Pneumococcal Infections, Pneumococcal Vaccines
Conditions
Brief summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V114 in healthy infants. The primary hypotheses are that: 1) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on response rates at 30 days following Dose 3; 2) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes compared with the lowest response rate of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 3) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes based on anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin g (IgG) geometric mean concentrations (GMCs) at 30 days following Dose 3; 4) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on the anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13™, excluding serotype 3, at 30 days following Dose 3; 5) V114 is non-inferior to Prevnar 13™ for the 13 shared serotypes between V114 and Prevnar 13™ based on anti-PnPs serotype-specific IgG GMCs at 30 days following Dose 4; and 6) V114 is non-inferior to Prevnar 13™ for the 2 unique V114 serotypes based on anti-PnPs serotype-specific IgG GMCs of the 2 unique V114 serotypes compared with the lowest IgG GMC of any of the shared serotypes in Prevnar 13, excluding serotype 3, at 30 days following Dose 4.
Interventions
BIOLOGICALV114
V114 15-valent pneumococcal conjugate vaccine containing 13 serotypes present in Prevnar 13® (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL intramuscular administration.
BIOLOGICALPrevnar 13™
Prevnar 13™ 13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration.
BIOLOGICALRotaTeq™
A total of 3 RotaTeq™ 2 mL oral dosings at \ 2, \ 4, and \ 6 months of age.
BIOLOGICALPentacel™
A total of 3 Pentacel™ 0.5 mL IM dosings at \ 2, \ 4, and \ 6 months of age.
BIOLOGICALRECOMBIVAX HB™
A total of 3 RECOMBIVAX HB™ 0.5 mL IM dosings at \ 2, \ 4, and \ 6 months of age.
BIOLOGICALVAQTA™
One VAQTA™ 0.5 mL IM dosing at 12 to 15 months of age.
BIOLOGICALMMR II™
One MMR II™ 0.5 mL subcutaneous (SC) dosing at 12 to 15 months of age.
BIOLOGICALVARIVAX™
One VARIVAX™ 0.5 mL SC dosing at 12 to 15 months of age.
BIOLOGICALHIBERIX™
One HIBERIX™ 0.5 mL IM dosing at Visit 5.
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
42 Days to 90 Days
Healthy volunteers
Yes
Inclusion criteria
* Is healthy (based on a review of medical history and physical examination) in the clinical judgement of the investigator * Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.
Exclusion criteria
* Has a history of invasive pneumococcal disease (IPD; positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease. * Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid-containing vaccine. * Has any contraindication to the concomitant study vaccines being administered in the study. * Had a recent febrile illness (rectal temperature ≥38.1°C \[=100.5°F\] or axillary temperature ≥37.8°C \[=100.0°F\]) occurring within 72 hours prior to receipt of study vaccine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™ | Up to 14 days after each vaccination with either V114 or Prevnar 13™ | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of swelling, redness, pain or tenderness, and hard lump. |
| Percentage of Participants With Solicited Systemic AEs | Up to 14 days after each vaccination with either V114 or Prevnar 13™ | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consisted of irritability, drowsiness, appetite lost, and hives or welts. |
| Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs) | From Day 1 up to 6 months after Vaccination 4 (up to 21 months) | An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an other important medical event. Any SAEs that are at least possibly related to vaccination are summarized. |
| Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | One month after Vaccination 3 (Month 7) | Anti-PnP serotype-specific IgG response rates for the 15 serotypes contained in V114 were measured with pneumococcal electrochemiluminescence (PnECL). The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for each serotype. |
| Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | One month after Vaccination 3 (Month 7) | The GMC of anti-PnP IgG Ab were measured with PnECL one month after vaccination 3 and reported for the 15 serotypes contained in V114. IgG GMCs were compared to the lowest in recipients of Prevnar 13™ excluding serotype 3 for the 2 serotypes unique to V114, and compared to the same serotypes for the 13 shared serotypes. |
| GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | One month after Vaccination 4 (Month 13 to Month 16) | The GMC of anti-PnP IgG Ab were measured with PnECL one month after vaccination 4 and reported for the 15 serotypes contained in V114. IgG GMCs were compared to the lowest in recipients of Prevnar 13™ excluding serotype 3 for the 2 serotypes unique to V114, and compared to the same serotypes for the 13 shared serotypes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 for 2 Unique V114 Seroptypes | One month after Vaccination 3 (Month 7) | Serotype-specific anti-PnP IgG GMCs for the 2 unique V114 serotypes were measured with PnECL. The GMCs for each serotype are reported. |
| Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Response Rates One Month After Vaccination 3 for 2 Unique V114 Seroptypes | One month after Vaccination 3 (Month 7) | Serotype-specific anti-PnP IgG response rates for the 2 unique V114 serotypes were measured with PnECL. The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for each serotype. |
| Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMC) One Month After Vaccination 4 for 2 Unique V114 Seroptypes | One month after Vaccination 4 (Month 13 to Month 16) | Serotype-specific anti-PnP GMCs were measured with PnECL. The GMC for each serotype is reported. |
| Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | One month after Vaccination 3 (Month 7) | Serotype-specific anti-PnP OPA GMTs were measured with multiplex opsonophagocytic assay (MOPA). The GMTs for each serotype are summarized. |
| Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | One month after Vaccination 3 (Month 7) | Antibody responses to diphtheria toxoid, tetanus toxoid, and pertussis antigens were measured using Luminex Assay. The percentage of participants meeting specific criteria are summarized for each serotype. The serotype-specific response rate criteria are as follows: diphtheria toxoid: % ≥0.1 IU/mL; tetanus toxoid: % ≥0.1 IU/mL; pertussis toxin (PT): % ≥ 5 EU/mL; pertussis filamentous hemagglutinin (FHA): % ≥5 EU/mL; pertussis fimbrae types 2/3 (FIM 2/3): % ≥20 EU/mL; pertussis pertactin (PRN): % ≥5 EU/mL; poliovirus 1: % neutralizing antibody (NAb) ≥1:8 dilution; poliovirus 2: % NAb ≥1:8 dilution, poliovirus 3: % NAb ≥1:8 dilution; and Haemophilus influenzae Type B polyribosylribitol phosphate (Hib-PRP): % ≥0.15 ug/mL. |
| Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Response Rate One Month After Vaccination 3 | One month after Vaccination 3 (Month 7) | Serotype 3-specific anti-PnP IgG response rates were measured with PnECL. The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for Serotype 3. |
| Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | One month after Vaccination 3 (Month 7) | Serotype 3-specific anti-PnP GMC was measured with PnECL. |
| Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 4 | One month after Vaccination 4 (Month 13 to Month 16) | Serotype 3-specific anti-PnP GMC were measured with PnECL. |
| Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | One month after Vaccination 3 (Month 7) | Serotype-specific anti-PnP OPA GMTs were measured with MOPA. The percentage of participants meeting ≥0.35 ug/mL are reported for each serotype. |
| Pertussis Antigen Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | One month after Vaccination 3 (Month 7) | Pertussis antibody GMCs were measured using Luminex Assay. |
| Hepatitis A Antibody Response Rate One Month After Vaccination 4 | One month after Vaccination 4 (Month 13 to Month 16) | Antibody response rates to hepatitis A were measured with hepatitis A virus enzyme immunoassay (HAV EIA). The percentage of participants with hepatitis A antigen ≥10 mIU/mL are reported. |
| Measles, Mumps, and Rubella Antibody Response Rate One Month After Vaccination 4 | One month after Vaccination 4 (Month 13 to Month 16) | Antibody responses to measles were measured with the bulk measles IgG enzyme immunoassay (EIA). Antibody responses to mumps were measured with enzyme-linked immunosorbent assay (ELISA). Antibody responses to rubella were measured with Bulk Rubella IgG EIA. The percentage of participants with measles antigen ≥255 mIU/ML; mumps antigen ≥10 mumps Ab units/mL; and rubella antigen ≥10 IU/mL, are reported. |
| Varicella-Zoster Virus (VZV) Antibody Response Rate One Month After Vaccination 4 | One month after Vaccination 4 (Month 13 to Month 16) | Antibody responses to varicella-zoster virus were measured with glycoprotein enzyme-linked immunosorbent assay (gpELISA). The percentage of participants with VZV antigen ≥5 gpELISA units/mL are reported. |
| Haemophilus Influenzae Type B Antibody Response Rate One Month After Vaccination 4 | One month after Vaccination 4 (Month 13 to Month 16) | Antibody responses to Haemophilus influenzae Type B polyribosylribitol phosphate (Hib PRP) were measured with ELISA. The percentage of participants with anti-HiB PRP antigen ≥0.15 ug/mL are reported. |
Countries
Puerto Rico, Thailand, Turkey (Türkiye), United States
Participant flow
Recruitment details
This study recruited healthy infants approximately 2 months (42 to 90 days, inclusive) of age, without a history of invasive pneumococcal disease or prior administration of any pneumococcal vaccine.
Pre-assignment details
1720 participants were randomized in a 1:1 ratio to receive a 4-dose regimen of either V114 or Prevnar 13™. One participant randomized to the Prevnar 13™ arm was inadvertently treated with Prevnar 13™ and V114.
Participants by arm
| Arm | Count |
|---|---|
| V114 Participants received a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 from 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15. | 860 |
| Prevnar 13™ Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 between 42-90 days of age inclusive (Vaccination 1), Month 4 from 4 months of age to 1 day prior to 5 months of age (Vaccination 2), Month 6 from 6 months of age to 1 day prior to 7 months of age (Vaccination 3) and Months 12-15 from 12 months of age to 1 day prior to 16 months of age (Vaccination 4). Participants concomitantly received other licensed paediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 4, and Month 6; VAQTA™, HIBERIX™, M-M-R™ II, VARIVAX™ on Months 12-15. | 860 |
| Total | 1,720 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 34 | 27 |
| Overall Study | Physician Decision | 8 | 14 |
| Overall Study | Withdrawal by Parent/Guardian | 59 | 85 |
Baseline characteristics
| Characteristic | V114 | Prevnar 13™ | Total |
|---|---|---|---|
| Age, Continuous | 8.4 weeks STANDARD_DEVIATION 1.2 | 8.4 weeks STANDARD_DEVIATION 1.3 | 8.4 weeks STANDARD_DEVIATION 1.2 |
| Age, Customized 85 years and over | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Adolescents (12-17 years) | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Adults (18-64 years) | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Children (2-11 years) | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized From 65-84 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Infants and toddlers (28 days-23 months) | 860 Participants | 860 Participants | 1720 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 weeks) | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 207 Participants | 204 Participants | 411 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 640 Participants | 645 Participants | 1285 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants | 11 Participants | 24 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 6 Participants | 13 Participants | 19 Participants |
| Race (NIH/OMB) Asian | 223 Participants | 227 Participants | 450 Participants |
| Race (NIH/OMB) Black or African American | 52 Participants | 53 Participants | 105 Participants |
| Race (NIH/OMB) More than one race | 98 Participants | 80 Participants | 178 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 6 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 474 Participants | 483 Participants | 957 Participants |
| Sex: Female, Male Female | 397 Participants | 428 Participants | 825 Participants |
| Sex: Female, Male Male | 463 Participants | 432 Participants | 895 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 860 | 1 / 859 | 0 / 1 |
| other Total, other adverse events | 790 / 858 | 778 / 855 | 1 / 1 |
| serious Total, serious adverse events | 88 / 858 | 81 / 855 | 1 / 1 |
Outcome results
Primary
Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3
The GMC of anti-PnP IgG Ab were measured with PnECL one month after vaccination 3 and reported for the 15 serotypes contained in V114. IgG GMCs were compared to the lowest in recipients of Prevnar 13™ excluding serotype 3 for the 2 serotypes unique to V114, and compared to the same serotypes for the 13 shared serotypes.
Time frame: One month after Vaccination 3 (Month 7)
Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 6B | 1.60 ug/mL |
| V114 | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 22F | 4.91 ug/mL |
| V114 | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 7F | 2.48 ug/mL |
| V114 | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 9V | 1.73 ug/mL |
| V114 | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 4 | 1.29 ug/mL |
| V114 | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 14 | 4.78 ug/mL |
| V114 | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 1 | 1.21 ug/mL |
| V114 | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 18C | 1.53 ug/mL |
| V114 | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 5 | 1.63 ug/mL |
| V114 | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 19A | 1.63 ug/mL |
| V114 | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 33F | 1.67 ug/mL |
| V114 | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 19F | 2.01 ug/mL |
| V114 | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 6A | 1.55 ug/mL |
| V114 | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 23F | 1.31 ug/mL |
| V114 | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 3 | 1.08 ug/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 23F | 1.47 ug/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 22F | 0.05 ug/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 33F | 0.06 ug/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 1 | 1.89 ug/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 3 | 0.62 ug/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 4 | 1.35 ug/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 5 | 2.25 ug/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 6A | 2.95 ug/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 6B | 1.97 ug/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 9V | 1.89 ug/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 14 | 6.80 ug/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 18C | 2.00 ug/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 19A | 2.29 ug/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 19F | 2.72 ug/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Anti-PnP IgG Ab One Month After Vaccination 3 | Serotype 7F | 3.23 ug/mL |
Comparison: Serotype 1 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [0.59, 0.69]t-test, 1 sided
Comparison: Serotype 3 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [1.61, 1.87]t-test, 1 sided
Comparison: Serotype 4 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [0.88, 1.03]t-test, 1 sided
Comparison: Serotype 5 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [0.66, 0.8]t-test, 1 sided
Comparison: Serotype 6A GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: =0.16795% CI: [0.48, 0.58]t-test, 1 sided
Comparison: Serotype 6B GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [0.71, 0.93]t-test, 1 sided
Comparison: Serotype 7F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [0.71, 0.83]t-test, 1 sided
Comparison: Serotype 9V GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [0.84, 1]t-test, 1 sided
Comparison: Serotype 14 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [0.63, 0.78]t-test, 1 sided
Comparison: Serotype 18C GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [0.7, 0.83]t-test, 1 sided
Comparison: Serotype 19A GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [0.65, 0.77]t-test, 1 sided
Comparison: Serotype 19F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [0.69, 0.79]t-test, 1 sided
Comparison: Serotype 23F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [0.8, 0.99]t-test, 1 sided
Comparison: Serotype 22F IgG GMC for Serotype 22F in recipients of V114 was compared to lowest IgG GMC (Serotype 4 at 1.35 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [3.33, 3.98]t-test, 1 sided
Comparison: Serotype 33F IgG GMC for Serotype 33F in recipients of V114 was compared to lowest IgG GMC (Serotype 4 at 1.35 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [1.1, 1.39]t-test, 1 sided
Primary
GMC of Anti-PnP IgG Ab One Month After Vaccination 4
The GMC of anti-PnP IgG Ab were measured with PnECL one month after vaccination 4 and reported for the 15 serotypes contained in V114. IgG GMCs were compared to the lowest in recipients of Prevnar 13™ excluding serotype 3 for the 2 serotypes unique to V114, and compared to the same serotypes for the 13 shared serotypes.
Time frame: One month after Vaccination 4 (Month 13 to Month 16)
Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 18C | 2.62 ug/mL |
| V114 | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 3 | 0.96 ug/mL |
| V114 | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 33F | 4.15 ug/mL |
| V114 | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 19A | 4.10 ug/mL |
| V114 | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 19F | 3.55 ug/mL |
| V114 | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 23F | 2.04 ug/mL |
| V114 | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 22F | 7.52 ug/mL |
| V114 | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 1 | 1.35 ug/mL |
| V114 | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 4 | 1.23 ug/mL |
| V114 | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 5 | 2.49 ug/mL |
| V114 | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 6A | 3.70 ug/mL |
| V114 | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 6B | 4.76 ug/mL |
| V114 | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 7F | 3.42 ug/mL |
| V114 | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 9V | 2.40 ug/mL |
| V114 | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 14 | 5.61 ug/mL |
| Prevnar 13™ | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 1 | 2.03 ug/mL |
| Prevnar 13™ | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 4 | 1.60 ug/mL |
| Prevnar 13™ | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 19F | 4.47 ug/mL |
| Prevnar 13™ | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 33F | 0.09 ug/mL |
| Prevnar 13™ | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 22F | 0.11 ug/mL |
| Prevnar 13™ | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 7F | 4.85 ug/mL |
| Prevnar 13™ | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 18C | 3.08 ug/mL |
| Prevnar 13™ | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 5 | 3.95 ug/mL |
| Prevnar 13™ | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 19A | 5.53 ug/mL |
| Prevnar 13™ | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 14 | 6.95 ug/mL |
| Prevnar 13™ | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 6A | 6.21 ug/mL |
| Prevnar 13™ | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 23F | 3.32 ug/mL |
| Prevnar 13™ | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 9V | 3.29 ug/mL |
| Prevnar 13™ | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 6B | 6.43 ug/mL |
| Prevnar 13™ | GMC of Anti-PnP IgG Ab One Month After Vaccination 4 | Serotype 3 | 0.71 ug/mL |
Comparison: Serotype 1 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [0.62, 0.72]t-test, 1 sided
Comparison: Serotype 3 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [1.25, 1.46]t-test, 1 sided
Comparison: Serotype 4 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [0.71, 0.84]t-test, 1 sided
Comparison: Serotype 5 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [0.58, 0.69]t-test, 1 sided
Comparison: Serotype 6A GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [0.54, 0.65]t-test, 1 sided
Comparison: Serotype 6B GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [0.67, 0.81]t-test, 1 sided
Comparison: Serotype 7F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [0.65, 0.77]t-test, 1 sided
Comparison: Serotype 9V GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [0.67, 0.8]t-test, 1 sided
Comparison: Serotype 14 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [0.73, 0.89]t-test, 1 sided
Comparison: Serotype 18C GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [0.78, 0.93]t-test, 1 sided
Comparison: Serotype 19A GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [0.68, 0.8]t-test, 1 sided
Comparison: Serotype 19F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [0.74, 0.86]t-test, 1 sided
Comparison: Serotype 23F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [0.56, 0.68]t-test, 1 sided
Comparison: Serotype 22F IgG GMC for Serotype 22F in recipients of V114 was compared to the lowest IgG GMC (Serotype 4 at 1.60 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [4.3, 5.11]t-test, 1 sided
Comparison: Serotype 33F IgG GMC for Serotype 33F in recipients of V114 was compared to the lowest IgG GMC (Serotype 4 at 1.60 ug/mL) for shared serotype in recipients of Prevnar 13™, excluding serotype 3. GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [2.36, 2.83]t-test, 1 sided
Primary
Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3
Anti-PnP serotype-specific IgG response rates for the 15 serotypes contained in V114 were measured with pneumococcal electrochemiluminescence (PnECL). The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for each serotype.
Time frame: One month after Vaccination 3 (Month 7)
Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 7F | 99.0 Percentage of participants |
| V114 | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 9V | 97.1 Percentage of participants |
| V114 | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 4 | 96.4 Percentage of participants |
| V114 | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 14 | 97.9 Percentage of participants |
| V114 | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 1 | 95.7 Percentage of participants |
| V114 | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 18C | 97.4 Percentage of participants |
| V114 | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 5 | 95.3 Percentage of participants |
| V114 | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 19A | 97.9 Percentage of participants |
| V114 | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 33F | 87.3 Percentage of participants |
| V114 | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 19F | 99.0 Percentage of participants |
| V114 | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 6A | 93.7 Percentage of participants |
| V114 | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 23F | 91.5 Percentage of participants |
| V114 | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 3 | 94.7 Percentage of participants |
| V114 | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 22F | 98.6 Percentage of participants |
| V114 | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 6B | 88.6 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 22F | 91.8 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 33F | 91.8 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 1 | 99.1 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 3 | 79.2 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 4 | 98.6 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 5 | 97.4 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 6A | 98.6 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 7F | 99.8 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 9V | 98.2 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 14 | 97.9 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 18C | 98.3 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 19A | 99.7 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 19F | 100.0 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 23F | 91.8 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With Anti-Pneumococcal Polysaccharide (Anti-PnP) Immunoglobulin G (IgG) Antibody (Ab) ≥0.35 ug/mL One Month After Vaccination 3 | Serotype 6B | 92.0 Percentage of participants |
Comparison: Serotype 1 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen methodp-value: <0.00195% CI: [-5.2, -1.8]Miettinen & Nurminen
Comparison: Serotype 3 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen methodp-value: <0.00195% CI: [12.1, 19.2]Miettinen & Nurminen
Comparison: Serotype 4 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen methodp-value: <0.00195% CI: [-4, -0.6]Miettinen & Nurminen
Comparison: Serotype 5 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen methodp-value: <0.00195% CI: [-4.2, -0.2]Miettinen & Nurminen
Comparison: Serotype 6A Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen methodp-value: <0.00195% CI: [-7.1, -3]Miettinen & Nurminen
Comparison: Serotype 6B Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen methodp-value: <0.00195% CI: [-6.6, -0.3]Miettinen & Nurminen
Comparison: Serotype 7F Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen methodp-value: <0.00195% CI: [-1.9, -0.1]Miettinen & Nurminen
Comparison: Serotype 9V Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen methodp-value: <0.00195% CI: [-2.8, 0.6]Miettinen & Nurminen
Comparison: Serotype 14 Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen methodp-value: <0.00195% CI: [-1.6, 1.6]Miettinen & Nurminen
Comparison: Serotype 18C Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen methodp-value: <0.00195% CI: [-2.6, 0.7]Miettinen & Nurminen
Comparison: Serotype 19A Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen methodp-value: <0.00195% CI: [-3.2, -0.8]Miettinen & Nurminen
Comparison: Serotype 19F Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen methodp-value: <0.00195% CI: [-2.1, -0.4]Miettinen & Nurminen
Comparison: Serotype 23F Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen methodp-value: <0.00195% CI: [-3.2, 2.7]Miettinen & Nurminen
Comparison: Serotype 22F This analysis represents the difference between response rate to Serotype 22F in recipients of V114 and lowest response (Serotype 23F at 91.8) in recipients of Prevnar 13™ for shared serotypes, excluding serotype 3. Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen methodp-value: <0.00195% CI: [4.6, 9.2]Miettinen & Nurminen
Comparison: Serotype 33F This analysis represents the difference between response rate to Serotype 33F in recipients of V114 and lowest response (Serotype 23F at 91.8) in recipients of Prevnar 13™ for shared serotypes, excluding serotype 3. Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen methodp-value: <0.00195% CI: [-7.8, -1.3]Miettinen & Nurminen
Primary
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs consisted of swelling, redness, pain or tenderness, and hard lump.
Time frame: Up to 14 days after each vaccination with either V114 or Prevnar 13™
Population: All randomized participants who received at least 1 dose of either V114 or Prevnar 13™. One participant in the Prevnar 13™ group inadvertently received both V114 and Prevnar 13™ and was excluded from the analysis population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™ | Injection site erythema (redness) | 33.7 Percentage of participants |
| V114 | Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™ | Injection site pain (pain) | 49.8 Percentage of participants |
| V114 | Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™ | Injection site induration (hard lump) | 26.3 Percentage of participants |
| V114 | Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™ | Injection site swelling (swelling) | 26.3 Percentage of participants |
| V114 | Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™ | Solicited injection site AEs | 69.0 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™ | Injection site swelling (swelling) | 24.0 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™ | Solicited injection site AEs | 69.2 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™ | Injection site erythema (redness) | 38.5 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™ | Injection site induration (hard lump) | 26.8 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) in V114 Versus Prevnar 13™ | Injection site pain (pain) | 46.9 Percentage of participants |
Comparison: Injection site erythema Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen methodp-value: =0.03995% CI: [-9.3, -0.2]Miettinen & Nurminen
Comparison: Injection site induration Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen methodp-value: =0.83695% CI: [-4.6, 3.7]Miettinen & Nurminen
Comparison: Injection site pain Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen methodp-value: =0.23595% CI: [-1.9, 7.6]Miettinen & Nurminen
Comparison: Injection site swelling Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen methodp-value: =0.2695% CI: [-1.7, 6.5]Miettinen & Nurminen
Primary
Percentage of Participants With Solicited Systemic AEs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs consisted of irritability, drowsiness, appetite lost, and hives or welts.
Time frame: Up to 14 days after each vaccination with either V114 or Prevnar 13™
Population: All randomized participants who received at least 1 dose of either V114 or Prevnar 13™. One participant in the Prevnar 13™ group inadvertently received both V114 and Prevnar 13™ and was excluded from the analysis population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With Solicited Systemic AEs | Decreased appetite | 34.3 Percentage of participants |
| V114 | Percentage of Participants With Solicited Systemic AEs | Somnolence (drowsiness) | 59.0 Percentage of participants |
| V114 | Percentage of Participants With Solicited Systemic AEs | Irritability | 76.5 Percentage of participants |
| V114 | Percentage of Participants With Solicited Systemic AEs | Urticaria (hives) | 6.5 Percentage of participants |
| V114 | Percentage of Participants With Solicited Systemic AEs | Solicited systemic adverse events | 84.4 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With Solicited Systemic AEs | Urticaria (hives) | 6.5 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With Solicited Systemic AEs | Solicited systemic adverse events | 84.8 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With Solicited Systemic AEs | Decreased appetite | 36.0 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With Solicited Systemic AEs | Irritability | 75.4 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With Solicited Systemic AEs | Somnolence (drowsiness) | 62.0 Percentage of participants |
Comparison: Decreased appetite Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen methodp-value: =0.44695% CI: [-6.3, 2.8]Miettinen & Nurminen
Comparison: Irritability Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen methodp-value: =0.62295% CI: [-3, 5.1]Miettinen & Nurminen
Comparison: Somnolence (drowsiness) Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen methodp-value: =0.20295% CI: [-7.6, 1.6]Miettinen & Nurminen
Comparison: Urticaria (Hives) Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen methodp-value: =0.98595% CI: [-2.4, 2.3]Miettinen & Nurminen
Primary
Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs)
An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an other important medical event. Any SAEs that are at least possibly related to vaccination are summarized.
Time frame: From Day 1 up to 6 months after Vaccination 4 (up to 21 months)
Population: All randomized participants who received at least 1 dose of either V114 or Prevnar 13™. One participant in the Prevnar 13™ group inadvertently received both V114 and Prevnar 13™ and was excluded from the analysis population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 | Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs) | 0.0 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs) | 0.0 Percentage of participants |
Comparison: Estimated difference, CI, and p-value are calculated based on the Miettinen \& Nurminen method95% CI: [-0.4, 0.4]
Secondary
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3
Serotype 3-specific anti-PnP GMC was measured with PnECL.
Time frame: One month after Vaccination 3 (Month 7)
Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis, who had sufficient blood volume to perform the analysis, and who had available serotype 3-specific IgG data.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | 1.08 ug/mL |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | 0.62 ug/mL |
Comparison: GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [1.61, 1.87]t-test, 1 sided
Secondary
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 4
Serotype 3-specific anti-PnP GMC were measured with PnECL.
Time frame: One month after Vaccination 4 (Month 13 to Month 16)
Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis who had sufficient blood volume to perform the analysis, and who had available serotype 3-specific IgG data.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 4 | 0.96 ug/mL |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 4 | 0.71 ug/mL |
Comparison: GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [1.25, 1.46]t-test, 1 sided
Secondary
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Response Rate One Month After Vaccination 3
Serotype 3-specific anti-PnP IgG response rates were measured with PnECL. The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for Serotype 3.
Time frame: One month after Vaccination 3 (Month 7)
Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis, who had sufficient blood volume to perform the analysis, and who had available serotype 3-specific IgG data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Response Rate One Month After Vaccination 3 | 94.7 Percentage of participants |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype 3-Specific Immunoglobulin G (IgG) Response Rate One Month After Vaccination 3 | 79.2 Percentage of participants |
Comparison: Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen methodp-value: <0.00195% CI: [12.1, 19.2]Miettinen & Nurminen
Secondary
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 for 2 Unique V114 Seroptypes
Serotype-specific anti-PnP IgG GMCs for the 2 unique V114 serotypes were measured with PnECL. The GMCs for each serotype are reported.
Time frame: One month after Vaccination 3 (Month 7)
Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 for 2 Unique V114 Seroptypes | 22F | 4.91 ug/mL |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 for 2 Unique V114 Seroptypes | 33F | 1.67 ug/mL |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 for 2 Unique V114 Seroptypes | 22F | 0.05 ug/mL |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) One Month After Vaccination 3 for 2 Unique V114 Seroptypes | 33F | 0.06 ug/mL |
Comparison: Serotype 22F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [83.47, 101.47]t-test, 1 sided
Comparison: Serotype 33F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [26.16, 33.26]t-test, 1 sided
Secondary
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMC) One Month After Vaccination 4 for 2 Unique V114 Seroptypes
Serotype-specific anti-PnP GMCs were measured with PnECL. The GMC for each serotype is reported.
Time frame: One month after Vaccination 4 (Month 13 to Month 16)
Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMC) One Month After Vaccination 4 for 2 Unique V114 Seroptypes | 22F | 7.52 ug/mL |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMC) One Month After Vaccination 4 for 2 Unique V114 Seroptypes | 33F | 4.15 ug/mL |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMC) One Month After Vaccination 4 for 2 Unique V114 Seroptypes | 22F | 0.11 ug/mL |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMC) One Month After Vaccination 4 for 2 Unique V114 Seroptypes | 33F | 0.09 ug/mL |
Comparison: Serotype 22F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [63.1, 75.02]t-test, 1 sided
Comparison: Serotype 33F GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [41.04, 49.14]t-test, 1 sided
Secondary
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Response Rates One Month After Vaccination 3 for 2 Unique V114 Seroptypes
Serotype-specific anti-PnP IgG response rates for the 2 unique V114 serotypes were measured with PnECL. The percentage of participants with IgG Ab ≥0.35 ug/mL are reported for each serotype.
Time frame: One month after Vaccination 3 (Month 7)
Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Response Rates One Month After Vaccination 3 for 2 Unique V114 Seroptypes | Serotype 22F | 98.6 Percentage of participants |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Response Rates One Month After Vaccination 3 for 2 Unique V114 Seroptypes | Serotype 33F | 87.3 Percentage of participants |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Response Rates One Month After Vaccination 3 for 2 Unique V114 Seroptypes | Serotype 22F | 3.5 Percentage of participants |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Immunoglobulin G (IgG) Response Rates One Month After Vaccination 3 for 2 Unique V114 Seroptypes | Serotype 33F | 2.1 Percentage of participants |
Comparison: Serotype 22F Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.p-value: <0.00195% CI: [93.1, 96.5]Miettinen & Nurminen
Comparison: Serotype 33F Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.p-value: <0.00195% CI: [82.3, 87.7]Miettinen & Nurminen
Secondary
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3
Serotype-specific anti-PnP OPA GMTs were measured with multiplex opsonophagocytic assay (MOPA). The GMTs for each serotype are summarized.
Time frame: One month after Vaccination 3 (Month 7)
Population: Due to the large serum volume required for MOPA, the analysis population for OPA testing was performed on a subset of participants, which included the first 20% of all participants with sufficient serum volume at 30 days post-dose 3.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 6A | 2072.1 Titers |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 14 | 2400.7 Titers |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 3 | 284.7 Titers |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 18C | 1171.2 Titers |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 6B | 1932.5 Titers |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 19A | 841.3 Titers |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 5 | 387.4 Titers |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 19F | 703.9 Titers |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 7F | 4973.2 Titers |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 23F | 2078.9 Titers |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 4 | 1304.8 Titers |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 22F | 1849.3 Titers |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 9V | 1217.3 Titers |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 33F | 8262.6 Titers |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 1 | 56.9 Titers |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 33F | 119.6 Titers |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 1 | 78.3 Titers |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 3 | 210.6 Titers |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 4 | 1566.7 Titers |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 5 | 510.8 Titers |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 6A | 2743.4 Titers |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 6B | 1963.7 Titers |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 7F | 7335.1 Titers |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 9V | 1534.1 Titers |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 14 | 1853.1 Titers |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 18C | 1330.2 Titers |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 19A | 1400.7 Titers |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 19F | 850.6 Titers |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 23F | 3668.8 Titers |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) One Month After Vaccination 3 | Serotype 22F | 9.1 Titers |
Secondary
Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3
Serotype-specific anti-PnP OPA GMTs were measured with MOPA. The percentage of participants meeting ≥0.35 ug/mL are reported for each serotype.
Time frame: One month after Vaccination 3 (Month 7)
Population: Due to the large serum volume required for MOPA, the analysis population for OPA testing was performed on a subset of participants, which included the first 20% of all participants with sufficient serum volume at 30 days post-dose 3.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 6A | 97.1 Percentage of participants |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 14 | 98.8 Percentage of participants |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 3 | 100.0 Percentage of participants |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 18C | 98.8 Percentage of participants |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 6B | 98.2 Percentage of participants |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 19A | 98.2 Percentage of participants |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 5 | 96.5 Percentage of participants |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 19F | 95.9 Percentage of participants |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 7F | 100.0 Percentage of participants |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 23F | 99.4 Percentage of participants |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 4 | 99.4 Percentage of participants |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 22F | 99.4 Percentage of participants |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 9V | 98.2 Percentage of participants |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 33F | 98.8 Percentage of participants |
| V114 | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 1 | 86.5 Percentage of participants |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 33F | 56.8 Percentage of participants |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 1 | 87.7 Percentage of participants |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 3 | 100.0 Percentage of participants |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 4 | 100.0 Percentage of participants |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 5 | 98.1 Percentage of participants |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 6A | 98.1 Percentage of participants |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 6B | 98.1 Percentage of participants |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 7F | 100.0 Percentage of participants |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 9V | 97.5 Percentage of participants |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 14 | 98.8 Percentage of participants |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 18C | 99.4 Percentage of participants |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 19A | 99.4 Percentage of participants |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 19F | 98.8 Percentage of participants |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 23F | 100.0 Percentage of participants |
| Prevnar 13™ | Anti-Pneumococcal Polysaccharide (Anti-PnP) Serotype-Specific Opsonophagocytic Activity (OPA) Response Rates One Month After Vaccination 3 | Serotype 22F | 5.8 Percentage of participants |
Secondary
Haemophilus Influenzae Type B Antibody Response Rate One Month After Vaccination 4
Antibody responses to Haemophilus influenzae Type B polyribosylribitol phosphate (Hib PRP) were measured with ELISA. The percentage of participants with anti-HiB PRP antigen ≥0.15 ug/mL are reported.
Time frame: One month after Vaccination 4 (Month 13 to Month 16)
Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity, who had sufficient blood volume to perform the analysis, and who had available Hib PRP ELISA data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 | Haemophilus Influenzae Type B Antibody Response Rate One Month After Vaccination 4 | 98.9 Percentage of participants |
| Prevnar 13™ | Haemophilus Influenzae Type B Antibody Response Rate One Month After Vaccination 4 | 100.0 Percentage of participants |
Comparison: Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.p-value: <0.00195% CI: [-2.2, -0.5]Miettinen & Nurminen
Secondary
Hepatitis A Antibody Response Rate One Month After Vaccination 4
Antibody response rates to hepatitis A were measured with hepatitis A virus enzyme immunoassay (HAV EIA). The percentage of participants with hepatitis A antigen ≥10 mIU/mL are reported.
Time frame: One month after Vaccination 4 (Month 13 to Month 16)
Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis, who had sufficient blood volume to perform the analysis, and who had available HAV EIA data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 | Hepatitis A Antibody Response Rate One Month After Vaccination 4 | 97.4 Percentage of participants |
| Prevnar 13™ | Hepatitis A Antibody Response Rate One Month After Vaccination 4 | 97.1 Percentage of participants |
Comparison: Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.p-value: <0.00195% CI: [-1.6, 2.2]Miettinen & Nurminen
Secondary
Measles, Mumps, and Rubella Antibody Response Rate One Month After Vaccination 4
Antibody responses to measles were measured with the bulk measles IgG enzyme immunoassay (EIA). Antibody responses to mumps were measured with enzyme-linked immunosorbent assay (ELISA). Antibody responses to rubella were measured with Bulk Rubella IgG EIA. The percentage of participants with measles antigen ≥255 mIU/ML; mumps antigen ≥10 mumps Ab units/mL; and rubella antigen ≥10 IU/mL, are reported.
Time frame: One month after Vaccination 4 (Month 13 to Month 16)
Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Measles, Mumps, and Rubella Antibody Response Rate One Month After Vaccination 4 | Measles antigen ≥255 mIU/ML | 98.1 Percentage of participants |
| V114 | Measles, Mumps, and Rubella Antibody Response Rate One Month After Vaccination 4 | Mumps antigen ≥10 mumps Ab units/mL | 95.8 Percentage of participants |
| V114 | Measles, Mumps, and Rubella Antibody Response Rate One Month After Vaccination 4 | Rubella antigen ≥10 IU/mL | 98.1 Percentage of participants |
| Prevnar 13™ | Measles, Mumps, and Rubella Antibody Response Rate One Month After Vaccination 4 | Measles antigen ≥255 mIU/ML | 98.3 Percentage of participants |
| Prevnar 13™ | Measles, Mumps, and Rubella Antibody Response Rate One Month After Vaccination 4 | Mumps antigen ≥10 mumps Ab units/mL | 97.5 Percentage of participants |
| Prevnar 13™ | Measles, Mumps, and Rubella Antibody Response Rate One Month After Vaccination 4 | Rubella antigen ≥10 IU/mL | 98.9 Percentage of participants |
Comparison: Measles antigen ≥255 mIU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.p-value: <0.00195% CI: [-1.8, 1.3]Miettinen & Nurminen
Comparison: Mumps antigen ≥10 mumps Ab units/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.p-value: <0.00195% CI: [-3.8, 0.2]Miettinen & Nurminen
Comparison: Rubella antigen ≥10 IU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.p-value: <0.00195% CI: [-2.3, 0.5]Miettinen & Nurminen
Secondary
Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3
Antibody responses to diphtheria toxoid, tetanus toxoid, and pertussis antigens were measured using Luminex Assay. The percentage of participants meeting specific criteria are summarized for each serotype. The serotype-specific response rate criteria are as follows: diphtheria toxoid: % ≥0.1 IU/mL; tetanus toxoid: % ≥0.1 IU/mL; pertussis toxin (PT): % ≥ 5 EU/mL; pertussis filamentous hemagglutinin (FHA): % ≥5 EU/mL; pertussis fimbrae types 2/3 (FIM 2/3): % ≥20 EU/mL; pertussis pertactin (PRN): % ≥5 EU/mL; poliovirus 1: % neutralizing antibody (NAb) ≥1:8 dilution; poliovirus 2: % NAb ≥1:8 dilution, poliovirus 3: % NAb ≥1:8 dilution; and Haemophilus influenzae Type B polyribosylribitol phosphate (Hib-PRP): % ≥0.15 ug/mL.
Time frame: One month after Vaccination 3 (Month 7)
Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | Pertussis pertactin | 67.3 Percentage of participants |
| V114 | Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | Diphtheria toxoid | 96.9 Percentage of participants |
| V114 | Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | Poliovirus 1 | 99.8 Percentage of participants |
| V114 | Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | Pertussis toxin | 99.0 Percentage of participants |
| V114 | Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | Poliovirus 2 | 100.0 Percentage of participants |
| V114 | Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | Pertussis filamentous hemagglutinin | 99.1 Percentage of participants |
| V114 | Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | Poliovirus 3 | 100.0 Percentage of participants |
| V114 | Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | Pertussis fimbrae types 2/3 | 63.7 Percentage of participants |
| V114 | Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | Hib-PRP | 92.1 Percentage of participants |
| V114 | Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | Tetanus toxoid | 100.0 Percentage of participants |
| Prevnar 13™ | Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | Hib-PRP | 93.5 Percentage of participants |
| Prevnar 13™ | Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | Diphtheria toxoid | 97.6 Percentage of participants |
| Prevnar 13™ | Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | Pertussis filamentous hemagglutinin | 99.4 Percentage of participants |
| Prevnar 13™ | Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | Pertussis toxin | 98.5 Percentage of participants |
| Prevnar 13™ | Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | Pertussis fimbrae types 2/3 | 61.7 Percentage of participants |
| Prevnar 13™ | Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | Pertussis pertactin | 65.5 Percentage of participants |
| Prevnar 13™ | Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | Poliovirus 1 | 99.8 Percentage of participants |
| Prevnar 13™ | Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | Poliovirus 2 | 100.0 Percentage of participants |
| Prevnar 13™ | Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | Poliovirus 3 | 100.0 Percentage of participants |
| Prevnar 13™ | Percentage of Participants Meeting Response Rate Criteria for Pentacel™-Specific (Anti-Diptheria Toxoid, Tetanus Toxoid, and Pertussis Antigens) Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | Tetanus toxoid | 99.8 Percentage of participants |
Comparison: Diphtheria toxoid % ≥0.1 IU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.p-value: <0.00195% CI: [-2.6, 1.1]Miettinen & Nurminen
Comparison: Tetanus toxoid: % ≥0.1 IU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.p-value: <0.00195% CI: [-0.4, 0.8]Miettinen & Nurminen
Comparison: Pertussis toxin (PT): % ≥ 5 EU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.p-value: <0.00195% CI: [-0.7, 1.9]Miettinen & Nurminen
Comparison: Pertussis filamentous hemagglutinin (FHA): % ≥5 EU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.p-value: <0.00195% CI: [-1.3, 0.8]Miettinen & Nurminen
Comparison: Pertussis fimbrae types 2/3 (FIM 2/3): % ≥20 EU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.p-value: <0.00195% CI: [-3.1, 7.1]Miettinen & Nurminen
Comparison: Pertussis pertactin (PRN): % ≥5 EU/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.p-value: <0.00195% CI: [-3.2, 6.8]Miettinen & Nurminen
Comparison: Poliovirus 1: % NAb ≥1:8 dilution Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.p-value: <0.00195% CI: [-0.7, 0.8]Miettinen & Nurminen
Comparison: Poliovirus 2: % NAb ≥1:8 dilution Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.p-value: <0.00195% CI: [-0.6, 0.6]Miettinen & Nurminen
Comparison: Poliovirus 3: % NAb ≥1:8 dilution Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.p-value: <0.00195% CI: [-0.6, 0.6]Miettinen & Nurminen
Comparison: Haemophilus influenzae Type B polyribosylribitol phosphate (Hib-PRP): % ≥0.15 ug/mL Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.p-value: <0.00195% CI: [-4.3, 1.5]Miettinen & Nurminen
Secondary
Pertussis Antigen Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3
Pertussis antibody GMCs were measured using Luminex Assay.
Time frame: One month after Vaccination 3 (Month 7)
Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient blood volume to perform the analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | Pertussis Antigen Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | Pertussis - PT | 43.73 ug/mL |
| V114 | Pertussis Antigen Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | Pertussis - FHA | 67.51 ug/mL |
| V114 | Pertussis Antigen Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | Pertussis - FIM 2/3 | 39.79 ug/mL |
| V114 | Pertussis Antigen Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | Pertussis - PRN | 13.16 ug/mL |
| Prevnar 13™ | Pertussis Antigen Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | Pertussis - PRN | 13.17 ug/mL |
| Prevnar 13™ | Pertussis Antigen Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | Pertussis - PT | 44.35 ug/mL |
| Prevnar 13™ | Pertussis Antigen Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | Pertussis - FIM 2/3 | 36.87 ug/mL |
| Prevnar 13™ | Pertussis Antigen Immunoglobulin G (IgG) Antibody (Ab) Geometric Mean Concentration (GMC) One Month After Vaccination 3 | Pertussis - FHA | 69.18 ug/mL |
Comparison: Pertussis - PT GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [0.89, 1.09]t-test, 1 sided
Comparison: Pertussis - FHA GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [0.87, 1.09]t-test, 1 sided
Comparison: Pertussis - FIM 2/3 GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [0.91, 1.28]t-test, 1 sided
Comparison: Pertussis - PRN GMC ratio, CI, and p-value are calculated using the t-distribution with the variance estimate from a serotype-specific linear model utilizing the natural log-transformed antibody concentrations as the response and a single term for vaccination group.p-value: <0.00195% CI: [0.84, 1.19]t-test, 1 sided
Secondary
Varicella-Zoster Virus (VZV) Antibody Response Rate One Month After Vaccination 4
Antibody responses to varicella-zoster virus were measured with glycoprotein enzyme-linked immunosorbent assay (gpELISA). The percentage of participants with VZV antigen ≥5 gpELISA units/mL are reported.
Time frame: One month after Vaccination 4 (Month 13 to Month 16)
Population: All randomized participants who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis, who had sufficient blood volume to perform the analysis, and who had available VZV gpELISA data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 | Varicella-Zoster Virus (VZV) Antibody Response Rate One Month After Vaccination 4 | 96.4 Percentage of participants |
| Prevnar 13™ | Varicella-Zoster Virus (VZV) Antibody Response Rate One Month After Vaccination 4 | 97.7 Percentage of participants |
Comparison: Estimated difference, CI, and p-value are based on the Miettinen \& Nurminen method.p-value: <0.00195% CI: [-3.2, 0.5]Miettinen & Nurminen