A Phase 3 interventional study of V114 and Prevnar 13™ in Pneumococcal Infections, sponsored by Merck Sharp & Dohme LLC. Completed at 13 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-05.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Prevention
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Among 43 studies in Pneumococcal Infections by Merck & Co., Inc — 1 open to participants now, 1 under way, none of them phase 3. Pneumococcal Infections · Merck & Co., Inc.
Among the 43 studies in Pneumococcal Infections by Merck & Co., Inc, this one is the 30th largest by enrollment, is one of 7 that started in 2018, is one of 31 in phase 3, and was the 16th registered.
298 studies on the registry are indexed under Pneumococcal Infections; 25 are open to participants now.
Browse Pneumococcal Infections studies →1 of the 43 studies in Pneumococcal Infections by Merck & Co., Inc is open now, in 1 country. Recruiting first, the newest first:
Merck Sharp & Dohme LLC · Sites in United States
Ages 2 mo–15 mo · Healthy volunteers
By country, each count listing its studies:
Of the 20 Pneumococcal Infections studies recruiting now, 4 (20%) set no upper age limit and 14 (70%) stop at 75 or younger; 14 take children under 18; 16 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
43 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 6 · Phase 2 7 · Phase 3 31 · Phase 4 1
First in 2005; this study’s year is marked. 7 started in 2018.
This study's enrollment of 302 is below the median of 373 across 253 interventional studies indexed under Pneumococcal Infections.
Median enrollment 518 across the 43 interventional studies. Of the 42 that completed or were terminated, 40 (95%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under Merck Sharp & Dohme LLC, one of the names counted as Merck & Co., Inc. Under that name alone:
Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 131 are open to participants now.
Of its 503 completed or terminated interventional studies of FDA-regulated products, 371 (74%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 43 studies in Pneumococcal Infections by Merck & Co., Inc, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adults infected with HIV and to 2) describe the safety, tolerability, and immunogenicity of PNEUMOVAX™23 when administered 8 weeks after receipt of either V114 or Prevnar 13™.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
Biological: V114 · Biological: PNEUMOVAX™23
Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
Biological: Prevnar 13™ · Biological: PNEUMOVAX™23
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose
13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose
Drug page: 23-valent pneumococcal capsular polysaccharide vaccine
23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose
Percentage of Participants With a Solicited Injection-site Adverse Event After Vaccination 1
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs consist of redness/erythema, swelling, and tenderness/pain. The 95% confidence interval (CI) were based on the exact binomial method proposed by Clopper and Pearson.
Time frame: Up to 5 days after Vaccination 1 (Up to Day 5)
Percentage of Participants With a Solicited Systemic Adverse Event After Vaccination 1
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs consist of muscle pain (myalgia), joint pain (arthralgia), headache, and tiredness (fatigue). The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.
Time frame: Up to 14 days after Vaccination 1 (Up to Day 14)
Percentage of Participants With a Vaccine-related Serious Adverse Event After Vaccination 1
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine is determined by the investigator. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.
Time frame: Day 1 up to 8 weeks after Vaccination 1 (Up to Week 8)
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) After Vaccination 1
Opsonization of pneumococci for phagocytosis is an important mechanism by which antibodies to polysaccharides protect against disease in vivo. Sera from participants was used to measure geometric mean titer (GMT) of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the Multiplexed Opsonophagocytic Assay (MOPA). This assay reads the reciprocal of the highest dilution (1/dil) that gives ≥50% bacterial killing, as determined by comparison to assay background controls. The 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Time frame: Day 30
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) After Vaccination 1
The geometric mean concentration of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by multiplex electrochemiluminescence (ECL) using the pneumococcal electrochemiluminescence (PnECL) v2.0 assay, based on the Meso-Scale Discovery technology, which employs disposable multi-spot microtiter plates. The 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Time frame: Day 30
Percentage of Participants With a Solicited Injection-site Adverse Event After Vaccination 2
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs consist of redness/erythema, swelling, and tenderness/pain. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.
Time frame: Up to 5 days after Vaccination 2 (Up to Day 61)
Percentage of Participants With a Solicited Systemic Adverse Event After Vaccination 2
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs consist of muscle pain (myalgia), joint pain (arthralgia), headache, and tiredness (fatigue). The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.
Time frame: Up to 14 days after Vaccination 2 (Up to Day 70)
Percentage of Participants With a Vaccine-related Serious Adverse Event After Vaccination 2
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine is determined by the investigator. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.
Time frame: From Week 8 up to Month 6
Geometric Mean Titer of Serotype-specific OPA After Vaccination 2
Opsonization of pneumococci for phagocytosis is an important mechanism by which antibodies to polysaccharides protect against disease in vivo. Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the MOPA. The MOPA reads the reciprocal of the highest dilution (1/dil) that gives ≥50% bacterial killing, as determined by comparison to assay background controls. The 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Time frame: Week 12
Geometric Mean Concentration of Serotype-specific IgG After Vaccination 2
The geometric mean concentration of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™ ; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by multiplex ECL using the PnECL v2.0 assay, based on the Meso-Scale Discovery technology, which employs disposable multi-spot microtiter plates. The 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Time frame: Week 12
Adults 18 years of age or older infected with human immunodeficiency virus (HIV) who did not receive a pneumococcal vaccine prior to study entry were enrolled in this study.
| Milestone | V114 | Prevnar 13™ |
|---|---|---|
| Started | 152 | 150 |
| Week 8 | 150 | 148 |
| Completed | 145 | 147 |
| Not completed | 7 | 3 |
| Withdrew: Lost to follow-up | 5 | 1 |
| Withdrew: Withdrawal by subject | 2 | 1 |
| Withdrew: Relocated | 0 | 1 |
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs consist of redness/erythema, swelling, and tenderness/pain. The 95% confidence interval (CI) were based on the exact binomial method proposed by Clopper and Pearson.
| Percentage of Participants | V114 | Prevnar 13™ |
|---|---|---|
| Injection site erythema | 4.6 (1.9 to 9.3) | 3.3 (1.1 to 7.6) |
| Injection site pain | 57.2 (49.0 to 65.2) | 51.3 (43.0 to 59.6) |
| Injection site swelling | 11.8 (7.2 to 18.1) | 4.0 (1.5 to 8.5) |
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs consist of muscle pain (myalgia), joint pain (arthralgia), headache, and tiredness (fatigue). The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.
| Percentage of Participants | V114 | Prevnar 13™ |
|---|---|---|
| Arthralgia | 3.3 (1.1 to 7.5) | 4.0 (1.5 to 8.5) |
| Fatigue | 20.4 (14.3 to 27.7) | 13.3 (8.3 to 19.8) |
| Headache | 13.2 (8.2 to 19.6) | 9.3 (5.2 to 15.2) |
| Myalgia | 12.5 (7.7 to 18.8) | 9.3 (5.2 to 15.2) |
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine is determined by the investigator. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.
| Percentage of Participants | V114 | Prevnar 13™ |
|---|---|---|
| Percentage of Participants With a Vaccine-related Serious Adverse Event After Vaccination 1 | 0 (0.0 to 2.4) | 0 (0.0 to 2.4) |
Opsonization of pneumococci for phagocytosis is an important mechanism by which antibodies to polysaccharides protect against disease in vivo. Sera from participants was used to measure geometric mean titer (GMT) of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the Multiplexed Opsonophagocytic Assay (MOPA). This assay reads the reciprocal of the highest dilution (1/dil) that gives ≥50% bacterial killing, as determined by comparison to assay background controls. The 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
| 1/dil | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 | 238.8 (173.1 to 329.3) | 200.9 (142.7 to 282.7) |
| Serotype 3 | 116.8 (94.9 to 143.7) | 72.3 (58.6 to 89.2) |
| Serotype 4 | 824.0 (618.8 to 1097.2) | 1465.5 (1154.5 to 1860.3) |
| Serotype 5 | 336.7 (242.4 to 467.7) | 276.7 (197.9 to 386.7) |
| Serotype 6A | 6421.0 (4890.4 to 8430.7) | 5645.1 (4278.9 to 7447.4) |
| Serotype 6B | 4772.9 (3628.3 to 6278.7) | 3554.0 (2751.0 to 4591.4) |
| Serotype 7F | 6085.8 (4871.6 to 7602.8) | 6144.3 (4982.8 to 7576.6) |
| Serotype 9V | 2836.3 (2311.5 to 3480.4) | 2133.9 (1721.8 to 2644.5) |
| Serotype 14 | 3508.7 (2730.6 to 4508.5) | 3000.3 (2350.0 to 3830.5) |
| Serotype 18C | 3002.2 (2435.5 to 3700.8) | 1560.3 (1213.8 to 2005.6) |
| Serotype 19A | 4240.7 (3415.4 to 5265.3) | 3715.9 (2949.2 to 4681.8) |
| Serotype 19F | 2438.6 (1972.7 to 3014.6) | 2042.0 (1618.9 to 2575.5) |
| Serotype 23F | 1757.4 (1276.1 to 2420.2) | 1787.0 (1309.0 to 2437.9) |
| Serotype 22F | 3943.7 (3049.2 to 5100.5) | 109.3 (66.2 to 180.3) |
| Serotype 33F | 11342.4 (9184.3 to 14007.6) | 1807.6 (1357.3 to 2407.3) |
The geometric mean concentration of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by multiplex electrochemiluminescence (ECL) using the pneumococcal electrochemiluminescence (PnECL) v2.0 assay, based on the Meso-Scale Discovery technology, which employs disposable multi-spot microtiter plates. The 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
| μg/mL | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 | 3.16 (2.48 to 4.01) | 4.27 (3.31 to 5.50) |
| Serotype 3 | 0.57 (0.48 to 0.68) | 0.50 (0.41 to 0.60) |
| Serotype 4 | 1.14 (0.90 to 1.44) | 2.00 (1.56 to 2.55) |
| Serotype 5 | 2.38 (1.89 to 3.01) | 2.03 (1.56 to 2.64) |
| Serotype 6A | 5.13 (3.73 to 7.04) | 4.91 (3.49 to 6.91) |
| Serotype 6B | 7.17 (5.34 to 9.63) | 5.23 (3.73 to 7.35) |
| Serotype 7F | 2.61 (2.00 to 3.41) | 3.74 (2.91 to 4.81) |
| Serotype 9V | 3.35 (2.71 to 4.14) | 3.55 (2.77 to 4.56) |
| Serotype 14 | 15.44 (11.69 to 20.39) | 15.22 (11.56 to 20.03) |
| Serotype 18C | 5.58 (4.33 to 7.18) | 5.07 (3.97 to 6.48) |
| Serotype 19A | 9.09 (7.08 to 11.67) | 9.61 (7.36 to 12.56) |
| Serotype 19F | 6.41 (4.89 to 8.39) | 6.21 (4.73 to 8.15) |
| Serotype 23F | 3.92 (2.94 to 5.22) | 4.90 (3.54 to 6.77) |
| Serotype 22F | 3.97 (3.06 to 5.15) | 0.20 (0.17 to 0.25) |
| Serotype 33F | 6.83 (5.14 to 9.07) | 0.77 (0.62 to 0.95) |
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs consist of redness/erythema, swelling, and tenderness/pain. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.
| Percentage of Participants | V114 | Prevnar 13™ |
|---|---|---|
| Injection site erythema | 10.0 (5.7 to 16.0) | 12.2 (7.4 to 18.5) |
| Injection site pain | 53.3 (45.0 to 61.5) | 61.5 (53.1 to 69.4) |
| Injection site swelling | 20.0 (13.9 to 27.3) | 29.1 (21.9 to 37.1) |
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs consist of muscle pain (myalgia), joint pain (arthralgia), headache, and tiredness (fatigue). The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.
| Percentage of Participants | V114 | Prevnar 13™ |
|---|---|---|
| Arthralgia | 2.7 (0.7 to 6.7) | 1.4 (0.2 to 4.8) |
| Fatigue | 12.7 (7.8 to 19.1) | 10.8 (6.3 to 17.0) |
| Headache | 8.7 (4.7 to 14.4) | 8.8 (4.8 to 14.6) |
| Myalgia | 11.3 (6.7 to 17.5) | 12.2 (7.4 to 18.5) |
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine is determined by the investigator. The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.
| Percentage of Participants | V114 | Prevnar 13™ |
|---|---|---|
| Percentage of Participants With a Vaccine-related Serious Adverse Event After Vaccination 2 | 0 (0.0 to 2.4) | 0 (0.0 to 2.5) |
Opsonization of pneumococci for phagocytosis is an important mechanism by which antibodies to polysaccharides protect against disease in vivo. Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the MOPA. The MOPA reads the reciprocal of the highest dilution (1/dil) that gives ≥50% bacterial killing, as determined by comparison to assay background controls. The 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
| 1/dil | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 | 212.0 (160.5 to 280.2) | 154.0 (111.6 to 212.4) |
| Serotype 3 | 102.8 (83.0 to 127.2) | 96.6 (79.5 to 117.4) |
| Serotype 4 | 915.4 (722.9 to 1159.1) | 984.7 (772.1 to 1255.7) |
| Serotype 5 | 418.1 (312.1 to 560.3) | 274.5 (199.9 to 376.8) |
| Serotype 6A | 4065.4 (3052.1 to 5415.1) | 4593.2 (3543.0 to 5954.7) |
| Serotype 6B | 3661.1 (2735.1 to 4900.6) | 2826.4 (2202.7 to 3626.8) |
| Serotype 7F | 5983.5 (4788.9 to 7476.1) | 5516.5 (4522.2 to 6729.5) |
| Serotype 9V | 2454.8 (2008.7 to 3000.0) | 1929.9 (1567.7 to 2375.7) |
| Serotype 14 | 3634.0 (2935.6 to 4498.5) | 2539.3 (1960.6 to 3288.9) |
| Serotype 18C | 2511.5 (1958.7 to 3220.3) | 1753.8 (1428.6 to 2153.1) |
| Serotype 19A | 3358.1 (2679.6 to 4208.4) | 3300.3 (2638.7 to 4127.7) |
| Serotype 19F | 2230.7 (1803.6 to 2759.0) | 1994.1 (1630.7 to 2438.4) |
| Serotype 23F | 1641.2 (1217.2 to 2212.9) | 1266.5 (944.3 to 1698.5) |
| Serotype 22F | 3399.9 (2697.6 to 4285.0) | 2952.7 (2207.7 to 3949.1) |
| Serotype 33F | 10576.3 (8383.1 to 13343.4) | 11926.3 (9085.9 to 15654.6) |
The geometric mean concentration of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™ ; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by multiplex ECL using the PnECL v2.0 assay, based on the Meso-Scale Discovery technology, which employs disposable multi-spot microtiter plates. The 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
| μg/mL | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 | 2.80 (2.25 to 3.49) | 4.04 (3.27 to 5.00) |
| Serotype 3 | 0.51 (0.43 to 0.61) | 0.59 (0.50 to 0.70) |
| Serotype 4 | 1.26 (1.10 to 1.57) | 1.61 (1.31 to 1.98) |
| Serotype 5 | 2.61 (2.08 to 3.28) | 2.13 (1.69 to 2.68) |
| Serotype 6A | 3.12 (2.27 to 4.30) | 3.71 (2.74 to 5.03) |
| Serotype 6B | 4.69 (3.52 to 6.25) | 4.35 (3.23 to 5.86) |
| Serotype 7F | 2.45 (1.91 to 3.15) | 3.17 (2.60 to 3.87) |
| Serotype 9V | 2.92 (2.39 to 3.57) | 3.24 (2.62 to 4.01) |
| Serotype 14 | 13.68 (10.34 to 18.10) | 14.37 (11.25 to 18.36) |
| Serotype 18C | 3.96 (3.08 to 5.09) | 3.96 (3.18 to 4.95) |
| Serotype 19A | 7.23 (5.80 to 9.02) | 8.54 (6.80 to 10.72) |
| Serotype 19F | 5.19 (4.06 to 6.62) | 5.84 (4.67 to 7.30) |
| Serotype 23F | 3.21 (2.42 to 4.25) | 3.74 (2.85 to 4.91) |
| Serotype 22F | 3.94 (3.07 to 5.05) | 3.50 (2.75 to 4.45) |
| Serotype 33F | 6.18 (4.72 to 8.09) | 9.20 (7.19 to 11.77) |
Collected over V114 and Prevnar 13™ arms: NSAEs from Day 1 up to 14 days after vaccination 1, and SAEs from Day 1 up to Week 8. V114 (Post-PPV23) and Prevnar 13™ (Post-PPV23) arms: NSAEs from week 8 up to 14 days after vaccination 2, and SAEs after Week 8 vaccination up to Month 6. All-Cause Mortality: From screening up to Month 6.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| V114 | 0/152 (0%) | 3/152 (2%) | 103/152 (67.8%) |
| Prevnar 13™ | 0/150 (0%) | 0/150 (0%) | 88/150 (58.7%) |
| V114 (Post-PPV23) | 0/150 (0%) | 2/150 (1.3%) | 88/150 (58.7%) |
| Prevnar 13™ (Post-PPV23) | 0/148 (0%) | 6/148 (4.1%) | 99/148 (66.9%) |
| Event | V114 | Prevnar 13™ | V114 (Post-PPV23) | Prevnar 13™ (Post-PPV23) |
|---|---|---|---|---|
| Herpes zosterInfections and infestations | 0/152 | 0/150 | 0/150 | 2/148 |
| Chest painGeneral disorders | 0/152 | 0/150 | 0/150 | 1/148 |
| PeritonitisInfections and infestations | 0/152 | 0/150 | 0/150 | 1/148 |
| Soft tissue infectionInfections and infestations | 0/152 | 0/150 | 0/150 | 1/148 |
| Foot fractureInjury, poisoning and procedural complications | 0/152 | 0/150 | 0/150 | 1/148 |
| Dry gangreneVascular disorders | 0/152 | 0/150 | 0/150 | 1/148 |
| AppendicitisInfections and infestations | 0/152 | 0/150 | 1/150 | 0/148 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 0/152 | 0/150 | 1/150 | 0/148 |
| Chondrocalcinosis pyrophosphateMusculoskeletal and connective tissue disorders | 1/152 | 0/150 | 0/150 | 0/148 |
| Transient ischaemic attackNervous system disorders | 1/152 | 0/150 | 0/150 | 0/148 |
| Event | V114 | Prevnar 13™ | V114 (Post-PPV23) | Prevnar 13™ (Post-PPV23) |
|---|---|---|---|---|
| Injection site painGeneral disorders | 88/152 | 78/150 | 80/150 | 92/148 |
| Injection site swellingGeneral disorders | 18/152 | 6/150 | 30/150 | 43/148 |
| FatigueGeneral disorders | 31/152 | 20/150 | 19/150 | 16/148 |
| HeadacheNervous system disorders | 20/152 | 14/150 | 13/150 | 13/148 |
| MyalgiaMusculoskeletal and connective tissue disorders | 19/152 | 14/150 | 17/150 | 18/148 |
| Injection site erythemaGeneral disorders | 8/152 | 5/150 | 15/150 | 18/148 |
| Age, Continuous(Years) | V114 | Prevnar 13™ | Total |
|---|---|---|---|
| Mean | 42.4 ± 12.5 | 41.3 ± 12.3 | 41.9 ± 12.4 |
| Sex: Female, Male(Participants) | V114 | Prevnar 13™ | Total |
|---|---|---|---|
| Female | 32 | 32 | 64 |
| Male | 120 | 118 | 238 |
| Ethnicity (NIH/OMB)(Participants) | V114 | Prevnar 13™ | Total |
|---|---|---|---|
| Hispanic or Latino | 49 | 45 | 94 |
| Not Hispanic or Latino | 102 | 104 | 206 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | V114 | Prevnar 13™ | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 24 | 30 | 54 |
| Native Hawaiian or Other Pacific Islander | 0 | 2 | 2 |
| Black or African American | 51 | 43 | 94 |
| White | 41 | 48 | 89 |
| More than one race | 36 | 26 | 62 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · engagezone.msd.com
Ran from Jul 2018 to primary completion in Sep 2019, 14 months.
Results were first posted in Nov 2020, 1 year 2 months after primary completion.
Of 81 industry-sponsored phase 3 interventional studies under Pneumococcal Infections, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 23. This study's 14 months is above that.
Counting every sponsor, half of 82 studies reached it within 13 months; a quarter within 9 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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