A Phase 3 interventional study of IMVAMUNE® and Placebo in Smallpox, sponsored by Bavarian Nordic. Completed at 34 sites in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-03.
Sponsored by Bavarian Nordic · Phase 3, Interventional, and Prevention
A randomized, double-blind, placebo-controlled Phase III trial to evaluate immunogenicity and safety of three consecutive production lots of IMVAMUNE® (MVA-BN®) smallpox vaccine in healthy, vaccinia-naïve subjects.
73 studies on the registry are indexed under Smallpox; 5 are open to participants now.
This study's enrollment of 4,005 is above the median of 150 across 61 interventional studies indexed under Smallpox.
Browse Smallpox studies →Bavarian Nordic is the lead sponsor of 58 studies on the registry; 2 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 12 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Adequate renal function defined as a calculated (CrCl) > 60 ml/min as estimated by the Cockcroft-Gault equation:
Adequate hepatic function defined as:
Exclusion criteria
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
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.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
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.
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #1
Biological: IMVAMUNE®
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #2
Biological: IMVAMUNE®
Two vaccinations four weeks apart (at Day 0 and Day 28) with IMVAMUNE® Lot #3
Biological: IMVAMUNE®
Two vaccinations four weeks apart (at Day 0 and Day 28) with 0.5 ml Placebo, Tris-buffered saline (TBS)
Other: Placebo
0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
Also known as: IMVANEX, MVA-BN®
0.5 ml TBS
Also known as: Tris-buffered-saline
PRNT GMT
Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'.
Time frame: 2 weeks following the second vaccination
ELISA GMT
Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'.
Time frame: 2 weeks following the second vaccination
PRNT Seroconversion Rate
Seroconversion rate based on Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (2) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Time frame: 2 weeks following the second vaccination
ELISA Seroconversion Rate
Seroconversion rate based on Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Time frame: 2 weeks following the second vaccination
Correlation PRNT vs ELISA Titers
Pearson Correlation Coefficient between the log10 transformed PRNT titers and the log10 transformed ELISA titers
Time frame: 2 weeks following the second vaccination
Serious Adverse Events
Incidence, relationship and intensity of any Serious Adverse Event (SAE)
Time frame: within 30 weeks
Cardiac Signs or Symptoms
Incidence, relationship and intensity of any cardiac sign or symptom indicating a case of myo-/pericarditis (Adverse Event of Special Interest (AESI)). An AESI was defined in this trial as: * Any cardiac sign or symptom developed since the first vaccination * ECG changes determined to be clinically significant * Cardiac enzyme Troponin I \>= 2 x ULN (\>= Grade 2)
Time frame: within 30 weeks
Related Grade >=3 Adverse Events
Incidence of any Grade \>=3 Adverse Events probably, possibly or definitely related to the trial vaccine. Pooled solicited (general only) and unsolicited AEs
Time frame: within 29 days after any vaccination
Unsolicited Non-serious AEs: Intensity
Occurrence of unsolicited non-serious AEs by Intensity
Time frame: within 29 days after any vaccination
Unsolicited Non-serious AEs: Relationship to Vaccination
Occurrence of unsolicited non-serious AEs by relationship to study vaccine
Time frame: within 29 days after any vaccination
Solicited Local AEs
Incidence and intensity of solicited local AEs (redness, swelling, induration, pruritus and pain). Percentages based on subjects with at least one completed diary card.
Time frame: within 8 days after any vaccination
Solicited General AEs
Incidence of solicited general AEs (pyrexia, headache, myalgia, chills, nausea, and fatigue): Intensity and relationship to vaccination. Percentages based on subjects with at least one completed diary card.
Time frame: within 8 days after any vaccination
| Milestone | Group 1 | Group 2 | Group 3 | Group 4 |
|---|---|---|---|---|
| Started | 999 | 1005 | 999 | 1002 |
| Completed | 925 | 929 | 939 | 946 |
| Not completed | 74 | 76 | 60 | 56 |
Geometric Mean Titers (GMT) based on vaccinia-specific Plaque Reduction Neutralization Test (PRNT). Titers below the detection limit are included with a value of '1'.
| Titer | Group 1 | Group 2 | Group 3 | Group 4 |
|---|---|---|---|---|
| PRNT GMT | 110.7 (103.4 to 118.4) | 100.5 (93.7 to 107.8) | 117.2 (109.0 to 126.0) | 1.0 (1.0 to 1.1) |
Geometric Mean Titers (GMT) based on vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA). Titers below the detection limit are included with a value of '1'.
| Titer | Group 1 | Group 2 | Group 3 | Group 4 |
|---|---|---|---|---|
| ELISA GMT | 901.0 (844.8 to 961.1) | 794.4 (738.1 to 855.0) | 946.7 (888.2 to 1008.9) | 1.2 (1.1 to 1.3) |
Seroconversion rate based on Plaque Reduction Neutralization Test (PRNT). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (2) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
| percentage of subjects | Group 1 | Group 2 | Group 3 | Group 4 |
|---|---|---|---|---|
| PRNT Seroconversion Rate | 99.8 (99.1 to 100.0) | 99.7 (98.9 to 100.0) | 99.8 (99.1 to 100.0) | 1.4 (0.6 to 2.6) |
Seroconversion rate based on Enzyme-linked Immunosorbent Assay (ELISA). Seroconversion is defined as the appearance of antibody titers ≥ detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
| percentage of subjects | Group 1 | Group 2 | Group 3 | Group 4 |
|---|---|---|---|---|
| ELISA Seroconversion Rate | 99.7 (98.9 to 100.0) | 99.5 (98.6 to 99.9) | 100.0 (99.4 to 100.0) | 2.0 (1.1 to 3.4) |
Pearson Correlation Coefficient between the log10 transformed PRNT titers and the log10 transformed ELISA titers
| Pearson correlation coefficient | Group 1 | Group 2 | Group 3 | Group 4 |
|---|---|---|---|---|
| Correlation PRNT vs ELISA Titers | 0.581 (0.527 to 0.630) | 0.620 (0.569 to 0.666) | 0.612 (0.561 to 0.658) | 0.486 (0.424 to 0.543) |
Incidence, relationship and intensity of any Serious Adverse Event (SAE)
| Participants | Group 1 | Group 2 | Group 3 | Group 4 |
|---|---|---|---|---|
| Any SAE | 11 | 7 | 7 | 8 |
| Any SAE with intensity >= Grade 3 | 8 | 6 | 6 | 5 |
| Any SAE assessed as related to vaccine | 0 | 0 | 0 | 1 |
Incidence, relationship and intensity of any cardiac sign or symptom indicating a case of myo-/pericarditis (Adverse Event of Special Interest (AESI)). An AESI was defined in this trial as: * Any cardiac sign or symptom developed since the first vaccination * ECG changes determined to be clinically significant * Cardiac enzyme Troponin I \>= 2 x ULN (\>= Grade 2)
| Participants | Group 1 | Group 2 | Group 3 | Group 4 |
|---|---|---|---|---|
| Any AESI | 2 | 5 | 1 | 1 |
| Any AESI with intensity >= Grade 3 | 0 | 0 | 0 | 0 |
| Any AESI assessed as related to vaccine | 0 | 1 | 1 | 0 |
Incidence of any Grade \>=3 Adverse Events probably, possibly or definitely related to the trial vaccine. Pooled solicited (general only) and unsolicited AEs
| Participants | Group 1 | Group 2 | Group 3 | Group 4 |
|---|---|---|---|---|
| Related Grade >=3 Adverse Events | 58 | 57 | 53 | 27 |
Occurrence of unsolicited non-serious AEs by Intensity
| events | Group 1 | Group 2 | Group 3 | Group 4 |
|---|---|---|---|---|
| Total | 288 | 350 | 320 | 280 |
| Grade 1 | 190 | 236 | 218 | 192 |
| Grade 2 | 88 | 100 | 94 | 82 |
| Grade 3 | 10 | 14 | 8 | 6 |
| Grade 4 | 0 | 0 | 0 | 0 |
| Missing | 0 | 0 | 0 | 0 |
Occurrence of unsolicited non-serious AEs by relationship to study vaccine
| events | Group 1 | Group 2 | Group 3 | Group 4 |
|---|---|---|---|---|
| Unrelated/None | 187 | 218 | 181 | 189 |
| Unlikely | 40 | 56 | 61 | 51 |
| Possible | 28 | 42 | 34 | 29 |
| Probable | 5 | 6 | 7 | 6 |
| Definite | 28 | 27 | 35 | 4 |
| Missing | 0 | 1 | 2 | 1 |
| Total | 288 | 350 | 320 | 280 |
Incidence and intensity of solicited local AEs (redness, swelling, induration, pruritus and pain). Percentages based on subjects with at least one completed diary card.
| Participants | Group 1 | Group 2 | Group 3 | Group 4 |
|---|---|---|---|---|
| Pain: Any | 846 | 823 | 830 | 187 |
| Pain: Grade >=3 | 76 | 66 | 76 | 10 |
| Erythema: Any | 597 | 610 | 581 | 173 |
| Erythema: Grade >=3 | 15 | 18 | 12 | 0 |
| Swelling: Any | 508 | 513 | 499 | 55 |
| Swelling: Grade >=3 | 9 | 10 | 4 | 0 |
| Induration: Any | 454 | 439 | 442 | 45 |
| Induration: Grade >=3 | 4 | 4 | 2 | 0 |
| Pruritis: Any | 430 | 424 | 414 | 115 |
| Pruritis: Grade >=3 | 20 | 15 | 13 | 2 |
Incidence of solicited general AEs (pyrexia, headache, myalgia, chills, nausea, and fatigue): Intensity and relationship to vaccination. Percentages based on subjects with at least one completed diary card.
| Participants | Group 1 | Group 2 | Group 3 | Group 4 |
|---|---|---|---|---|
| Pyrexia: Any | 17 | 19 | 14 | 9 |
| Pyrexia: Related | 13 | 15 | 14 | 6 |
| Pyrexia: Grade >=3 | 2 | 4 | 1 | 0 |
| Headache: Any | 321 | 349 | 354 | 251 |
| Headache: Related | 279 | 314 | 318 | 208 |
| Headache: Grade >=3 | 28 | 24 | 20 | 21 |
| Myalgia: Any | 425 | 403 | 431 | 172 |
| Myalgia: Related | 404 | 381 | 414 | 156 |
| Myalgia: Grade >=3 | 25 | 25 | 27 | 7 |
| Chills: Any | 108 | 108 | 90 | 57 |
| Chills: Related | 96 | 96 | 84 | 51 |
| Chills: Grade >=3 | 10 | 7 | 12 | 3 |
| Nausea: Any | 166 | 179 | 163 | 128 |
| Nausea: Related | 146 | 158 | 144 | 99 |
| Nausea: Grade >=3 | 13 | 16 | 16 | 12 |
| Fatigue: Any | 305 | 303 | 287 | 201 |
| Fatigue: Related | 276 | 279 | 267 | 176 |
| Fatigue: Grade >=3 | 32 | 27 | 29 | 13 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 | 1/999 (0.1%) | 11/999 (1.1%) | 53/999 (5.3%) |
| Group 2 | 0/1,005 (0%) | 7/1,005 (0.7%) | 70/1,005 (7%) |
| Group 3 | 0/999 (0%) | 7/999 (0.7%) | 65/999 (6.5%) |
| Group 4 | 0/1,002 (0%) | 8/1,002 (0.8%) | 48/1,002 (4.8%) |
| Event | Group 1 | Group 2 | Group 3 | Group 4 |
|---|---|---|---|---|
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 0/999 | 0/1005 | 1/999 | 2/1002 |
| AppendicitisInfections and infestations | 0/999 | 2/1005 | 1/999 | 0/1002 |
| ColitisGastrointestinal disorders | 0/999 | 0/1005 | 1/999 | 0/1002 |
| Gastric ulcerGastrointestinal disorders | 0/999 | 0/1005 | 1/999 | 0/1002 |
| Gastrooesophageal reflux diseaseGastrointestinal disorders | 1/999 | 0/1005 | 0/999 | 0/1002 |
| Hiatus herniaGastrointestinal disorders | 1/999 | 0/1005 | 0/999 | 0/1002 |
| Chest painGeneral disorders | 1/999 | 0/1005 | 0/999 | 0/1002 |
| Abscess limbInfections and infestations | 0/999 | 0/1005 | 1/999 | 0/1002 |
| Appendicitis perforatedInfections and infestations | 1/999 | 0/1005 | 0/999 | 0/1002 |
| MeningitisInfections and infestations | 0/999 | 0/1005 | 1/999 | 0/1002 |
| Event | Group 1 | Group 2 | Group 3 | Group 4 |
|---|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 17/999 | 21/1005 | 20/999 | 31/1002 |
| Injection site indurationGeneral disorders | 14/999 | 15/1005 | 21/999 | 0/1002 |
| NasopharyngitisInfections and infestations | 11/999 | 14/1005 | 11/999 | 3/1002 |
| Injection site haematomaGeneral disorders | 5/999 | 11/1005 | 8/999 | 5/1002 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 9/999 | 9/1005 | 6/999 | 10/1002 |
Full Analysis Set
| Age, Continuous(years) | Group 1 | Group 2 | Group 3 | Group 4 | Total |
|---|---|---|---|---|---|
| Mean | 27.6 ± 6.28 | 27.5 ± 6.24 | 28.0 ± 6.31 | 27.7 ± 6.38 | 27.7 ± 6.30 |
| Sex: Female, Male(Participants) | Group 1 | Group 2 | Group 3 | Group 4 | Total |
|---|---|---|---|---|---|
| Female | 526 | 527 | 494 | 539 | 2086 |
| Male | 473 | 478 | 505 | 463 | 1919 |
The record gives a start of Feb 2013, a primary completion of Nov 2013 and a completion of Jun 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2019, 5 years 2 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: MVA-BN smallpox vaccine