Pneumococcal Infections
Conditions
Brief summary
This study is designed to assess the effect of different dose levels of pneumococcal polysaccharide and adjuvant on the safety and immunogenicity of V114 in healthy adults and infants.
Interventions
BIOLOGICALV114 Medium Dose
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose
BIOLOGICALV114 High Dose
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) in each 0.5 mL dose
BIOLOGICALV114 Medium Dose with Alternative Carrier Protein
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg), and Merck Aluminum Phosphate Adjuvant (125 mcg) with alternative carrier protein in each 0.5 mL dose
BIOLOGICALV114 High Dose with Alternative Carrier Protein
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) with alternative carrier protein in each 0.5 mL dose
BIOLOGICALPrevnar 13™
13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) 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
2 Months to 49 Years
Healthy volunteers
Yes
Inclusion criteria
Adult Cohort: 18 to 49 years and in good health * Highly unlikely to conceive from vaccination through 6 weeks after administration of the study vaccine. Infant Cohort: approximately 2 months (42 to 90 days) and in good health.
Exclusion criteria
Adult cohort: Prior administration of any pneumococcal vaccine * History of invasive pneumococcal disease * Known hypersensitivity to any vaccine component * Known or suspected impairment of immune function * Coagulation disorder contraindicating intramuscular vaccination * Received a blood transfusion or blood products within 6 months * Participated in another clinical study of an investigational product within 2 months * Breast feeding. Infant cohort: Prior administration of any pneumococcal vaccine * Known hypersensitivity to any vaccine component * Known or suspected impairment of immune function * History of congenital or acquired immunodeficiency * Has or mother has documented Human Immunodeficiency virus (HIV) infection * Has or mother has documented hepatitis B surface antigen positive result * Functional or anatomic asplenia * History of failure to thrive * Coagulation disorder contraindicating intramuscular vaccination * History of autoimmune disease or autoimmune disorder * Known neurologic or cognitive behavioral disorder * Received systemic corticosteroids within 14 days * Received other licensed non-live vaccine within 14 days * Received other licensed live virus vaccine within 30 days * Received a blood transfusion or blood products * Participated in another clinical study of an investigational product * History of invasive pneumococcal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | 1 month after Vaccination 3 (Month 5) | Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay. |
| Adults: Percentage of Participants With an Adverse Event | Up to 6 weeks 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. |
| Infants: Percentage of Participants With an Adverse Event | Up to 1 month after Vaccination 4 (Month 11-15) | 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. |
| Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event | Up to time of Vaccination 4 (Month 10-13) | 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. |
| Infants: Percentage of Participants With a Solicited Injection-site Adverse Event | Up to 14 days after any vaccination | Solicited injection-site AEs were injection-site erythema, injection-site induration, injection-site pain, and injection-site swelling. |
| Infants: Percentage of Participants With a Solicited Systemic Adverse Event | Up to 14 days after any vaccination | Solicited systemic AEs were irritability, decreased appetite, somnolence, and urticaria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | 1 month after vaccination | Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay. |
| Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Baseline and 1 month after vaccination | Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay. GMFR is defined as the geometric mean of the ratio of concentration at 1 month after vaccination divided by concentration at baseline. |
| Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | 1 month after Vaccination 3 (Month 5) | Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay. |
| Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Before Vaccination 4 (Month 10-13) | Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay. |
| Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | 1 month after Vaccination 4 (Month 11-15) | Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay. |
| Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Before Vaccination 4 (Month 10-13) | Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adults: V114 Medium Dose Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 on Day 1 | 20 |
| Adults: V114 High Dose Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 on Day 1 | 20 |
| Adults: V114 Medium Dose + ACP Adult participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) on Day 1 | 20 |
| Adults: V114 High Dose + ACP Adult participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP on Day 1 | 20 |
| Infants: V114 Medium Dose Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 at 2, 4, 6, and 12-15 months of age | 50 |
| Infants: V114 High Dose Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 at 2, 4, 6, and 12-15 months of age | 50 |
| Infants: V114 Medium Dose + ACP Infant participants received a single 0.5 mL intramuscular injection of medium-dose V114 with alternative carrier protein (ACP) at 2, 4, 6, and 12-15 months of age | 52 |
| Infants: V114 High Dose + ACP Infant participants received a single 0.5 mL intramuscular injection of high-dose V114 with ACP at 2, 4, 6, and 12-15 months of age | 52 |
| Infants: Prevnar 13™ Infant participants received a single 0.5 mL intramuscular injection of Prevnar 13™ at 2, 4, 6, and 12-15 months of age | 52 |
| Total | 336 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 0 | 0 | 0 | 3 | 2 | 4 | 8 | 5 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 |
| Overall Study | Withdrawal by Parent/Guardian | 0 | 0 | 0 | 0 | 0 | 3 | 4 | 1 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Infants: Prevnar 13™ | Infants: V114 High Dose + ACP | Infants: V114 Medium Dose + ACP | Infants: V114 High Dose | Infants: V114 Medium Dose | Adults: V114 High Dose + ACP | Adults: V114 Medium Dose + ACP | Adults: V114 High Dose | Adults: V114 Medium Dose |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized 10 weeks | 20 Participants | 2 Participants | 4 Participants | 4 Participants | 6 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 11 weeks | 16 Participants | 4 Participants | 0 Participants | 6 Participants | 3 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 12 weeks | 7 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 18 to 29 years | 20 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 7 Participants | 3 Participants | 4 Participants | 6 Participants |
| Age, Customized 30 to 39 years | 35 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 6 Participants | 10 Participants | 9 Participants | 10 Participants |
| Age, Customized 40 to 49 years | 25 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 7 Participants | 7 Participants | 7 Participants | 4 Participants |
| Age, Customized 6 weeks | 9 Participants | 1 Participants | 3 Participants | 0 Participants | 1 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 7 weeks | 15 Participants | 2 Participants | 4 Participants | 3 Participants | 2 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 8 weeks | 95 Participants | 26 Participants | 19 Participants | 16 Participants | 15 Participants | 19 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 9 weeks | 94 Participants | 16 Participants | 20 Participants | 22 Participants | 22 Participants | 14 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 45 Participants | 7 Participants | 8 Participants | 5 Participants | 6 Participants | 7 Participants | 3 Participants | 2 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 24 Participants | 5 Participants | 3 Participants | 5 Participants | 3 Participants | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 264 Participants | 40 Participants | 41 Participants | 41 Participants | 40 Participants | 38 Participants | 16 Participants | 18 Participants | 16 Participants | 14 Participants |
| Sex: Female, Male Female | 182 Participants | 25 Participants | 32 Participants | 29 Participants | 23 Participants | 23 Participants | 13 Participants | 11 Participants | 14 Participants | 12 Participants |
| Sex: Female, Male Male | 154 Participants | 27 Participants | 20 Participants | 23 Participants | 27 Participants | 27 Participants | 7 Participants | 9 Participants | 6 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 50 | 0 / 50 | 0 / 51 | 0 / 52 | 0 / 52 |
| other Total, other adverse events | 18 / 20 | 19 / 20 | 19 / 20 | 18 / 20 | 47 / 50 | 46 / 50 | 49 / 51 | 51 / 52 | 51 / 52 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 | 5 / 50 | 4 / 50 | 1 / 51 | 3 / 52 | 4 / 52 |
Outcome results
Primary
Adults: Percentage of Participants With an 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 6 weeks after vaccination
Population: The analysis population included all randomized adult participants who received study vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adults: V114 Medium Dose | Adults: Percentage of Participants With an Adverse Event | 90.0 Percentage of participants |
| Adults: V114 High Dose | Adults: Percentage of Participants With an Adverse Event | 95.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Adults: Percentage of Participants With an Adverse Event | 95.0 Percentage of participants |
| Adults: V114 High Dose + ACP | Adults: Percentage of Participants With an Adverse Event | 95.0 Percentage of participants |
Primary
Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Time frame: 1 month after Vaccination 3 (Month 5)
Population: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 6B | 1.80 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 4 | 1.46 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 19A | 1.47 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 7F | 2.23 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 3 | 0.94 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 18C | 0.96 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 9V | 1.68 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 22F (non-Prevnar serotype) | 4.34 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 14 | 4.24 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 5 | 1.29 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 33F (non-Prevnar serotype) | 1.32 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 1 | 1.33 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 6A | 1.41 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 23F | 1.08 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 19F | 1.81 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 19F | 2.37 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 1 | 1.49 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 3 | 1.12 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 4 | 1.31 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 5 | 1.13 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 6A | 1.52 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 6B | 1.30 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 7F | 2.87 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 9V | 1.44 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 14 | 4.58 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 18C | 1.22 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 19A | 1.43 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 22F (non-Prevnar serotype) | 4.79 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 23F | 1.16 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 33F (non-Prevnar serotype) | 1.09 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 6B | 1.62 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 23F | 1.19 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 19A | 1.63 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 6A | 2.82 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 5 | 1.36 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 19F | 2.19 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 4 | 1.14 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 1 | 1.63 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 22F (non-Prevnar serotype) | 0.05 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 9V | 1.48 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 3 | 0.53 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 14 | 4.94 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 7F | 2.97 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 33F (non-Prevnar serotype) | 0.06 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 18C | 1.54 µg/mL |
Comparison: Serotype 195% CI: [0.61, 1.1]
Comparison: Serotype 395% CI: [1.33, 2.35]
Comparison: Serotype 495% CI: [0.91, 1.81]
Comparison: Serotype 595% CI: [0.59, 1.51]
Comparison: Serotype 6A95% CI: [0.29, 0.86]
Comparison: Serotype 6B95% CI: [0.58, 2.1]
Comparison: Serotype 7F95% CI: [0.55, 1.03]
Comparison: Serotype 9V95% CI: [0.74, 1.75]
Comparison: Serotype 1495% CI: [0.58, 1.27]
Comparison: Serotype 18C95% CI: [0.43, 0.92]
Comparison: Serotype 19A95% CI: [0.64, 1.26]
Comparison: Serotype 19F95% CI: [0.62, 1.11]
Comparison: Serotype 22F (non-Prevnar serotype)95% CI: [60.51, 109.68]
Comparison: Serotype 23F95% CI: [0.56, 1.47]
Comparison: Serotype 33F (non-Prevnar serotype)95% CI: [11.77, 41.97]
Comparison: Serotype 195% CI: [0.68, 1.23]
Comparison: Serotype 395% CI: [1.6, 2.8]
Comparison: Serotype 495% CI: [0.82, 1.62]
Comparison: Serotype 595% CI: [0.53, 1.31]
Comparison: Serotype 6A95% CI: [0.31, 0.92]
Comparison: Serotype 6B95% CI: [0.42, 1.5]
Comparison: Serotype 7F95% CI: [0.71, 1.31]
Comparison: Serotype 9V95% CI: [0.64, 1.49]
Comparison: Serotype 1495% CI: [0.63, 1.37]
Comparison: Serotype 18C95% CI: [0.55, 1.16]
Comparison: Serotype 19A95% CI: [0.63, 1.22]
Comparison: Serotype 19F95% CI: [0.81, 1.44]
Comparison: Serotype 22F (non-Prevnar serotype)95% CI: [67.02, 120.51]
Comparison: Serotype 23F95% CI: [0.61, 1.57]
Comparison: Serotype 33F (non-Prevnar serotype)95% CI: [9.82, 34.41]
Primary
Infants: Percentage of Participants With an 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.
Time frame: Up to 1 month after Vaccination 4 (Month 11-15)
Population: The analysis population included all randomized infant participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adults: V114 Medium Dose | Infants: Percentage of Participants With an Adverse Event | 96.0 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With an Adverse Event | 94.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With an Adverse Event | 96.1 Percentage of participants |
| Adults: V114 High Dose + ACP | Infants: Percentage of Participants With an Adverse Event | 98.1 Percentage of participants |
| Infants: Prevnar 13™ | Infants: Percentage of Participants With an Adverse Event | 100.0 Percentage of participants |
95% CI: [-13.5, 3.1]
95% CI: [-16.3, 1.2]
95% CI: [-13.3, 3.2]
95% CI: [-10.2, 5.1]
Primary
Infants: Percentage of Participants With a Solicited Injection-site Adverse Event
Solicited injection-site AEs were injection-site erythema, injection-site induration, injection-site pain, and injection-site swelling.
Time frame: Up to 14 days after any vaccination
Population: The analysis population included all randomized infant participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adults: V114 Medium Dose | Infants: Percentage of Participants With a Solicited Injection-site Adverse Event | 78.0 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With a Solicited Injection-site Adverse Event | 80.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With a Solicited Injection-site Adverse Event | 58.8 Percentage of participants |
| Adults: V114 High Dose + ACP | Infants: Percentage of Participants With a Solicited Injection-site Adverse Event | 80.8 Percentage of participants |
| Infants: Prevnar 13™ | Infants: Percentage of Participants With a Solicited Injection-site Adverse Event | 57.7 Percentage of participants |
p-value: 0.02995% CI: [2.1, 37.3]Miettinen and Nurminen method
p-value: 0.01695% CI: [4.3, 39.1]Miettinen and Nurminen method
p-value: 0.90895% CI: [-17.7, 19.9]Miettinen and Nurminen method
p-value: 0.01195% CI: [5.4, 39.6]Miettinen and Nurminen method
Primary
Infants: Percentage of Participants With a Solicited Systemic Adverse Event
Solicited systemic AEs were irritability, decreased appetite, somnolence, and urticaria.
Time frame: Up to 14 days after any vaccination
Population: The analysis population included all randomized infant participants who received at least one dose of study vaccination and had follow-up for the outcome measure. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adults: V114 Medium Dose | Infants: Percentage of Participants With a Solicited Systemic Adverse Event | 88.0 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With a Solicited Systemic Adverse Event | 86.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With a Solicited Systemic Adverse Event | 92.2 Percentage of participants |
| Adults: V114 High Dose + ACP | Infants: Percentage of Participants With a Solicited Systemic Adverse Event | 94.2 Percentage of participants |
| Infants: Prevnar 13™ | Infants: Percentage of Participants With a Solicited Systemic Adverse Event | 88.5 Percentage of participants |
p-value: 0.94395% CI: [-14, 12.9]Miettinen and Nurminen method
p-value: 0.71195% CI: [-16.4, 11.2]Miettinen and Nurminen method
p-value: 0.52995% CI: [-8.7, 16.4]Miettinen and Nurminen method
p-value: 0.29895% CI: [-5.8, 18.2]Miettinen and Nurminen method
Primary
Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an 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.
Time frame: Up to time of Vaccination 4 (Month 10-13)
Population: The analysis population included all randomized infant participants who received at least one dose of study vaccination. One cross-treated participant in the Infants: V114 Medium Dose + ACP group was excluded from the safety analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adults: V114 Medium Dose | Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event | 0.0 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event | 0.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event | 0.0 Percentage of participants |
| Adults: V114 High Dose + ACP | Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event | 0.0 Percentage of participants |
| Infants: Prevnar 13™ | Infants: Percentage of Participants With Study Vaccination Withdrawn Due to an Adverse Event | 0.0 Percentage of participants |
95% CI: [-6.9, 7.2]
95% CI: [-6.9, 7.2]
95% CI: [-6.9, 7.1]
95% CI: [-6.9, 6.9]
Secondary
Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Time frame: 1 month 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. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adults: V114 Medium Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 6A | 8.42 µg/mL |
| Adults: V114 Medium Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 14 | 14.97 µg/mL |
| Adults: V114 Medium Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 3 | 0.50 µg/mL |
| Adults: V114 Medium Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 18C | 9.48 µg/mL |
| Adults: V114 Medium Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 6B | 7.25 µg/mL |
| Adults: V114 Medium Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 19A | 15.19 µg/mL |
| Adults: V114 Medium Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 5 | 3.08 µg/mL |
| Adults: V114 Medium Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 19F | 8.67 µg/mL |
| Adults: V114 Medium Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 7F | 5.12 µg/mL |
| Adults: V114 Medium Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 22F | 2.93 µg/mL |
| Adults: V114 Medium Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 4 | 0.96 µg/mL |
| Adults: V114 Medium Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 23F | 11.55 µg/mL |
| Adults: V114 Medium Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 9V | 2.76 µg/mL |
| Adults: V114 Medium Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 33F | 4.06 µg/mL |
| Adults: V114 Medium Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 1 | 3.47 µg/mL |
| Adults: V114 High Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 33F | 6.16 µg/mL |
| Adults: V114 High Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 1 | 4.99 µg/mL |
| Adults: V114 High Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 3 | 0.71 µg/mL |
| Adults: V114 High Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 4 | 1.47 µg/mL |
| Adults: V114 High Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 5 | 2.20 µg/mL |
| Adults: V114 High Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 6A | 4.78 µg/mL |
| Adults: V114 High Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 6B | 3.71 µg/mL |
| Adults: V114 High Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 7F | 6.12 µg/mL |
| Adults: V114 High Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 9V | 2.27 µg/mL |
| Adults: V114 High Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 14 | 9.96 µg/mL |
| Adults: V114 High Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 18C | 8.91 µg/mL |
| Adults: V114 High Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 19A | 4.62 µg/mL |
| Adults: V114 High Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 19F | 7.96 µg/mL |
| Adults: V114 High Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 22F | 4.04 µg/mL |
| Adults: V114 High Dose | Adults: Geometric Mean Concentration (GMC) of Pneumococcal Serotype IgG Antibodies | Serotype 23F | 8.91 µg/mL |
Secondary
Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay. GMFR is defined as the geometric mean of the ratio of concentration at 1 month after vaccination divided by concentration at baseline.
Time frame: Baseline and 1 month 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. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adults: V114 Medium Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 6A | 47.27 Ratio |
| Adults: V114 Medium Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 14 | 14.99 Ratio |
| Adults: V114 Medium Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 3 | 3.12 Ratio |
| Adults: V114 Medium Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 18C | 29.41 Ratio |
| Adults: V114 Medium Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 6B | 35.70 Ratio |
| Adults: V114 Medium Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 19A | 8.04 Ratio |
| Adults: V114 Medium Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 5 | 6.59 Ratio |
| Adults: V114 Medium Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 19F | 20.63 Ratio |
| Adults: V114 Medium Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 7F | 12.84 Ratio |
| Adults: V114 Medium Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 22F | 12.87 Ratio |
| Adults: V114 Medium Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 4 | 7.24 Ratio |
| Adults: V114 Medium Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 23F | 45.59 Ratio |
| Adults: V114 Medium Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 9V | 12.28 Ratio |
| Adults: V114 Medium Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 33F | 9.69 Ratio |
| Adults: V114 Medium Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 1 | 14.94 Ratio |
| Adults: V114 High Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 33F | 13.25 Ratio |
| Adults: V114 High Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 1 | 14.41 Ratio |
| Adults: V114 High Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 3 | 4.73 Ratio |
| Adults: V114 High Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 4 | 12.66 Ratio |
| Adults: V114 High Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 5 | 5.79 Ratio |
| Adults: V114 High Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 6A | 23.26 Ratio |
| Adults: V114 High Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 6B | 18.23 Ratio |
| Adults: V114 High Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 7F | 17.51 Ratio |
| Adults: V114 High Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 9V | 14.61 Ratio |
| Adults: V114 High Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 14 | 11.96 Ratio |
| Adults: V114 High Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 18C | 38.44 Ratio |
| Adults: V114 High Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 19A | 8.80 Ratio |
| Adults: V114 High Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 19F | 13.52 Ratio |
| Adults: V114 High Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 22F | 20.85 Ratio |
| Adults: V114 High Dose | Adults: Geometric Mean Fold Rise (GMFR) From Baseline in GMC of Pneumococcal Serotype IgG Antibodies | Serotype 23F | 28.44 Ratio |
Secondary
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Time frame: Before Vaccination 4 (Month 10-13)
Population: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 4 | 0.21 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 14 | 0.83 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 19A | 0.27 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 5 | 0.42 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 9V | 0.34 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 18C | 0.16 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 6A | 0.35 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 22F (non-Prevnar serotype) | 0.97 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 7F | 0.56 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 1 | 0.27 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 33F (non-Prevnar serotype) | 0.91 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 6B | 0.52 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 3 | 0.14 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 23F | 0.23 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 19F | 0.28 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 19F | 0.35 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 6B | 0.50 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 9V | 0.42 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 14 | 0.92 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 1 | 0.30 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 3 | 0.21 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 4 | 0.26 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 5 | 0.40 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 6A | 0.33 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 7F | 0.79 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 18C | 0.20 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 19A | 0.32 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 22F (non-Prevnar serotype) | 1.14 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 23F | 0.26 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 33F (non-Prevnar serotype) | 0.96 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 4 | 0.23 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 23F | 0.26 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 19A | 0.39 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 3 | 0.09 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 1 | 0.40 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 19F | 0.48 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 7F | 0.89 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 6B | 0.43 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 22F (non-Prevnar serotype) | 0.06 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 6A | 0.63 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 9V | 0.35 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 14 | 1.53 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 5 | 0.59 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 33F (non-Prevnar serotype) | 0.05 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 18C | 0.28 µg/mL |
Secondary
Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Time frame: 1 month after Vaccination 4 (Month 11-15)
Population: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 6B | 6.46 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 23F | 2.76 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 19A | 4.85 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 7F | 2.94 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 4 | 1.35 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 18C | 1.68 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 9V | 2.53 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 33F (non-Prevnar serotype) | 5.22 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 14 | 5.87 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 22F (non-Prevnar serotype) | 6.57 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 3 | 1.02 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 5 | 2.33 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 6A | 5.59 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 1 | 1.74 µg/mL |
| Adults: V114 Medium Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 19F | 4.24 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 19F | 4.30 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 1 | 2.32 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 3 | 1.26 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 4 | 1.84 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 5 | 2.53 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 6A | 5.24 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 6B | 5.12 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 7F | 4.34 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 9V | 2.36 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 14 | 4.42 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 18C | 2.49 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 19A | 4.92 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 22F (non-Prevnar serotype) | 8.20 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 23F | 2.99 µg/mL |
| Adults: V114 High Dose | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 33F (non-Prevnar serotype) | 4.84 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 6B | 6.80 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 23F | 3.81 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 19A | 6.60 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 6A | 9.13 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 5 | 3.80 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 19F | 4.28 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 4 | 1.68 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 1 | 2.05 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 22F (non-Prevnar serotype) | 0.07 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 9V | 3.09 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 3 | 0.87 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 14 | 5.68 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 7F | 5.26 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 33F (non-Prevnar serotype) | 0.05 µg/mL |
| Adults: V114 Medium Dose + ACP | Infants: Geometric Mean Concentration of Pneumococcal Serotype IgG Antibodies | Serotype 18C | 2.62 µg/mL |
Secondary
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Time frame: 1 month after Vaccination 3 (Month 5)
Population: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 6B | 89.2 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 4 | 100.0 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 19A | 94.6 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 7F | 100.0 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 3 | 94.6 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 18C | 86.5 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 9V | 94.6 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 22F (non-Prevnar serotype) | 100.0 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 14 | 100.0 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 5 | 94.6 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 33F (non-Prevnar serotype) | 81.1 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 1 | 97.3 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 6A | 91.9 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 23F | 86.5 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 19F | 97.3 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 19F | 100.0 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 1 | 100.0 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 3 | 97.4 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 4 | 97.4 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 5 | 84.6 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 6A | 89.7 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 6B | 82.1 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 7F | 100.0 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 9V | 92.3 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 14 | 100.0 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 18C | 97.4 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 19A | 100.0 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 22F (non-Prevnar serotype) | 100.0 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 23F | 86.8 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 33F (non-Prevnar serotype) | 71.8 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 6B | 85.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 23F | 85.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 19A | 95.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 6A | 95.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 5 | 85.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 19F | 100.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 4 | 95.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 1 | 100.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 22F (non-Prevnar serotype) | 0.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 9V | 95.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 3 | 70.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 14 | 97.5 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 7F | 100.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 33F (non-Prevnar serotype) | 0.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 3 | Serotype 18C | 97.5 Percentage of participants |
Secondary
Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Time frame: 1 month after Vaccination 4 (Month 11-15)
Population: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 1 | 100.0 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 18C | 100.0 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 6B | 100.0 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 33F (non-Prevnar serotype) | 100.0 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 14 | 100.0 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 23F | 100.0 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 9V | 100.0 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 3 | 96.9 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 4 | 90.6 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 7F | 100.0 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 22F (non-Prevnar serotype) | 100.0 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 5 | 100.0 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 19F | 100.0 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 19A | 100.0 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 6A | 100.0 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 19F | 97.1 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 1 | 100.0 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 4 | 97.1 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 5 | 100.0 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 6A | 100.0 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 6B | 97.1 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 7F | 100.0 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 9V | 100.0 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 14 | 100.0 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 18C | 97.1 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 19A | 100.0 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 3 | 97.1 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 22F (non-Prevnar serotype) | 100.0 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 23F | 100.0 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 33F (non-Prevnar serotype) | 100.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 18C | 100.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 5 | 100.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 33F (non-Prevnar serotype) | 0.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 19A | 100.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 23F | 100.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 19F | 100.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 4 | 97.2 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 7F | 100.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 3 | 83.3 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 9V | 100.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 6B | 100.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 22F (non-Prevnar serotype) | 5.6 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 14 | 97.2 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 6A | 100.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL at 1 Month After Vaccination 4 | Serotype 1 | 100.0 Percentage of participants |
Secondary
Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4
Pneumococcal serotype-specific IgG was measured in serum using an electrochemiluminescence assay.
Time frame: Before Vaccination 4 (Month 10-13)
Population: The analysis population included all infant participants who did not have a protocol violation that could have impacted the validity of the antibody responses. This outcome measure was exploratory for the groups receiving ACP-containing vaccine; results for those groups are thus not included here.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 6B | 71.8 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 4 | 17.9 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 19A | 33.3 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 7F | 82.1 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 3 | 10.3 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 18C | 12.8 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 9V | 53.8 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 22F (non-Prevnar serotype) | 97.4 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 14 | 87.2 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 5 | 61.5 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 33F (non-Prevnar serotype) | 92.3 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 1 | 30.8 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 6A | 48.7 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 23F | 33.3 Percentage of participants |
| Adults: V114 Medium Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 19F | 35.9 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 19F | 46.2 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 1 | 43.6 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 3 | 15.4 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 4 | 33.3 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 5 | 56.4 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 6A | 56.4 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 6B | 71.8 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 7F | 92.3 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 9V | 64.1 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 14 | 87.2 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 18C | 23.1 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 19A | 28.2 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 22F (non-Prevnar serotype) | 97.4 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 23F | 43.6 Percentage of participants |
| Adults: V114 High Dose | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 33F (non-Prevnar serotype) | 87.2 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 6B | 62.5 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 23F | 32.5 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 19A | 55.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 6A | 82.5 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 5 | 72.5 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 19F | 62.5 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 4 | 27.5 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 1 | 57.5 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 22F (non-Prevnar serotype) | 2.5 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 9V | 45.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 3 | 7.5 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 14 | 87.5 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 7F | 97.5 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 33F (non-Prevnar serotype) | 0.0 Percentage of participants |
| Adults: V114 Medium Dose + ACP | Infants: Percentage of Participants With GMC ≥0.35 µg/mL Before Vaccination 4 | Serotype 18C | 35.0 Percentage of participants |