Pneumococcal Infections
Conditions
Brief summary
This study will evaluate the safety and tolerability and immunogenicity of V114 when administered to 2-month old infants. The primary hypotheses are: 1) V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes between V114 and Prevenar 13™ based on response rates at 30 days post toddler dose (PTD); 2) V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on the response rates at 30 days PTD; 3) V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes between V114 and Prevenar 13™ based on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobin G (IgG) geometric mean concentrations (GMCs) at 30 days PTD; and 4) V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114 based on anti-PnPs serotype-specific IgG GMCs at 30 days PTD.
Interventions
DRUGRotarix™
Single 1.5 mL oral dose at 2 and 4 months of age (Study Day 1 and Month 2)
DRUGInfanrix™ hexa
Single 0.5 mL intramuscular injection at 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13)
DRUGV114
15-valent pneumococcal conjugate vaccine (PCV) containing 13 serotypes present in Prevenar 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,
DRUGPrevenar 13™
13-valent PCV containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL intramuscular administration.
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
* Healthy * 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
* 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 or suspected impairment of immunological function * Has a history of congenital or acquired immunodeficiency * Has, or his/her mother has, a documented human immunodeficiency virus (HIV) infection * Has, or his/her mother has, a documented hepatitis B surface antigen - positive test * Has known or history of functional or anatomic asplenia * Has failure to thrive based on the clinical judgement of the Investigator * Has a bleeding disorder contraindicating intramuscular vaccination * Has a history of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, Type 1 diabetes mellitus, or other autoimmune disorders) * Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders * Has received a dose of any pneumococcal vaccine prior to study entry * Has received \>1 dose of monovalent hepatitis B vaccine or hepatitis B-based combination vaccine prior to study entry * Has received a dose of any acellular pertussis- or whole cell pertussis-based combination vaccines, Haemophilus influenzae type b conjugate vaccine, poliovirus vaccine, rotavirus vaccine, or any other combination thereof, prior to study entry * Has received a blood transfusion or blood products, including immunoglobulins * Has participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included; these will be reviewed on a case-by-case basis for approval by the Sponsor * Is or has an immediate family member (eg, parent/legal guardian or sibling) who is investigational site or Sponsor staff directly involved with this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants That Report at Least 1 Solicited Injection-site Adverse Event (AE) | Up to 14 days post any vaccination (up to approximately study month 13) | An AE is any untoward medical occurrence in a participant temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a study intervention. Injection-site AEs solicited on the Vaccine Report Card (VRC) consisted of erythema (redness), induration (hard lump), pain (tenderness) and swelling. |
| Percentage of Participants That Report at Least 1 Solicited Systemic AE | Up to 14 days post any vaccination (up to approximately study month 13) | An AE is any untoward medical occurrence in a participant temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a study intervention. Systemic AEs solicited on the VRC consisted of decreased appetite (loss of appetite), irritability, somnolence (drowsiness) and urticaria (hive/welts). |
| Percentage of Participants That Report at Least 1 Vaccine-related Serious Adverse Event (SAE) | Up to 6 months post last vaccination (up to approximately study month 20) | A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event. The relatedness of a vaccine to a SAE is determined by an investigator who is a qualified physician. |
| Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | 30 days PTD (Up to approximately study month 14) | Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for each serotype using pneumococcal electrochemiluminescence (PnECL). The Geometric Mean Concentration (GMC) for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed. Per protocol, within-group CIs were not calculated. |
| Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | 30 days PTD (Up to approximately study month 14) | Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for the 15 serotypes using pneumococcal electrochemiluminescence (PnECL). The percentage of participants that achieve the threshold value of ≥0.35 μg/mL for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | 30 days PTD (Up to approximately study month 14) | Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific OPA using the MOPA. The threshold dilution (% ≥) for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F) were as follows: 1:9, 1:19, 1:34, 1:27, 1:232, 1:40, 1:61, 1:151, 1:62, 1:115, 1:31, 1:113, 1:55. For Serotypes 22F and 33F the threshold dilution was 1:15 and 1:20 respectively. The within-group CIs were based on the exact binomial method of Clopper and Pearson. |
| Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD | 30 days PTD (Up to approximately study month 14) | Sera from participants was used to measure vaccine-induced responses to 10 pre-specified Infanrix™ hexa antigens with the following threshold (% ≥) values: Diphtheria toxoid-0.1 international unit (IU)/mL;Tetanus toxoid-0.1 IU/mL; Pertussis pertussis toxin (PT)-5 endotoxin unit (EU)/mL; Pertussis filamentous hemagglutinin (FHA)-5 EU/mL; Pertussis pertactin (PRN)-5 EU/mL; Haemophilus influenzae type b (Hib) polyribosylribitol phosphate (PRP)-0.15 μg/mL; hepatitis B surface antigen (HBsAg)-10 mIU/mL; Poliovirus 1,2 and 3-1:8 neutralizing antibodies (NAb) dilution. |
| Percentage of Participants Who Achieved the IgG Serotype-Specific Threshold Value of ≥0.35 μg/mL For Protocol Pre-Specified Serotypes at 30 Days PTD | 30 days PTD (Up to approximately study month 14) | Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for the 15 serotypes using PnECL. As pre-specified in the protocol the percentage of participants from the two serotypes unique to V114 (Serotypes 22F and 33F) are presented, as well as the percentage of participants with the lowest response rate from any of the 13 shared serotypes randomized to Prevenar 13™ (Serotype 3). |
| Anti-rotavirus Immunoglobulin A (IgA) Geometric Mean Titers (GMTs) at 30 Days Post Primary Series (PPS) of Rotarix™ | 30 days PPS (Up to approximately study month 3) | Sera from participants was used to measure vaccine-induced antibodies in response to vaccination with Rotarix™ by assessing the GMT for IgA. Per protocol, within-group CIs were not calculated. |
| Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | 30 days PPS (Up to approximately study month 3) | Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for each serotype using PnECL. The GMC for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed. Per protocol, within-group CIs were not calculated. |
| Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | 30 days PPS (Up to approximately study month 3) | Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for the 15 serotypes using PnECL. The percentage of participants that achieve the threshold value of ≥0.35 μg/mL for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed. |
| Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | 30 days PTD (Up to approximately study month 14) | Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific OPA using the multiplexed opsonophagocytic assay (MOPA). The GMT for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed. The within-group CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. |
Countries
Australia, Belgium, Czechia, Estonia, Germany, Greece, Poland, Russia, Spain
Participant flow
Pre-assignment details
Healthy males and females aged 42 to 90 days (inclusive) were enrolled. One participant randomized to the V114 group, who was cross-treated with both pneumococcal conjugate vaccines (PCVs), V114 and Prevenar 13™, was excluded from the all participants as treated (APaT) i.e. the safety endpoints population; but was included in the AE module as a separate treatment group.
Participants by arm
| Arm | Count |
|---|---|
| V114 Full-term infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of V114 at approximately 2, 3, 4,and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2). | 591 |
| Prevenar 13™ Full-term infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 4, and 11-15 months of age (Study Day 1, Month 2, and Month 9-13). Preterm infants received a 0.5 mL intramuscular injection of Prevenar 13™ at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13). All infants also received licensed background intramuscular injections of 0.5 mL Infanrix™ hexa at approximately 2, 3, 4, and 11-15 months of age (Study Day 1, Months 1, 2, and Month 9-13); and also 1.5 mL oral dose of Rotarix™ at 2 and 4 months of age (Study Day 1 and Month 2). | 593 |
| Total | 1,184 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 4 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal By Parent/Guardian | 17 | 17 |
Baseline characteristics
| Characteristic | V114 | Prevenar 13™ | Total |
|---|---|---|---|
| Age, Continuous | 8.4 Weeks STANDARD_DEVIATION 1.5 | 8.5 Weeks STANDARD_DEVIATION 1.5 | 8.5 Weeks STANDARD_DEVIATION 1.5 |
| 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) | 591 Participants | 593 Participants | 1184 Participants |
| Age, Customized In utero | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Newborns (0-27 days) | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Preterm newborn infants (gestational age < 37 wks) | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 66 Participants | 65 Participants | 131 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 525 Participants | 526 Participants | 1051 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 7 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 574 Participants | 573 Participants | 1147 Participants |
| Sex: Female, Male Female | 283 Participants | 286 Participants | 569 Participants |
| Sex: Female, Male Male | 308 Participants | 307 Participants | 615 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 591 | 0 / 593 | 0 / 1 |
| other Total, other adverse events | 548 / 587 | 540 / 591 | 1 / 1 |
| serious Total, serious adverse events | 57 / 587 | 70 / 591 | 0 / 1 |
Outcome results
Primary
Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD)
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for each serotype using pneumococcal electrochemiluminescence (PnECL). The Geometric Mean Concentration (GMC) for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed. Per protocol, within-group CIs were not calculated.
Time frame: 30 days PTD (Up to approximately study month 14)
Population: All randomized participants without deviations from the protocol that may substantially affect the results. Deviations include, but are not limited to, failure to receive vaccination; receipt of prohibited medication or vaccine; failure to receive vaccination at the required time point; failure to receive the required vaccination dose; and collection of blood sample at a time point outside of the prespecified time window.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 6A | 3.10 μg/mL |
| V114 | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 14 | 5.26 μg/mL |
| V114 | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 3 | 0.84 μg/mL |
| V114 | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 18C | 1.94 μg/mL |
| V114 | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 6B | 4.17 μg/mL |
| V114 | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 19A | 4.68 μg/mL |
| V114 | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 5 | 1.97 μg/mL |
| V114 | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 19F | 4.09 μg/mL |
| V114 | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 7F | 3.09 μg/mL |
| V114 | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 23F | 1.52 μg/mL |
| V114 | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 4 | 1.29 μg/mL |
| V114 | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 22F | 5.98 μg/mL |
| V114 | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 9V | 2.14 μg/mL |
| V114 | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 33F | 3.41 μg/mL |
| V114 | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 1 | 1.29 μg/mL |
| Prevenar 13™ | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 33F | 0.07 μg/mL |
| Prevenar 13™ | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 1 | 2.08 μg/mL |
| Prevenar 13™ | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 3 | 0.66 μg/mL |
| Prevenar 13™ | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 4 | 1.73 μg/mL |
| Prevenar 13™ | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 5 | 3.06 μg/mL |
| Prevenar 13™ | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 6A | 4.57 μg/mL |
| Prevenar 13™ | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 6B | 4.37 μg/mL |
| Prevenar 13™ | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 7F | 3.93 μg/mL |
| Prevenar 13™ | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 9V | 2.99 μg/mL |
| Prevenar 13™ | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 14 | 7.04 μg/mL |
| Prevenar 13™ | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 18C | 2.22 μg/mL |
| Prevenar 13™ | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 19A | 5.65 μg/mL |
| Prevenar 13™ | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 19F | 4.63 μg/mL |
| Prevenar 13™ | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 23F | 1.75 μg/mL |
| Prevenar 13™ | Anti-pneumococcal Polysaccharide (PnPs) Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMC) for Each Serotype at 30 Days Post Toddler Dose (PTD) | Serotype 22F | 0.08 μg/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: [0.57, 0.68]t-distribution
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: [1.17, 1.39]t-distribution
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: [0.68, 0.82]t-distribution
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: [0.59, 0.7]t-distribution
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: [0.61, 0.76]t-distribution
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: [0.85, 1.07]t-distribution
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: [0.72, 0.85]t-distribution
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: [0.66, 0.78]t-distribution
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: [0.67, 0.83]t-distribution
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: [0.8, 0.95]t-distribution
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: [0.75, 0.91]t-distribution
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: [0.8, 0.97]t-distribution
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: [0.79, 0.97]t-distribution
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: [65.16, 79.1]t-distribution
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: [42.19, 51.42]t-distribution
Primary
Percentage of Participants That Report at Least 1 Solicited Injection-site Adverse Event (AE)
An AE is any untoward medical occurrence in a participant temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a study intervention. Injection-site AEs solicited on the Vaccine Report Card (VRC) consisted of erythema (redness), induration (hard lump), pain (tenderness) and swelling.
Time frame: Up to 14 days post any vaccination (up to approximately study month 13)
Population: Participants who received at least 1 dose of study vaccination based on the group to which they were randomized, and corresponding to the study vaccination they actually received. One participant randomized to V114, who inadvertently received both V114 and Prevenar 13™, was excluded from this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants That Report at Least 1 Solicited Injection-site Adverse Event (AE) | Injection site erythema | 45.3 Percentage of Participants |
| V114 | Percentage of Participants That Report at Least 1 Solicited Injection-site Adverse Event (AE) | Injection site induration | 41.9 Percentage of Participants |
| V114 | Percentage of Participants That Report at Least 1 Solicited Injection-site Adverse Event (AE) | Injection site pain | 40.5 Percentage of Participants |
| V114 | Percentage of Participants That Report at Least 1 Solicited Injection-site Adverse Event (AE) | Injection site swelling | 33.6 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants That Report at Least 1 Solicited Injection-site Adverse Event (AE) | Injection site swelling | 29.4 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants That Report at Least 1 Solicited Injection-site Adverse Event (AE) | Injection site erythema | 44.7 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants That Report at Least 1 Solicited Injection-site Adverse Event (AE) | Injection site pain | 29.3 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants That Report at Least 1 Solicited Injection-site Adverse Event (AE) | Injection site induration | 39.1 Percentage of Participants |
Comparison: Difference in % : Injection site erythemap-value: =0.82495% CI: [-5, 6.3]Miettinen & Nurminen
Comparison: Difference in %: Injection site indurationp-value: =0.32495% CI: [-2.8, 8.4]Miettinen & Nurminen
Comparison: Difference in %: Injection site painp-value: <0.00195% CI: [5.8, 16.6]Miettinen & Nurminen
Comparison: Difference in %: Injection site swellingp-value: =0.12895% CI: [-1.2, 9.4]Miettinen & Nurminen
Primary
Percentage of Participants That Report at Least 1 Solicited Systemic AE
An AE is any untoward medical occurrence in a participant temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a study intervention. Systemic AEs solicited on the VRC consisted of decreased appetite (loss of appetite), irritability, somnolence (drowsiness) and urticaria (hive/welts).
Time frame: Up to 14 days post any vaccination (up to approximately study month 13)
Population: Participants who received at least 1 dose of study vaccination based on the group to which they were randomized, and corresponding to the study vaccination they actually received. One participant randomized to V114, who inadvertently received both V114 and Prevenar 13™, was excluded from this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants That Report at Least 1 Solicited Systemic AE | Decreased appetite | 33.9 Percentage of Participants |
| V114 | Percentage of Participants That Report at Least 1 Solicited Systemic AE | Somnolence | 46.2 Percentage of Participants |
| V114 | Percentage of Participants That Report at Least 1 Solicited Systemic AE | Irritability | 71.7 Percentage of Participants |
| V114 | Percentage of Participants That Report at Least 1 Solicited Systemic AE | Urticaria | 3.7 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants That Report at Least 1 Solicited Systemic AE | Urticaria | 3.9 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants That Report at Least 1 Solicited Systemic AE | Decreased appetite | 33.5 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants That Report at Least 1 Solicited Systemic AE | Irritability | 66.3 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants That Report at Least 1 Solicited Systemic AE | Somnolence | 41.8 Percentage of Participants |
Comparison: Difference in %: Decreased appetitep-value: =0.88595% CI: [-5, 5.8]Miettinen & Nurminen
Comparison: Difference in %: Irritabilityp-value: =0.04595% CI: [0.1, 10.7]Miettinen & Nurminen
Comparison: Difference in %: Somnolencep-value: =0.13195% CI: [-1.3, 10]Miettinen & Nurminen
Comparison: Difference in %: Urticariap-value: =0.89895% CI: [-2.4, 2.1]Miettinen & Nurminen
Primary
Percentage of Participants That Report at Least 1 Vaccine-related Serious Adverse Event (SAE)
A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event. The relatedness of a vaccine to a SAE is determined by an investigator who is a qualified physician.
Time frame: Up to 6 months post last vaccination (up to approximately study month 20)
Population: Participants who received at least 1 dose of study vaccination based on the group to which they were randomized, and corresponding to the study vaccination they actually received. One participant randomized to V114, who inadvertently received both V114 and Prevenar 13™, was excluded from this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 | Percentage of Participants That Report at Least 1 Vaccine-related Serious Adverse Event (SAE) | 0.0 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants That Report at Least 1 Vaccine-related Serious Adverse Event (SAE) | 0.2 Percentage of Participants |
Comparison: Difference in %95% CI: [-1, 0.5]
Primary
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for the 15 serotypes using pneumococcal electrochemiluminescence (PnECL). The percentage of participants that achieve the threshold value of ≥0.35 μg/mL for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed.
Time frame: 30 days PTD (Up to approximately study month 14)
Population: All randomized participants without deviations from the protocol that may substantially affect the results. Deviations include, but are not limited to, failure to receive vaccination; receipt of prohibited medication or vaccine; failure to receive vaccination at the required time point; failure to receive the required vaccination dose; and collection of blood sample at a time point outside of the prespecified time window.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 6A | 98.5 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 14 | 99.8 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 1 | 96.7 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 18C | 98.9 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 6B | 97.4 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 19A | 99.1 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 5 | 99.1 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 19F | 99.6 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 7F | 99.8 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 23F | 96.8 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 4 | 95.7 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 22F | 99.6 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 9V | 98.9 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 33F | 99.1 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 3 | 92.0 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 33F | 4.2 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 1 | 99.4 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 3 | 83.8 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 4 | 97.9 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 5 | 100.0 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 6A | 98.9 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 6B | 99.1 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 7F | 99.8 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 9V | 100.0 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 14 | 100.0 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 18C | 99.3 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 19A | 100.0 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 19F | 100.0 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 23F | 97.4 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PTD | Serotype 22F | 5.8 Percentage of Participants |
Comparison: Percentage Difference: Serotype 19Fp-value: <0.00195% CI: [-1.3, 0.3]Miettinen & Nurminen
Comparison: Percentage Difference: Serotype 1p-value: <0.00195% CI: [-4.7, -1.3]Miettinen & Nurminen
Comparison: Percentage Difference: Serotype 3p-value: <0.00195% CI: [4.4, 12.2]Miettinen & Nurminen
Comparison: Percentage Difference: Serotype 4p-value: <0.00195% CI: [-4.5, -0.1]Miettinen & Nurminen
Comparison: Percentage Difference: Serotype 5p-value: <0.00195% CI: [-2.2, -0.2]Miettinen & Nurminen
Comparison: Percentage Difference: Serotype 6Ap-value: <0.00195% CI: [-1.9, 1.1]Miettinen & Nurminen
Comparison: Percentage Difference: Serotype 6Bp-value: <0.00195% CI: [-3.5, -0.1]Miettinen & Nurminen
Comparison: Percentage Difference: Serotype 7Fp-value: <0.00195% CI: [-0.9, 0.9]Miettinen & Nurminen
Comparison: Percentage Difference: Serotype 9Vp-value: <0.00195% CI: [-2.4, -0.4]Miettinen & Nurminen
Comparison: Percentage Difference: Serotype 14p-value: <0.00195% CI: [-1, 0.5]Miettinen & Nurminen
Comparison: Percentage Difference: Serotype 18Cp-value: <0.00195% CI: [-1.8, 0.9]Miettinen & Nurminen
Comparison: Percentage Difference: Serotype 19Ap-value: <0.00195% CI: [-2.2, -0.2]Miettinen & Nurminen
Comparison: Percentage Difference: Serotype 23Fp-value: <0.00195% CI: [-2.7, 1.5]Miettinen & Nurminen
Comparison: Percentage Difference: Serotype 22Fp-value: <0.00195% CI: [91.5, 95.6]Miettinen & Nurminen
Comparison: Percentage Difference: Serotype 33Fp-value: <0.00195% CI: [92.7, 96.5]Miettinen & Nurminen
Secondary
Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for each serotype using PnECL. The GMC for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed. Per protocol, within-group CIs were not calculated.
Time frame: 30 days PPS (Up to approximately study month 3)
Population: All randomized participants without deviations from the protocol that may substantially affect the results. Deviations include, but are not limited to, failure to receive vaccination; receipt of prohibited medication or vaccine; failure to receive vaccination at the required time point; failure to receive the required vaccination dose; and collection of blood sample at a time point outside of the prespecified time window.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 6A | 0.64 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 14 | 3.87 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 3 | 0.88 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 18C | 1.17 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 6B | 0.43 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 19A | 1.71 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 5 | 0.89 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 19F | 2.63 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 7F | 2.04 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 23F | 0.76 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 4 | 1.41 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 22F | 2.76 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 9V | 1.23 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 33F | 0.31 μg/mL |
| V114 | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 1 | 1.30 μg/mL |
| Prevenar 13™ | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 33F | 0.05 μg/mL |
| Prevenar 13™ | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 1 | 1.62 μg/mL |
| Prevenar 13™ | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 3 | 0.48 μg/mL |
| Prevenar 13™ | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 4 | 1.30 μg/mL |
| Prevenar 13™ | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 5 | 1.06 μg/mL |
| Prevenar 13™ | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 6A | 1.42 μg/mL |
| Prevenar 13™ | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 6B | 0.36 μg/mL |
| Prevenar 13™ | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 7F | 2.46 μg/mL |
| Prevenar 13™ | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 9V | 1.43 μg/mL |
| Prevenar 13™ | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 14 | 5.14 μg/mL |
| Prevenar 13™ | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 18C | 1.37 μg/mL |
| Prevenar 13™ | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 19A | 2.20 μg/mL |
| Prevenar 13™ | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 19F | 3.40 μg/mL |
| Prevenar 13™ | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 23F | 0.62 μg/mL |
| Prevenar 13™ | Anti-PnPs Serotype-specific IgG GMCs for Each Serotype at 30 Days PPS | Serotype 22F | 0.05 μg/mL |
Comparison: GMC Ratio Serotype 1: CI 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.95% CI: [0.73, 0.88]
Comparison: GMC Ratio Serotype 3: CI 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.95% CI: [1.7, 2.02]
Comparison: GMC Ratio Serotype 4: CI 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.95% CI: [0.98, 1.19]
Comparison: GMC Ratio Serotype 5: CI 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.95% CI: [0.74, 0.94]
Comparison: GMC Ratio Serotype 6A: CI 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.95% CI: [0.4, 0.52]
Comparison: GMC Ratio Serotype 6B: CI 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.95% CI: [1, 1.41]
Comparison: GMC Ratio Serotype 7F: CI 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.95% CI: [0.76, 0.91]
Comparison: GMC Ratio Serotype 9V: CI 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.95% CI: [0.77, 0.96]
Comparison: GMC Ratio Serotype 14: CI 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.95% CI: [0.66, 0.86]
Comparison: GMC Ratio Serotype 18C: CI 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.95% CI: [0.77, 0.95]
Comparison: GMC Ratio Serotype 19A: CI 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.95% CI: [0.7, 0.87]
Comparison: GMC Ratio Serotype 19F: CI 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.95% CI: [0.7, 0.85]
Comparison: GMC Ratio Serotype 23F: CI 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.95% CI: [1.07, 1.4]
Comparison: GMC Ratio Serotype 22F: CI 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.95% CI: [51.2, 65]
Comparison: GMC Ratio Serotype 33F: CI 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.95% CI: [5.46, 7.14]
Secondary
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific OPA using the multiplexed opsonophagocytic assay (MOPA). The GMT for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed. The within-group CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
Time frame: 30 days PTD (Up to approximately study month 14)
Population: All randomized participants without deviations from the protocol that may substantially affect the results. Deviations include, but are not limited to, failure to receive vaccination; receipt of prohibited medication or vaccine; failure to receive vaccination at the required time point; failure to receive the required vaccination dose; and collection of blood sample at a time point outside of the prespecified time window.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 6 | 3274.9 Titer |
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 14 | 2633.8 Titer |
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 3 | 321.5 Titer |
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 18C | 1968.6 Titer |
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 6B | 2439.9 Titer |
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 19A | 2995.6 Titer |
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 5 | 791.6 Titer |
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 19F | 1793.9 Titer |
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 7F | 6300.9 Titer |
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 23F | 4517.8 Titer |
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 4 | 2231.7 Titer |
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 22F | 2405.2 Titer |
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 9V | 1904.4 Titer |
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 33F | 14268.4 Titer |
| V114 | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 1 | 136.8 Titer |
| Prevenar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 33F | 1875.6 Titer |
| Prevenar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 1 | 164.6 Titer |
| Prevenar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 3 | 303.0 Titer |
| Prevenar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 4 | 3206.4 Titer |
| Prevenar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 5 | 947.9 Titer |
| Prevenar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 6 | 5387.2 Titer |
| Prevenar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 6B | 3182.4 Titer |
| Prevenar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 7F | 10071.4 Titer |
| Prevenar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 9V | 2616.6 Titer |
| Prevenar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 14 | 2582.1 Titer |
| Prevenar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 18C | 2091.8 Titer |
| Prevenar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 19A | 4254.3 Titer |
| Prevenar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 19F | 2012.3 Titer |
| Prevenar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 23F | 7987.6 Titer |
| Prevenar 13™ | Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) GMTs for Each Serotype at 30 Days PTD | Serotype 22F | 24.5 Titer |
Secondary
Anti-rotavirus Immunoglobulin A (IgA) Geometric Mean Titers (GMTs) at 30 Days Post Primary Series (PPS) of Rotarix™
Sera from participants was used to measure vaccine-induced antibodies in response to vaccination with Rotarix™ by assessing the GMT for IgA. Per protocol, within-group CIs were not calculated.
Time frame: 30 days PPS (Up to approximately study month 3)
Population: All randomized participants without deviations from the protocol that may substantially affect the results. Deviations include, but are not limited to, failure to receive vaccination; receipt of prohibited medication or vaccine; failure to receive vaccination at the required time point; failure to receive the required vaccination dose; and collection of blood sample at a time point outside of the prespecified time window.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| V114 | Anti-rotavirus Immunoglobulin A (IgA) Geometric Mean Titers (GMTs) at 30 Days Post Primary Series (PPS) of Rotarix™ | 45.39 Titer |
| Prevenar 13™ | Anti-rotavirus Immunoglobulin A (IgA) Geometric Mean Titers (GMTs) at 30 Days Post Primary Series (PPS) of Rotarix™ | 47.07 Titer |
Comparison: GMT 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 groupp-value: <0.00195% CI: [0.8, 1.16]t-distribution
Secondary
Percentage of Participants Who Achieved the IgG Serotype-Specific Threshold Value of ≥0.35 μg/mL For Protocol Pre-Specified Serotypes at 30 Days PTD
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for the 15 serotypes using PnECL. As pre-specified in the protocol the percentage of participants from the two serotypes unique to V114 (Serotypes 22F and 33F) are presented, as well as the percentage of participants with the lowest response rate from any of the 13 shared serotypes randomized to Prevenar 13™ (Serotype 3).
Time frame: 30 days PTD (Up to approximately study month 14)
Population: All randomized participants without deviations from the protocol that may substantially affect the results. For each pre-specified serotype, participants were only analyzed for the treatment group that they were randomized to.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants Who Achieved the IgG Serotype-Specific Threshold Value of ≥0.35 μg/mL For Protocol Pre-Specified Serotypes at 30 Days PTD | Serotype 22F | 99.6 Percentage of Participants |
| V114 | Percentage of Participants Who Achieved the IgG Serotype-Specific Threshold Value of ≥0.35 μg/mL For Protocol Pre-Specified Serotypes at 30 Days PTD | Serotype 33F | 99.1 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Achieved the IgG Serotype-Specific Threshold Value of ≥0.35 μg/mL For Protocol Pre-Specified Serotypes at 30 Days PTD | Serotype 3 | 83.8 Percentage of Participants |
Comparison: Percentage Difference: V114 Serotype 22F minus Prevenar 13™ Serotype 395% CI: [12.9, 19.2]
Comparison: Percentage Difference: V114 Serotype 33F minus Prevenar 13™ Serotype 395% CI: [12.2, 18.7]
Secondary
Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD
Sera from participants was used to measure vaccine-induced responses to 10 pre-specified Infanrix™ hexa antigens with the following threshold (% ≥) values: Diphtheria toxoid-0.1 international unit (IU)/mL;Tetanus toxoid-0.1 IU/mL; Pertussis pertussis toxin (PT)-5 endotoxin unit (EU)/mL; Pertussis filamentous hemagglutinin (FHA)-5 EU/mL; Pertussis pertactin (PRN)-5 EU/mL; Haemophilus influenzae type b (Hib) polyribosylribitol phosphate (PRP)-0.15 μg/mL; hepatitis B surface antigen (HBsAg)-10 mIU/mL; Poliovirus 1,2 and 3-1:8 neutralizing antibodies (NAb) dilution.
Time frame: 30 days PTD (Up to approximately study month 14)
Population: All randomized participants without deviations from the protocol that may substantially affect the results. Deviations include, but are not limited to, failure to receive vaccination; receipt of prohibited medication or vaccine; failure to receive vaccination at the required time point; failure to receive the required vaccination dose; and collection of blood sample at a time point outside of the prespecified time window.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD | Diphtheria toxoid | 99.3 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD | Tetanus toxoid | 99.6 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD | Pertussis PT | 99.4 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD | Pertussis FHA | 99.8 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD | Pertussis PRN | 99.6 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD | Hib PRP | 98.5 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD | HBsAg | 99.2 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD | Poliovirus 1 | 100.0 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD | Poliovirus 2 | 100.0 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD | Poliovirus 3 | 100.0 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD | Poliovirus 1 | 100.0 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD | Diphtheria toxoid | 99.8 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD | Hib PRP | 98.1 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD | Tetanus toxoid | 100.0 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD | Poliovirus 3 | 99.8 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD | Pertussis PT | 99.6 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD | HBsAg | 100.0 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD | Pertussis FHA | 100.0 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD | Poliovirus 2 | 100.0 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Antigen-Specific Threshold Value for Each Antigen in Infanrix™ Hexa at 30 Days PTD | Pertussis PRN | 100.0 Percentage of Participants |
Comparison: Percentage Difference: Diphtheria toxoidp-value: <0.00195% CI: [-1.7, 0.4]Miettinen & Nurminen
Comparison: Percentage Difference: Tetanus toxoidp-value: <0.00195% CI: [-1.3, 0.3]Miettinen & Nurminen
Comparison: Percentage Difference: Pertussis PTp-value: <0.00195% CI: [-1.3, 0.9]Miettinen & Nurminen
Comparison: Percentage Difference: Pertussis FHAp-value: <0.00195% CI: [-1, 0.5]Miettinen & Nurminen
Comparison: Percentage Difference: Pertussis PRNp-value: <0.00195% CI: [-1.3, 0.3]Miettinen & Nurminen
Comparison: Percentage Difference: Hib PRPp-value: <0.00195% CI: [-1.3, 2.1]Miettinen & Nurminen
Comparison: Percentage Difference: HBsAgp-value: <0.00195% CI: [-2, 0]Miettinen & Nurminen
Comparison: Percentage Difference: Poliovirus 1p-value: <0.00195% CI: [-0.7, 0.7]Miettinen & Nurminen
Comparison: Percentage Difference: Poliovirus 2p-value: <0.00195% CI: [-0.7, 0.7]Miettinen & Nurminen
Comparison: Percentage Difference: Poliovirus 3p-value: <0.00195% CI: [-0.5, 1.1]Miettinen & Nurminen
Secondary
Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific IgG for the 15 serotypes using PnECL. The percentage of participants that achieve the threshold value of ≥0.35 μg/mL for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F); and the 2 serotypes unique to V114 (Serotypes 22F and 33F) was assessed.
Time frame: 30 days PPS (Up to approximately study month 3)
Population: All randomized participants without deviations from the protocol that may substantially affect the results. Deviations include, but are not limited to, failure to receive vaccination; receipt of prohibited medication or vaccine; failure to receive vaccination at the required time point; failure to receive the required vaccination dose; and collection of blood sample at a time point outside of the prespecified time window.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 6A | 73.2 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 14 | 96.9 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 3 | 93.5 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 18C | 92.3 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 6B | 57.3 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 19A | 96.2 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 5 | 84.5 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 19F | 98.9 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 7F | 97.9 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 23F | 78.5 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 4 | 93.9 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 22F | 95.6 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 9V | 88.7 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 33F | 48.7 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 1 | 95.4 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 33F | 2.8 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 1 | 97.4 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 3 | 67.8 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 4 | 96.8 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 5 | 88.4 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 6A | 92.6 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 6B | 52.7 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 7F | 99.0 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 9V | 95.4 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 14 | 97.4 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 18C | 93.0 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 19A | 97.4 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 19F | 99.4 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 23F | 71.9 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype at 30 Days PPS | Serotype 22F | 5.2 Percentage of Participants |
Comparison: Percentage Difference: Serotype 195% CI: [-4.4, 0.3]
Comparison: Percentage Difference: Serotype 395% CI: [21.1, 30.3]
Comparison: Percentage Difference: Serotype 495% CI: [-5.7, -0.3]
Comparison: Percentage Difference: Serotype 595% CI: [-8.1, 0.3]
Comparison: Percentage Difference: Serotype 6A95% CI: [-23.9, -15]
Comparison: Percentage Difference: Serotype 6B95% CI: [-1.5, 10.7]
Comparison: Percentage Difference: Serotype 7F95% CI: [-2.9, 0.5]
Comparison: Percentage Difference: Serotype 9V95% CI: [-10.1, -3.5]
Comparison: Percentage Difference: Serotype 1495% CI: [-2.6, 1.7]
Comparison: Percentage Difference: Serotype 18C95% CI: [-3.9, 2.6]
Comparison: Percentage Difference: Serotype 19A95% CI: [-3.5, 1]
Comparison: Percentage Difference: Serotype 19F95% CI: [-2, 0.7]
Comparison: Percentage Difference: Serotype 23F95% CI: [1.3, 11.9]
Comparison: Percentage Difference: Serotype 22F95% CI: [87.4, 92.7]
Comparison: Percentage Difference: Serotype 33F95% CI: [41.3, 50.3]
Secondary
Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD
Sera from participants was used to measure vaccine-induced anti-PnPs serotype-specific OPA using the MOPA. The threshold dilution (% ≥) for each of the 13 serotypes shared by both V114 and Prevenar 13™ (Serotypes 1 to 23F) were as follows: 1:9, 1:19, 1:34, 1:27, 1:232, 1:40, 1:61, 1:151, 1:62, 1:115, 1:31, 1:113, 1:55. For Serotypes 22F and 33F the threshold dilution was 1:15 and 1:20 respectively. The within-group CIs were based on the exact binomial method of Clopper and Pearson.
Time frame: 30 days PTD (Up to approximately study month 14)
Population: All randomized participants without deviations from the protocol that may substantially affect the results. Deviations include, but are not limited to, failure to receive vaccination; receipt of prohibited medication or vaccine; failure to receive vaccination at the required time point; failure to receive the required vaccination dose; and collection of blood sample at a time point outside of the prespecified time window.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 6A | 99.0 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 14 | 100.0 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 3 | 100.0 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 18C | 100.0 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 6B | 100.0 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 19A | 100.0 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 5 | 100.0 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 19F | 100.0 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 7F | 100.0 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 23F | 100.0 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 4 | 100.0 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 22F | 99.0 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 9V | 97.9 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 33F | 100.0 Percentage of Participants |
| V114 | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 1 | 95.0 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 33F | 98.0 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 1 | 98.1 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 3 | 98.1 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 4 | 100.0 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 5 | 100.0 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 6A | 100.0 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 6B | 100.0 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 7F | 100.0 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 9V | 100.0 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 14 | 99.0 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 18C | 100.0 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 19A | 100.0 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 19F | 99.0 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 23F | 100.0 Percentage of Participants |
| Prevenar 13™ | Percentage of Participants Who Meet Serotype-specific OPA Threshold Value for Each Serotype at 30 Days PTD | Serotype 22F | 28.1 Percentage of Participants |