Pneumococcal Infections
Conditions
Brief summary
This study is designed to evaluate the safety and tolerability of V114 and Prevnar 13™ in healthy infants. This study will include both full-term infants (≥37 weeks gestational age) and premature infants (\<37 weeks gestational age). Premature infants will be included in a Premature Infant Immunogenicity Substudy, which will assess immunogenicity and safety following administration of V114 or Prevnar 13™.
Interventions
BIOLOGICALV114
V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
BIOLOGICALPrevnar 13™
Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each) and 6B (4.4 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
42 Days to 90 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy (based on a review of medical history and physical examination) based on the clinical judgment of the investigator * Male or female approximately 2 months of age, from 42 days to 90 days inclusive, at the time of obtaining the informed consent * Have 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 * Known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV) or any diphtheria toxoid containing vaccine * Known or suspected impairment of immunological function * History of congenital or acquired immunodeficiency * Has or his/her mother has a documented human immunodeficiency virus (HIV) infection * Known or history of functional or anatomic asplenia * Failure to thrive based on the clinical judgment of the investigator * Known coagulation disorder contraindicating intramuscular vaccination * 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) * Known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders * Received a dose of any pneumococcal vaccine prior to study entry * Received a blood transfusion or blood products, including immunoglobulins, before receipt of first dose of study vaccine * 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. * Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study * Has an immediate family member who is investigational site or Sponsor staff directly involved with this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Solicited Injection-site Adverse Event | Up to Day 14 after each study vaccination | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling. |
| Percentage of Participants With a Solicited Systemic Adverse Event | Up to Day 14 after each study vaccination | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included decreased appetite, irritability, somnolence (drowsiness), and urticaria (hives or welts). |
| Percentage of Participants With a Vaccine-related Serious Adverse Event | Up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1) | A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | 30 days after Vaccination 3 (approximately 5 months after Vaccination 1) | The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy. |
| Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | 30 days after Vaccination 3 (approximately 5 months after Vaccination 1) | The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. Immunoglobulin G for the 15 serotypes contained in V114 vaccine was determined using a pneumococcal electrochemiluminescence (PnECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy. |
| GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Before Vaccination 4 (10-13 months after Vaccination 1) | The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy. |
| GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | 30 days after Vaccination 4 (11-14 months after Vaccination 1) | The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy. |
Countries
Australia, Canada, Finland, Germany, Israel, Malaysia, Peru, Taiwan, Thailand, United States
Participant flow
Pre-assignment details
This study enrolled healthy infants. Other inclusion criteria applied.
Participants by arm
| Arm | Count |
|---|---|
| V114 Participants received a single 0.5 mL intramuscular (IM) injection of V114 at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4). | 1,972 |
| Prevnar 13™ Participants received a single 0.5 mL IM injection of Prevnar 13™ at approximately 2 months of age (Vaccination 1); approximately 4 months of age (Vaccination 2); approximately 6 months of age (Vaccination 3); and approximately 12-15 months of age (Vaccination 4). | 437 |
| Total | 2,409 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Lost to Follow-up | 24 | 9 |
| Overall Study | Physician Decision | 22 | 7 |
| Overall Study | Protocol Deviation | 1 | 0 |
| Overall Study | Withdrawal by Parent/Guardian | 77 | 20 |
Baseline characteristics
| Characteristic | Prevnar 13™ | Total | V114 |
|---|---|---|---|
| Age, Continuous | 8.8 weeks STANDARD_DEVIATION 1.5 | 8.7 weeks STANDARD_DEVIATION 1.5 | 8.7 weeks STANDARD_DEVIATION 1.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 74 Participants | 367 Participants | 293 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 362 Participants | 2040 Participants | 1678 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 20 Participants | 84 Participants | 64 Participants |
| Race (NIH/OMB) Asian | 152 Participants | 882 Participants | 730 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 73 Participants | 54 Participants |
| Race (NIH/OMB) More than one race | 31 Participants | 185 Participants | 154 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 214 Participants | 1180 Participants | 966 Participants |
| Sex: Female, Male Female | 227 Participants | 1175 Participants | 948 Participants |
| Sex: Female, Male Male | 210 Participants | 1234 Participants | 1024 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 1,972 | 1 / 437 |
| other Total, other adverse events | 1,807 / 1,965 | 395 / 433 |
| serious Total, serious adverse events | 192 / 1,965 | 45 / 433 |
Outcome results
Primary
Percentage of Participants With a Solicited Injection-site Adverse Event
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling.
Time frame: Up to Day 14 after each study vaccination
Population: All randomized participants who received at least 1 dose of study vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection-site erythema | 43.9 Percentage of participants |
| V114 | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection-site induration | 25.3 Percentage of participants |
| V114 | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection-site pain | 42.9 Percentage of participants |
| V114 | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection-site swelling | 27.9 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection-site swelling | 23.3 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection-site erythema | 36.0 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection-site pain | 36.5 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection-site induration | 25.6 Percentage of participants |
Comparison: Injection-site erythemap-value: =0.00395% CI: [2.8, 12.8]Miettinen & Nurminen method
Comparison: Injection-site indurationp-value: =0.88295% CI: [-5, 4]Miettinen & Nurminen method
Comparison: Injection-site painp-value: =0.01495% CI: [1.3, 11.3]Miettinen & Nurminen method
Comparison: Injection-site swellingp-value: =0.05195% CI: [0, 8.9]Miettinen & Nurminen method
Primary
Percentage of Participants With a Solicited Systemic Adverse Event
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs included decreased appetite, irritability, somnolence (drowsiness), and urticaria (hives or welts).
Time frame: Up to Day 14 after each study vaccination
Population: All randomized participants who received at least 1 dose of study vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants With a Solicited Systemic Adverse Event | Decreased appetite | 41.6 Percentage of participants |
| V114 | Percentage of Participants With a Solicited Systemic Adverse Event | Irritability | 74.9 Percentage of participants |
| V114 | Percentage of Participants With a Solicited Systemic Adverse Event | Somnolence | 55.4 Percentage of participants |
| V114 | Percentage of Participants With a Solicited Systemic Adverse Event | Urticaria | 5.9 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With a Solicited Systemic Adverse Event | Urticaria | 6.7 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With a Solicited Systemic Adverse Event | Decreased appetite | 36.0 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With a Solicited Systemic Adverse Event | Somnolence | 55.0 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With a Solicited Systemic Adverse Event | Irritability | 69.3 Percentage of participants |
Comparison: Decreased appetitep-value: =0.03395% CI: [0.4, 10.5]Miettinen & Nurminen method
Comparison: Irritabilityp-value: =0.01695% CI: [1, 10.5]Miettinen & Nurminen method
Comparison: Somnolencep-value: =0.87895% CI: [-4.7, 5.6]Miettinen & Nurminen method
Comparison: Urticariap-value: =0.50395% CI: [-3.8, 1.5]Miettinen & Nurminen method
Primary
Percentage of Participants With a Vaccine-related Serious Adverse Event
A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized.
Time frame: Up to 6 months after Vaccination 4 (up to 19 months after Vaccination 1)
Population: All randomized participants who received at least 1 dose of study vaccination
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| V114 | Percentage of Participants With a Vaccine-related Serious Adverse Event | 0.1 Percentage of participants |
| Prevnar 13™ | Percentage of Participants With a Vaccine-related Serious Adverse Event | 0 Percentage of participants |
Comparison: Percentage of participants with a vaccine-related SAE95% CI: [-0.8, 0.4]
Secondary
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only)
The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.
Time frame: 30 days after Vaccination 3 (approximately 5 months after Vaccination 1)
Population: All randomized participants in the Premature Infant Immunogenicity Substudy who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient data to perform the analysis for each serotype
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 6A | 1.37 μg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 14 | 4.38 μg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 3 | 0.86 μg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 18C | 1.46 μg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 6B | 1.69 μg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 19A | 1.63 μg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 5 | 1.48 μg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 19F | 2.03 μg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 7F | 1.95 μg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 23F | 1.17 μg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 4 | 1.41 μg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 22F | 4.33 μg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 9V | 1.47 μg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 33F | 1.58 μg/mL |
| V114 | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 1 | 1.15 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 33F | 0.05 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 1 | 1.61 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 3 | 0.58 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 4 | 1.27 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 5 | 1.66 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 6A | 3.19 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 6B | 2.53 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 7F | 2.92 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 9V | 1.50 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 14 | 6.52 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 18C | 1.54 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 19A | 3.00 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 19F | 2.78 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 23F | 1.18 μg/mL |
| Prevnar 13™ | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 22F | 0.05 μg/mL |
Secondary
GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only)
The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.
Time frame: 30 days after Vaccination 4 (11-14 months after Vaccination 1)
Population: All randomized participants in the Premature Infant Immunogenicity Substudy who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient data to perform the analysis for each serotype
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 6A | 4.18 μg/mL |
| V114 | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 14 | 5.40 μg/mL |
| V114 | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 3 | 1.04 μg/mL |
| V114 | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 18C | 3.21 μg/mL |
| V114 | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 6B | 6.62 μg/mL |
| V114 | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 19A | 4.96 μg/mL |
| V114 | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 5 | 3.30 μg/mL |
| V114 | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 19F | 4.48 μg/mL |
| V114 | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 7F | 4.01 μg/mL |
| V114 | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 23F | 2.38 μg/mL |
| V114 | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 4 | 1.55 μg/mL |
| V114 | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 22F | 9.83 μg/mL |
| V114 | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 9V | 3.10 μg/mL |
| V114 | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 33F | 5.46 μg/mL |
| V114 | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 1 | 1.56 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 33F | 0.10 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 1 | 1.96 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 3 | 0.79 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 4 | 1.61 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 5 | 3.60 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 6A | 6.38 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 6B | 6.75 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 7F | 5.10 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 9V | 3.09 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 14 | 7.15 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 18C | 2.77 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 19A | 6.47 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 19F | 4.83 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 23F | 3.04 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG at 30 Days After Vaccination 4 (Premature Infants Only) | Serotype 22F | 0.08 μg/mL |
Secondary
GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only)
The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.
Time frame: Before Vaccination 4 (10-13 months after Vaccination 1)
Population: All randomized participants in the Premature Infant Immunogenicity Substudy who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient data to perform the analysis for each serotype
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| V114 | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 6A | 0.32 μg/mL |
| V114 | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 14 | 1.14 μg/mL |
| V114 | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 3 | 0.22 μg/mL |
| V114 | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 18C | 0.35 μg/mL |
| V114 | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 6B | 0.59 μg/mL |
| V114 | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 19A | 0.38 μg/mL |
| V114 | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 5 | 0.77 μg/mL |
| V114 | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 19F | 0.41 μg/mL |
| V114 | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 7F | 0.57 μg/mL |
| V114 | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 23F | 0.33 μg/mL |
| V114 | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 4 | 0.24 μg/mL |
| V114 | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 22F | 1.24 μg/mL |
| V114 | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 9V | 0.40 μg/mL |
| V114 | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 33F | 1.09 μg/mL |
| V114 | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 1 | 0.30 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 33F | 0.05 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 1 | 0.47 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 3 | 0.13 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 4 | 0.31 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 5 | 0.89 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 6A | 0.72 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 6B | 0.61 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 7F | 0.95 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 9V | 0.46 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 14 | 2.22 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 18C | 0.36 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 19A | 0.81 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 19F | 0.69 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 23F | 0.37 μg/mL |
| Prevnar 13™ | GMC of Serotype-specific IgG Before Vaccination 4 (Premature Infants Only) | Serotype 22F | 0.05 μg/mL |
Secondary
Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only)
The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay. Immunoglobulin G for the 15 serotypes contained in V114 vaccine was determined using a pneumococcal electrochemiluminescence (PnECL) assay. This endpoint was part of a Premature Infant Immunogenicity Substudy.
Time frame: 30 days after Vaccination 3 (approximately 5 months after Vaccination 1)
Population: All randomized participants in the Premature Infant Immunogenicity Substudy who did not have protocol deviations that could have substantially affected the results of the immunogenicity analysis and who had sufficient data to perform the analysis for each serotype
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 6A | 97.4 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 14 | 100 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 3 | 89.5 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 18C | 97.4 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 6B | 92.1 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 19A | 94.7 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 5 | 97.4 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 19F | 97.4 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 7F | 97.4 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 23F | 89.5 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 4 | 94.7 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 22F | 97.4 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 9V | 97.4 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 33F | 86.8 Percentage of participants |
| V114 | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 1 | 97.4 Percentage of participants |
| Prevnar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 33F | 2.9 Percentage of participants |
| Prevnar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 1 | 97.1 Percentage of participants |
| Prevnar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 3 | 74.3 Percentage of participants |
| Prevnar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 4 | 97.1 Percentage of participants |
| Prevnar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 5 | 88.6 Percentage of participants |
| Prevnar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 6A | 97.1 Percentage of participants |
| Prevnar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 6B | 94.3 Percentage of participants |
| Prevnar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 7F | 100 Percentage of participants |
| Prevnar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 9V | 94.3 Percentage of participants |
| Prevnar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 14 | 97.1 Percentage of participants |
| Prevnar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 18C | 94.3 Percentage of participants |
| Prevnar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 19A | 97.1 Percentage of participants |
| Prevnar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 19F | 100 Percentage of participants |
| Prevnar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 23F | 94.3 Percentage of participants |
| Prevnar 13™ | Percentage of Participants Meeting Serotype-specific IgG Threshold of ≥0.35 μg/mL 30 Days After Vaccination 3 (Premature Infants Only) | Serotype 22F | 2.9 Percentage of participants |