A Phase 3 interventional study of V114 and Prevnar 13™ in Pneumococcal Infections, sponsored by Merck Sharp & Dohme LLC. Completed at 19 sites in 7 countries. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2021-06-16.
Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Prevention
This study is designed to describe the safety, tolerability, and immunogenicity of V114 in children with sickle cell disease.
281 studies on the registry are indexed under Pneumococcal Infections; 27 are open to participants now.
This study's enrollment of 104 is below the median of 379 across 230 interventional studies indexed under Pneumococcal Infections.
Browse Pneumococcal Infections studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Female participants: not pregnant or breastfeeding, and at least 1 of the following conditions apply:
Exclusion Criteria:
Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
Biological: V114
Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
Biological: Prevnar 13™
V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
Prevnar 13™ pneumococcal capsular polysaccharide 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
Percentage of Participants With a Solicited Injection-site Adverse Event
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling.
Time frame: Up to 14 days post-vaccination
Percentage of Participants With a Solicited Systemic Adverse Event
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), and urticaria (hives or welts).
Time frame: Up to 14 days post-vaccination
Percentage of Participants With a Vaccine-related Serious Adverse Event
A serious adverse event (SAE) is an AE that results in death, 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. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized.
Time frame: Up to 6 months post-vaccination
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30
The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay.
Time frame: Day 30
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30
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 2 serotypes (22F and 33F) unique to V114 using the multiplexed opsonophagocytic assay (MOPA).
Time frame: Day 30
Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30
IgG for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes unique to V114 (22F and 33F) was determined using an electrochemiluminescence assay. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline (Day 1, pre-vaccination).
Time frame: Day 1 (Baseline) and Day 30
GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30
Activity for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes unique to V114 (22F and 33F) was determined using a MOPA. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline (Day 1, pre-vaccination).
Time frame: Day 1 (Baseline) and Day 30
| Milestone | V114 | Prevnar 13™ |
|---|---|---|
| Started | 70 | 34 |
| V114 or prevnar 13™ vaccination (day 1) | 69 | 34 |
| Completed | 65 | 34 |
| Not completed | 5 | 0 |
| Withdrew: Lost to follow-up | 2 | 0 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Withdrawal by parent/guardian | 2 | 0 |
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling.
| Percentage of participants | V114 | Prevnar 13™ |
|---|---|---|
| Injection site erythema | 4.3 ± 0.9 | 5.9 ± 0.7 |
| Injection site induration | 8.7 ± 3.3 | 8.8 ± 1.9 |
| Injection site pain | 60.9 ± 48.4 | 67.6 ± 49.5 |
| Injection site swelling | 27.5 ± 17.5 | 35.3 ± 19.7 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), and urticaria (hives or welts).
| Percentage of participants | V114 | Prevnar 13™ |
|---|---|---|
| Arthralgia | 2.9 ± 0.4 | 8.8 ± 1.9 |
| Fatigue | 13.0 ± 6.1 | 20.6 ± 8.7 |
| Headache | 24.6 ± 15.1 | 17.6 ± 6.8 |
| Myalgia | 23.2 ± 13.9 | 11.8 ± 3.3 |
| Urticaria | 0.0 ± 0.0 | 2.9 ± 0.1 |
A serious adverse event (SAE) is an AE that results in death, 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. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized.
| Percentage of participants | V114 | Prevnar 13™ |
|---|---|---|
| Percentage of Participants With a Vaccine-related Serious Adverse Event | 0.0 ± 0.0 | 0.0 ± 0.0 |
The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay.
| μg/mL | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 | 2.12 (1.63 to 2.75) | 2.76 (1.95 to 3.91) |
| Serotype 3 | 1.09 (0.87 to 1.38) | 1.07 (0.70 to 1.65) |
| Serotype 4 | 1.58 (1.18 to 2.10) | 2.90 (2.00 to 4.20) |
| Serotype 5 | 4.44 (3.19 to 6.17) | 6.56 (4.09 to 10.52) |
| Serotype 6A | 23.29 (17.22 to 31.52) | 15.97 (8.82 to 28.91) |
| Serotype 6B | 38.38 (28.53 to 51.64) | 22.94 (13.60 to 38.71) |
| Serotype 7F | 5.81 (4.42 to 7.64) | 4.65 (3.06 to 7.06) |
| Serotype 9V | 4.46 (3.44 to 5.78) | 5.36 (3.45 to 8.33) |
| Serotype 14 | 16.03 (11.23 to 22.90) | 20.53 (12.39 to 34.03) |
| Serotype 18C | 6.11 (4.47 to 8.35) | 4.20 (2.66 to 6.62) |
| Serotype 19A | 19.86 (14.77 to 26.70) | 21.65 (14.45 to 32.44) |
| Serotype 19F | 13.88 (9.96 to 19.35) | 12.80 (9.10 to 18.01) |
| Serotype 23F | 5.38 (3.88 to 7.46) | 6.88 (4.01 to 11.83) |
| Serotype 22F | 7.30 (5.68 to 9.36) | 0.49 (0.33 to 0.73) |
| Serotype 33F | 4.46 (3.38 to 5.87) | 0.97 (0.62 to 1.51) |
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 2 serotypes (22F and 33F) unique to V114 using the multiplexed opsonophagocytic assay (MOPA).
| 1/dil | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 | 484.0 (327.5 to 715.4) | 504.0 (254.8 to 997.0) |
| Serotype 3 | 264.8 (193.4 to 362.4) | 234.3 (133.0 to 412.6) |
| Serotype 4 | 4670.8 (2965.9 to 7355.6) | 7015.5 (3994.0 to 12322.6) |
| Serotype 5 | 1383.9 (957.1 to 2000.9) | 1198.2 (638.1 to 2250.0) |
| Serotype 6A | 27305.7 (19797.6 to 37661.2) | 20277.1 (11740.2 to 35021.7) |
| Serotype 6B | 31560.4 (24134.1 to 41272.1) | 18531.0 (11024.7 to 31148.1) |
| Serotype 7F | 19411.5 (15195.9 to 24796.5) | 16928.1 (11107.4 to 25799.0) |
| Serotype 9V | 4561.8 (3240.7 to 6421.4) | 3941.7 (2659.6 to 5841.7) |
| Serotype 14 | 6597.6 (4706.8 to 9248.0) | 8112.2 (4827.2 to 13632.8) |
| Serotype 18C | 9684.6 (6642.1 to 14120.7) | 5685.1 (3329.4 to 9707.6) |
| Serotype 19A | 14067.7 (9972.8 to 19843.9) | 9224.9 (5015.5 to 16967.1) |
| Serotype 19F | 4931.8 (3387.8 to 7179.7) | 3313.3 (2039.4 to 5383.1) |
| Serotype 23F | 17190.9 (12066.0 to 24492.4) | 19197.1 (10511.1 to 35061.1) |
| Serotype 22F | 7257.5 (5278.5 to 9978.3) | 1013.2 (477.4 to 2150.1) |
| Serotype 33F | 24013.6 (17612.4 to 32741.4) | 4824.8 (3216.3 to 7237.9) |
IgG for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes unique to V114 (22F and 33F) was determined using an electrochemiluminescence assay. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline (Day 1, pre-vaccination).
| Ratio | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 | 6.2 (4.6 to 8.5) | 6.0 (3.7 to 9.9) |
| Serotype 3 | 4.8 (3.5 to 6.6) | 4.1 (2.6 to 6.7) |
| Serotype 4 | 6.0 (4.3 to 8.3) | 9.3 (5.4 to 16.2) |
| Serotype 5 | 5.3 (3.8 to 7.4) | 6.4 (3.8 to 10.8) |
| Serotype 6A | 54.7 (37.9 to 78.9) | 40.6 (22.9 to 71.9) |
| Serotype 6B | 37.2 (25.8 to 53.6) | 25.0 (13.8 to 45.3) |
| Serotype 7F | 11.6 (8.3 to 16.0) | 9.8 (6.3 to 15.3) |
| Serotype 9V | 7.4 (5.3 to 10.3) | 8.1 (4.9 to 13.2) |
| Serotype 14 | 10.8 (6.8 to 17.2) | 7.2 (3.5 to 14.8) |
| Serotype 18C | 10.8 (7.7 to 15.1) | 7.6 (4.5 to 12.8) |
| Serotype 19A | 8.2 (5.4 to 12.4) | 8.6 (5.0 to 14.9) |
| Serotype 19F | 8.3 (5.6 to 12.3) | 7.6 (4.5 to 12.8) |
| Serotype 23F | 9.3 (6.1 to 14.2) | 13.1 (7.4 to 23.4) |
| Serotype 22F | 15.0 (10.1 to 22.1) | 1.1 (0.9 to 1.3) |
| Serotype 33F | 9.0 (6.7 to 12.1) | 1.3 (1.0 to 1.7) |
Activity for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes unique to V114 (22F and 33F) was determined using a MOPA. GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline (Day 1, pre-vaccination).
| Ratio | V114 | Prevnar 13™ |
|---|---|---|
| Serotype 1 | 24.1 (14.9 to 39.1) | 13.3 (5.1 to 34.2) |
| Serotype 3 | 4.9 (3.5 to 7.0) | 3.1 (1.8 to 5.6) |
| Serotype 4 | 10.2 (6.3 to 16.6) | 18.5 (8.8 to 38.9) |
| Serotype 5 | 23.7 (15.0 to 37.5) | 13.8 (6.6 to 28.6) |
| Serotype 6A | 20.7 (13.3 to 32.1) | 11.2 (4.8 to 26.2) |
| Serotype 6B | 21.7 (12.7 to 36.9) | 13.7 (6.8 to 27.7) |
| Serotype 7F | 5.4 (3.8 to 7.7) | 5.4 (3.2 to 9.1) |
| Serotype 9V | 4.4 (3.0 to 6.5) | 6.1 (3.6 to 10.4) |
| Serotype 14 | 6.9 (4.3 to 11.1) | 4.6 (2.1 to 10.2) |
| Serotype 18C | 14.0 (8.9 to 22.0) | 4.8 (2.5 to 9.3) |
| Serotype 19A | 9.0 (5.4 to 15.0) | 7.8 (4.4 to 14.0) |
| Serotype 19F | 6.4 (4.3 to 9.7) | 6.6 (3.3 to 12.9) |
| Serotype 23F | 10.4 (5.8 to 18.4) | 18.1 (8.8 to 37.1) |
| Serotype 22F | 6.5 (3.7 to 11.3) | 0.9 (0.7 to 1.2) |
| Serotype 33F | 3.8 (2.7 to 5.2) | 0.8 (0.7 to 1.0) |
Collected over Serious AEs and All-Cause Mortality: up to 6 months post-vaccination; Other AEs (non-serious): up to 14 days post-vaccination. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| V114 | 0/70 (0%) | 13/69 (18.8%) | 52/69 (75.4%) |
| Prevnar 13 | 0/34 (0%) | 8/34 (23.5%) | 27/34 (79.4%) |
| Event | V114 | Prevnar 13 |
|---|---|---|
| Sickle cell anaemia with crisisBlood and lymphatic system disorders | 7/69 | 6/34 |
| PneumoniaInfections and infestations | 1/69 | 1/34 |
| Viral infectionInfections and infestations | 0/69 | 1/34 |
| PyelonephritisInfections and infestations | 1/69 | 0/34 |
| Respiratory tract infectionInfections and infestations | 1/69 | 0/34 |
| Upper respiratory tract infectionInfections and infestations | 1/69 | 0/34 |
| Infusion related reactionInjury, poisoning and procedural complications | 1/69 | 0/34 |
| Medical observationInvestigations | 1/69 | 0/34 |
| Cerebrovascular accidentNervous system disorders | 1/69 | 0/34 |
| Acute chest syndromeRespiratory, thoracic and mediastinal disorders | 1/69 | 0/34 |
| Event | V114 | Prevnar 13 |
|---|---|---|
| Injection site painGeneral disorders | 42/69 | 23/34 |
| Injection site swellingGeneral disorders | 19/69 | 12/34 |
| HeadacheNervous system disorders | 17/69 | 6/34 |
| MyalgiaMusculoskeletal and connective tissue disorders | 16/69 | 4/34 |
| FatigueGeneral disorders | 9/69 | 7/34 |
| Injection site indurationGeneral disorders | 6/69 | 3/34 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/69 | 3/34 |
| Injection site erythemaGeneral disorders | 3/69 | 2/34 |
| PyrexiaGeneral disorders | 4/69 | 1/34 |
| Back painMusculoskeletal and connective tissue disorders | 4/69 | 1/34 |
| Age, Continuous(years) | V114 | Prevnar 13™ | Total |
|---|---|---|---|
| Mean | 10.8 ± 3.5 | 10.8 ± 3.3 | 10.8 ± 3.4 |
| Sex: Female, Male(Participants) | V114 | Prevnar 13™ | Total |
|---|---|---|---|
| Female | 33 | 14 | 47 |
| Male | 37 | 20 | 57 |
| Ethnicity (NIH/OMB)(Participants) | V114 | Prevnar 13™ | Total |
|---|---|---|---|
| Hispanic or Latino | 44 | 24 | 68 |
| Not Hispanic or Latino | 26 | 10 | 36 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | V114 | Prevnar 13™ | Total |
|---|---|---|---|
| American Indian or Alaska Native | 9 | 3 | 12 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 38 | 25 | 63 |
| White | 10 | 2 | 12 |
| More than one race | 13 | 4 | 17 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Merck Sharp & Dohme LLC