A Phase 1 interventional study of NDV-3 vaccine with alum IM and NDV-3 vaccine without alum IM in Staphylococcal Infections, Yeast Infections and Candidiasis, sponsored by NovaDigm Therapeutics, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-04.
Sponsored by NovaDigm Therapeutics, Inc. · Phase 1, Interventional, and Prevention
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Among 125 studies in Staphylococcal Infections with a site in United States — 6 open to participants now, 11 under way, none of them phase 3. Staphylococcal Infections · United States.
Among the 125 studies in Staphylococcal Infections with a site in United States, this one is the 45th largest by enrollment of the 92 interventional ones that give a count, is one of 11 that started in 2011, is one of 13 in phase 1, and was the 63rd registered.
303 studies on the registry are indexed under Staphylococcal Infections; 34 are open to participants now.
Browse Staphylococcal Infections studies →6 of the 125 studies in Staphylococcal Infections with a site in United States are open now. Recruiting first, the newest first:
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 2–120
Johns Hopkins University · Sites in United States
Ages 0–60 · Healthy volunteers
University of Virginia · Sites in United States
Ages 18–65
University of Melbourne · Sites in United States, Australia, Canada and 10 more countries
Texas Woman's University · Sites in United States
Ages 18–45 · Women only · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 22 Staphylococcal Infections studies recruiting now, 16 (73%) set no upper age limit and 4 (18%) stop at 75 or younger; 5 take children under 18; 5 take healthy volunteers.
This study: 18 Years to 50 Years · 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.
125 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 19 · Phase 2 26 · Phase 3 15 · Phase 4 16
First in 2000; this study’s year is marked. 11 started in 2011.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 164 is above the median of 124 across 198 interventional studies indexed under Staphylococcal Infections.
Median enrollment 158 across the 92 interventional studies, 217 across the 32 observational. Of the 105 that completed or were terminated, 44 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
38 of 125 have an industry lead sponsor. The 10 most frequent:
NovaDigm Therapeutics, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
NovaDigm Therapeutics, Inc. has 3 studies filed under Staphylococcal Infections — fewer than ten, so there is no comparison to draw.
3 of the studies in Staphylococcal Infections with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06749457AstraZenecaA Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa) | 2027-03-08 |
| NCT01879761University of ChicagoImmune Resolution After Staphylococcus Aureus Bacteremia | 2027-06 |
| NCT06805994Johns Hopkins UniversityAdministering NMT to Reestablish Infant Nasal Microbiome Diversity Following Intranasal Mupirocin Treatment | 2027-09-01 |
Add all 3 to your calendar (.ics) → With an account.
Among the 125 studies in Staphylococcal Infections with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This partially-blind, placebo controlled study is a Phase 1b study using an investigational vaccine, NDV-3, directed against Staphylococcus aureus and Candida sp. This study will compare NDV-3 administered with or without alum delivered intramuscularly (IM) at one dose level. It will also evaluate a lower dose of NDV-3 without alum delivered intradermally (ID) compared to placebo delivered ID.
Preclinical studies in mice have established that several members of the Als family of proteins induce a protective immune response in mice and allow high survival rates following challenge with highly virulent doses of either Candida or S. aureus. Als3 (the antigen in the NDV-3 investigational vaccine) is the most effective member of the Als protein family in protecting mice from challenge with either Candida or S. aureus. The first Phase 1 study enrolled 40 healthy subjects that received placebo (N=10), 1 dose (N=30) or 2 doses (N=19) of the NDV-3 vaccine administered intramuscularly (IM). The vaccine was well tolerated and highly immunogenic. This study will evaluate the safety, tolerability and immunogenicity of one dose of NDV-3 vaccine formulated with and without alum given IM and also a lower dose without alum given intradermally (ID). Subjects will have follow-up visits to assess the safety tolerability and immune responses at selected time points up to 90 days post-vaccination.
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 volunteers must be one of the following:
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
300 ug Als3 and 0.5 mg Al as alum in PBS per dose, one dose administered IM
Biological: NDV-3 vaccine with alum IM
300 ug Als3 in PBS per dose, one dose administered IM
Biological: NDV-3 vaccine without alum IM
0.5 mg Al as alum in PBS per dose, one dose administered IM
Biological: Placebo with alum IM
30 ug Als3 in PBS per dose, one dose administered ID
Biological: NDV-3 vaccine without alum ID
One dose administered IM
One dose administered IM
One dose administered ID
One dose administered ID
Number of Participants With Treatment Emergent Adverse Events
The primary objective of this study is to assess the safety of a single dose of NDV-3 vaccine, administered either IM with or without alum adjuvant at one dose level or ID at a lower dose level, compared to placebo. Clinical evaluations will be assessed on each subject at selected time points up to 90 days post-vaccination.
Time frame: Up to 90 days post-vaccination
Immunogenicity - Serum Anti-Als3 IgG
A secondary objective is to compare the serum IgG immune response between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. Serum IgG will be evaluated by ELISA on serial-diluted samples, resulting in titer values of reciprocal dilution at which the ELISA readout is three times greater than the assay background value.
Time frame: Baseline, Day 7, Day 14, Day 28, Day 90/Exit
Immunogenicity - Serum Anti-Als3 IgA1
A secondary objective is to compare the serum IgA1 immune response between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. Serum IgA1 will be evaluated by ELISA on serial-diluted samples, resulting in titer values of reciprocal dilution at which the ELISA readout is three times greater than the assay background value.
Time frame: Baseline, Day 7, Day 14, Day 28, Day 90/Exit
Immunogenicity - Cervicovaginal Wash Anti-Als3 IgG
A secondary objective is to compare the cervicovaginal wash IgG immune response between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. Cervicovaginal wash IgG will be evaluated by ELISA on serial-diluted samples, resulting in titer values of reciprocal dilution at which the ELISA readout is three times greater than the assay background value.
Time frame: Baseline, Day 7, Day 14, Day 28, Day 90/Exit
Immunogenicity - Cervicovaginal Wash Anti-Als3 IgA1
A secondary objective is to compare the cervicovaginal wash IgA1 immune response between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. Cervicovaginal wash IgA1 will be evaluated by ELISA on serial-diluted samples, resulting in titer values of reciprocal dilution at which the ELISA readout is three times greater than the assay background value.
Time frame: Baseline, Day 7, Day 14, Day 28, Day 90/Exit
Immunogenicity - Number of Participants Positive for Peripheral Blood Mononuclear Cells (PBMCs) Producing Als3-specific Interferon-gamma (IFN-g)
A secondary objective is to compare the cellular immune response for Als3-specific production of IFN-g from PBMCs between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. The IFN-g cellular immune responses will be evaluated by ELISpot using approximately 200,000 PBMCs per well. A positive response was defined as a sample with greater than 20 spot forming units per 10\^6 PBMCs.
Time frame: Baseline, Day 7, Day 14, Day 28, Day 90/Exit
Immunogenicity - Number of Participants Positive for Peripheral Blood Mononuclear Cells (PBMCs) Producing Als3-specific Interleukin-17A (IL-17A)
A secondary objective is to compare the cellular immune response for Als3-specific production of IL-17A from PBMCs between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. The IL-17A cellular immune responses will be evaluated by ELISpot using approximately 200,000 PBMCs per well. A positive response was defined as a sample with greater than 20 spot forming units per 10\^6 PBMCs.
Time frame: Baseline, Day 7, Day 14, Day 28, Day 90/Exit
| Milestone | NDV-3 Vaccine With Alum | NDV-3 Vaccine Without Alum | Placebo | NDV-3 Vaccine ID |
|---|---|---|---|---|
| Started | 41 | 40 | 41 | 42 |
| Completed | 39 | 40 | 40 | 40 |
| Not completed | 2 | 0 | 1 | 2 |
| Withdrew: Withdrawal by subject | 2 | 0 | 0 | 1 |
| Withdrew: Physician decision | 0 | 0 | 1 | 1 |
The primary objective of this study is to assess the safety of a single dose of NDV-3 vaccine, administered either IM with or without alum adjuvant at one dose level or ID at a lower dose level, compared to placebo. Clinical evaluations will be assessed on each subject at selected time points up to 90 days post-vaccination.
| participants | NDV-3 Vaccine With Alum | NDV-3 Vaccine Without Alum | Placebo | NDV-3 Vaccine ID |
|---|---|---|---|---|
| >=1 TEAE | 35 | 33 | 30 | 36 |
| >=1 severe TEAE | 2 | 0 | 4 | 2 |
| >=1 severe drug-related TEAE | 0 | 0 | 0 | 0 |
| DIscontinued for >=1 TEAE | 0 | 0 | 0 | 0 |
A secondary objective is to compare the serum IgG immune response between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. Serum IgG will be evaluated by ELISA on serial-diluted samples, resulting in titer values of reciprocal dilution at which the ELISA readout is three times greater than the assay background value.
| Titer | NDV-3 Vaccine With Alum | NDV-3 Vaccine Without Alum | Placebo | NDV-3 Vaccine ID |
|---|---|---|---|---|
| Baseline | 372 ± 3.12 | 320 ± 3.07 | 363 ± 2.93 | 375 ± 3.53 |
| Day 7 | 4447 ± 6.31 | 3070 ± 6.71 | 365 ± 2.81 | 874 ± 5.25 |
| Day 14 | 44675 ± 3.04 | 22675 ± 6.58 | 370 ± 2.89 | 5153 ± 6.97 |
| Day 28 | 38898 ± 2.83 | 19220 ± 6.00 | 377 ± 2.93 | 4513 ± 6.60 |
| Day 90/Exit | 20853 ± 3.24 | 11771 ± 5.93 | 347 ± 2.71 | 3282 ± 5.55 |
A secondary objective is to compare the serum IgA1 immune response between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. Serum IgA1 will be evaluated by ELISA on serial-diluted samples, resulting in titer values of reciprocal dilution at which the ELISA readout is three times greater than the assay background value.
| Titer | NDV-3 Vaccine With Alum | NDV-3 Vaccine Without Alum | Placebo | NDV-3 Vaccine ID |
|---|---|---|---|---|
| Baseline | 573 ± 4.07 | 480 ± 3.44 | 418 ± 3.72 | 550 ± 4.93 |
| Day 7 | 7643 ± 6.61 | 5497 ± 7.01 | 431 ± 3.69 | 1640 ± 6.56 |
| Day 14 | 69616 ± 3.1 | 34946 ± 6.77 | 429 ± 3.93 | 9356 ± 6014 |
| Day 28 | 43790 ± 2.59 | 19999 ± 5.36 | 412 ± 3.86 | 7400 ± 6.33 |
| Day 90/Exit | 20656 ± 2.51 | 10698 ± 4.61 | 404 ± 3.78 | 3641 ± 5.18 |
A secondary objective is to compare the cervicovaginal wash IgG immune response between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. Cervicovaginal wash IgG will be evaluated by ELISA on serial-diluted samples, resulting in titer values of reciprocal dilution at which the ELISA readout is three times greater than the assay background value.
| Titer | NDV-3 Vaccine With Alum | NDV-3 Vaccine Without Alum | Placebo | NDV-3 Vaccine ID |
|---|---|---|---|---|
| Baseline | 2 ± 1.5 | 2 ± 1.55 | 3 ± 2.12 | 3 ± 1.98 |
| Day 7 | 4 ± 3.98 | 6 ± 5.84 | 2 ± 1.61 | 3 ± 2.45 |
| Day 14 | 78 ± 7.12 | 26 ± 7.50 | 3 ± 1.99 | 8 ± 4.27 |
| Day 28 | 44 ± 5.85 | 26 ± 7.09 | 3 ± 2.20 | 8 ± 4.63 |
| Day 90/Exit | 20 ± 4.93 | 13 ± 4.65 | 3 ± 2.11 | 6 ± 4.35 |
A secondary objective is to compare the cervicovaginal wash IgA1 immune response between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. Cervicovaginal wash IgA1 will be evaluated by ELISA on serial-diluted samples, resulting in titer values of reciprocal dilution at which the ELISA readout is three times greater than the assay background value.
| Titer | NDV-3 Vaccine With Alum | NDV-3 Vaccine Without Alum | Placebo | NDV-3 Vaccine ID |
|---|---|---|---|---|
| Baseline | 3 ± 2.03 | 3 ± 2.08 | 3 ± 2.24 | 3 ± 2.5 |
| Day 7 | 5 ± 2.87 | 7 ± 6.64 | 3 ± 1.45 | 4 ± 2.71 |
| Day 14 | 83 ± 4.50 | 29 ± 6.48 | 3 ± 1.64 | 12 ± 4.23 |
| Day 28 | 36 ± 3.82 | 25 ± 6.72 | 3 ± 2.40 | 8 ± 4.56 |
| Day 90/Exit | 15 ± 3.18 | 8 ± 3.27 | 3 ± 1.98 | 5 ± 3.40 |
A secondary objective is to compare the cellular immune response for Als3-specific production of IFN-g from PBMCs between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. The IFN-g cellular immune responses will be evaluated by ELISpot using approximately 200,000 PBMCs per well. A positive response was defined as a sample with greater than 20 spot forming units per 10\^6 PBMCs.
| Participants | NDV-3 Vaccine With Alum | NDV-3 Vaccine Without Alum | Placebo | NDV-3 Vaccine ID |
|---|---|---|---|---|
| Baseline | 7 | 9 | 7 | 5 |
| Day 7 | 27 | 25 | 10 | 20 |
| Day 14 | 19 | 21 | 5 | 20 |
| Day 90/Exit | 25 | 18 | 9 | 14 |
A secondary objective is to compare the cellular immune response for Als3-specific production of IL-17A from PBMCs between the 2 dose levels, routes of administration, and effects of alum adjuvant, at selected time points up to 90 days post-vaccination. The IL-17A cellular immune responses will be evaluated by ELISpot using approximately 200,000 PBMCs per well. A positive response was defined as a sample with greater than 20 spot forming units per 10\^6 PBMCs.
| Participants | NDV-3 Vaccine With Alum | NDV-3 Vaccine Without Alum | Placebo | NDV-3 Vaccine ID |
|---|---|---|---|---|
| Baseline | 6 | 10 | 12 | 9 |
| Day 7 | 22 | 19 | 8 | 13 |
| Day 14 | 15 | 17 | 7 | 16 |
| Day 90/Exit | 17 | 15 | 18 | 23 |
Collected over 90 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NDV-3 Vaccine With Alum | 0/41 (0%) | 0/41 (0%) | 35/41 (85.4%) |
| NDV-3 Vaccine Without Alum | 0/40 (0%) | 0/40 (0%) | 33/40 (82.5%) |
| Placebo | 0/41 (0%) | 0/41 (0%) | 30/41 (73.2%) |
| NDV-3 Vaccine ID | 0/42 (0%) | 0/42 (0%) | 36/42 (85.7%) |
| Event | NDV-3 Vaccine With Alum | NDV-3 Vaccine Without Alum | Placebo | NDV-3 Vaccine ID |
|---|---|---|---|---|
| Injection site painGeneral disorders | 32/41 | 18/40 | 3/41 | 15/42 |
| HeadacheNervous system disorders | 10/41 | 7/40 | 9/41 | 19/42 |
| FatigueGeneral disorders | 4/41 | 4/40 | 4/41 | 13/42 |
| Red blood cells urine positiveInvestigations | 5/41 | 7/40 | 9/41 | 7/42 |
| Protein total decreasedInvestigations | 2/41 | 8/40 | 3/41 | 7/42 |
| Injection site erythemaGeneral disorders | 1/41 | 1/40 | 0/41 | 8/42 |
| Injection site pruritusGeneral disorders | 1/41 | 1/40 | 0/41 | 8/42 |
| MyalgiaMusculoskeletal and connective tissue disorders | 1/41 | 1/40 | 1/41 | 8/42 |
| NauseaGastrointestinal disorders | 5/41 | 2/40 | 1/41 | 7/42 |
| Blood glucose increasedInvestigations | 3/41 | 1/40 | 5/41 | 6/42 |
| Age, Continuous(years) | NDV-3 Vaccine With Alum | NDV-3 Vaccine Without Alum | Placebo | NDV-3 Vaccine ID | Total |
|---|---|---|---|---|---|
| Mean | 31.8 (18 to 47) | 30.1 (18 to 49) | 32.3 (19 to 50) | 31.0 (18 to 50) | 31.3 (18 to 50) |
| Sex: Female, Male(Participants) | NDV-3 Vaccine With Alum | NDV-3 Vaccine Without Alum | Placebo | NDV-3 Vaccine ID | Total |
|---|---|---|---|---|---|
| Female | 33 | 33 | 34 | 34 | 134 |
| Male | 8 | 7 | 7 | 8 | 30 |
| Ethnicity (NIH/OMB)(Participants) | NDV-3 Vaccine With Alum | NDV-3 Vaccine Without Alum | Placebo | NDV-3 Vaccine ID | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 1 | 1 |
| Not Hispanic or Latino | 41 | 40 | 41 | 41 | 163 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | NDV-3 Vaccine With Alum | NDV-3 Vaccine Without Alum | Placebo | NDV-3 Vaccine ID | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 | 2 | 4 |
| White | 38 | 37 | 36 | 38 | 149 |
| More than one race | 3 | 1 | 3 | 2 | 9 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
The record gives a start of Sep 2011, a primary completion of Mar 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2020, 8 years after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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NovaDigm Therapeutics, Inc.