Pneumococcal Infections
Conditions
Keywords
Pneumococcal vaccines
Brief summary
This study is being conducted to evaluate the safety, tolerability, and immunogenicity of 15-valent pneumococcal conjugate vaccine (V114) compared to Prevnar™ in healthy adults and toddlers.
Detailed description
The study was extended to obtain additional sera from adult participants to support further development, validation, and performance of anti-pneumococcal antibody assays.
Interventions
BIOLOGICALPrevnar™
13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each), serotype 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.
BIOLOGICALV114, Aluminum Adjuvanted
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.0 mcg each), serotype 6B (4.0 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.
BIOLOGICALV114, Aluminum Nonadjuvanted
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.0 mcg each), serotype 6B (4.0 mcg) in each 0.5 mL dose.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Months to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Adult Stage: * Adults ≥18 to 45 years of age in good health. * Signed and dated informed consent prior to receipt of vaccine. * Afebrile (\<100.4°F \[\<38.0°C\] oral or equivalent) on day of vaccination. * Participant is able to read, understand, and complete study questionnaires (i.e., the Vaccine Report Card). * Participant is able to attend all scheduled visits and to comply with the study procedures. * Participant has access to a telephone. * Females must have a negative urine pregnancy test. Toddler Stage: * Healthy toddlers, 12-15 months of age who have previously completed a documented full 3 dose infant series of Prevnar™ at 2, 4, and 6 months of age. * Participant's parent/legal guardian understands the study procedures, alternate treatments available and risks involved with the study, and voluntarily agrees to participate by giving written informed consent. * Afebrile, with a rectal temperature \<38.1°C (\<100.5°F) or axillary temperature \<37.8°C (\<100.0°F) on day of vaccination. * Participant's parent/legal guardian is able to read, understand, and complete study questionnaires (i.e., the Vaccination Report Card). * Participant is able to attend all scheduled visits and to comply with the study procedures. * Participant's parent/legal guardian has access to a telephone.
Exclusion criteria
Adult Stage: * Receipt of any pneumococcal polysaccharide vaccine at any time or receipt of polysaccharide conjugate vaccine after the second year of life. * Known hypersensitivity to any component of the pneumococcal conjugate vaccine. * Known or suspected immunocompromised persons, including persons with congenital immunodeficiency, human immunodeficiency virus (HIV) infection, leukemia, lymphoma, Hodgkin's disease, multiple myeloma, generalized malignancy, chronic renal failure (most recent serum creatinine values in medical record ≥3 mg/dL), nephritic syndrome, or other conditions associated with immunosuppression such as organ or bone marrow transplant. * Functional or anatomic asplenia. * History of autoimmune disease including multiple sclerosis (MS), systemic lupus, polymyositis, inclusion body myositis, dermatomyositis, Hashimoto's thyroiditis, Sjogren's syndrome, rheumatoid arthritis, other autoimmune disorders. * History of chronic fatigue syndrome. * Known neurologic or cognitive behavioral disorders including multiple sclerosis (MS), MS-like disease, encephalitis/myelitis, acute disseminating encephalomyelitis (ADEM), pervasive developmental disorder, and related disorders. * Participant has a coagulation disorder contraindicating IM vaccination. * Use of any immunosuppressive therapy (Note: topical and inhaled/nebulized steroids are permitted). Participants on corticosteroids should be excluded if they are receiving or are expected to receive, in the period from 30 days prior to Visit 1 through Visit 2, systemic doses greater than required for physiological replacement, i.e., \>5 mg of prednisone (or equivalent) daily and for \>2 weeks. Excluded immunosuppressive therapies also include chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation, or autoimmune disease. * Any underlying illness that would complicate evaluation and completion of this study. * Any licensed non-live virus vaccine administered within the 14 days prior to receipt of study vaccine or is scheduled to receive any other licensed vaccine within 30 days following receipt of study vaccine. (Exception: Inactivated influenza vaccine may be administered during the study, but must be given at least 7 days prior to receipt of the study vaccine or at least 15 days after receipt of the study vaccine.) * Participant has received a licensed live virus vaccine within 30 days prior of receipt of study vaccine or is scheduled to receive vaccination with a licensed live virus vaccine within 30 days of receipt of study vaccine. * Participant has received diphtheria toxoid within 6 months prior to receipt of study vaccine. * Prior receipt of a blood transfusion or blood products including immune globulin administered within the 6 months before receipt of study vaccine. * Investigational drugs or vaccines received within the 2 months before receipt of study vaccine. * Participation in another clinical study within 42 days before the beginning or anytime during the duration of the current clinical study. * Recent hospitalization for acute illness within the 3 months before receipt of study vaccine. * History of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease. * History of febrile illness (≥100.40 F \[≥38.00 C\] oral or equivalent) occurring within 72 hours before receipt of study vaccine. * Participant is pregnant or breastfeeding or expecting to conceive within the projected duration of the study. Female participants of reproductive potential must have been using 2 acceptable methods of birth control for 2 weeks prior to enrollment, and agree to use 2 acceptable methods of birth control for 1 month after vaccination. (Acceptable methods of birth control include use of hormonal contraceptives, intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, tubal ligation, condoms, or abstinence). * Any participant who cannot be adequately followed for safety according to the protocol plan. * Participant is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study. * Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study. Toddler Stage: * Have received less than the full 3-dose infant series of Prevnar™ or 3rd dose less than 2 months before study vaccine. * Known hypersensitivity to any component of the pneumococcal conjugate vaccine. * Known or suspected impairment of immunological function. * Participant has a history of congenital or acquired immunodeficiency (e.g., splenomegaly). * Participant or his/her mother has documented HIV infection. * Functional or anatomic asplenia. * History of autoimmune disease including multiple sclerosis (MS), systemic lupus, polymyositis, inclusion body myositis, dermatomyositis, Hashimoto's thyroiditis, Sjogren's syndrome, rheumatoid arthritis, other autoimmune disorders. * Known neurologic or cognitive behavioral disorders including multiple sclerosis (MS), MS-like disease, encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive developmental disorder, and related disorders. * Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 2 weeks prior to vaccination. (Note: Toddlers on topical and inhaled/nebulized steroids may participate in the study.) Use of systemic steroids are only permitted when the participant is receiving less than 2 mg/kg per day of prednisone (or its equivalent), or less than 20 mg/d if they weigh more than 10 kg and are not otherwise immunocompromised. * Participant has received other licensed non-live vaccines administered within the 14 days before receipt of study vaccine. * Participant has received a licensed live virus vaccine within 30 days prior of receipt of study vaccine (Exception: Influenza virus vaccine given according to recommended guidelines within 7 days of receiving study vaccine). * Prior receipt of a blood transfusion or blood products, including immunoglobulins. * Investigational drugs or vaccines received within the 2 months before receipt of study vaccine. * Participation in another clinical study within 42 days before the beginning or anytime during the duration of the current clinical study. * History of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease. * A recent (\<72 hours) febrile illness (rectal temperature ≥38.1°C \[≥100.5°F\]) occurring within 48 hours before receipt of study vaccine. * History of failure to thrive. * Participant has a coagulation disorder contraindicating IM vaccination. * Participant and his/her mother is documented hepatitis B surface antigen-positive. * Any toddler who cannot be adequately followed for safety according to the protocol plan. * Participant's parent/legal guardian is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study. * Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adult: Percentage of Participants With Any Adverse Event | Up to Day 14 after vaccination | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. |
| Toddler: Percentage of Participants With Any Adverse Event | Up to Day 14 after vaccination | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. |
| Adult: Percentage of Participants With Any Serious Adverse Event | Up to Day 14 after vaccination | A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. |
| Toddler: Percentage of Participants With Any Serious Adverse Event | Up to Day 14 after vaccination | A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. |
| Adult: Percentage of Participants With Any Vaccine-related Adverse Event | Up to Day 14 after vaccination | An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. Relatedness of the AE to study vaccine was determined by the investigator. |
| Toddler: Percentage of Participants With Any Vaccine-related Adverse Event | Up to Day 14 after vaccination | An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. Relatedness of the AE to study vaccine was determined by the investigator. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Day 30 after vaccination | OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay |
| Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Day 30 after vaccination | Immunoglobulin G (IgG) for the serotypes contained in V114 was determined using an electrochemiluminescence assay. |
| Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Day 30 after vaccination | OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay |
| Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Day 30 after vaccination | Immunoglobulin G (IgG) for the serotypes contained in V114 was determined using an electrochemiluminescence assay. |
| Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Day 30 after vaccination | Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay. |
| Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Day 30 after vaccination | Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay. |
| Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Day 30 after vaccination | OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay. |
| Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Day 30 after vaccination | OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay. |
Participant flow
Recruitment details
The study was conducted in 15 sites in the US and Finland. Of the 60 randomized adult participants only one participant discontinued from the study. Of the 90 randomized toddler participants only one participant discontinued from the study. A total of 150 participants were screened and all were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| V114 Adjuvanted - Adult Cohort Healthy adult participants received a single 0.5 mL intramuscular injection of aluminum adjuvanted V114 on Day 1. | 30 |
| Prevnar™ - Adult Cohort Healthy adult participants received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1. | 30 |
| V114 Adjuvanted - Toddler Cohort Healthy toddlers (12-15 months of age) participants who completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of aluminum non-adjuvanted V114 on Day 1. | 33 |
| V114 Nonadjuvanted-Toddler Cohort Healthy toddlers (12-15 months of age) participants who completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of aluminum non-adjuvanted V114 on Day 1. | 29 |
| Prevnar™ - Toddler Cohort Healthy toddlers (12-15 months of age) participants who had previously completed a full 3-dose infant series of Prevnar™ received a single 0.5 mL intramuscular injection of Prevnar™ on Day 1. | 28 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Total | V114 Adjuvanted - Adult Cohort | Prevnar™ - Adult Cohort | V114 Adjuvanted - Toddler Cohort | V114 Nonadjuvanted-Toddler Cohort | Prevnar™ - Toddler Cohort |
|---|---|---|---|---|---|---|
| Age, Customized 12 Months | 41 Participants | 0 Participants | 0 Participants | 16 Participants | 14 Participants | 11 Participants |
| Age, Customized < 12 months (enrolled in error) | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Age, Customized 13 Months | 8 Participants | 0 Participants | 0 Participants | 3 Participants | 4 Participants | 1 Participants |
| Age, Customized 14 Months | 13 Participants | 0 Participants | 0 Participants | 3 Participants | 4 Participants | 6 Participants |
| Age, Customized 15 Months | 27 Participants | 0 Participants | 0 Participants | 10 Participants | 7 Participants | 10 Participants |
| Age, Customized 18 to 29 Years | 16 Participants | 8 Participants | 8 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 30 to 39 Years | 29 Participants | 14 Participants | 15 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 40 to 45 Years | 15 Participants | 8 Participants | 7 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 82 Participants | 13 Participants | 16 Participants | 21 Participants | 15 Participants | 17 Participants |
| Sex: Female, Male Male | 68 Participants | 17 Participants | 14 Participants | 12 Participants | 14 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 | 0 / 33 | 0 / 28 | 0 / 28 |
| other Total, other adverse events | 28 / 30 | 25 / 30 | 31 / 33 | 25 / 28 | 24 / 28 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 33 | 0 / 28 | 0 / 28 |
Outcome results
Primary
Adult: Percentage of Participants With Any Adverse Event
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Time frame: Up to Day 14 after vaccination
Population: The analysis population included all randomized participants who received study vaccination and who had available post-treatment safety data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants With Any Adverse Event | 93.3 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants With Any Adverse Event | 83.3 Percentage of Participants |
95% CI: [-7.4, 28.3]
Primary
Adult: Percentage of Participants With Any Serious Adverse Event
A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.
Time frame: Up to Day 14 after vaccination
Population: The analysis population included all randomized participants who received study vaccination and who had available post-treatment safety data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants With Any Serious Adverse Event | 0.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants With Any Serious Adverse Event | 0.0 Percentage of Participants |
95% CI: [-11.5, 11.5]
Primary
Adult: Percentage of Participants With Any Vaccine-related Adverse Event
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. Relatedness of the AE to study vaccine was determined by the investigator.
Time frame: Up to Day 14 after vaccination
Population: The analysis population included all randomized participants who received study vaccination and who had available post-treatment safety data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants With Any Vaccine-related Adverse Event | 93.3 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants With Any Vaccine-related Adverse Event | 83.3 Percentage of Participants |
95% CI: [-7.4, 28.3]
Primary
Toddler: Percentage of Participants With Any Adverse Event
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE.
Time frame: Up to Day 14 after vaccination
Population: The analysis population included all randomized participants who received study vaccination and who had available post-treatment safety data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants With Any Adverse Event | 93.9 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants With Any Adverse Event | 89.3 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants With Any Adverse Event | 85.7 Percentage of Participants |
95% CI: [-7.9, 26.6]
95% CI: [-15.5, 22.9]
Primary
Toddler: Percentage of Participants With Any Serious Adverse Event
A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.
Time frame: Up to Day 14 after vaccination
Population: The analysis population included all randomized participants who received study vaccination and who had available post-treatment safety data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants With Any Serious Adverse Event | 0.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants With Any Serious Adverse Event | 0.0 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants With Any Serious Adverse Event | 0.0 Percentage of Participants |
95% CI: [-12.2, 10.6]
95% CI: [-12.3, 12.3]
Primary
Toddler: Percentage of Participants With Any Vaccine-related Adverse Event
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. Relatedness of the AE to study vaccine was determined by the investigator.
Time frame: Up to Day 14 after vaccination
Population: The analysis population included all randomized toddler participants who received study vaccination and who had available post-treatment safety data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants With Any Vaccine-related Adverse Event | 84.8 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants With Any Vaccine-related Adverse Event | 78.6 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants With Any Vaccine-related Adverse Event | 75.0 Percentage of Participants |
95% CI: [-10.6, 30.9]
95% CI: [-19.1, 26]
Secondary
Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Time frame: Day 30 after vaccination
Population: The analysis population included all adult participants who did not have a protocol violation that could have impacted the validity of the antibody responses.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 6A (non-Prevnar serotype) | 12.4 µg/mL |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 14 | 25.8 µg/mL |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 3 (non-Prevnar serotype) | 2.9 µg/mL |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 18C | 14.7 µg/mL |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 6B | 20.1 µg/mL |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 19A (non-Prevnar serotype) | 19.1 µg/mL |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 5 (non-Prevnar serotype) | 15.1 µg/mL |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 19F | 12.1 µg/mL |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 7F (non-Prevnar serotype) | 6.8 µg/mL |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 22F (non-Prevnar serotype) | 5.9 µg/mL |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 4 | 4.2 µg/mL |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 23F | 11.2 µg/mL |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 9V | 7.9 µg/mL |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 33F (non-Prevnar serotype) | 8.2 µg/mL |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 1 (non-Prevnar serotype) | 7.9 µg/mL |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 33F (non-Prevnar serotype) | 1.1 µg/mL |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 1 (non-Prevnar serotype) | 0.7 µg/mL |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 3 (non-Prevnar serotype) | 1.1 µg/mL |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 4 | 3.4 µg/mL |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 5 (non-Prevnar serotype) | 1.8 µg/mL |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 6A (non-Prevnar serotype) | 4.0 µg/mL |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 6B | 5.9 µg/mL |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 7F (non-Prevnar serotype) | 0.7 µg/mL |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 9V | 7.4 µg/mL |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 14 | 12.5 µg/mL |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 18C | 8.6 µg/mL |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 19A (non-Prevnar serotype) | 5.8 µg/mL |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 19F | 7.5 µg/mL |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 22F (non-Prevnar serotype) | 0.7 µg/mL |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 23F | 14.2 µg/mL |
Secondary
Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA)
OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay
Time frame: Day 30 after vaccination
Population: The analysis population included all adult participants who did not have a protocol violation that could have impacted the validity of the antibody responses.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 9V | 29321.9 Titer |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6C (non-Prevnar serotype) | 10940.7 Titer |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 4 | 9684.2 Titer |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 1 (non-Prevnar serotype) | 471.9 Titer |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 14 | 17469.5 Titer |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 5 (non-Prevnar serotype) | 2405.5 Titer |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 18C | 12180.6 Titer |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 19F | 4597.9 Titer |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 19A (non-Prevnar serotype) | 8458.3 Titer |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6A (non-Prevnar serotype) | 21117.8 Titer |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 22F (non-Prevnar serotype) | 11404.1 Titer |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 3 (non-Prevnar serotype) | 357.9 Titer |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 23F | 8616.0 Titer |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6B | 21795.1 Titer |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 33F (non-Prevnar serotype) | 169577.5 Titer |
| V114 Adjuvanted - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 7F (non-Prevnar serotype) | 11685.4 Titer |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 33F (non-Prevnar serotype) | 8430.4 Titer |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 7F (non-Prevnar serotype) | 261.4 Titer |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 19F | 2665.8 Titer |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 1 (non-Prevnar serotype) | 3.7 Titer |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 3 (non-Prevnar serotype) | 26.1 Titer |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 4 | 8928.4 Titer |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 5 (non-Prevnar serotype) | 8.1 Titer |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6A (non-Prevnar serotype) | 3475.2 Titer |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6B | 9073.3 Titer |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6C (non-Prevnar serotype) | 462.6 Titer |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 9V | 18343.5 Titer |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 14 | 13145.2 Titer |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 18C | 6287.9 Titer |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 19A (non-Prevnar serotype) | 2778.0 Titer |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 22F (non-Prevnar serotype) | 41.2 Titer |
| Prevnar™ - Adult Cohort | Adult: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 23F | 8664.4 Titer |
Secondary
Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8
OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay.
Time frame: Day 30 after vaccination
Population: The analysis population included all adult participants who did not have a protocol violation that could have impacted the validity of the antibody responses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 1 (non-Prevnar serotype) | 92.3 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 3 (non-Prevnar serotype) | 96.2 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 4 | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 5 (non-Prevnar serotype) | 92.3 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 6A (non-Prevnar serotype) | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 6B | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 6C (non-Prevnar serotype) | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 7F (non-Prevnar serotype) | 96.2 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 9V | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 14 | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 18C | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 19A (non-Prevnar serotype) | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 19F | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 22F (non-Prevnar serotype) | 92.3 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 23F | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 33F (non-Prevnar serotype) | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 33F (non-Prevnar serotype) | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 1 (non-Prevnar serotype) | 16.7 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 9V | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 3 (non-Prevnar serotype) | 69.6 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 19F | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 4 | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 14 | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 5 (non-Prevnar serotype) | 29.2 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 23F | 95.8 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 6A (non-Prevnar serotype) | 91.7 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 18C | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 6B | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 22F (non-Prevnar serotype) | 45.8 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 6C (non-Prevnar serotype) | 79.2 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 19A (non-Prevnar serotype) | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 7F (non-Prevnar serotype) | 68.2 Percentage of Participants |
Secondary
Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL
Immunoglobulin G (IgG) for the serotypes contained in V114 was determined using an electrochemiluminescence assay.
Time frame: Day 30 after vaccination
Population: The analysis population included all adult participants who did not have a protocol violation that could have impacted the validity of the antibody responses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 6A (non-Prevnar serotype) | 96.2 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 14 | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 3 (non-Prevnar serotype) | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 18C | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 6B | 96.2 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 19A (non-Prevnar serotype) | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 5 (non-Prevnar serotype) | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 19F | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 7F(non-Prevnar serotype) | 96.2 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 22F (non-Prevnar serotype) | 96.2 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 4 | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 23F | 96.2 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 9V | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 33F (non-Prevnar serotype) | 96.2 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 1 (non-Prevnar serotype) | 96.2 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 33F (non-Prevnar serotype) | 62.5 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 1 (non-Prevnar serotype) | 41.7 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 3 (non-Prevnar serotype) | 83.3 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 4 | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 5 (non-Prevnar serotype) | 95.8 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 6A (non-Prevnar serotype) | 87.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 6B | 87.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 7F(non-Prevnar serotype) | 50.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 9V | 95.7 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 14 | 95.7 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 18C | 95.7 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 19A (non-Prevnar serotype) | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 19F | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 22F (non-Prevnar serotype) | 45.8 Percentage of Participants |
| Prevnar™ - Adult Cohort | Adult: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 23F | 100.0 Percentage of Participants |
Secondary
Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Time frame: Day 30 after vaccination
Population: The analysis population included all toddler participants who did not have a protocol violation that could have impacted the validity of the antibody responses.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 6A (non-Prevnar serotype) | 3.5 µg/mL |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 22F (non-Prevnar serotype) | 12.5 µg/mL |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 14 | 9.4 µg/mL |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 6B | 7.1 µg/mL |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 3 (non-Prevnar serotype) | 2.2 µg/mL |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 9V | 3.3 µg/mL |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 7F (non-Prevnar serotype) | 2.0 µg/mL |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 23F | 4.3 µg/mL |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 19F | 1.9 µg/mL |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 4 | 1.5 µg/mL |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 1 (non-Prevnar serotype) | 3.0 µg/mL |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 19A (non-Prevnar serotype) | 1.6 µg/mL |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 5 (non-Prevnar serotype) | 1.8 µg/mL |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 33F (non-Prevnar serotype) | 0.9 µg/mL |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 18C | 2.1 µg/mL |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 19A (non-Prevnar serotype) | 2.3 µg/mL |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 1 (non-Prevnar serotype) | 4.3 µg/mL |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 3 (non-Prevnar serotype) | 2.5 µg/mL |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 4 | 2.5 µg/mL |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 5 (non-Prevnar serotype) | 2.5 µg/mL |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 6A (non-Prevnar serotype) | 2.8 µg/mL |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 6B | 8.2 µg/mL |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 7F (non-Prevnar serotype) | 3.2 µg/mL |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 9V | 4.7 µg/mL |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 14 | 10.0 µg/mL |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 18C | 2.7 µg/mL |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 22F (non-Prevnar serotype) | 8.8 µg/mL |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 19F | 2.7 µg/mL |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 23F | 4.3 µg/mL |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 33F (non-Prevnar serotype) | 1.1 µg/mL |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 5 (non-Prevnar serotype) | 0.7 µg/mL |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 33F (non-Prevnar serotype) | 0.1 µg/mL |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 18C | 3.9 µg/mL |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 4 | 2.8 µg/mL |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 23F | 7.1 µg/mL |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 19A (non-Prevnar serotype) | 1.7 µg/mL |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 3 (non-Prevnar serotype) | 0.4 µg/mL |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 22F (non-Prevnar serotype) | 0.2 µg/mL |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 7F (non-Prevnar serotype) | 0.1 µg/mL |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 6B | 7.0 µg/mL |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 19F | 4.2 µg/mL |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 9V | 5.9 µg/mL |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 6A (non-Prevnar serotype) | 2.2 µg/mL |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 1 (non-Prevnar serotype) | 0.1 µg/mL |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Concentration (GMC) of Pneumococcal Serotype Immunoglobulin G (IgG) Antibodies | Serotype 14 | 10.8 µg/mL |
Secondary
Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA)
OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay
Time frame: Day 30 after vaccination
Population: The analysis population included all toddler participants who did not have a protocol violation that could have impacted the validity of the antibody responses.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 1 (non-Prevnar serotype) | 94.0 Titer |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 3 (non-Prevnar serotype) | 438.8 Titer |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 4 | 2933.4 Titer |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 5 (non-Prevnar serotype) | 477.6 Titer |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 14 | 5868.1 Titer |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 18C | 2119.0 Titer |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 19A (non-Prevnar serotype) | 1275.2 Titer |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 22F (non-Prevnar serotype) | 6736.5 Titer |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 23F | 7058.5 Titer |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 33F (non-Prevnar serotype) | 48824.6 Titer |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6A (non-Prevnar serotype) | 2894.0 Titer |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6B | 6884.6 Titer |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6C (non-Prevnar serotype) | 534.8 Titer |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 7F (non-Prevnar serotype) | 12555.7 Titer |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 9V | 5154.5 Titer |
| V114 Adjuvanted - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 19F | 1136.4 Titer |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 14 | 4408.6 Titer |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6C (non-Prevnar serotype) | 459.5 Titer |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 18C | 3435.2 Titer |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 19A (non-Prevnar serotype) | 1223.8 Titer |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 22F (non-Prevnar serotype) | 9382.9 Titer |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 7F (non-Prevnar serotype) | 22607.1 Titer |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 23F | 6150.7 Titer |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 33F (non-Prevnar serotype) | 50461.3 Titer |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 4 | 4360.9 Titer |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 1 (non-Prevnar serotype) | 164.3 Titer |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 3 (non-Prevnar serotype) | 566.2 Titer |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 19F | 1117.8 Titer |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 9V | 5933.3 Titer |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 5 (non-Prevnar serotype) | 1060.2 Titer |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6A (non-Prevnar serotype) | 3880.4 Titer |
| Prevnar™ - Adult Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6B | 6673.5 Titer |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 19A (non-Prevnar serotype) | 378.7 Titer |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 14 | 7954.7 Titer |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6B | 8309.3 Titer |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 1 (non-Prevnar serotype) | 2.0 Titer |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 18C | 3862.0 Titer |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6C (non-Prevnar serotype) | 171.7 Titer |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 5 (non-Prevnar serotype) | 2.0 Titer |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 19F | 2493.4 Titer |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 23F | 18352.1 Titer |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 9V | 7435.1 Titer |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 22F (non-Prevnar serotype) | 4.1 Titer |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 3 (non-Prevnar serotype) | 33.8 Titer |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 6A (non-Prevnar serotype) | 2435.8 Titer |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 7F (non-Prevnar serotype) | 56.0 Titer |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 4 | 5163.6 Titer |
| Prevnar™ - Toddler Cohort | Toddler: Geometric Mean Titer (GMT) of Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) | Serotype 33F (non-Prevnar serotype) | 2697.9 Titer |
Secondary
Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8
OPA for the serotypes contained in V114 was determined using a Multiplex Opsonophagocytic Assay.
Time frame: Day 30 after vaccination
Population: The analysis population included all toddler participants who did not have a protocol violation that could have impacted the validity of the antibody responses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 6B | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 19A (non-Prevnar serotype) | 96.6 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 3 (non-Prevnar serotype) | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 1 (non-Prevnar serotype) | 96.6 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 19F | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 9V | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 23F | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 22F (non-Prevnar serotype) | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 5 (non-Prevnar serotype) | 96.6 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 33F (non-Prevnar serotype) | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 7F (non-Prevnar serotype) | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 6A (non-Prevnar serotype) | 96.6 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 14 | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 6C (non-Prevnar serotype) | 79.3 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 18C | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 4 | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 6C (non-Prevnar serotype) | 77.8 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 3 (non-Prevnar serotype) | 100 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 4 | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 5 (non-Prevnar serotype) | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 14 | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 18C | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 19A (non-Prevnar serotype) | 89.5 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 19F | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 22F (non-Prevnar serotype) | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 23F | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 6A (non-Prevnar serotype) | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 6B | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 1 (non-Prevnar serotype) | 94.7 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 7F (non-Prevnar serotype) | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 9V | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 33F (non-Prevnar serotype) | 100.0 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 3 (non-Prevnar serotype) | 81.0 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 6B | 100.0 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 14 | 100.0 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 23F | 100.0 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 6C (non-Prevnar serotype) | 61.9 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 5 (non-Prevnar serotype) | 0.0 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 1 (non-Prevnar serotype) | 0.0 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 7F (non-Prevnar serotype) | 50.0 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 4 | 100.0 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 22F (non-Prevnar serotype) | 9.1 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 19F | 100.0 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 33F (non-Prevnar serotype) | 95.5 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 19A (non-Prevnar serotype) | 90.9 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 9V | 100.0 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 6A (non-Prevnar serotype) | 95.5 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving Opsonophagocytic Activity (OPA) ≥1:8 | Serotype 18C | 100.0 Percentage of Participants |
Secondary
Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL
Immunoglobulin G (IgG) for the serotypes contained in V114 was determined using an electrochemiluminescence assay.
Time frame: Day 30 after vaccination
Population: The analysis population included all toddler participants who did not have a protocol violation that could have impacted the validity of the antibody responses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 6B | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 23F | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 19A (non-Prevnar serotype) | 83.3 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 7F(non-Prevnar serotype) | 90.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 33F (non-Prevnar serotype) | 63.3 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 18C | 86.7 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 9V | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 22F non-Prevnar serotype) | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 14 | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 5 (non-Prevnar serotype) | 90.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 3 (non-Prevnar serotype) | 93.3 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 4 | 93.3 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 6A (non-Prevnar serotype) | 96.7 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 1 (non-Prevnar serotype) | 100.0 Percentage of Participants |
| V114 Adjuvanted - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 19F | 96.7 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 19F | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 1 (non-Prevnar serotype) | 95.7 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 3 (non-Prevnar serotype) | 95.7 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 4 | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 5 (non-Prevnar serotype) | 95.7 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 6A (non-Prevnar serotype) | 87.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 6B | 95.7 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 7F(non-Prevnar serotype) | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 9V | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 14 | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 18C | 95.7 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 19A (non-Prevnar serotype) | 95.7 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 22F non-Prevnar serotype) | 100.0 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 23F | 95.7 Percentage of Participants |
| Prevnar™ - Adult Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 33F (non-Prevnar serotype) | 69.6 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 6B | 95.5 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 23F | 100.0 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 19A (non-Prevnar serotype) | 72.7 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 6A (non-Prevnar serotype) | 86.4 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 5 (non-Prevnar serotype) | 68.2 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 19F | 100.0 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 4 | 100.0 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 1 (non-Prevnar serotype) | 0.0 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 22F non-Prevnar serotype) | 3.8 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 9V | 100.0 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 3 (non-Prevnar serotype) | 18.2 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 14 | 100.0 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 7F(non-Prevnar serotype) | 9.1 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 33F (non-Prevnar serotype) | 0.0 Percentage of Participants |
| Prevnar™ - Toddler Cohort | Toddler: Percentage of Participants Achieving the Immunoglobulin G (IgG) Serotype-specific Threshold Value of ≥ 0.35μg/mL | Serotype 18C | 100.0 Percentage of Participants |