSK1437173A and Prevenar13 in Herpes Zoster, sponsored by GlaxoSmithKline. Completed at 13 sites in 4 countries. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-11.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention
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Among 46 studies testing shingrix in Herpes Zoster — 8 open to participants now, 11 under way, 3 of them phase 3. shingrix · Herpes Zoster.
Among the 46 studies testing shingrix in Herpes Zoster, this one is the 11th largest by enrollment, is one of 2 that started in 2018, is one of 22 in phase 3, and was the 21st registered.
299 studies on the registry are indexed under Herpes Zoster; 55 are open to participants now.
Browse Herpes Zoster studies →8 of the 46 studies testing shingrix in Herpes Zoster are open now, in 5 countries. Recruiting first, the newest first:
GlaxoSmithKline · Sites in Finland
Ages 76+ · Healthy volunteers
Seoul National University Hospital · Sites in Korea, Republic of
Ages 19+
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 18+ · Healthy volunteers
Loyola University · Sites in United States
University of Colorado, Denver · Sites in United States
Ages 18–70
By country, each count listing its studies:
shingrix: first FDA approval 2017 (Shingrix). What it is approved for, and how studies give it, is on its page →
Of the 37 Herpes Zoster studies recruiting now, 26 (70%) set no upper age limit and 6 (16%) stop at 75 or younger; 3 take children under 18; 13 take healthy volunteers.
This study: 50 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
46 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 10 · Phase 3 22 · Phase 4 8
First in 2009; this study’s year is marked. 2 started in 2018.
This study's enrollment of 913 is above the median of 160 across 247 interventional studies indexed under Herpes Zoster.
Median enrollment 239 across the 46 interventional studies. Of the 32 that completed or were terminated, 27 (84%) have results posted.
This tab as a report to print or save as PDF → With an account.
29 of 46 have an industry lead sponsor. The 10 most frequent:
GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
44 studies in Herpes Zoster by GlaxoSmithKline: 3 open now, 5 under way, 1 of them phase 3. Of 39 finished, 34 (87%) have results posted.
Among the 44 studies in Herpes Zoster by GlaxoSmithKline, this one is the 12th largest by enrollment of the 37 interventional ones that give a count, is one of 2 that started in 2018, is one of 25 in phase 3, and was the 32nd registered.
GlaxoSmithKline’s Herpes Zoster studies by the year they started, since 2007.
4 of the studies testing shingrix in Herpes Zoster that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05371080Phase 3GlaxoSmithKlineA Study on the Long-term Efficacy, Safety and Persistence of Immune Response of a Vaccine Against Herpes Zoster in Older Adults | 2027-08-23 |
| NCT05580458National Institute of Allergy and Infectious Diseases (NIAID)Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population | 2027-02-01 |
| NCT06162494Ann & Robert H Lurie Children's Hospital of ChicagoRecombinant Zoster Vaccine in Young Adult Solid Organ Transplant Recipients | 2027-03-31 |
| NCT06569823Dynavax Technologies CorporationSafety and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adults 50 Years of Age and Over | 2027-06 |
Add all 4 to your calendar (.ics) → With an account.
Among the 46 studies testing shingrix in Herpes Zoster, from their registry updates:
Among GlaxoSmithKline’s 44 in Herpes Zoster:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to assess immunogenicity and safety of GSK Biologicals' HZ vaccine when its first dose is co-administered with a pneumococcal polysaccharide conjugate vaccine (Prevenar13) in adults aged ≥50 YOA, as compared to the control group where the two HZ/su doses are administered subsequent to Prevenar13.
Following the initial approval of the GlaxoSmithKline (GSK) Biologicals' HZ/su vaccine, the protocol was amended to indicate that the trademark is Shingrix. In addition, the term "candidate" vaccine has been replaced by "study" vaccine throughout the protocol.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
Exclusion Criteria:
Acute disease and/or fever at the time of enrollment.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults aged ≥50 years of age who received the first dose of GSK1437173A and one dose of Prevenar13 at Day 1 and the second dose of GSK1437173A at Month 2. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
Biological: HZ/su vaccine GSK1437173A · Biological: Prevenar13
Adults aged ≥50 years of age who received one dose of Prevenar13 at Day 1, the first dose of GSK1437173A at Month 2 and the second dose of GSK1437173A at Month 4. Both vaccines were administered intramuscularly, GSK1437173A was administered in the deltoid muscle of the non-dominant arm, while Prevenar13 was administered in the deltoid muscle of the dominant arm
Biological: HZ/su vaccine GSK1437173A · Biological: Prevenar13
Drug page: Shingrix
2 doses of 0.5 mL of the vaccine in a 0,2 Months schedule. Administered by intramuscular injection into the deltoid muscle of the non-dominant arm.
1 dose of 0.5 mL of the vaccine. Administered by intramuscular injection into the deltoid muscle of the dominant arm.
Also known as: PCV13
Percentage of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in Co-Ad Group
Vaccine response rate (VRR) for Varicella Zoster Virus (VZV) anti-glycoprotein E (gE) humoral immunogenicity was determined by Enzyme Limked Immunosorbent Assay (ELISA). The VRR for anti-gE is defined as the percentage of subjects who had at least: a 4-fold increase in the anti-gE antibodies concentration as compared to the pre-vaccination anti-gE antibodies concentration, for subjects who are seropositive at baseline, or, a 4-fold increase in the anti-gE antibodies concentration as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who are seronegative at baseline.
Time frame: One month post-dose 2 (Month 3)
Anti-gE Antibody Concentrations
Anti-gE antibody concentrations in terms of Geometric Mean concentrations (GMC) were determined by ELISA and expressed as milli-international units per milliliter (mIU/mL)
Time frame: One month post-dose 2 (at Month 3 for the Co-Ad and Month 5 for the Control group).
Anti-pneumococcal Antibody Titers
Anti-pneumococcal antibody titers for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) were determined by Multiplex Opsonophagocytosis Assay (MOPA)
Time frame: At one month post-dose 1 (Month 1)
Adjusted Geometric Mean Concentrations (GMCs) for Anti-gE Antibody
Anti-gE antibody concentrations (GMCs) adjusted for age and baseline concentrations were determined using Analysis Of Covariance (ANCOVA) model. Adjusted GMCs were expressed in milli-international units per milliliter (mIU/mL)
Time frame: One month post-dose 2 (at Month 3 for the Co-Ad and Month 5 for the Control group).
Adjusted Geometric Mean Titers (GMTs) of Anti-pneumococcal Antibodies
Geometric mean antibody (anti-pneumococcal antibodies: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) titers adjusted for age and baseline concentration were determined using ANCOVA model.
Time frame: At one month post-dose 1 (Month 1)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Vaccine and Dose
Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 erythema/swelling = erythema/swelling that had spread beyond 100 millimeters (mm) of injection site. The Co-Ad Group received only 2 vaccine doses.
Time frame: Within 7 days (Day 1 - 7) after each vaccination
Number of Days With Each Solicited Local Symptoms
The number of days with any local symptoms had been assessed during the post-vaccination period.
Time frame: Within 7 days (Day 1 - 7) after each vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were fatigue, fever \[defined as oral temperature ≥ 38.0 degrees Celsius (°C)/ 100.4 degrees Fahrenheit (°F)\], GastroIntestinal (GI) symptoms, headache, myalgia and shivering. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: Within 7 days (Day 1 - 7) after each vaccination
Number of Days With Solicited General Symptoms
The number of days with any general symptoms had been assessed during the post-vaccination period. Assessed solicited general symptoms were fatigue, fever, GastroIntestinal (GI) symptoms, headache, myalgia and shivering.
Time frame: Within 7 days (Day 1 - 7) after each vaccination
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AE)
An unsolicited AE covered 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time frame: Within 30 days (Day 1 to 30) after each vaccination
Number of Subjects With Any and Related Serious Adverse Events (SAE) From Day 1 to 30 Days Post Last Vaccination
SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related SAEs= SAEs assessed by the investigator as causally related to the study vaccination.
Time frame: From first vaccination at Day 1 up to 30 days post last vaccination
Number of Subjects With Any and Related SAEs From 30 Days Post Last Vaccination up to Study End.
Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related SAEs= SAEs assessed by the investigator as causally related to the study vaccination.
Time frame: From 30 days post last vaccination up to study end (Month 14 for the Co-Ad group and Month 16 for the Control group)
Number of Subjects With Any and Related Potential Immune-mediated Diseases (pIMDs) From Day 1 to 30 Days Post Last Vaccination
pIMDs assessed were a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not had an autoimmune aetiology. Related pIMDs= pIMDs assessed by the investigator as causally related to the study vaccination.
Time frame: From first vaccination at Day 1 up to 30 days post last vaccination.
Number of Subjects With Any pIMDs From 30 Days Post Last Vaccination up to Study End.
pIMDs assessed were a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not had an autoimmune aetiology.
Time frame: From 30 days post last vaccination up to study end (Month 14 for the Co-Ad group and Month 16 for the Control group)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms by Dose
Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 erythema/swelling = erythema/swelling that had spread beyond 100 millimeters (mm) of injection site. The Co-Ad Group received only 2 vaccine doses.
Time frame: Within 7 days (Day 1 - 7) after each vaccination
The study was conducted in 4 countries (Canada, Estonia, Germany \& United States)
| Milestone | Co-Ad Group | Control Group |
|---|---|---|
| Started | 449 | 463 |
| Completed | 442 | 459 |
| Not completed | 7 | 4 |
| Withdrew: Adverse event | 2 | 3 |
| Withdrew: Lost to follow-up | 1 | 0 |
| Withdrew: Protocol violation | 1 | 1 |
| Withdrew: Consent withdrawal, not due to an adverse event | 3 | 0 |
Vaccine response rate (VRR) for Varicella Zoster Virus (VZV) anti-glycoprotein E (gE) humoral immunogenicity was determined by Enzyme Limked Immunosorbent Assay (ELISA). The VRR for anti-gE is defined as the percentage of subjects who had at least: a 4-fold increase in the anti-gE antibodies concentration as compared to the pre-vaccination anti-gE antibodies concentration, for subjects who are seropositive at baseline, or, a 4-fold increase in the anti-gE antibodies concentration as compared to the anti-gE antibodies cut-off value for seropositivity, for subjects who are seronegative at baseline.
| Percentage of subjects | Co-Ad Group |
|---|---|
| Percentage of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in Co-Ad Group | 99.1 (97.6 to 99.7) |
Anti-gE antibody concentrations in terms of Geometric Mean concentrations (GMC) were determined by ELISA and expressed as milli-international units per milliliter (mIU/mL)
| mlU/mL | Co-Ad Group | Control Group |
|---|---|---|
| Anti-gE Antibody Concentrations | 54789.9 (51586.3 to 58192.4) | 59126.7 (55973.8 to 62457.1) |
Anti-pneumococcal antibody titers for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) were determined by Multiplex Opsonophagocytosis Assay (MOPA)
| Titers | Co-Ad Group | Control Group |
|---|---|---|
| MOPA-1 | 144.2 (120.5 to 172.6) | 151.5 (126.0 to 182.1) |
| MOPA-3 | 99.8 (87.2 to 114.1) | 100.2 (88.0 to 114.1) |
| MOPA-4 | 1127.2 (975.5 to 1302.5) | 1392.4 (1206.5 to 1607.0) |
| MOPA-5 | 279.4 (231.2 to 337.7) | 292.8 (243.5 to 352.1) |
| MOPA-6A | 1839.3 (1570.0 to 2154.9) | 2354.9 (2015.0 to 2752.2) |
| MOPA-6B | 1499.4 (1241.2 to 1811.4) | 2025.9 (1715.5 to 2392.4) |
| MOPA-7F | 1981 (1735.2 to 2261.5) | 2387.5 (2112.7 to 2698.0) |
| MOPA-9V | 2541.9 (2219.2 to 2911.7) | 3049.3 (2693.7 to 3451.9) |
| MOPA-14 | 1752.6 (1505.2 to 2040.6) | 2096 (1796.6 to 2445.2) |
| MOPA-18C | 1450.3 (1262.5 to 1666.1) | 1606.6 (1402.6 to 1840.4) |
| MOPA-19A | 1684.9 (1477.2 to 1921.9) | 1664.3 (1465.7 to 1889.7) |
| MOPA-19F | 712 (617.1 to 821.6) | 802.4 (696.2 to 924.8) |
| MOPA-23F | 758.1 (644.9 to 891.2) | 925.5 (782.5 to 1094.7) |
Anti-gE antibody concentrations (GMCs) adjusted for age and baseline concentrations were determined using Analysis Of Covariance (ANCOVA) model. Adjusted GMCs were expressed in milli-international units per milliliter (mIU/mL)
| mlU/mL | Control Group | Co-Ad Group |
|---|---|---|
| Adjusted Geometric Mean Concentrations (GMCs) for Anti-gE Antibody | 58526.8 (55248.5 to 61999.7) | 54634.9 (51546.0 to 57909.0) |
Geometric mean antibody (anti-pneumococcal antibodies: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) titers adjusted for age and baseline concentration were determined using ANCOVA model.
| Titers | Control Group | Co-Ad Group |
|---|---|---|
| MOPA-1 | 147.1 (123.9 to 174.7) | 141.2 (118.7 to 167.9) |
| MOPA-3 | 99.6 (88.1 to 112.6) | 97.3 (86.0 to 110.0) |
| MOPA-4 | 1331.6 (1155.2 to 1535.0) | 1066.9 (924.2 to 1231.5) |
| MOPA-5 | 278.9 (234.4 to 331.8) | 269.1 (225.8 to 320.8) |
| MOPA-6A | 2253.8 (1935.6 to 2624.3) | 1784.4 (1530.2 to 2080.8) |
| MOPA-6B | 1967.3 (1661.5 to 2329.3) | 1445.4 (1219.3 to 1713.4) |
| MOPA-7F | 2337.3 (2061.2 to 2650.5) | 1935.1 (1704.3 to 2197.1) |
| MOPA-9V | 2955.8 (2601.9 to 3357.9) | 2553.5 (2244.2 to 2905.4) |
| MOPA-14 | 1992.3 (1718.5 to 2309.7) | 1730.7 (1491.3 to 2008.5) |
| MOPA-18C | 1558.9 (1363.9 to 1781.9) | 1403.8 (1226.4 to 1606.8) |
| MOPA-19A | 1663.5 (1474.0 to 1877.2) | 1619.2 (1433.7 to 1828.7) |
| MOPA-19F | 760.2 (664.8 to 869.2) | 696.4 (608.2 to 797.3) |
| MOPA-23F | 896.6 (765.0 to 1050.9) | 748.2 (637.6 to 878.0) |
Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 erythema/swelling = erythema/swelling that had spread beyond 100 millimeters (mm) of injection site. The Co-Ad Group received only 2 vaccine doses.
| Participants | Co-Ad Group | Control Group |
|---|---|---|
| Any Erythema, GSK1437173A, Dose1 | 120 | 0 |
| Grade3 Erythema, GSK1437173A, Dose1 | 5 | 0 |
| Any Erythema, Prevenar13, Dose1 | 48 | 31 |
| Grade3 Erythema, Prevenar13, Dose1 | 2 | 1 |
| Any Pain, GSK1437173A, Dose1 | 332 | 0 |
| Grade3 Pain, GSK1437173A, Dose1 | 25 | 0 |
| Any Pain, Prevenar13, Dose1 | 233 | 241 |
| Grade3 Pain, Prevenar13, Dose1 | 11 | 9 |
| Any Swelling, GSK1437173A, Dose1 | 69 | 0 |
| Grade3 Swelling, GSK1437173A, Dose1 | 0 | 0 |
| Any Swelling, Prevenar13, Dose1 | 33 | 21 |
| Grade3 Swelling, Prevenar13, Dose1 | 1 | 0 |
| Any Erythema, GSK1437173A, Dose2 | 147 | 128 |
| Grade3 Erythema, GSK1437173A, Dose2 | 9 | 5 |
| Any Pain, GSK1437173A, Dose2 | 326 | 359 |
| Grade3 Pain, GSK1437173A, Dose2 | 28 | 32 |
| Any Swelling, GSK1437173A, Dose2 | 70 | 72 |
| Grade3 Swelling, GSK1437173A, Dose2 | 1 | 2 |
| Any Erythema, GSK1437173A, Dose3 | 0 | 123 |
| Grade3 Erythema, GSK1437173A, Dose3 | 0 | 1 |
| Any Pain, GSK1437173A, Dose3 | 0 | 350 |
| Grade3 Pain, GSK1437173A, Dose3 | 0 | 41 |
| Any Swelling, GSK1437173A, Dose3 | 0 | 60 |
| Grade3 Swelling, GSK1437173A, Dose3 | 0 | 0 |
The number of days with any local symptoms had been assessed during the post-vaccination period.
| Days | Co-Ad Group | Control Group |
|---|---|---|
| Any erythema,Dose1 | 3 (2 to 5) | 2 (1 to 4) |
| Any pain,Dose1 | 3 (2 to 4) | 2 (1 to 2) |
| Any swelling, Dose1 | 2 (2 to 4) | 2 (1 to 3) |
| Any erythema, Dose2 | 3 (2 to 4) | 2 (2 to 4) |
| Any pain,Dose2 | 3 (2 to 4) | 3 (2 to 4) |
| Any swelling, Dose2 | 3 (2 to 4) | 2 (1.5 to 4) |
| Any erythema,Dose3 | — | 2 (2 to 3) |
| Any pain,Dose3 | — | 3 (2 to 3) |
| Any swelling,Dose3 | — | 2 (1 to 4) |
Assessed solicited general symptoms were fatigue, fever \[defined as oral temperature ≥ 38.0 degrees Celsius (°C)/ 100.4 degrees Fahrenheit (°F)\], GastroIntestinal (GI) symptoms, headache, myalgia and shivering. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
| Participants | Co-Ad Group | Control Group |
|---|---|---|
| Any Fatigue, Dose1 | 166 | 85 |
| Grade3 Fatigue, Dose1 | 21 | 5 |
| Related Fatigue, Dose1 | 149 | 67 |
| Any Fever, Dose1 | 10 | 2 |
| Grade3 Fever, Dose1 | 1 | 0 |
| Related Fever, Dose1 | 8 | 0 |
| Any GI symptoms, Dose1 | 61 | 37 |
| Grade3 GI symptoms, Dose1 | 6 | 1 |
| Related GI symptoms, Dose1 | 55 | 30 |
| Any Headache, Dose1 | 130 | 72 |
| Grade3 Headache, Dose1 | 10 | 0 |
| Related Headache, Dose1 | 113 | 59 |
| Any Myalgia, Dose1 | 168 | 102 |
| Grade3 Myalgia, Dose1 | 17 | 4 |
| Related Myalgia, Dose1 | 150 | 86 |
| Any Shivering, Dose1 | 78 | 7 |
| Grade3 Shivering, Dose1 | 9 | 0 |
| Related Shivering, Dose1 | 71 | 7 |
| Any Fatigue, Dose2 | 192 | 152 |
| Grade3 Fatigue, Dose2 | 22 | 17 |
| Related Fatigue, Dose2 | 177 | 141 |
| Any Fever, Dose2 | 16 | 7 |
| Grade3 Fever, Dose2 | 2 | 2 |
| Related Fever, Dose2 | 10 | 2 |
| Any GI symptoms, Dose2 | 57 | 47 |
| Grade3 GI symptoms, Dose2 | 8 | 4 |
| Related GI symptoms, Dose2 | 50 | 44 |
| Any Headache, Dose2 | 156 | 115 |
| Grade3 Headache, Dose2 | 18 | 7 |
| Related Headache, Dose2 | 143 | 99 |
| Any Myalgia, Dose2 | 203 | 174 |
| Grade3 Myalgia, Dose2 | 23 | 24 |
| Related Myalgia, Dose2 | 186 | 163 |
| Any Shivering, Dose2 | 95 | 50 |
| Grade3 Shivering, Dose2 | 12 | 8 |
| Related Shivering, Dose2 | 86 | 47 |
| Any Fatigue, Dose3 | 0 | 210 |
| Grade3 Fatigue, Dose3 | 0 | 27 |
| Related Fatigue, Dose3 | 0 | 202 |
| Any Fever, Dose3 | 0 | 23 |
| Grade3 Fever, Dose3 | 0 | 2 |
| Related Fever, Dose3 | 0 | 17 |
| Any GI symptoms, Dose3 | 0 | 69 |
| Grade3 GI symptoms, Dose3 | 0 | 3 |
| Related GI symptoms, Dose3 | 0 | 63 |
| Any Headache, Dose3 | 0 | 180 |
| Grade3 Headache, Dose3 | 0 | 23 |
| Related Headache, Dose3 | 0 | 168 |
| Any Myalgia, Dose3 | 0 | 224 |
| Grade3 Myalgia, Dose3 | 0 | 37 |
| Related Myalgia, Dose3 | 0 | 215 |
| Any Shivering, Dose3 | 0 | 122 |
| Grade3 Shivering, Dose3 | 0 | 20 |
| Related Shivering, Dose3 | 0 | 117 |
The number of days with any general symptoms had been assessed during the post-vaccination period. Assessed solicited general symptoms were fatigue, fever, GastroIntestinal (GI) symptoms, headache, myalgia and shivering.
| Days | Co-Ad Group | Control Group |
|---|---|---|
| Any fatigue,Dose1 | 2 (1 to 3) | 2 (1 to 3) |
| Any GI symptoms,Dose1 | 2 (1 to 2) | 1 (1 to 2) |
| Any headache,Dose1 | 2 (1 to 3) | 1 (1 to 2) |
| Any myalgia,Dose1 | 2 (1 to 3) | 2 (1 to 3) |
| Any shivering,Dose1 | 1 (1 to 2) | 1 (1 to 3) |
| Any fever,Dose1 | 1 (1 to 1) | 1 (1 to 1) |
| Any fatigue,Dose2 | 2 (1 to 3) | 2 (1 to 3) |
| Any GI symptoms,Dose2 | 1 (1 to 2) | 1 (1 to 2) |
| Any headache,Dose2 | 2 (1 to 3) | 2 (1 to 3) |
| Any myalgia,Dose2 | 2 (1 to 3) | 2 (1 to 3) |
| Any shivering,Dose2 | 1 (1 to 2) | 1 (1 to 2) |
| Any fever,Dose2 | 1 (1 to 1) | 1 (1 to 3) |
| Any fatigue,Dose3 | — | 2 (1 to 3) |
| Any GI symptoms,Dose3 | — | 1 (1 to 2) |
| Any headache,Dose3 | — | 1.5 (1 to 2) |
| Any myalgia,Dose3 | — | 2 (1 to 3) |
| Any shivering,Dose3 | — | 1 (1 to 2) |
| Any fever,Dose3 | — | 1 (1 to 1) |
An unsolicited AE covered 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
| Participants | Co-Ad Group | Control Group |
|---|---|---|
| Subjects with any AEs | 95 | 107 |
| Subjects with Grade 3 AEs | 9 | 13 |
| Subjects with related AEs | 35 | 25 |
SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related SAEs= SAEs assessed by the investigator as causally related to the study vaccination.
| Participants | Co-Ad Group | Control Group |
|---|---|---|
| Subjects with any SAEs | 7 | 8 |
| Subjects with related SAEs | 0 | 0 |
Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Related SAEs= SAEs assessed by the investigator as causally related to the study vaccination.
| Participants | Co-Ad Group | Control Group |
|---|---|---|
| Subjects with any SAEs | 10 | 10 |
| Subjects with related SAEs | 0 | 0 |
pIMDs assessed were a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not had an autoimmune aetiology. Related pIMDs= pIMDs assessed by the investigator as causally related to the study vaccination.
| Participants | Co-Ad Group | Control Group |
|---|---|---|
| Subjects with any pIMDs | 1 | 1 |
| Subjects with related pIMDs | 0 | 0 |
pIMDs assessed were a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which might or might not had an autoimmune aetiology.
| Participants | Co-Ad Group | Control Group |
|---|---|---|
| Number of Subjects With Any pIMDs From 30 Days Post Last Vaccination up to Study End. | 1 | 0 |
Assessed solicited local symptoms were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 erythema/swelling = erythema/swelling that had spread beyond 100 millimeters (mm) of injection site. The Co-Ad Group received only 2 vaccine doses.
| Participants | Co-Ad Group | Control Group |
|---|---|---|
| Any Erythema, Dose1 | 131 | 31 |
| Grade3 Erythema, Dose1 | 7 | 1 |
| Any Pain, Dose1 | 347 | 241 |
| Grade3 Pain, Dose1 | 28 | 9 |
| Any Swelling, Dose1 | 76 | 21 |
| Grade3 Swelling, Dose1 | 1 | 0 |
| Any Erythema, Dose2 | 147 | 128 |
| Grade3 Erythema, Dose2 | 9 | 5 |
| Any Pain, Dose2 | 326 | 359 |
| Grade3 Pain, Dose2 | 28 | 32 |
| Any Swelling, Dose2 | 70 | 72 |
| Grade3 Swelling, Dose2 | 1 | 2 |
| Any Erythema, Dose3 | 0 | 123 |
| Grade3 Erythema, Dose3 | 0 | 1 |
| Any Pain, Dose3 | 0 | 350 |
| Grade3 Pain, Dose3 | 0 | 41 |
| Any Swelling, Dose3 | 0 | 60 |
| Grade3 Swelling, Dose3 | 0 | 0 |
Collected over Solicited AEs: During the 7-day (Days 1 to 7) after each vaccination, Unsolicited AEs: During the 30 day (Days 1 to 30) after any vaccination, SAEs: Throughout the study period [ Day 1 to study end (Month 14 for Co-Ad group and Month-16 for Control Group)]. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Co-Ad Group | 2/449 (0.4%) | 16/449 (3.6%) | 419/449 (93.3%) |
| Control Group | 4/463 (0.9%) | 16/463 (3.5%) | 427/463 (92.2%) |
| Event | Co-Ad Group | Control Group |
|---|---|---|
| Coronary artery diseaseCardiac disorders | 2/449 | 1/463 |
| Acute myocardial infarctionCardiac disorders | 1/449 | 1/463 |
| Angina pectorisCardiac disorders | 1/449 | 0/463 |
| Angina unstableCardiac disorders | 1/449 | 0/463 |
| Cardiac failure chronicCardiac disorders | 1/449 | 0/463 |
| Dressler's syndromeCardiac disorders | 1/449 | 0/463 |
| Myocardial infarctionCardiac disorders | 1/449 | 0/463 |
| Stress cardiomyopathyCardiac disorders | 1/449 | 0/463 |
| Ventricular fibrillationCardiac disorders | 1/449 | 0/463 |
| Hypertrophic cardiomyopathyCongenital, familial and genetic disorders | 1/449 | 0/463 |
| Event | Co-Ad Group | Control Group |
|---|---|---|
| Injection site painGeneral disorders | 389/449 | 406/463 |
| MyalgiaMusculoskeletal and connective tissue disorders | 260/449 | 284/463 |
| FatigueGeneral disorders | 243/449 | 261/463 |
| HeadacheNervous system disorders | 206/449 | 241/463 |
| Injection site erythemaGeneral disorders | 192/449 | 190/463 |
| ChillsGeneral disorders | 139/449 | 143/463 |
| Gastrointestinal disorderGastrointestinal disorders | 102/449 | 119/463 |
| Injection site swellingGeneral disorders | 108/449 | 117/463 |
| PyrexiaGeneral disorders | 23/449 | 29/463 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 5/449 | 8/463 |
| Age, Continuous(Years) | Co-Ad Group | Control Group | Total |
|---|---|---|---|
| Mean | 63.1 ± 8.3 | 63.2 ± 8.4 | 63.1 ± 8.4 |
| Sex: Female, Male(Participants) | Co-Ad Group | Control Group | Total |
|---|---|---|---|
| Female | 259 | 284 | 543 |
| Male | 190 | 179 | 369 |
| Race/Ethnicity, Customized(Participants) | Co-Ad Group | Control Group | Total |
|---|---|---|---|
| American Indian Or Alaska Native | 1 | 0 | 1 |
| Black Or African American | 8 | 8 | 16 |
| Mixed Origin | 0 | 2 | 2 |
| White - Arabic / North African Heritage | 1 | 1 | 2 |
| White - Caucasian / European Heritage | 439 | 452 | 891 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Apr 2018 to primary completion in May 2019, 12 months.
Results were first posted in Mar 2021, 1 year 10 months after primary completion. A results delay was requested in Oct 2019.
Of 33 industry-sponsored phase 3 interventional studies under Herpes Zoster, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 45. This study's 12 months is below that.
Counting every sponsor, half of 40 studies reached it within 16 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Shingrix · 13-valent pneumococcal vaccine