A Phase 3 interventional study of V114 and Prevnar 13™ in Pneumococcal Infections, sponsored by Merck Sharp & Dohme LLC. Completed at 22 sites in 4 countries. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-02.
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 20th 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: 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.
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 652 is above 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.
This tab as a report to print or save as PDF → With an account.
This study is designed 1) to evaluate the safety, tolerability, and immunogenicity of V114 and Prevnar 13™, 2) to describe the safety of sequential administration of V114 or Prevnar 13™ followed by PNEUMOVAX™23, and 3) to evaluate the immune responses to the 15 serotypes contained in V114 when PNEUMOVAX™23 is given approximately 12 months after receipt of either V114 or Prevnar 13™ in healthy adults 50 years of age or older. There was no formal hypothesis testing.
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.
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.
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.
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.
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 Month 12 (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 Month 12 (Vaccination 2)
Biological: Prevnar 13™ · Biological: PNEUMOVAX™23
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 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) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose
Also known as: PCV13
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, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose
Also known as: PPV23
Percentage of Participants With Solicited Injection-site Adverse Events Following V114 or Prevnar 13™
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. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain.
Time frame: Up to 5 days after Vaccination 1
Percentage of Participants With Solicited Injection-site Adverse Events Following PNEUMOVAX™23
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. Following vaccination with PNEUMOVAX™23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.
Time frame: Up to 5 days after Vaccination 2
Percentage of Participants With Solicited Systemic Adverse Events Following V114 or Prevnar 13™
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. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.
Time frame: Up to 14 days after Vaccination 1
Percentage of Participants With Solicited Systemic Adverse Events Following PNEUMOVAX™23
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. Following vaccination with PNEUMOVAX™23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.
Time frame: Up to 14 days after Vaccination 2
Percentage of Participants With Vaccine-related Serious Adverse Events Following V114 or Prevnar 13™
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 will be determined by the investigator. Following vaccination with V114 or Prevnar 13™, the percentage of participants with vaccine-related serious adverse events was assessed.
Time frame: Up to 12 months after Vaccination 1
Percentage of Participants With Vaccine-related Serious Adverse Events Following PNEUMOVAX™23
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 will be determined by the investigator. Following vaccination with PNEUMOVAX™23, the percentage of participants with vaccine-related serious adverse events was assessed.
Time frame: Month 12 to Month 13 (Up to 44 days after Vaccination 2)
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following PNEUMOVAX™23
Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) (estimated) and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated. OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay.
Time frame: Month 13 (30 days after Vaccination 2)
Geometric Mean Concentration of Serotype-specific Immunoglobulin G at 30 Days Following PNEUMOVAX™23
Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) (estimated) and GMC ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMC ratios); within-group CIs were not calculated. IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay.
Time frame: Month 13 (30 days after Vaccination 2)
GMT of Serotype-specific OPA at Day 30
Serotype-specific OPA GMTs (estimated) and GMT ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated. OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay.
Time frame: Day 30
GMC of Serotype-specific IgG at Day 30
Serotype-specific IgG GMC (estimated) and GMC ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMC ratios); within-group CIs were not calculated. IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay.
Time frame: Day 30
Geometric Mean Fold Rise in Serotype-specific OPA Day 1 to Day 30
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
Time frame: Day 1 (Baseline) and Day 30
GMFR in Serotype-specific IgG Day 1 to Day 30
Activity for the serotypes contained in Prevnar 13™ and V114 and (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
Time frame: Day 1 (Baseline) and Day 30
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Day 30
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
Time frame: Day 1 (Baseline) and Day 30
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Day 30
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
Time frame: Day 1 (Baseline) and Day 30
GMT of Serotype-specific OPA at Month 12
Serotype-specific OPA GMTs (estimated) and GMT ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated. OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay.
Time frame: Month 12
GMC of Serotype-specific IgG at Month 12
Serotype-specific IgG GMC (estimated) and GMC ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMC ratios); within-group CIs were not calculated. IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay.
Time frame: Month 12
GMFR in Serotype-specific OPA Day 1 to Month 12
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
Time frame: Day 1 (Baseline) and Month 12
GMFR in Serotype-specific IgG Day 1 to Month 12
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
Time frame: Day 1 (Baseline) and Month 12
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 12
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
Time frame: Day 1 (Baseline) and Month 12
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 12
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
Time frame: Day 1 (Baseline) and Month 12
GMFR in Serotype-specific OPA Day 1 to Month 13
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
Time frame: Day 1 (Baseline) and Month 13
GMFR in Serotype-specific IgG Day 1 to Month 13
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
Time frame: Day 1 (Baseline) and Month 13
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Day 1 to Month 13
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
Time frame: Day 1 (Baseline) and Month 13
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Day 1 to Month 13
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
Time frame: Day 1 (Baseline) and Month 13
GMFR in Serotype-specific OPA Month 12 to Month 13
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
Time frame: Month 12 (Baseline) and Month 13
GMFR in Serotype-specific IgG Month 12 to Month 13
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
Time frame: Month 12 (Baseline) and Month 13
Percentage of Participants With ≥4-Fold Rise in Serotype-specific OPA Titer Month 12 to Month 13
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
Time frame: Month 12 (Baseline) and Month 13
Percentage of Participants With ≥4-Fold Rise in Serotype-specific IgG Concentration Month 12 to Month 13
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
Time frame: Month 12 (Baseline) and Month 13
| Milestone | V114 | Prevnar 13™ |
|---|---|---|
| Started | 327 | 325 |
| Vaccination 1 - (v114 or prevnar 13™, day 1) | 326 | 325 |
| Vaccination 2 - (pneumovax™23, month 12) | 298 | 302 |
| Completed | 303 | 306 |
| Not completed | 24 | 19 |
| Withdrew: Withdrawal by subject | 18 | 10 |
| Withdrew: Lost to follow-up | 4 | 7 |
| Withdrew: Non-study pneumococcal vaccine | 1 | 0 |
| Withdrew: Oncological treatment | 0 | 2 |
| Withdrew: Pain with vaccination | 1 | 0 |
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. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and tenderness/pain.
| Percentage of Participants | V114 | Prevnar 13™ |
|---|---|---|
| Injection site redness/erythema | 9.8 | 5.6 |
| Injection site tenderness/pain | 55.0 | 41.4 |
| Injection site swelling | 16.2 | 11.4 |
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. Following vaccination with PNEUMOVAX™23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.
| Percentage of Participants | V114 | Prevnar 13™ |
|---|---|---|
| Injection site redness/erythema | 17.4 | 16.9 |
| Injection site tenderness/pain | 62.1 | 58.6 |
| Injection site swelling | 28.2 | 26.2 |
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. Following vaccination with V114 or Prevnar 13™, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.
| Percentage of Participants | V114 | Prevnar 13™ |
|---|---|---|
| Joint pain/arthralgia | 6.4 | 5.2 |
| Tiredness/fatigue | 23.5 | 13.9 |
| Headache | 14.1 | 12.7 |
| Muscle pain/myalgia | 17.7 | 11.1 |
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. Following vaccination with PNEUMOVAX™23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue.
| Percentage of Participants | V114 | Prevnar 13™ |
|---|---|---|
| Joint pain/arthralgia | 8.4 | 8.3 |
| Tiredness/fatigue | 25.8 | 21.9 |
| Headache | 12.1 | 12.6 |
| Muscle pain/myalgia | 21.5 | 16.6 |
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 will be determined by the investigator. Following vaccination with V114 or Prevnar 13™, the percentage of participants with vaccine-related serious adverse events was assessed.
| Percentage of Participants | V114 | Prevnar 13™ |
|---|---|---|
| Percentage of Participants With Vaccine-related Serious Adverse Events Following V114 or Prevnar 13™ | 0.0 | 0.0 |
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 will be determined by the investigator. Following vaccination with PNEUMOVAX™23, the percentage of participants with vaccine-related serious adverse events was assessed.
| Percentage of Participants | V114 | Prevnar 13™ |
|---|---|---|
| Percentage of Participants With Vaccine-related Serious Adverse Events Following PNEUMOVAX™23 | 0.0 | 0.0 |
Serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) (estimated) and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated. OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay.
| Titers | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 (Shared) | 392.2 | 283.2 |
| Serotype 3 (Shared) | 282.6 | 262.8 |
| Serotype 4 (Shared) | 1671.9 | 1580.4 |
| Serotype 5 (Shared) | 705.5 | 583.9 |
| Serotype 6A (Shared) | 3261.5 | 2806.8 |
| Serotype 6B (Shared) | 3223.9 | 2872.0 |
| Serotype 7F (Shared) | 5125.6 | 4848.0 |
| Serotype 9V (Shared) | 2059.5 | 1872.0 |
| Serotype 14 (Shared) | 3370.9 | 2660.5 |
| Serotype 18C (Shared) | 2379.6 | 2103.9 |
| Serotype 19A (Shared) | 3657.1 | 3170.8 |
| Serotype 19F (Shared) | 2229.7 | 2156.2 |
| Serotype 23F (Shared) | 1894.2 | 1485.1 |
| Serotype 22F (Unique to V114) | 3124.4 | 1921.6 |
| Serotype 33F (Unique to V114) | 7881.6 | 8269.9 |
Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) (estimated) and GMC ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMC ratios); within-group CIs were not calculated. IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay.
| µg/mL | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 (Shared) | 5.21 | 5.68 |
| Serotype 3 (Shared) | 1.05 | 1.05 |
| Serotype 4 (Shared) | 1.99 | 2.29 |
| Serotype 5 (Shared) | 5.77 | 5.82 |
| Serotype 6A (Shared) | 4.97 | 4.28 |
| Serotype 6B (Shared) | 6.71 | 5.77 |
| Serotype 7F (Shared) | 5.99 | 6.06 |
| Serotype 9V (Shared) | 4.96 | 4.75 |
| Serotype 14 (Shared) | 14.82 | 12.72 |
| Serotype 18C (Shared) | 7.31 | 6.29 |
| Serotype 19A (Shared) | 13.10 | 11.88 |
| Serotype 19F (Shared) | 9.38 | 8.62 |
| Serotype 23F (Shared) | 4.83 | 4.24 |
| Serotype 22F (Unique to V114) | 4.85 | 3.39 |
| Serotype 33F (Unique to V114) | 10.60 | 13.30 |
Serotype-specific OPA GMTs (estimated) and GMT ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated. OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay.
| Titers | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 (Shared) | 361.6 | 296.2 |
| Serotype 3 (Shared) | 245.4 | 129.4 |
| Serotype 4 (Shared) | 1280.4 | 1685.9 |
| Serotype 5 (Shared) | 699.0 | 655.9 |
| Serotype 6A (Shared) | 7352.8 | 6184.2 |
| Serotype 6B (Shared) | 5958.1 | 3631.2 |
| Serotype 7F (Shared) | 4966.9 | 5207.6 |
| Serotype 9V (Shared) | 2329.9 | 2293.0 |
| Serotype 14 (Shared) | 2677.3 | 2458.1 |
| Serotype 18C (Shared) | 4298.2 | 2896.3 |
| Serotype 19A (Shared) | 4856.1 | 3783.0 |
| Serotype 19F (Shared) | 2418.8 | 2203.5 |
| Serotype 23F (Shared) | 2648.7 | 1726.9 |
| Serotype 22F (Unique to V114) | 3471.1 | 99.6 |
| Serotype 33F (Unique to V114) | 11392.4 | 1244.7 |
Serotype-specific IgG GMC (estimated) and GMC ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMC ratios); within-group CIs were not calculated. IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay.
| µg/mL | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 (Shared) | 6.97 | 7.86 |
| Serotype 3 (Shared) | 1.02 | 0.59 |
| Serotype 4 (Shared) | 2.36 | 2.98 |
| Serotype 5 (Shared) | 5.43 | 5.21 |
| Serotype 6A (Shared) | 11.48 | 8.22 |
| Serotype 6B (Shared) | 13.69 | 8.35 |
| Serotype 7F (Shared) | 7.14 | 7.82 |
| Serotype 9V (Shared) | 6.10 | 5.39 |
| Serotype 14 (Shared) | 12.68 | 11.59 |
| Serotype 18C (Shared) | 16.67 | 10.66 |
| Serotype 19A (Shared) | 18.59 | 16.48 |
| Serotype 19F (Shared) | 12.00 | 10.53 |
| Serotype 23F (Shared) | 9.76 | 6.07 |
| Serotype 22F (Unique to V114) | 5.07 | 0.31 |
| Serotype 33F (Unique to V114) | 14.31 | 1.12 |
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
| Ratio | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 (Shared) | 22.3 (18.5 to 26.9) | 16.7 (13.8 to 20.2) |
| Serotype 3 (Shared) | 8.0 (6.9 to 9.2) | 4.4 (3.8 to 5.1) |
| Serotype 4 (Shared) | 18.3 (15.0 to 22.4) | 23.3 (19.3 to 28.3) |
| Serotype 5 (Shared) | 17.2 (14.2 to 20.9) | 16.2 (13.3 to 19.7) |
| Serotype 6A (Shared) | 17.4 (14.2 to 21.2) | 13.9 (11.5 to 16.8) |
| Serotype 6B (Shared) | 28.5 (23.1 to 35.2) | 18.4 (14.9 to 22.7) |
| Serotype 7F (Shared) | 10.7 (8.7 to 13.0) | 10.5 (8.5 to 13.1) |
| Serotype 9V (Shared) | 6.1 (5.2 to 7.1) | 5.6 (4.7 to 6.5) |
| Serotype 14 (Shared) | 6.6 (5.4 to 8.0) | 6.0 (4.9 to 7.4) |
| Serotype 18C (Shared) | 18.1 (15.1 to 21.7) | 12.2 (10.2 to 14.5) |
| Serotype 19A (Shared) | 13.4 (11.1 to 16.3) | 10.0 (8.4 to 12.0) |
| Serotype 19F (Shared) | 7.8 (6.7 to 9.2) | 6.4 (5.5 to 7.5) |
| Serotype 23F (Shared) | 18.8 (15.2 to 23.1) | 12.2 (9.8 to 15.2) |
| Serotype 22F (Unique to V114) | 32.5 (24.2 to 43.6) | 1.1 (0.8 to 1.4) |
| Serotype 33F (Unique to V114) | 8.3 (6.7 to 10.1) | 0.9 (0.8 to 1.0) |
Activity for the serotypes contained in Prevnar 13™ and V114 and (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
| Ratio | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 (Shared) | 13.0 (11.0 to 15.3) | 14.4 (12.3 to 16.8) |
| Serotype 3 (Shared) | 6.7 (5.8 to 7.8) | 3.9 (3.4 to 4.3) |
| Serotype 4 (Shared) | 10.1 (8.6 to 11.9) | 12.4 (10.6 to 14.5) |
| Serotype 5 (Shared) | 5.6 (4.8 to 6.5) | 5.2 (4.4 to 6.2) |
| Serotype 6A (Shared) | 30.2 (25.3 to 36.1) | 20.8 (17.5 to 24.6) |
| Serotype 6B (Shared) | 28.2 (23.4 to 34.1) | 17.1 (14.4 to 20.4) |
| Serotype 7F (Shared) | 13.6 (11.5 to 16.1) | 14.3 (12.1 to 17.0) |
| Serotype 9V (Shared) | 11.7 (9.9 to 13.9) | 10.3 (8.8 to 12.0) |
| Serotype 14 (Shared) | 6.6 (5.4 to 7.9) | 6.3 (5.3 to 7.5) |
| Serotype 18C (Shared) | 22.4 (18.7 to 26.7) | 13.7 (11.6 to 16.2) |
| Serotype 19A (Shared) | 11.3 (9.5 to 13.5) | 9.5 (8.1 to 11.1) |
| Serotype 19F (Shared) | 14.2 (12.0 to 16.9) | 11.9 (10.2 to 14.0) |
| Serotype 23F (Shared) | 17.7 (14.7 to 21.3) | 11.0 (9.3 to 13.1) |
| Serotype 22F (Unique to V114) | 14.9 (12.4 to 18.0) | 0.9 (0.9 to 1.0) |
| Serotype 33F (Unique to V114) | 11.1 (9.3 to 13.1) | 0.8 (0.8 to 0.9) |
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
| Percentage of Participants | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 (Shared) | 83.4 (78.7 to 87.4) | 76.1 (71.0 to 80.7) |
| Serotype 3 (Shared) | 72.1 (66.7 to 77.1) | 51.1 (45.4 to 56.8) |
| Serotype 4 (Shared) | 79.3 (74.4 to 83.7) | 84.6 (80.1 to 88.4) |
| Serotype 5 (Shared) | 76.8 (71.7 to 81.4) | 79.0 (74.1 to 83.4) |
| Serotype 6A (Shared) | 79.2 (74.0 to 83.8) | 78.1 (72.8 to 82.8) |
| Serotype 6B (Shared) | 83.4 (78.8 to 87.5) | 76.1 (71.0 to 80.8) |
| Serotype 7F (Shared) | 67.2 (61.6 to 72.5) | 65.9 (60.2 to 71.3) |
| Serotype 9V (Shared) | 61.2 (55.4 to 66.8) | 56.8 (51.1 to 62.4) |
| Serotype 14 (Shared) | 53.0 (47.2 to 58.7) | 53.2 (47.5 to 58.9) |
| Serotype 18C (Shared) | 83.4 (78.7 to 87.4) | 74.2 (68.9 to 79.0) |
| Serotype 19A (Shared) | 70.4 (64.9 to 75.5) | 69.6 (64.1 to 74.7) |
| Serotype 19F (Shared) | 63.4 (57.7 to 68.9) | 56.2 (50.4 to 61.8) |
| Serotype 23F (Shared) | 79.2 (74.0 to 83.8) | 70.8 (65.2 to 76.0) |
| Serotype 22F (Unique to V114) | 72.8 (66.8 to 78.2) | 16.5 (12.1 to 21.7) |
| Serotype 33F (Unique to V114) | 61.3 (55.6 to 66.8) | 3.0 (1.4 to 5.7) |
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
| Percentage of Participants | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 (Shared) | 74.9 (69.7 to 79.6) | 80.8 (76.1 to 85.0) |
| Serotype 3 (Shared) | 62.4 (56.7 to 67.8) | 42.8 (37.3 to 48.4) |
| Serotype 4 (Shared) | 71.4 (66.0 to 76.3) | 74.2 (69.0 to 78.9) |
| Serotype 5 (Shared) | 52.4 (46.7 to 58.1) | 49.4 (43.7 to 55.0) |
| Serotype 6A (Shared) | 88.4 (84.3 to 91.8) | 84.3 (79.8 to 88.1) |
| Serotype 6B (Shared) | 85.5 (81.1 to 89.2) | 77.4 (72.4 to 81.8) |
| Serotype 7F (Shared) | 76.8 (71.8 to 81.4) | 75.5 (70.4 to 80.1) |
| Serotype 9V (Shared) | 73.0 (67.7 to 77.8) | 70.4 (65.1 to 75.4) |
| Serotype 14 (Shared) | 54.0 (48.3 to 59.7) | 56.0 (50.3 to 61.5) |
| Serotype 18C (Shared) | 83.9 (79.4 to 87.8) | 75.5 (70.4 to 80.1) |
| Serotype 19A (Shared) | 71.4 (66.0 to 76.3) | 69.2 (63.8 to 74.2) |
| Serotype 19F (Shared) | 77.5 (72.4 to 82.0) | 76.3 (71.3 to 80.9) |
| Serotype 23F (Shared) | 79.7 (74.8 to 84.1) | 70.1 (64.8 to 75.1) |
| Serotype 22F (Unique to V114) | 76.8 (71.8 to 81.4) | 0.9 (0.2 to 2.7) |
| Serotype 33F (Unique to V114) | 71.1 (65.7 to 76.0) | 0.6 (0.1 to 2.3) |
Serotype-specific OPA GMTs (estimated) and GMT ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMT ratios); within-group CIs were not calculated. OPA for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay.
| Titers | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 (Shared) | 138.2 | 116.2 |
| Serotype 3 (Shared) | 88.3 | 56.3 |
| Serotype 4 (Shared) | 477.2 | 666.5 |
| Serotype 5 (Shared) | 213.4 | 209.6 |
| Serotype 6A (Shared) | 2421.7 | 2111.3 |
| Serotype 6B (Shared) | 2079.7 | 1453.7 |
| Serotype 7F (Shared) | 2161.8 | 2291.1 |
| Serotype 9V (Shared) | 1006.8 | 1030.5 |
| Serotype 14 (Shared) | 1543.8 | 1395.1 |
| Serotype 18C (Shared) | 1520.4 | 1191.8 |
| Serotype 19A (Shared) | 1724.3 | 1575.3 |
| Serotype 19F (Shared) | 948.4 | 876.0 |
| Serotype 23F (Shared) | 984.7 | 720.3 |
| Serotype 22F (Unique to V114) | 1267.4 | 99.1 |
| Serotype 33F (Unique to V114) | 4099.0 | 1266.6 |
Serotype-specific IgG GMC (estimated) and GMC ratios with 95% CIs were calculated using a constrained longitudinal data analysis (cLDA) model utilizing data from both vaccination groups. Per the statistical analysis plan, the only CIs calculated were the between-group CIs (for the GMC ratios); within-group CIs were not calculated. IgG for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay.
| µg/mL | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 (Shared) | 2.73 | 3.52 |
| Serotype 3 (Shared) | 0.39 | 0.28 |
| Serotype 4 (Shared) | 1.00 | 1.31 |
| Serotype 5 (Shared) | 2.59 | 2.91 |
| Serotype 6A (Shared) | 4.27 | 3.13 |
| Serotype 6B (Shared) | 5.13 | 3.46 |
| Serotype 7F (Shared) | 2.95 | 3.45 |
| Serotype 9V (Shared) | 2.85 | 2.75 |
| Serotype 14 (Shared) | 7.91 | 7.50 |
| Serotype 18C (Shared) | 5.99 | 4.32 |
| Serotype 19A (Shared) | 8.19 | 7.22 |
| Serotype 19F (Shared) | 4.67 | 4.14 |
| Serotype 23F (Shared) | 3.57 | 2.66 |
| Serotype 22F (Unique to V114) | 2.07 | 0.33 |
| Serotype 33F (Unique to V114) | 6.24 | 1.24 |
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
| Ratio | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 (Shared) | 9.2 (7.7 to 11.1) | 7.3 (6.1 to 8.7) |
| Serotype 3 (Shared) | 3.0 (2.6 to 3.5) | 2.1 (1.9 to 2.4) |
| Serotype 4 (Shared) | 7.0 (5.8 to 8.3) | 9.4 (7.7 to 11.3) |
| Serotype 5 (Shared) | 5.5 (4.6 to 6.7) | 5.7 (4.7 to 6.9) |
| Serotype 6A (Shared) | 5.7 (4.9 to 6.8) | 4.9 (4.2 to 5.7) |
| Serotype 6B (Shared) | 10.4 (8.4 to 12.7) | 7.3 (6.1 to 8.8) |
| Serotype 7F (Shared) | 4.6 (3.8 to 5.5) | 4.9 (4.1 to 6.0) |
| Serotype 9V (Shared) | 2.7 (2.3 to 3.1) | 2.7 (2.3 to 3.1) |
| Serotype 14 (Shared) | 3.9 (3.3 to 4.7) | 3.5 (2.9 to 4.2) |
| Serotype 18C (Shared) | 6.5 (5.6 to 7.6) | 5.2 (4.5 to 6.1) |
| Serotype 19A (Shared) | 4.9 (4.1 to 5.9) | 4.3 (3.6 to 5.0) |
| Serotype 19F (Shared) | 3.0 (2.6 to 3.5) | 2.8 (2.5 to 3.3) |
| Serotype 23F (Shared) | 7.1 (5.8 to 8.7) | 5.1 (4.2 to 6.3) |
| Serotype 22F (Unique to V114) | 12.3 (9.3 to 16.3) | 1.3 (1.0 to 1.6) |
| Serotype 33F (Unique to V114) | 3.0 (2.5 to 3.6) | 0.9 (0.8 to 1.0) |
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
| Ratio | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 (Shared) | 5.2 (4.5 to 6.0) | 6.6 (5.7 to 7.7) |
| Serotype 3 (Shared) | 2.6 (2.3 to 2.9) | 1.8 (1.7 to 2.0) |
| Serotype 4 (Shared) | 4.3 (3.8 to 4.9) | 5.5 (4.8 to 6.3) |
| Serotype 5 (Shared) | 2.7 (2.4 to 3.0) | 3.0 (2.6 to 3.4) |
| Serotype 6A (Shared) | 11.1 (9.5 to 13.0) | 8.1 (6.9 to 9.3) |
| Serotype 6B (Shared) | 10.3 (8.7 to 12.2) | 7.2 (6.2 to 8.4) |
| Serotype 7F (Shared) | 5.5 (4.8 to 6.2) | 6.4 (5.5 to 7.5) |
| Serotype 9V (Shared) | 5.6 (4.9 to 6.4) | 5.4 (4.7 to 6.1) |
| Serotype 14 (Shared) | 3.9 (3.4 to 4.6) | 4.1 (3.5 to 4.7) |
| Serotype 18C (Shared) | 8.0 (6.9 to 9.3) | 5.6 (4.9 to 6.5) |
| Serotype 19A (Shared) | 4.9 (4.3 to 5.6) | 4.3 (3.8 to 4.9) |
| Serotype 19F (Shared) | 5.2 (4.6 to 6.0) | 4.9 (4.3 to 5.6) |
| Serotype 23F (Shared) | 6.6 (5.7 to 7.6) | 4.9 (4.3 to 5.7) |
| Serotype 22F (Unique to V114) | 6.0 (5.1 to 7.0) | 1.0 (0.9 to 1.1) |
| Serotype 33F (Unique to V114) | 4.7 (4.1 to 5.4) | 0.9 (0.9 to 1.0) |
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
| Percentage of Participants | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 (Shared) | 69.4 (63.6 to 74.7) | 61.4 (55.4 to 67.1) |
| Serotype 3 (Shared) | 39.4 (33.6 to 45.5) | 25.7 (20.7 to 31.3) |
| Serotype 4 (Shared) | 63.0 (57.1 to 68.8) | 67.1 (61.3 to 72.6) |
| Serotype 5 (Shared) | 58.4 (52.4 to 64.2) | 57.5 (51.5 to 63.4) |
| Serotype 6A (Shared) | 61.2 (54.9 to 67.2) | 54.3 (48.0 to 60.6) |
| Serotype 6B (Shared) | 68.8 (62.9 to 74.2) | 60.4 (54.4 to 66.3) |
| Serotype 7F (Shared) | 50.4 (44.2 to 56.5) | 48.9 (42.7 to 55.1) |
| Serotype 9V (Shared) | 34.6 (28.9 to 40.5) | 32.0 (26.5 to 37.9) |
| Serotype 14 (Shared) | 41.6 (35.7 to 47.7) | 42.2 (36.3 to 48.4) |
| Serotype 18C (Shared) | 63.3 (57.3 to 69.0) | 54.4 (48.3 to 60.4) |
| Serotype 19A (Shared) | 53.2 (47.0 to 59.2) | 47.5 (41.4 to 53.5) |
| Serotype 19F (Shared) | 41.2 (35.2 to 47.4) | 35.3 (29.6 to 41.3) |
| Serotype 23F (Shared) | 62.4 (56.1 to 68.3) | 53.5 (47.2 to 59.7) |
| Serotype 22F (Unique to V114) | 64.0 (57.4 to 70.3) | 14.1 (9.7 to 19.5) |
| Serotype 33F (Unique to V114) | 34.5 (29.0 to 40.4) | 4.8 (2.6 to 8.1) |
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
| Percentage of Participants | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 (Shared) | 56.0 (50.0 to 61.9) | 65.6 (59.7 to 71.1) |
| Serotype 3 (Shared) | 27.0 (21.9 to 32.5) | 12.4 (8.8 to 16.8) |
| Serotype 4 (Shared) | 47.2 (41.2 to 53.2) | 57.7 (51.6 to 63.5) |
| Serotype 5 (Shared) | 30.9 (25.5 to 36.6) | 34.4 (28.9 to 40.3) |
| Serotype 6A (Shared) | 75.5 (70.1 to 80.4) | 66.7 (60.8 to 72.1) |
| Serotype 6B (Shared) | 73.0 (67.5 to 78.1) | 62.1 (56.1 to 67.7) |
| Serotype 7F (Shared) | 59.9 (54.0 to 65.7) | 64.9 (59.0 to 70.5) |
| Serotype 9V (Shared) | 60.6 (54.7 to 66.4) | 55.3 (49.3 to 61.2) |
| Serotype 14 (Shared) | 42.6 (36.7 to 48.6) | 46.8 (40.9 to 52.8) |
| Serotype 18C (Shared) | 70.2 (64.5 to 75.5) | 58.5 (52.5 to 64.3) |
| Serotype 19A (Shared) | 53.9 (47.9 to 59.8) | 50.0 (44.0 to 56.0) |
| Serotype 19F (Shared) | 56.9 (50.9 to 62.8) | 52.3 (46.3 to 58.3) |
| Serotype 23F (Shared) | 59.6 (53.6 to 65.4) | 51.4 (45.4 to 57.4) |
| Serotype 22F (Unique to V114) | 58.9 (52.9 to 64.7) | 1.8 (0.6 to 4.1) |
| Serotype 33F (Unique to V114) | 52.5 (46.5 to 58.4) | 1.1 (0.2 to 3.1) |
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
| Ratio | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 (Shared) | 24.7 (20.7 to 29.4) | 15.5 (12.9 to 18.5) |
| Serotype 3 (Shared) | 9.1 (7.9 to 10.5) | 8.7 (7.5 to 10.0) |
| Serotype 4 (Shared) | 23.8 (19.5 to 29.2) | 21.5 (17.5 to 26.3) |
| Serotype 5 (Shared) | 17.2 (14.1 to 21.1) | 14.5 (12.0 to 17.5) |
| Serotype 6A (Shared) | 7.7 (6.5 to 9.2) | 6.3 (5.4 to 7.3) |
| Serotype 6B (Shared) | 16.2 (13.3 to 19.8) | 14.3 (11.7 to 17.4) |
| Serotype 7F (Shared) | 11.0 (9.0 to 13.4) | 10.2 (8.2 to 12.5) |
| Serotype 9V (Shared) | 5.2 (4.5 to 6.1) | 4.6 (3.9 to 5.3) |
| Serotype 14 (Shared) | 8.2 (6.8 to 9.8) | 6.7 (5.6 to 8.0) |
| Serotype 18C (Shared) | 10.1 (8.6 to 11.7) | 9.0 (7.7 to 10.4) |
| Serotype 19A (Shared) | 10.4 (8.5 to 12.6) | 8.5 (7.2 to 10.2) |
| Serotype 19F (Shared) | 7.0 (6.0 to 8.1) | 6.3 (5.5 to 7.2) |
| Serotype 23F (Shared) | 12.6 (10.3 to 15.5) | 9.7 (7.8 to 12.0) |
| Serotype 22F (Unique to V114) | 30.2 (22.7 to 40.1) | 16.2 (11.8 to 22.2) |
| Serotype 33F (Unique to V114) | 5.8 (4.8 to 7.0) | 5.5 (4.5 to 6.7) |
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
| Ratio | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 (Shared) | 9.9 (8.7 to 11.4) | 10.5 (9.1 to 12.2) |
| Serotype 3 (Shared) | 6.9 (6.0 to 7.8) | 6.7 (6.0 to 7.6) |
| Serotype 4 (Shared) | 8.6 (7.6 to 9.8) | 9.5 (8.3 to 11.0) |
| Serotype 5 (Shared) | 5.9 (5.2 to 6.8) | 5.9 (5.2 to 6.8) |
| Serotype 6A (Shared) | 13.1 (11.2 to 15.3) | 10.8 (9.3 to 12.5) |
| Serotype 6B (Shared) | 13.7 (11.7 to 16.1) | 11.9 (10.2 to 13.9) |
| Serotype 7F (Shared) | 11.1 (9.8 to 12.7) | 11.2 (9.7 to 12.9) |
| Serotype 9V (Shared) | 9.8 (8.5 to 11.3) | 9.2 (8.0 to 10.5) |
| Serotype 14 (Shared) | 7.4 (6.3 to 8.7) | 6.9 (5.9 to 8.1) |
| Serotype 18C (Shared) | 9.8 (8.5 to 11.3) | 8.2 (7.1 to 9.4) |
| Serotype 19A (Shared) | 7.9 (6.9 to 9.0) | 7.0 (6.1 to 8.0) |
| Serotype 19F (Shared) | 10.7 (9.3 to 12.4) | 10.0 (8.6 to 11.5) |
| Serotype 23F (Shared) | 9.1 (7.9 to 10.5) | 7.6 (6.6 to 8.7) |
| Serotype 22F (Unique to V114) | 14.2 (12.0 to 16.7) | 10.0 (8.4 to 12.0) |
| Serotype 33F (Unique to V114) | 8.1 (7.1 to 9.2) | 10.1 (8.6 to 11.8) |
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
| Percentage of Participants | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 (Shared) | 87.9 (83.4 to 91.5) | 78.8 (73.4 to 83.5) |
| Serotype 3 (Shared) | 78.7 (73.3 to 83.5) | 76.0 (70.4 to 81.0) |
| Serotype 4 (Shared) | 83.7 (78.7 to 87.9) | 84.3 (79.4 to 88.5) |
| Serotype 5 (Shared) | 79.9 (74.6 to 84.4) | 80.9 (75.7 to 85.4) |
| Serotype 6A (Shared) | 68.3 (62.1 to 74.1) | 64.5 (58.1 to 70.5) |
| Serotype 6B (Shared) | 78.0 (72.5 to 82.9) | 77.1 (71.5 to 82.0) |
| Serotype 7F (Shared) | 72.1 (66.3 to 77.5) | 64.6 (58.3 to 70.4) |
| Serotype 9V (Shared) | 55.8 (49.6 to 61.9) | 50.8 (44.6 to 56.9) |
| Serotype 14 (Shared) | 63.8 (57.7 to 69.6) | 58.7 (52.5 to 64.7) |
| Serotype 18C (Shared) | 75.7 (70.1 to 80.7) | 73.7 (68.0 to 78.9) |
| Serotype 19A (Shared) | 70.2 (64.3 to 75.7) | 66.3 (60.3 to 71.9) |
| Serotype 19F (Shared) | 68.4 (62.4 to 74.0) | 62.1 (56.0 to 68.0) |
| Serotype 23F (Shared) | 74.4 (68.5 to 79.7) | 66.3 (60.0 to 72.1) |
| Serotype 22F (Unique to V114) | 79.5 (73.6 to 84.6) | 62.6 (56.0 to 68.9) |
| Serotype 33F (Unique to V114) | 55.8 (49.6 to 61.8) | 51.6 (45.3 to 57.8) |
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
| Percentage of Participants | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 (Shared) | 79.5 (74.2 to 84.1) | 78.5 (73.1 to 83.2) |
| Serotype 3 (Shared) | 72.5 (66.8 to 77.7) | 68.6 (62.8 to 74.1) |
| Serotype 4 (Shared) | 76.6 (71.1 to 81.5) | 75.5 (69.9 to 80.4) |
| Serotype 5 (Shared) | 59.7 (53.6 to 65.6) | 59.9 (53.8 to 65.7) |
| Serotype 6A (Shared) | 81.0 (75.8 to 85.4) | 77.0 (71.6 to 81.9) |
| Serotype 6B (Shared) | 81.0 (75.8 to 85.4) | 77.0 (71.6 to 81.9) |
| Serotype 7F (Shared) | 81.7 (76.6 to 86.1) | 81.4 (76.3 to 85.8) |
| Serotype 9V (Shared) | 76.2 (70.7 to 81.1) | 73.4 (67.7 to 78.5) |
| Serotype 14 (Shared) | 68.5 (62.6 to 74.0) | 63.9 (57.9 to 69.6) |
| Serotype 18C (Shared) | 78.0 (72.6 to 82.8) | 70.8 (65.0 to 76.1) |
| Serotype 19A (Shared) | 70.0 (64.1 to 75.3) | 66.4 (60.5 to 72.0) |
| Serotype 19F (Shared) | 77.3 (71.9 to 82.1) | 74.0 (68.4 to 79.1) |
| Serotype 23F (Shared) | 72.2 (66.4 to 77.4) | 69.7 (63.9 to 75.1) |
| Serotype 22F (Unique to V114) | 80.6 (75.4 to 85.1) | 71.9 (66.2 to 77.1) |
| Serotype 33F (Unique to V114) | 75.5 (69.9 to 80.4) | 76.6 (71.2 to 81.5) |
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a Multiplexed Opsonophagocytic Assay. Geometric mean fold rise (GMFR) is the geometric mean of fold rise from baseline to postvaccination.
| Ratio | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 (Shared) | 2.7 (2.4 to 3.0) | 2.3 (2.0 to 2.6) |
| Serotype 3 (Shared) | 3.0 (2.7 to 3.4) | 4.1 (3.6 to 4.6) |
| Serotype 4 (Shared) | 3.3 (2.9 to 3.9) | 2.3 (2.0 to 2.6) |
| Serotype 5 (Shared) | 3.1 (2.7 to 3.5) | 2.6 (2.3 to 2.9) |
| Serotype 6A (Shared) | 1.3 (1.2 to 1.5) | 1.3 (1.2 to 1.5) |
| Serotype 6B (Shared) | 1.5 (1.4 to 1.7) | 1.9 (1.8 to 2.2) |
| Serotype 7F (Shared) | 2.3 (2.1 to 2.6) | 2.1 (1.9 to 2.3) |
| Serotype 9V (Shared) | 2.0 (1.8 to 2.2) | 1.7 (1.6 to 2.0) |
| Serotype 14 (Shared) | 2.1 (1.9 to 2.4) | 1.9 (1.7 to 2.1) |
| Serotype 18C (Shared) | 1.5 (1.4 to 1.7) | 1.7 (1.5 to 1.9) |
| Serotype 19A (Shared) | 2.1 (1.9 to 2.4) | 2.0 (1.8 to 2.3) |
| Serotype 19F (Shared) | 2.3 (2.0 to 2.6) | 2.3 (2.1 to 2.6) |
| Serotype 23F (Shared) | 1.9 (1.6 to 2.1) | 1.9 (1.7 to 2.2) |
| Serotype 22F (Unique to V114) | 2.5 (2.1 to 2.9) | 14.2 (10.6 to 19.0) |
| Serotype 33F (Unique to V114) | 2.0 (1.8 to 2.2) | 6.2 (5.2 to 7.5) |
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. GMFR is the geometric mean of fold rise from baseline to postvaccination.
| Ratio | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 (Shared) | 1.9 (1.8 to 2.1) | 1.6 (1.5 to 1.7) |
| Serotype 3 (Shared) | 2.6 (2.4 to 2.9) | 3.7 (3.3 to 4.1) |
| Serotype 4 (Shared) | 2.0 (1.8 to 2.2) | 1.7 (1.6 to 1.9) |
| Serotype 5 (Shared) | 2.3 (2.1 to 2.5) | 2.0 (1.8 to 2.1) |
| Serotype 6A (Shared) | 1.2 (1.1 to 1.2) | 1.3 (1.3 to 1.4) |
| Serotype 6B (Shared) | 1.3 (1.2 to 1.4) | 1.6 (1.5 to 1.8) |
| Serotype 7F (Shared) | 2.1 (1.9 to 2.2) | 1.8 (1.6 to 1.9) |
| Serotype 9V (Shared) | 1.8 (1.6 to 1.9) | 1.7 (1.6 to 1.9) |
| Serotype 14 (Shared) | 1.9 (1.7 to 2.1) | 1.7 (1.6 to 1.8) |
| Serotype 18C (Shared) | 1.2 (1.2 to 1.3) | 1.5 (1.4 to 1.6) |
| Serotype 19A (Shared) | 1.6 (1.5 to 1.7) | 1.6 (1.5 to 1.7) |
| Serotype 19F (Shared) | 2.0 (1.9 to 2.2) | 2.1 (1.9 to 2.3) |
| Serotype 23F (Shared) | 1.4 (1.3 to 1.5) | 1.6 (1.5 to 1.7) |
| Serotype 22F (Unique to V114) | 2.4 (2.2 to 2.6) | 10.0 (8.4 to 11.9) |
| Serotype 33F (Unique to V114) | 1.7 (1.6 to 1.9) | 10.7 (9.1 to 12.5) |
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using a Multiplexed Opsonophagocytic Assay. The percentage of participants who had ≥4-fold rise in OPA titers were calculated from baseline to postvaccination.
| Percentage of Participants | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 (Shared) | 29.7 (24.3 to 35.5) | 25.6 (20.5 to 31.2) |
| Serotype 3 (Shared) | 39.0 (33.1 to 45.1) | 49.6 (43.5 to 55.8) |
| Serotype 4 (Shared) | 36.3 (30.6 to 42.3) | 22.3 (17.5 to 27.8) |
| Serotype 5 (Shared) | 34.9 (29.3 to 40.9) | 29.2 (23.9 to 35.0) |
| Serotype 6A (Shared) | 9.1 (5.9 to 13.2) | 10.4 (7.1 to 14.7) |
| Serotype 6B (Shared) | 8.8 (5.7 to 12.8) | 16.1 (11.9 to 21.0) |
| Serotype 7F (Shared) | 24.7 (19.7 to 30.3) | 21.2 (16.5 to 26.5) |
| Serotype 9V (Shared) | 20.1 (15.5 to 25.3) | 16.5 (12.3 to 21.4) |
| Serotype 14 (Shared) | 21.3 (16.6 to 26.7) | 12.9 (9.1 to 17.4) |
| Serotype 18C (Shared) | 10.7 (7.3 to 15.0) | 15.7 (11.6 to 20.6) |
| Serotype 19A (Shared) | 20.4 (15.7 to 25.7) | 17.9 (13.6 to 23.0) |
| Serotype 19F (Shared) | 25.3 (20.2 to 30.9) | 27.4 (22.2 to 33.1) |
| Serotype 23F (Shared) | 19.0 (14.5 to 24.2) | 17.8 (13.4 to 22.9) |
| Serotype 22F (Unique to V114) | 26.8 (21.6 to 32.6) | 62.0 (55.6 to 68.1) |
| Serotype 33F (Unique to V114) | 22.1 (17.3 to 27.6) | 54.4 (48.1 to 60.5) |
Activity for the serotypes contained in Prevnar 13™ and V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) will be determined using an electrochemiluminescence assay. The percentage of participants who had ≥ 4-fold rise in IgG concentration are calculated from baseline to postvaccination.
| Percentage of Participants | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 (Shared) | 15.0 (11.0 to 19.7) | 8.8 (5.7 to 12.8) |
| Serotype 3 (Shared) | 31.4 (25.9 to 37.2) | 43.8 (37.8 to 49.9) |
| Serotype 4 (Shared) | 14.2 (10.3 to 18.9) | 8.8 (5.7 to 12.8) |
| Serotype 5 (Shared) | 20.1 (15.5 to 25.3) | 15.0 (11.0 to 19.7) |
| Serotype 6A (Shared) | 1.1 (0.2 to 3.2) | 4.4 (2.3 to 7.5) |
| Serotype 6B (Shared) | 4.7 (2.6 to 8.0) | 11.3 (7.8 to 15.7) |
| Serotype 7F (Shared) | 17.2 (12.9 to 22.1) | 10.2 (6.9 to 14.4) |
| Serotype 9V (Shared) | 10.6 (7.2 to 14.8) | 9.1 (6.0 to 13.2) |
| Serotype 14 (Shared) | 14.2 (10.3 to 18.9) | 9.5 (6.3 to 13.6) |
| Serotype 18C (Shared) | 0.4 (0.0 to 2.0) | 6.9 (4.2 to 10.6) |
| Serotype 19A (Shared) | 8.0 (5.1 to 11.9) | 7.7 (4.8 to 11.5) |
| Serotype 19F (Shared) | 13.9 (10.0 to 18.6) | 17.9 (13.5 to 22.9) |
| Serotype 22F (Shared) | 3.6 (1.8 to 6.6) | 10.2 (6.9 to 14.4) |
| Serotype 23F (Unique to V114) | 21.5 (16.8 to 26.9) | 71.2 (65.4 to 76.5) |
| Serotype 33F (Unique to V114) | 10.6 (7.2 to 14.8) | 77.0 (71.6 to 81.9) |
Collected over Non-serious adverse events: Up to 14 days after each vaccination; Serious adverse events and all-cause mortality: Up to Month 13 (Up to 44 days after vaccination 2). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| V114 | 0/327 (0%) | 17/327 (5.2%) | 221/327 (67.6%) |
| Prevnar 13™ | 0/324 (0%) | 19/324 (5.9%) | 181/324 (55.9%) |
| V114 (Post-PNEUMOVAX™23) | 0/298 (0%) | 1/298 (0.3%) | 217/298 (72.8%) |
| Prevnar 13™ (Post-PNEUMOVAX™23) | 0/302 (0%) | 2/302 (0.7%) | 210/302 (69.5%) |
| Event | V114 | Prevnar 13™ | V114 (Post-PNEUMOVAX™23) | Prevnar 13™ (Post-PNEUMOVAX™23) |
|---|---|---|---|---|
| Cerebrovascular accidentNervous system disorders | 1/327 | 2/324 | 0/298 | 0/302 |
| CellulitisInfections and infestations | 2/327 | 1/324 | 0/298 | 0/302 |
| OsteomyelitisInfections and infestations | 2/327 | 0/324 | 0/298 | 0/302 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 2/327 | 1/324 | 0/298 | 0/302 |
| Acute pulmonary oedemaRespiratory, thoracic and mediastinal disorders | 0/327 | 0/324 | 1/298 | 0/302 |
| Rib fractureInjury, poisoning and procedural complications | 0/327 | 0/324 | 0/298 | 1/302 |
| AdenocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/327 | 0/324 | 0/298 | 1/302 |
| SyncopeNervous system disorders | 1/327 | 1/324 | 0/298 | 1/302 |
| Coronary artery diseaseCardiac disorders | 0/327 | 1/324 | 0/298 | 0/302 |
| Intestinal pseudo-obstructionGastrointestinal disorders | 0/327 | 1/324 | 0/298 | 0/302 |
| Event | V114 | Prevnar 13™ | V114 (Post-PNEUMOVAX™23) | Prevnar 13™ (Post-PNEUMOVAX™23) |
|---|---|---|---|---|
| Injection site painGeneral disorders | 181/327 | 137/324 | 186/298 | 177/302 |
| Injection site swellingGeneral disorders | 54/327 | 40/324 | 84/298 | 79/302 |
| FatigueGeneral disorders | 77/327 | 45/324 | 77/298 | 66/302 |
| MyalgiaMusculoskeletal and connective tissue disorders | 58/327 | 36/324 | 64/298 | 50/302 |
| Injection site erythemaGeneral disorders | 39/327 | 26/324 | 53/298 | 51/302 |
| HeadacheNervous system disorders | 46/327 | 41/324 | 36/298 | 38/302 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 21/327 | 17/324 | 25/298 | 25/302 |
| Age, Continuous(years) | V114 | Prevnar 13™ | Total |
|---|---|---|---|
| Mean | 64.0 ± 8.0 | 64.1 ± 8.4 | 64.1 ± 8.2 |
| Sex: Female, Male(Participants) | V114 | Prevnar 13™ | Total |
|---|---|---|---|
| Female | 190 | 181 | 371 |
| Male | 137 | 144 | 281 |
| Ethnicity (NIH/OMB)(Participants) | V114 | Prevnar 13™ | Total |
|---|---|---|---|
| Hispanic or Latino | 42 | 37 | 79 |
| Not Hispanic or Latino | 283 | 287 | 570 |
| Unknown or Not Reported | 2 | 1 | 3 |
| Race (NIH/OMB)(Participants) | V114 | Prevnar 13™ | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 103 | 103 | 206 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 18 | 22 | 40 |
| White | 203 | 198 | 401 |
| More than one race | 2 | 2 | 4 |
| Unknown or Not Reported | 1 | 0 | 1 |
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 Jun 2018 to primary completion in Dec 2019, 18 months.
Results were first posted in Jan 2021, 1 year 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 18 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 Oct 2021. You cannot join it, but the record below documents what was studied.
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