Pneumococcal Infections
Conditions
Brief summary
The purpose of this study is to 1) evaluate the safety and tolerability, and immunogenicity of blinded V114 and Prevnar 13™ within each vaccination group, and 2) evaluate the safety and tolerability, and immunogenicity of PNEUMOVAX™23 (administered as open label, 12 months after allogeneic hematopoietic stem cell transplant \[allo-HSCT\] in participants who do not develop chronic graft-versus-host disease \[GVHD\]).
Interventions
BIOLOGICALV114
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.
BIOLOGICALPrevnar 13™
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 aluminum) in each 0.5 ml dose
BIOLOGICALPNEUMOVAX™23
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
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Received a human leukocyte antigen (HLA) compatible donor including haploidentical and mismatched (related or unrelated) first allogeneic HSCT (i.e., bone marrow or peripheral blood stem cell) 90 to 180 days prior to randomization. * Received the allogeneic HSCT for acute lymphoblastic leukemia (ALL) in first or second remission, acute myeloid leukemia (AML) in first or second remission, chronic myeloid leukemia (CML) in first chronic or accelerated phase, Hodgkin's lymphoma, non-Hodgkin's lymphoma, myelodysplastic syndrome (MDS), myelofibrosis and myeloproliferative diseases, and non-malignant disease such as aplastic anemia or sickle cell disease in participants ≥18 years of age and any non-malignant disease for participants 3 to \<18 years of age. * Life expectancy \>12 months after allogeneic HSCT, according to investigator judgement. * Clinically stable engraftment according to investigator judgment. * A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies: a) not a woman of childbearing potential (WOCBP) OR b) a WOCBP who agrees to use acceptable contraceptive methods during the treatment period and for at least 6 weeks after the last dose of study intervention.
Exclusion criteria
* Receipt of a previous allogeneic HSCT. * Received allogeneic HSCT with ex-vivo graft manipulation, in vivo T cell depletion with alemtuzumab, or haploidentical allogeneic HSCT with high dose anti-thymocyte globulin. * Received allogeneic HSCT for multiple myeloma or, for participants ≥18 years of age only, for any nonmalignant diseases except sickle cell disease and aplastic anemia. * Persistent or relapsed primary disease after allogeneic HSCT. * History of severe GVHD (Grade 3 or 4 GVHD) after allogeneic HSCT. * Planned organ transplantation after allogeneic HSCT. * History of culture-positive pneumococcal disease occurring after allogeneic HSCT. * Known hypersensitivity to any component of pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine. * History of acquired immunodeficiency such as documented HIV infection, or anatomic asplenia. * Coagulation disorder contraindicating intramuscular vaccinations. * Severe hepatic impairment (defined as Child-Pugh Class C) at Screening. * Serum aspartate transaminase (AST) or alanine transaminase (ALT) \>6 × upper limit of normal (ULN) or serum total bilirubin \>2.5 × ULN at Screening. * A WOCBP who has a positive urine or serum pregnancy test before the 1st vaccination. * Received chimeric antigen receptor T-cell (CAR-T) therapy or checkpoint inhibitor directed therapy (i.e., anti-Programmed Cell Death (PD)-1) after allogeneic HSCT. * Received or planned to receive anti-Cluster of Differentiation (CD) 20 B-cell targeted therapy (e.g., rituximab) after allogeneic HSCT. * Non-study pneumococcal vaccine administered after allogeneic HSCT, or is expected to receive non-study pneumococcal vaccine during participation in the study. * Is currently participating or has participated in an interventional clinical study with an investigational compound/agent or device within 2 weeks of participating in this current study, or plans to receive any investigational compound/agent or device (in addition to existing therapy) within 2 weeks of any vaccination, that in the opinion of the investigator would interfere with the evaluation of the study objectives. * Is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence as assessed by the study investigator. * Has history or current evidence of any condition, therapy, laboratory test result abnormality, or other circumstance that might expose the participant to risk by participating in the study, confound the results of the study, or interfere with the participant's participation for the full duration of the study. * Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Up to 5 days after any of the Day 1, Day 30, or Day 60 vaccinations (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 any of the first 3 doses of V114 or Prevnar 13™, the percentage of adult participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, pain, and swelling. |
| Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Up to 14 days after any of the Day 1, Day 30, or Day 60 vaccinations (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 any of the first 3 doses of V114 or Prevnar 13™, the percentage of pediatric participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, induration, pain, and swelling. |
| Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Up to 14 days after any of the Day 1, Day 30, or Day 60 vaccinations (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 any of the first 3 doses of V114 or Prevnar 13™, the percentage of adult participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were arthralgia, fatigue, headache, and myalgia. |
| Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Up to 14 days after any of the Day 1, Day 30, or Day 60 vaccinations (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 any of the first 3 doses of V114 or Prevnar 13™, the percentage of pediatric participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were arthralgia, fatigue, headache, myalgia, and hives or welts. |
| Percentage of Participants With a Vaccine-related Serious Adverse Event Up to Month 12 After Allogeneic HSCT | Up to 9 months | 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. The percentage of participants with a vaccine-related SAE following dose 1 (with either V114 or Prevnar 13™) was reported. Vaccine-related SAEs were counted starting after vaccine dose 1 up to 12 months post-HSCT, which could be up to 9 months post-vaccine dose 1. |
| Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Day 90 (30 days after the Day 60 vaccinations with V114 or Prevnar 13™) | The GMC of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pediatric Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Up to 14 days after the fourth V114 or Prevnar 13™ vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1) | This end point applies to pediatric participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13™ as the fourth vaccination dose. 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 dose 4 with V114 or Prevnar 13™, the percentage of pediatric participants with solicited injection-site AEs was assessed. The solicited injection-site AE assessed were pain, erythema, swelling, and induration. |
| Adult Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Up to 14 days after the fourth V114 or Prevnar 13™ vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1) | This end point applies to adult participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13™ as the fourth vaccination dose. 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 dose 4 with V114 or Prevnar 13™, the percentage of adult participants with solicited systemic AEs was assessed. The solicited systemic AEs were arthralgia, fatigue, headache, and myalgia. |
| Pediatric Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Up to 14 days after the fourth V114 or Prevnar 13™ vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1) | This end point applies to pediatric participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13™ as the fourth vaccination. 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 dose 4 with V114 or Prevnar 13™, the percentage of pediatric participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed myalgia, arthralgia, headache, fatigue, and hives or welts. |
| Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23 | Up to 5 days after the PNEUMOVAX™23 vaccination (12 months after HSCT and approximately 6 to 9 months after Day 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 a single dose vaccination with PNEUMOVAX™23, the percentage of adult participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, pain, and swelling. |
| Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Up to Day 90 (30 days after the Day 60 vaccinations with V114 or Prevnar 13™) | The GMT of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplexed opsonophagocytic assay. |
| Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Day 1 (Baseline) and Day 90 (30 days after the Day 60 vaccinations with V114 or Prevnar 13™) | The GMFR of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay. |
| Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Time Frame: Day 1 (Baseline) and Day 90 (30 days after the Day 60 vaccinations with V114 or Prevnar 13™) | Activity for the 15 serotypes contained in V114 vaccine were determined using a Multiplex Opsonophagocytic Assay. The GMFR of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using multiplexed opsonophagocytic assay. |
| Participants With GVHD: Percentage of Participants With a Vaccine-related Serious Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Up to 6 months after the fourth V114 or Prevnar 13™ vaccination (12 months after HSCT and approximately 6 to 15 months after Day 1) | This end point applies to participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13™ as vaccine dose 4. An 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. The percentage of participants with a vaccine-related SAE following dose 4 with V114 or Prevnar 13™ through completion of study was reported. |
| Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23 | Up to 14 days after the PNEUMOVAX™23 vaccination (12 months after HSCT and approximately 6 to 9 months after Day 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 single dose vaccination with PNEUMOVAX™23, the percentage of pediatric participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were induration, pain, swelling, and erythema. |
| Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Up to 14 days after the PNEUMOVAX™23 vaccination (12 months after HSCT and approximately 6 to 9 months after Day 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 a single dose vaccination with PNEUMOVAX™23, the percentage of adult participants with solicited systemic AEs was assessed. The solicited systemic AEs were arthralgia, fatigue, headache, and myalgia. |
| Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Up to 14 days after the PNEUMOVAX™23 vaccination (12 months after HSCT and approximately 6 to 9 months after Day 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 a single dose vaccination with PNEUMOVAX™23, the percentage of pediatric participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, headache, myalgia, hives or welts, and arthralgia. |
| Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination With PNEUMOVAX™23 | Up to 1 month after PNEUMOVAX™23 vaccination (12 months after HSCT and approximately 6 to 10 months after Day 1) | A 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. The percentage of participants with a vaccine-related SAE following a single dose vaccination with PNEUMOVAX™23 was reported. |
| Adult Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Up to 5 days after the fourth V114 or Prevnar 13™ vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1) | This end point applies to adult participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13™ as the fourth vaccination. 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 dose 4 with V114 or Prevnar 13™, the percentage of adult participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, pain, and swelling. |
Countries
Australia, Belgium, Brazil, Canada, Colombia, France, Germany, Mexico, Sweden, United States
Participant flow
Recruitment details
This study recruited male and female participants at least 3 years of age who have received allogeneic hematopoietic stem cell transplant (allo-HSCT) 90 to 180 days prior to randomization.
Pre-assignment details
263 adult participants and 14 pediatric participants (3 to 18 years of age) were randomized in a 1:1 ratio to receive either V114 or Prevnar 13™ on Day 1.
Participants by arm
| Arm | Count |
|---|---|
| V114 Participants received single 0.5 mL intramuscular (IM) injection of V114 on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants received HSCT 90 to 180 days prior to Day 1. Those who developed chronic graft-versus-host-disease (GVHD) during the first year after HSCT received V114 instead of PNEUMOVAX™23 as their fourth dose. | 139 |
| Prevnar 13™ Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1, Day 30 and Day 60 and a single 0.5 mL IM injection of PNEUMOVAX™23 at 12 months after HSCT. Participants will have received HSCT 90 to 180 days prior to Day 1. Those who developed chronic GVHD during the first year after HSCT received Prevnar 13™ instead of PNEUMOVAX™23 as their fourth dose. | 138 |
| Total | 277 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 9 | 7 |
| Overall Study | Disposition Unknown | 4 | 1 |
| Overall Study | Physician Decision | 7 | 11 |
| Overall Study | Randomized By Mistake | 0 | 2 |
| Overall Study | Withdrawal By Parent/Guardian | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 5 |
Baseline characteristics
| Characteristic | Prevnar 13™ | Total | V114 |
|---|---|---|---|
| Age, Continuous | 46.3 years STANDARD_DEVIATION 18.3 | 47.1 years STANDARD_DEVIATION 17.1 | 47.9 years STANDARD_DEVIATION 16 |
| Age, Customized 85 years and over | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Adolescents (12-17 years) | 2 Participants | 5 Participants | 3 Participants |
| Age, Customized Adults (18-64 years) | 107 Participants | 215 Participants | 108 Participants |
| Age, Customized Children (2-11 years) | 4 Participants | 9 Participants | 5 Participants |
| Age, Customized From 65-84 years | 25 Participants | 48 Participants | 23 Participants |
| Age, Customized Infants and toddlers (28 days-23 months) | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized In utero | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Newborns (0-27 days) | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Preterm newborn infants (gestational age < 37 wks) | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 29 Participants | 59 Participants | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 104 Participants | 208 Participants | 104 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 10 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 7 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 15 Participants | 20 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 115 Participants | 237 Participants | 122 Participants |
| Sex: Female, Male Female | 62 Participants | 119 Participants | 57 Participants |
| Sex: Female, Male Male | 76 Participants | 158 Participants | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 6 / 131 | 9 / 129 | 1 / 84 | 0 / 71 | 2 / 27 | 1 / 36 | 1 / 8 | 0 / 6 | 0 / 5 | 0 / 4 | 0 / 2 | 0 / 1 |
| other Total, other adverse events | 125 / 131 | 108 / 129 | 65 / 84 | 53 / 71 | 22 / 27 | 26 / 36 | 7 / 8 | 6 / 6 | 3 / 5 | 3 / 4 | 1 / 2 | 0 / 1 |
| serious Total, serious adverse events | 38 / 131 | 48 / 129 | 2 / 84 | 4 / 71 | 6 / 27 | 7 / 36 | 2 / 8 | 1 / 6 | 0 / 5 | 0 / 4 | 0 / 2 | 0 / 1 |
Outcome results
Primary
Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With 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 any of the first 3 doses of V114 or Prevnar 13™, the percentage of adult participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, pain, and swelling.
Time frame: Up to 5 days after any of the Day 1, Day 30, or Day 60 vaccinations (V114 or Prevnar 13™)
Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 (Adult) | Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Injection site erythema | 20.6 Percentage of Participants |
| V114 (Adult) | Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Injection site pain | 88.5 Percentage of Participants |
| V114 (Adult) | Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Injection site swelling | 32.1 Percentage of Participants |
| Prevnar 13™ (Adult) | Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Injection site erythema | 14.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Injection site pain | 74.4 Percentage of Participants |
| Prevnar 13™ (Adult) | Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Injection site swelling | 17.8 Percentage of Participants |
Primary
Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With 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 any of the first 3 doses of V114 or Prevnar 13™, the percentage of adult participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were arthralgia, fatigue, headache, and myalgia.
Time frame: Up to 14 days after any of the Day 1, Day 30, or Day 60 vaccinations (V114 or Prevnar 13™)
Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 (Adult) | Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Arthralgia | 16.0 Percentage of Participants |
| V114 (Adult) | Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Fatigue | 45.0 Percentage of Participants |
| V114 (Adult) | Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Headache | 29.0 Percentage of Participants |
| V114 (Adult) | Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Myalgia | 48.9 Percentage of Participants |
| Prevnar 13™ (Adult) | Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Myalgia | 34.9 Percentage of Participants |
| Prevnar 13™ (Adult) | Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Arthralgia | 18.6 Percentage of Participants |
| Prevnar 13™ (Adult) | Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Headache | 31.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Fatigue | 40.3 Percentage of Participants |
Primary
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
The GMC of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay.
Time frame: Day 90 (30 days after the Day 60 vaccinations with V114 or Prevnar 13™)
Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 6A (Shared) | 3.40 µg/mL |
| V114 (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 14 (Shared) | 6.50 µg/mL |
| V114 (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 3 (Shared) | 0.80 µg/mL |
| V114 (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 18C (Shared) | 3.84 µg/mL |
| V114 (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 6B (Shared) | 3.49 µg/mL |
| V114 (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 19A (Shared) | 5.03 µg/mL |
| V114 (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 5 (Shared) | 2.85 µg/mL |
| V114 (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 19F (Shared) | 5.03 µg/mL |
| V114 (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 7F (Shared) | 3.20 µg/mL |
| V114 (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 23F (Shared) | 3.59 µg/mL |
| V114 (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 4 (Shared) | 1.61 µg/mL |
| V114 (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 22F (Unique to V114) | 4.09 µg/mL |
| V114 (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 9V (Shared) | 2.56 µg/mL |
| V114 (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 33F (Unique to V114) | 3.40 µg/mL |
| V114 (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 1 (Shared) | 2.97 µg/mL |
| Prevnar 13™ (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 33F (Unique to V114) | 0.39 µg/mL |
| Prevnar 13™ (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 1 (Shared) | 1.90 µg/mL |
| Prevnar 13™ (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 3 (Shared) | 0.52 µg/mL |
| Prevnar 13™ (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 4 (Shared) | 1.52 µg/mL |
| Prevnar 13™ (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 5 (Shared) | 1.91 µg/mL |
| Prevnar 13™ (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 6A (Shared) | 2.79 µg/mL |
| Prevnar 13™ (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 6B (Shared) | 2.86 µg/mL |
| Prevnar 13™ (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 7F (Shared) | 3.01 µg/mL |
| Prevnar 13™ (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 9V (Shared) | 1.83 µg/mL |
| Prevnar 13™ (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 14 (Shared) | 4.61 µg/mL |
| Prevnar 13™ (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 18C (Shared) | 2.58 µg/mL |
| Prevnar 13™ (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 19A (Shared) | 4.31 µg/mL |
| Prevnar 13™ (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 19F (Shared) | 3.67 µg/mL |
| Prevnar 13™ (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 23F (Shared) | 2.62 µg/mL |
| Prevnar 13™ (Adult) | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 22F (Unique to V114) | 0.15 µg/mL |
Primary
Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With 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 any of the first 3 doses of V114 or Prevnar 13™, the percentage of pediatric participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, induration, pain, and swelling.
Time frame: Up to 14 days after any of the Day 1, Day 30, or Day 60 vaccinations (V114 or Prevnar 13™)
Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Injection site erythema | 0.0 Percentage of Participants |
| V114 (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Injection site induration | 12.5 Percentage of Participants |
| V114 (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Injection site pain | 75.0 Percentage of Participants |
| V114 (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Injection site swelling | 25.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Injection site swelling | 50.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Injection site erythema | 33.3 Percentage of Participants |
| Prevnar 13™ (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Injection site pain | 83.3 Percentage of Participants |
| Prevnar 13™ (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Injection site induration | 33.3 Percentage of Participants |
Primary
Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With 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 any of the first 3 doses of V114 or Prevnar 13™, the percentage of pediatric participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were arthralgia, fatigue, headache, myalgia, and hives or welts.
Time frame: Up to 14 days after any of the Day 1, Day 30, or Day 60 vaccinations (V114 or Prevnar 13™)
Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Arthralgia | 12.5 Percentage of Participants |
| V114 (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Myalgia | 50.0 Percentage of Participants |
| V114 (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Fatigue | 25.0 Percentage of Participants |
| V114 (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Hives or welts | 0.0 Percentage of Participants |
| V114 (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Headache | 12.5 Percentage of Participants |
| Prevnar 13™ (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Hives or welts | 0.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Arthralgia | 0.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Headache | 16.7 Percentage of Participants |
| Prevnar 13™ (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Myalgia | 16.7 Percentage of Participants |
| Prevnar 13™ (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Any of the First 3 Doses With V114 or Prevnar 13™ | Fatigue | 16.7 Percentage of Participants |
Primary
Percentage of Participants With a Vaccine-related Serious Adverse Event Up to Month 12 After Allogeneic HSCT
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. The percentage of participants with a vaccine-related SAE following dose 1 (with either V114 or Prevnar 13™) was reported. Vaccine-related SAEs were counted starting after vaccine dose 1 up to 12 months post-HSCT, which could be up to 9 months post-vaccine dose 1.
Time frame: Up to 9 months
Population: All randomized participants who received at least 1 dose of the relevant study vaccination for the timepoint of interest were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 (Adult) | Percentage of Participants With a Vaccine-related Serious Adverse Event Up to Month 12 After Allogeneic HSCT | 0.8 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With a Vaccine-related Serious Adverse Event Up to Month 12 After Allogeneic HSCT | 0.0 Percentage of Participants |
| V114 (Pediatric) | Percentage of Participants With a Vaccine-related Serious Adverse Event Up to Month 12 After Allogeneic HSCT | 0.0 Percentage of Participants |
| Prevnar 13™ (Pediatric) | Percentage of Participants With a Vaccine-related Serious Adverse Event Up to Month 12 After Allogeneic HSCT | 0.0 Percentage of Participants |
Secondary
Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With 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 a single dose vaccination with PNEUMOVAX™23, the percentage of adult participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, pain, and swelling.
Time frame: Up to 5 days after the PNEUMOVAX™23 vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 (Adult) | Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23 | Injection site erythema | 17.9 Percentage of Participants |
| V114 (Adult) | Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23 | Injection site pain | 67.9 Percentage of Participants |
| V114 (Adult) | Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23 | Injection site swelling | 21.4 Percentage of Participants |
| Prevnar 13™ (Adult) | Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23 | Injection site erythema | 22.5 Percentage of Participants |
| Prevnar 13™ (Adult) | Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23 | Injection site pain | 57.7 Percentage of Participants |
| Prevnar 13™ (Adult) | Adult Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23 | Injection site swelling | 23.9 Percentage of Participants |
Secondary
Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With 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 a single dose vaccination with PNEUMOVAX™23, the percentage of adult participants with solicited systemic AEs was assessed. The solicited systemic AEs were arthralgia, fatigue, headache, and myalgia.
Time frame: Up to 14 days after the PNEUMOVAX™23 vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 (Adult) | Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Arthralgia | 7.1 Percentage of Participants |
| V114 (Adult) | Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Fatigue | 22.6 Percentage of Participants |
| V114 (Adult) | Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Headache | 21.4 Percentage of Participants |
| V114 (Adult) | Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Myalgia | 32.1 Percentage of Participants |
| Prevnar 13™ (Adult) | Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Myalgia | 26.8 Percentage of Participants |
| Prevnar 13™ (Adult) | Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Arthralgia | 8.5 Percentage of Participants |
| Prevnar 13™ (Adult) | Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Headache | 19.7 Percentage of Participants |
| Prevnar 13™ (Adult) | Adult Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Fatigue | 16.9 Percentage of Participants |
Secondary
Adult Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™
This end point applies to adult participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13™ as the fourth vaccination. 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 dose 4 with V114 or Prevnar 13™, the percentage of adult participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, pain, and swelling.
Time frame: Up to 5 days after the fourth V114 or Prevnar 13™ vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 (Adult) | Adult Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Injection site erythema | 3.7 Percentage of Participants |
| V114 (Adult) | Adult Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Injection site pain | 77.8 Percentage of Participants |
| V114 (Adult) | Adult Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Injection site swelling | 22.2 Percentage of Participants |
| Prevnar 13™ (Adult) | Adult Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Injection site erythema | 8.3 Percentage of Participants |
| Prevnar 13™ (Adult) | Adult Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Injection site pain | 61.1 Percentage of Participants |
| Prevnar 13™ (Adult) | Adult Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Injection site swelling | 13.9 Percentage of Participants |
Secondary
Adult Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™
This end point applies to adult participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13™ as the fourth vaccination dose. 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 dose 4 with V114 or Prevnar 13™, the percentage of adult participants with solicited systemic AEs was assessed. The solicited systemic AEs were arthralgia, fatigue, headache, and myalgia.
Time frame: Up to 14 days after the fourth V114 or Prevnar 13™ vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 (Adult) | Adult Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Arthralgia | 11.1 Percentage of Participants |
| V114 (Adult) | Adult Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Fatigue | 29.6 Percentage of Participants |
| V114 (Adult) | Adult Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Headache | 22.2 Percentage of Participants |
| V114 (Adult) | Adult Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Myalgia | 29.6 Percentage of Participants |
| Prevnar 13™ (Adult) | Adult Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Myalgia | 22.2 Percentage of Participants |
| Prevnar 13™ (Adult) | Adult Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Arthralgia | 8.3 Percentage of Participants |
| Prevnar 13™ (Adult) | Adult Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Headache | 11.1 Percentage of Participants |
| Prevnar 13™ (Adult) | Adult Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Fatigue | 16.7 Percentage of Participants |
Secondary
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
The GMT of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplexed opsonophagocytic assay.
Time frame: Up to Day 90 (30 days after the Day 60 vaccinations with V114 or Prevnar 13™)
Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 6A (Shared) | 2494.5 Titers |
| V114 (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 14 (Shared) | 1953.6 Titers |
| V114 (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 3 (Shared) | 152.1 Titers |
| V114 (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 18C (Shared) | 1146.6 Titers |
| V114 (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 6B (Shared) | 2280.2 Titers |
| V114 (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 19A (Shared) | 1365.6 Titers |
| V114 (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 5 (Shared) | 317.6 Titers |
| V114 (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 19F (Shared) | 965.6 Titers |
| V114 (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 7F (Shared) | 1945.3 Titers |
| V114 (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 23F (Shared) | 1158.3 Titers |
| V114 (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 4 (Shared) | 1008.4 Titers |
| V114 (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 22F (Unique to V114) | 1127.5 Titers |
| V114 (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 9V (Shared) | 1059.4 Titers |
| V114 (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 33F (Unique to V114) | 4441.7 Titers |
| V114 (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 1 (Shared) | 90.9 Titers |
| Prevnar 13™ (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 33F (Unique to V114) | 173.6 Titers |
| Prevnar 13™ (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 1 (Shared) | 59.3 Titers |
| Prevnar 13™ (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 3 (Shared) | 128.5 Titers |
| Prevnar 13™ (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 4 (Shared) | 1357.7 Titers |
| Prevnar 13™ (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 5 (Shared) | 169.1 Titers |
| Prevnar 13™ (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 6A (Shared) | 2295.0 Titers |
| Prevnar 13™ (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 6B (Shared) | 3000.4 Titers |
| Prevnar 13™ (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 7F (Shared) | 3076.9 Titers |
| Prevnar 13™ (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 9V (Shared) | 1050.0 Titers |
| Prevnar 13™ (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 14 (Shared) | 1689.2 Titers |
| Prevnar 13™ (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 18C (Shared) | 714.6 Titers |
| Prevnar 13™ (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 19A (Shared) | 1201.6 Titers |
| Prevnar 13™ (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 19F (Shared) | 1065.6 Titers |
| Prevnar 13™ (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 23F (Shared) | 2065.2 Titers |
| Prevnar 13™ (Adult) | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 22F (Unique to V114) | 19.0 Titers |
Secondary
Participants With GVHD: Percentage of Participants With a Vaccine-related Serious Adverse Event Following Dose 4 With V114 or Prevnar 13™
This end point applies to participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13™ as vaccine dose 4. An 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. The percentage of participants with a vaccine-related SAE following dose 4 with V114 or Prevnar 13™ through completion of study was reported.
Time frame: Up to 6 months after the fourth V114 or Prevnar 13™ vaccination (12 months after HSCT and approximately 6 to 15 months after Day 1)
Population: All randomized participants who received at least 1 dose of relevant study vaccination for the timepoint of interest were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 (Adult) | Participants With GVHD: Percentage of Participants With a Vaccine-related Serious Adverse Event Following Dose 4 With V114 or Prevnar 13™ | 0.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Participants With GVHD: Percentage of Participants With a Vaccine-related Serious Adverse Event Following Dose 4 With V114 or Prevnar 13™ | 0.0 Percentage of Participants |
| V114 (Pediatric) | Participants With GVHD: Percentage of Participants With a Vaccine-related Serious Adverse Event Following Dose 4 With V114 or Prevnar 13™ | 0.0 Percentage of Participants |
| Prevnar 13™ (Pediatric) | Participants With GVHD: Percentage of Participants With a Vaccine-related Serious Adverse Event Following Dose 4 With V114 or Prevnar 13™ | 0.0 Percentage of Participants |
Secondary
Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With 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 single dose vaccination with PNEUMOVAX™23, the percentage of pediatric participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were induration, pain, swelling, and erythema.
Time frame: Up to 14 days after the PNEUMOVAX™23 vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23 | Injection site induration | 0.0 Percentage of Participants |
| V114 (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23 | Injection site pain | 60.0 Percentage of Participants |
| V114 (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23 | Injection site swelling | 20.0 Percentage of Participants |
| V114 (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23 | Injection site erythema | 0.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23 | Injection site erythema | 0.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23 | Injection site induration | 25.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23 | Injection site swelling | 25.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Injection-site Adverse Event Following Vaccination With PNEUMOVAX™23 | Injection site pain | 50.0 Percentage of Participants |
Secondary
Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With 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 a single dose vaccination with PNEUMOVAX™23, the percentage of pediatric participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, headache, myalgia, hives or welts, and arthralgia.
Time frame: Up to 14 days after the PNEUMOVAX™23 vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Headache | 20.0 Percentage of Participants |
| V114 (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Hives or welts | 0.0 Percentage of Participants |
| V114 (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Myalgia | 40.0 Percentage of Participants |
| V114 (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Arthralgia | 0.0 Percentage of Participants |
| V114 (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Fatigue | 20.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Arthralgia | 0.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Fatigue | 0.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Headache | 0.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Myalgia | 0.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Pediatric Participants: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 | Hives or welts | 0.0 Percentage of Participants |
Secondary
Pediatric Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™
This end point applies to pediatric participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13™ as the fourth vaccination dose. 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 dose 4 with V114 or Prevnar 13™, the percentage of pediatric participants with solicited injection-site AEs was assessed. The solicited injection-site AE assessed were pain, erythema, swelling, and induration.
Time frame: Up to 14 days after the fourth V114 or Prevnar 13™ vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 (Adult) | Pediatric Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Injection site pain | 50.0 Percentage of Participants |
| V114 (Adult) | Pediatric Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Injection site erythema | 0.0 Percentage of Participants |
| V114 (Adult) | Pediatric Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Injection site swelling | 0.0 Percentage of Participants |
| V114 (Adult) | Pediatric Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Injection site induration | 0.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Pediatric Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Injection site induration | 0.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Pediatric Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Injection site pain | 0.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Pediatric Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Injection site swelling | 0.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Pediatric Participants With GVHD: Percentage of Participants With a Solicited Injection-site Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Injection site erythema | 0.0 Percentage of Participants |
Secondary
Pediatric Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™
This end point applies to pediatric participants who developed GVHD within 12 months of HSCT and received V114 or Prevnar 13™ as the fourth vaccination. 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 dose 4 with V114 or Prevnar 13™, the percentage of pediatric participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed myalgia, arthralgia, headache, fatigue, and hives or welts.
Time frame: Up to 14 days after the fourth V114 or Prevnar 13™ vaccination (12 months after HSCT and approximately 6 to 9 months after Day 1)
Population: All randomized participants who received at least 1 dose of study vaccination were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 (Adult) | Pediatric Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Arthralgia | 0.0 Percentage of Participants |
| V114 (Adult) | Pediatric Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Fatigue | 0.0 Percentage of Participants |
| V114 (Adult) | Pediatric Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Headache | 0.0 Percentage of Participants |
| V114 (Adult) | Pediatric Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Hives or welts | 0.0 Percentage of Participants |
| V114 (Adult) | Pediatric Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Myalgia | 0.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Pediatric Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Hives or welts | 0.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Pediatric Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Myalgia | 0.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Pediatric Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Arthralgia | 0.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Pediatric Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Headache | 0.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Pediatric Participants With GVHD: Percentage of Participants With a Solicited Systemic Adverse Event Following Dose 4 With V114 or Prevnar 13™ | Fatigue | 0.0 Percentage of Participants |
Secondary
Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination With PNEUMOVAX™23
A 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. The percentage of participants with a vaccine-related SAE following a single dose vaccination with PNEUMOVAX™23 was reported.
Time frame: Up to 1 month after PNEUMOVAX™23 vaccination (12 months after HSCT and approximately 6 to 10 months after Day 1)
Population: All randomized participants who received at least 1 dose of the relevant study vaccination for the timepoint of interest were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 (Adult) | Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination With PNEUMOVAX™23 | 1.2 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination With PNEUMOVAX™23 | 0.0 Percentage of Participants |
| V114 (Pediatric) | Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination With PNEUMOVAX™23 | 0.0 Percentage of Participants |
| Prevnar 13™ (Pediatric) | Percentage of Participants With a Vaccine-related Serious Adverse Event Following Vaccination With PNEUMOVAX™23 | 0.0 Percentage of Participants |
Secondary
Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
The GMFR of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay.
Time frame: Day 1 (Baseline) and Day 90 (30 days after the Day 60 vaccinations with V114 or Prevnar 13™)
Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 6A (Shared) | 73.8 Percentage of Participants |
| V114 (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 14 (Shared) | 51.5 Percentage of Participants |
| V114 (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 3 (Shared) | 62.1 Percentage of Participants |
| V114 (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 18C (Shared) | 67.0 Percentage of Participants |
| V114 (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 6B (Shared) | 71.8 Percentage of Participants |
| V114 (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 19A (Shared) | 55.3 Percentage of Participants |
| V114 (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 5 (Shared) | 60.2 Percentage of Participants |
| V114 (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 19F (Shared) | 63.1 Percentage of Participants |
| V114 (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 7F (Shared) | 69.9 Percentage of Participants |
| V114 (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 23F (Shared) | 61.2 Percentage of Participants |
| V114 (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 4 (Shared) | 73.8 Percentage of Participants |
| V114 (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 22F (Unique to V114) | 74.8 Percentage of Participants |
| V114 (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 9V (Shared) | 65.0 Percentage of Participants |
| V114 (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 33F (Unique to V114) | 54.4 Percentage of Participants |
| V114 (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 1 (Shared) | 69.9 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 33F (Unique to V114) | 4.8 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 1 (Shared) | 64.3 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 3 (Shared) | 48.8 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 4 (Shared) | 70.2 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 5 (Shared) | 60.7 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 6A (Shared) | 69.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 6B (Shared) | 69.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 7F (Shared) | 70.2 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 9V (Shared) | 63.1 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 14 (Shared) | 50.6 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 18C (Shared) | 61.9 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 19A (Shared) | 48.8 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 19F (Shared) | 61.9 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 23F (Shared) | 61.9 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With Geometric Mean Fold Rises (GMFR) ≥4 in Serotype-specific IgG at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 22F (Unique to V114) | 1.2 Percentage of Participants |
Secondary
Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90)
Activity for the 15 serotypes contained in V114 vaccine were determined using a Multiplex Opsonophagocytic Assay. The GMFR of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using multiplexed opsonophagocytic assay.
Time frame: Time Frame: Day 1 (Baseline) and Day 90 (30 days after the Day 60 vaccinations with V114 or Prevnar 13™)
Population: All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity endpoint and who had sufficient data to perform the analyses were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 6A (Shared) | 64.4 Percentage of Participants |
| V114 (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 14 (Shared) | 54.7 Percentage of Participants |
| V114 (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 3 (Shared) | 58.0 Percentage of Participants |
| V114 (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 18C (Shared) | 69.3 Percentage of Participants |
| V114 (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 6B (Shared) | 69.4 Percentage of Participants |
| V114 (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 19A (Shared) | 64.0 Percentage of Participants |
| V114 (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 5 (Shared) | 70.5 Percentage of Participants |
| V114 (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 19F (Shared) | 61.4 Percentage of Participants |
| V114 (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 7F (Shared) | 68.6 Percentage of Participants |
| V114 (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 23F (Shared) | 63.5 Percentage of Participants |
| V114 (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 4 (Shared) | 71.3 Percentage of Participants |
| V114 (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 22F (Unique to V114) | 70.2 Percentage of Participants |
| V114 (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 9V (Shared) | 54.5 Percentage of Participants |
| V114 (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 33F (Unique to V114) | 61.6 Percentage of Participants |
| V114 (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 1 (Shared) | 65.9 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 33F (Unique to V114) | 11.3 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 1 (Shared) | 54.1 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 3 (Shared) | 55.7 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 4 (Shared) | 78.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 5 (Shared) | 53.2 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 6A (Shared) | 68.9 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 6B (Shared) | 73.3 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 7F (Shared) | 71.7 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 9V (Shared) | 53.3 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 14 (Shared) | 58.1 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 18C (Shared) | 46.7 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 19A (Shared) | 59.0 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 19F (Shared) | 68.9 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 23F (Shared) | 69.1 Percentage of Participants |
| Prevnar 13™ (Adult) | Percentage of Participants With GMFR ≥4 in Serotype-specific OPA at 30 Days Following Dose 3 With V114 or Prevnar 13™ (Day 90) | Serotype 22F (Unique to V114) | 3.4 Percentage of Participants |