Pneumococcal Infections
Conditions
Brief summary
The goal of this study is to evaluate the safety, tolerability, and immunogenicity of the Pneumococcal Conjugate Vaccines (PCVs) V114 and Prevnar 13™ in healthy infants switched from Prevnar 13™ to V114 during the four-dose PCV immunization schedule.
Interventions
BIOLOGICALPrevnar 13™
Prevnar 13™ contains the 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 given via IM injection.
BIOLOGICALV114
V114 contains the pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose given via IM injection.
BIOLOGICALRotaTeq™
RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.
BIOLOGICALPentacel™
Pentacel™ Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine, given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
BIOLOGICALRECOMBIVAX HB™
RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
BIOLOGICALHIBERIX™
HIBERIX™ Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
BIOLOGICALM-M-R™ II
M-M-R™ II (Measles, Mumps, and Rubella Virus Vaccine Live), given as background treatment via subcutaneous (SC) injection in the opposite limb to V114 and Prevnar 13™ administration.
BIOLOGICALVARIVAX™
VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
42 Days to 90 Days
Healthy volunteers
Yes
Inclusion criteria
* Is Healthy, based on clinical judgment of the investigator * Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent.
Exclusion criteria
* Has a history of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease * Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid-containing vaccine * Has any contraindication to the concomitant study vaccines being administered in the study * Has a known or suspected impairment of immunological function * Has a history of congenital or acquired immunodeficiency * Has or his/her mother has a documented human immunodeficiency virus (HIV) infection * Has or his/her mother has a documented hepatitis B surface antigen - positive test * Has known or history of functional or anatomic asplenia * Has failure to thrive based on the clinical judgment of the investigator * Has a known coagulation disorder contraindicating intramuscular vaccination * Has a history of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or other autoimmune disorders) * Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders * Has received a dose of any pneumococcal vaccine prior to study entry * Has received \>1 dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry * Has received a dose of rotavirus vaccine prior to study entry * Has received a blood transfusion or blood products, including immunoglobulins * Has participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study * 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 (e.g., parent/legal guardian or sibling) who is investigational site or Sponsor staff directly involved with this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Up to ~14 days after each vaccination | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, the percentage of participants with solicited injection-site AEs was assessed for up to \ 14 days after each vaccination. The solicited injection-site AEs assessed were erythema/redness, induration/hard lump, tenderness/pain and swelling. |
| Percentage of Participants With a Solicited Systemic AE | Up to ~14 days after each vaccination | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, the percentage of participants with solicited systemic AEs was assessed for up to \ 14 days after each vaccination. The solicited systemic AEs assessed were appetite lost/decreased appetite, irritability, drowsiness/somnolence and hives or welts/urticaria. |
| Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) | Up to ~6 months after Vaccination 4 (up to ~19 months) | An SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgement. Relatedness of an SAE to the study vaccine was determined by the investigator. Per protocol, the percentage of participants with vaccine-related SAEs was assessed through 6 months following Vaccination 4. |
| Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | 30 Days after Vaccination 4 (Months 11-14) | The GMC of anti-PnP serotype-specific IgG for 13 shared serotypes contained in V114 and Prevnar 13™ (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) was assessed using a pneumococcal electrochemiluminescence (PnECL) assay. Per protocol, 13 IgG serotypes in Groups 2, 3, 4 (experimental arms) were compared to Group 1 (comparator arm) at 30 days post Vaccination 4 as a pre-specified primary outcome analysis; 13 IgG serotypes in Group 5 (experimental arm) were compared to Group 1 (comparator arm) at 30 days post Vaccination 4, as a separate protocol-specified secondary outcome analysis and reported later in the record. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Group 5 Versus Group 1 + Group 2: Percentage of Participants With Anti-Hepatitis B Surface Antigen (HBsAg) ≥10 mIU/mL at 30 Days Post Vaccination 3 | 30 Days after Vaccination 3 (Month 5) | The concentration of anti-HBsAg was assessed using an enhanced chemiluminescence assay. The protocol-specified analysis of the percentage of participants with anti-HBsAg ≥10 mIU/mL at 30 days post vaccination 3 was conducted in participants combined across vaccine dosing schedules (Group 1 + Group 2) as well as in participants separated across vaccine dosing schedules (Group 1, Group 2). Per protocol, participants with anti-HBsAg ≥10 mIU/mL in Group 5 were compared to Group 1 + Group 2 at 30 days post Vaccination 3, as a pre-specified secondary outcome analysis. Analysis of participants with anti-HBsAg ≥10 mIU/mL was not planned to be reported in Group 3 and Group 4, per protocol. |
| Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | 30 Days after Vaccination 4 (Months 11-14) | The GMC of anti-PnP serotype-specific IgG for 13 shared serotypes contained in V114 and Prevnar 13™ (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) was assessed using a PnECL assay. Per protocol, GMC of 13 IgG serotypes was analysed by vaccine dosing schedules (Groups 1, 5). Per protocol, 13 IgG serotypes in Group 5 (experimental arm) were compared to Group 1 (comparator arm) at 30 days post Vaccination 4 as a pre-specified secondary outcome analysis; 13 IgG serotypes in Groups 2, 3, 4 (experimental arms) were compared to Group 1 (comparator arm) at 30 days post Vaccination 4, as a separate protocol-specified primary outcome analysis and reported earlier in the record. |
| Group 5 Versus Group 1 + Group 2: Geometric Mean Titer (GMT) of Anti-Rotavirus Immunoglobulin A (IgA) at 30 Days Post Vaccination 3 | 30 Days after Vaccination 3 (Month 5) | The GMT of anti-rotavirus IgA was assessed using a serum IgA enzyme linked immunosorbent assay. The protocol specified analysis of anti-rotavirus IgA GMT at 30 days post vaccination 3 was conducted in participants combined across vaccine dosing schedules (Group 1 + Group 2) as well as in participants separated across vaccine dosing schedules (Group 1, Group 2). Per protocol, GMT of anti-rotavirus IgA in Group 5 was compared to Group 1 + Group 2 at 30 days post Vaccination 3, as a pre-specified secondary outcome analysis. Anti-rotavirus IgA GMT analysis was not planned to be reported in Group 3 and Group 4, per protocol. |
| GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | 30 Days after Vaccination 3 (Month 5) | The concentration of anti-PnP serotype-specific IgG for 15 serotypes contained in V114 (13 serotypes shared with Prevnar 13™ \[1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F\] and 2 unique serotypes \[22F, 33F\]) was assessed using a PnECL assay. Per protocol, GMC of 15 IgG serotypes was assessed at 30 days post Vaccination 3. |
| Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | 30 Days after Vaccination 3 (Month 5) | The concentration of anti-PnP serotype-specific IgG for 15 serotypes contained in V114 (13 serotypes shared with Prevnar 13™ \[1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F\] and 2 unique serotypes \[22F, 33F\]) was assessed using a PnECL assay. Per protocol, percentage of participants with anti-PnP IgG concentrations ≥0.35 µg/mL was assessed at 30 days post Vaccination 3. |
Countries
Puerto Rico, Thailand, Turkey (Türkiye), United States
Participant flow
Pre-assignment details
Participants were screened at Study Day 1, prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ Participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13. | 179 |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and a single 0.5 mL IM injection of V114 on Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13. | 181 |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1), Month 2 (Vaccination 2) and a single 0.5 mL IM injection of V114 on Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13. | 180 |
| Group 4: Prevnar 13™-V114-V114-V114 Participants received a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of V114 on Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13. | 180 |
| Group 5: V114-V114-V114-V114 Participants received a single 0.5 mL IM injection of V114 on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3) and Months 10-13 (Vaccination 4). Participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeq™, Pentacel™, RECOMBIVAX HB™ on Day 1, Month 2, and on Month 4; HIBERIX™, M-M-R™ II, VARIVAX™ on Months 10-13. | 180 |
| Total | 900 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Consent withdrawn by parent/guardian | 9 | 8 | 25 | 17 | 9 |
| Overall Study | Lost to Follow-up | 2 | 6 | 7 | 3 | 2 |
| Overall Study | Physician Decision | 4 | 0 | 1 | 0 | 2 |
Baseline characteristics
| Characteristic | Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Group 4: Prevnar 13™-V114-V114-V114 | Group 5: V114-V114-V114-V114 | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 63.0 days STANDARD_DEVIATION 7.8 | 63.6 days STANDARD_DEVIATION 8.4 | 62.7 days STANDARD_DEVIATION 9.1 | 63.4 days STANDARD_DEVIATION 9.3 | 64.0 days STANDARD_DEVIATION 9.3 | 63.3 days STANDARD_DEVIATION 8.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 33 Participants | 47 Participants | 47 Participants | 43 Participants | 43 Participants | 213 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 146 Participants | 134 Participants | 133 Participants | 136 Participants | 137 Participants | 686 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 36 Participants | 34 Participants | 37 Participants | 32 Participants | 38 Participants | 177 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 11 Participants | 3 Participants | 3 Participants | 9 Participants | 34 Participants |
| Race (NIH/OMB) More than one race | 19 Participants | 30 Participants | 26 Participants | 30 Participants | 28 Participants | 133 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 115 Participants | 106 Participants | 114 Participants | 114 Participants | 104 Participants | 553 Participants |
| Sex: Female, Male Female | 76 Participants | 91 Participants | 85 Participants | 86 Participants | 88 Participants | 426 Participants |
| Sex: Female, Male Male | 103 Participants | 90 Participants | 95 Participants | 94 Participants | 92 Participants | 474 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 179 | 0 / 181 | 0 / 180 | 0 / 180 | 0 / 180 |
| other Total, other adverse events | 164 / 179 | 161 / 181 | 160 / 178 | 163 / 179 | 160 / 179 |
| serious Total, serious adverse events | 21 / 179 | 24 / 181 | 15 / 178 | 18 / 179 | 21 / 179 |
Outcome results
Primary
Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
The GMC of anti-PnP serotype-specific IgG for 13 shared serotypes contained in V114 and Prevnar 13™ (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) was assessed using a pneumococcal electrochemiluminescence (PnECL) assay. Per protocol, 13 IgG serotypes in Groups 2, 3, 4 (experimental arms) were compared to Group 1 (comparator arm) at 30 days post Vaccination 4 as a pre-specified primary outcome analysis; 13 IgG serotypes in Group 5 (experimental arm) were compared to Group 1 (comparator arm) at 30 days post Vaccination 4, as a separate protocol-specified secondary outcome analysis and reported later in the record.
Time frame: 30 Days after Vaccination 4 (Months 11-14)
Population: All randomized participants who were compliant with the protocol, got scheduled dosing of V114 or Prevnar 13™ and had IgG GMC data for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F or 23F in Groups 1, 2, 3, 4 or 5 at 30 Days post Vaccination 4. 13 IgG serotypes in Groups 2, 3, 4 were compared to Group 1 as a protocol-specified primary outcome analysis; 13 IgG serotypes in Group 5 were compared to Group 1 as a separate protocol-specified secondary outcome analysis and reported later.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 18C | 2.57 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 6B | 6.15 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 23F | 2.89 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 14 | 7.62 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 7F | 5.10 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 3 | 0.72 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 9V | 2.93 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 1 | 2.02 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 19F | 4.78 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 4 | 1.51 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 19A | 5.92 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 5 | 3.66 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 6A | 6.42 µg/mL |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 23F | 2.72 µg/mL |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 14 | 10.59 µg/mL |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 1 | 1.69 µg/mL |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 4 | 1.33 µg/mL |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 6B | 7.58 µg/mL |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 9V | 2.76 µg/mL |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 19A | 5.52 µg/mL |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 7F | 5.69 µg/mL |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 18C | 3.88 µg/mL |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 6A | 7.16 µg/mL |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 3 | 0.77 µg/mL |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 5 | 3.39 µg/mL |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 19F | 4.88 µg/mL |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 18C | 3.70 µg/mL |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 6A | 7.16 µg/mL |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 9V | 2.57 µg/mL |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 19A | 5.20 µg/mL |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 1 | 1.89 µg/mL |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 3 | 0.68 µg/mL |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 4 | 1.27 µg/mL |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 5 | 3.82 µg/mL |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 6B | 6.64 µg/mL |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 7F | 5.06 µg/mL |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 14 | 10.91 µg/mL |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 19F | 5.02 µg/mL |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 23F | 2.29 µg/mL |
| Group 4: Prevnar 13™-V114-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 9V | 2.46 µg/mL |
| Group 4: Prevnar 13™-V114-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 6B | 6.62 µg/mL |
| Group 4: Prevnar 13™-V114-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 14 | 7.87 µg/mL |
| Group 4: Prevnar 13™-V114-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 6A | 5.17 µg/mL |
| Group 4: Prevnar 13™-V114-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 5 | 2.90 µg/mL |
| Group 4: Prevnar 13™-V114-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 18C | 2.76 µg/mL |
| Group 4: Prevnar 13™-V114-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 4 | 1.23 µg/mL |
| Group 4: Prevnar 13™-V114-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 19A | 4.95 µg/mL |
| Group 4: Prevnar 13™-V114-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 3 | 0.73 µg/mL |
| Group 4: Prevnar 13™-V114-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 23F | 2.22 µg/mL |
| Group 4: Prevnar 13™-V114-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 19F | 4.60 µg/mL |
| Group 4: Prevnar 13™-V114-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 1 | 1.68 µg/mL |
| Group 4: Prevnar 13™-V114-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 7F | 3.98 µg/mL |
| Group 5: V114-V114-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 7F | 3.43 µg/mL |
| Group 5: V114-V114-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 9V | 2.89 µg/mL |
| Group 5: V114-V114-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 19F | 4.10 µg/mL |
| Group 5: V114-V114-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 6A | 4.43 µg/mL |
| Group 5: V114-V114-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 23F | 2.11 µg/mL |
| Group 5: V114-V114-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 19A | 4.66 µg/mL |
| Group 5: V114-V114-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 14 | 6.57 µg/mL |
| Group 5: V114-V114-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 3 | 0.89 µg/mL |
| Group 5: V114-V114-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 5 | 2.90 µg/mL |
| Group 5: V114-V114-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 1 | 1.46 µg/mL |
| Group 5: V114-V114-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 6B | 5.83 µg/mL |
| Group 5: V114-V114-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 18C | 2.65 µg/mL |
| Group 5: V114-V114-V114-V114 | Geometric Mean Concentration (GMC) of Anti-Pneumococcal Polysaccharide (PnP) Immunoglobulin G (IgG) For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 4 | 1.35 µg/mL |
Comparison: GMC Ratio: Serotype 1 (Group 4 vs 1)95% CI: [0.69, 1]
Comparison: GMC Ratio: Serotype 1 (Group 3 vs 1)95% CI: [0.77, 1.12]
Comparison: GMC Ratio: Serotype 1 (Group 2 vs 1)95% CI: [0.7, 1]
Comparison: GMC Ratio: Serotype 3 (Group 4 vs 1)95% CI: [0.86, 1.19]
Comparison: GMC Ratio: Serotype 3 (Group 3 vs 1)95% CI: [0.8, 1.12]
Comparison: GMC Ratio: Serotype 3 (Group 2 vs 1)95% CI: [0.9, 1.25]
Comparison: GMC Ratio: Serotype 4 (Group 4 vs 1)95% CI: [0.66, 1]
Comparison: GMC Ratio: Serotype 4 (Group 3 vs 1)95% CI: [0.68, 1.03]
Comparison: GMC Ratio: Serotype 4 (Group 2 vs 1)95% CI: [0.72, 1.08]
Comparison: GMC Ratio: Serotype 5 (Group 4 vs 1)95% CI: [0.64, 0.98]
Comparison: GMC Ratio: Serotype 5 (Group 3 vs 1)95% CI: [0.84, 1.29]
Comparison: GMC Ratio: Serotype 5 (Group 2 vs 1)95% CI: [0.75, 1.14]
Comparison: GMC Ratio: Serotype 6A (Group 4 vs 1)95% CI: [0.66, 0.98]
Comparison: GMC Ratio: Serotype 6A (Group 3 vs 1)95% CI: [0.91, 1.37]
Comparison: GMC Ratio: Serotype 6A (Group 2 vs 1)95% CI: [0.92, 1.36]
Comparison: GMC Ratio: Serotype 6B (Group 4 vs 1)95% CI: [0.88, 1.31]
Comparison: GMC Ratio: Serotype 6B (Group 3 vs 1)95% CI: [0.88, 1.32]
Comparison: GMC Ratio: Serotype 6B (Group 2 vs 1)95% CI: [1.02, 1.49]
Comparison: GMC Ratio: Serotype 7F (Group 4 vs 1)95% CI: [0.64, 0.95]
Comparison: GMC Ratio: Serotype 7F (Group 3 vs 1)95% CI: [0.81, 1.21]
Comparison: GMC Ratio: Serotype 7F (Group 2 vs 1)95% CI: [0.92, 1.35]
Comparison: GMC Ratio: Serotype 9V (Group 4 vs 1)95% CI: [0.7, 1.01]
Comparison: GMC Ratio: Serotype 9V (Group 3 vs 1)95% CI: [0.73, 1.06]
Comparison: GMC Ratio: Serotype 9V (Group 2 vs 1)95% CI: [0.79, 1.13]
Comparison: GMC Ratio: Serotype 14 (Group 4 vs 1)95% CI: [0.83, 1.28]
Comparison: GMC Ratio: Serotype 14 (Group 3 vs 1)95% CI: [1.15, 1.78]
Comparison: GMC Ratio: Serotype 14 (Group 2 vs 1)95% CI: [1.13, 1.71]
Comparison: GMC Ratio: Serotype 18C (Group 4 vs 1)95% CI: [0.88, 1.3]
Comparison: GMC Ratio: Serotype 18C (Group 3 vs 1)95% CI: [1.18, 1.76]
Comparison: GMC Ratio: Serotype 18C (Group 2 vs 1)95% CI: [1.25, 1.83]
Comparison: GMC Ratio: Serotype 19A (Group 4 vs 1)95% CI: [0.69, 1.01]
Comparison: GMC Ratio: Serotype 19A (Group 3 vs 1)95% CI: [0.72, 1.07]
Comparison: GMC Ratio: Serotype 19A (Group 2 vs 1)95% CI: [0.77, 1.13]
Comparison: GMC Ratio: Serotype 19F (Group 4 vs 1)95% CI: [0.81, 1.15]
Comparison: GMC Ratio: Serotype 19F (Group 3 vs 1)95% CI: [0.88, 1.26]
Comparison: GMC Ratio: Serotype 19F (Group 2 vs 1)95% CI: [0.86, 1.21]
Comparison: GMC Ratio: Serotype 23F (Group 4 vs 1)95% CI: [0.61, 0.96]
Comparison: GMC Ratio: Serotype 23F (Group 3 vs 1)95% CI: [0.63, 0.99]
Comparison: GMC Ratio: Serotype 23F (Group 2 vs 1)95% CI: [0.76, 1.17]
Primary
Percentage of Participants With a Solicited Injection-site Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, the percentage of participants with solicited injection-site AEs was assessed for up to \ 14 days after each vaccination. The solicited injection-site AEs assessed were erythema/redness, induration/hard lump, tenderness/pain and swelling.
Time frame: Up to ~14 days after each vaccination
Population: All randomized participants who got ≥1 dose of V114 or Prevnar 13™.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Erythema/Redness | 47.5 Percentage of Participants |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Induration/Hard lump | 34.6 Percentage of Participants |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Swelling | 22.9 Percentage of Participants |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Tenderness/Pain | 44.1 Percentage of Participants |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Tenderness/Pain | 43.6 Percentage of Participants |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Swelling | 18.8 Percentage of Participants |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Induration/Hard lump | 26.0 Percentage of Participants |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Erythema/Redness | 37.6 Percentage of Participants |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Erythema/Redness | 38.8 Percentage of Participants |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Induration/Hard lump | 28.1 Percentage of Participants |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Swelling | 24.7 Percentage of Participants |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Tenderness/Pain | 46.1 Percentage of Participants |
| Group 4: Prevnar 13™-V114-V114-V114 | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Tenderness/Pain | 43.6 Percentage of Participants |
| Group 4: Prevnar 13™-V114-V114-V114 | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Induration/Hard lump | 25.1 Percentage of Participants |
| Group 4: Prevnar 13™-V114-V114-V114 | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Erythema/Redness | 43.0 Percentage of Participants |
| Group 4: Prevnar 13™-V114-V114-V114 | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Swelling | 20.7 Percentage of Participants |
| Group 5: V114-V114-V114-V114 | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Tenderness/Pain | 47.5 Percentage of Participants |
| Group 5: V114-V114-V114-V114 | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Swelling | 22.9 Percentage of Participants |
| Group 5: V114-V114-V114-V114 | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Erythema/Redness | 44.1 Percentage of Participants |
| Group 5: V114-V114-V114-V114 | Percentage of Participants With a Solicited Injection-site Adverse Event (AE) | Induration/Hard lump | 26.3 Percentage of Participants |
Comparison: Difference in Percentage: Erythema(Group 5 vs 1)p-value: =0.52595% CI: [-13.6, 7]Miettinen & Nurminen method
Comparison: Difference in Percentage: Erythema(Group 4 vs 1)p-value: =0.39695% CI: [-14.7, 5.8]Miettinen & Nurminen method
Comparison: Difference in Percentage: Erythema(Group 3 vs 1)p-value: =0.09795% CI: [-18.8, 1.6]Miettinen & Nurminen method
Comparison: Difference in Percentage: Erythema(Group 2 vs 1)p-value: =0.05795% CI: [-19.9, 0.3]Miettinen & Nurminen method
Comparison: Difference in Percentage: Induration(Group 5 vs 1)p-value: =0.08595% CI: [-17.8, 1.2]Miettinen & Nurminen method
Comparison: Difference in Percentage: Induration(Group 4 vs 1)p-value: =0.0595% CI: [-18.9, 0]Miettinen & Nurminen method
Comparison: Difference in Percentage: Induration(Group 3 vs 1)p-value: =0.18395% CI: [-16.1, 3.1]Miettinen & Nurminen method
Comparison: Difference in Percentage: Induration(Group 2 vs 1)p-value: =0.07495% CI: [-18.1, 0.8]Miettinen & Nurminen method
Comparison: Difference in Percentage: Tenderness(Group 5 vs 1)p-value: =0.52595% CI: [-7, 13.6]Miettinen & Nurminen method
Comparison: Difference in Percentage: Tenderness(Group 4 vs 1)p-value: =0.91595% CI: [-10.8, 9.7]Miettinen & Nurminen method
Comparison: Difference in Percentage: Tenderness(Group 3 vs 1)p-value: =0.71495% CI: [-8.4, 12.2]Miettinen & Nurminen method
Comparison: Difference in Percentage: Tenderness(Group 2 vs 1)p-value: =0.92695% CI: [-10.7, 9.7]Miettinen & Nurminen method
Comparison: Difference in Percentage: Swelling(Group 5 vs 1)p-value: >0.99995% CI: [-8.7, 8.7]Miettinen & Nurminen method
Comparison: Difference in Percentage: Swelling(Group 4 vs 1)p-value: =0.60995% CI: [-10.8, 6.4]Miettinen & Nurminen method
Comparison: Difference in Percentage: Swelling(Group 3 vs 1)p-value: =0.68895% CI: [-7.1, 10.7]Miettinen & Nurminen method
Comparison: Difference in Percentage: Swelling(Group 2 vs 1)p-value: =0.33695% CI: [-12.6, 4.3]Miettinen & Nurminen method
Primary
Percentage of Participants With a Solicited Systemic AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Per protocol, the percentage of participants with solicited systemic AEs was assessed for up to \ 14 days after each vaccination. The solicited systemic AEs assessed were appetite lost/decreased appetite, irritability, drowsiness/somnolence and hives or welts/urticaria.
Time frame: Up to ~14 days after each vaccination
Population: All randomized participants who got ≥1 dose of V114 or Prevnar 13™.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Percentage of Participants With a Solicited Systemic AE | Irritability | 67.6 Percentage of Participants |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Percentage of Participants With a Solicited Systemic AE | Appetite lost/Decreased Appetite | 35.8 Percentage of Participants |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Percentage of Participants With a Solicited Systemic AE | Hives/Urticaria | 7.3 Percentage of Participants |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Percentage of Participants With a Solicited Systemic AE | Drowsiness/Somnolence | 57.0 Percentage of Participants |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Percentage of Participants With a Solicited Systemic AE | Drowsiness/Somnolence | 55.8 Percentage of Participants |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Percentage of Participants With a Solicited Systemic AE | Irritability | 60.8 Percentage of Participants |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Percentage of Participants With a Solicited Systemic AE | Appetite lost/Decreased Appetite | 32.0 Percentage of Participants |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Percentage of Participants With a Solicited Systemic AE | Hives/Urticaria | 3.9 Percentage of Participants |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Percentage of Participants With a Solicited Systemic AE | Appetite lost/Decreased Appetite | 27.0 Percentage of Participants |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Percentage of Participants With a Solicited Systemic AE | Hives/Urticaria | 5.6 Percentage of Participants |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Percentage of Participants With a Solicited Systemic AE | Drowsiness/Somnolence | 56.7 Percentage of Participants |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Percentage of Participants With a Solicited Systemic AE | Irritability | 62.9 Percentage of Participants |
| Group 4: Prevnar 13™-V114-V114-V114 | Percentage of Participants With a Solicited Systemic AE | Appetite lost/Decreased Appetite | 35.2 Percentage of Participants |
| Group 4: Prevnar 13™-V114-V114-V114 | Percentage of Participants With a Solicited Systemic AE | Irritability | 68.2 Percentage of Participants |
| Group 4: Prevnar 13™-V114-V114-V114 | Percentage of Participants With a Solicited Systemic AE | Drowsiness/Somnolence | 57.0 Percentage of Participants |
| Group 4: Prevnar 13™-V114-V114-V114 | Percentage of Participants With a Solicited Systemic AE | Hives/Urticaria | 8.9 Percentage of Participants |
| Group 5: V114-V114-V114-V114 | Percentage of Participants With a Solicited Systemic AE | Appetite lost/Decreased Appetite | 34.6 Percentage of Participants |
| Group 5: V114-V114-V114-V114 | Percentage of Participants With a Solicited Systemic AE | Drowsiness/Somnolence | 60.3 Percentage of Participants |
| Group 5: V114-V114-V114-V114 | Percentage of Participants With a Solicited Systemic AE | Hives/Urticaria | 6.7 Percentage of Participants |
| Group 5: V114-V114-V114-V114 | Percentage of Participants With a Solicited Systemic AE | Irritability | 70.4 Percentage of Participants |
Comparison: Difference in Percentage:Appetite lost(Group5 vs1)p-value: =0.82595% CI: [-11, 8.8]Miettinen & Nurminen method
Comparison: Difference in Percentage:Appetite lost(Group4 vs1)p-value: =0.91295% CI: [-10.4, 9.3]Miettinen & Nurminen method
Comparison: Difference in Percentage:Appetite lost(Group3 vs1)p-value: =0.07495% CI: [-18.3, 0.9]Miettinen & Nurminen method
Comparison: Difference in Percentage:Appetite lost(Group2 vs1)p-value: =0.45895% CI: [-13.4, 6.1]Miettinen & Nurminen method
Comparison: Difference in Percentage:Irritability(Group 5 vs1)p-value: =0.56895% CI: [-6.8, 12.3]Miettinen & Nurminen method
Comparison: Difference in Percentage:Irritability(Group 4 vs1)p-value: =0.9195% CI: [-9.1, 10.2]Miettinen & Nurminen method
Comparison: Difference in Percentage:Irritability(Group 3 vs1)p-value: =0.35495% CI: [-14.5, 5.2]Miettinen & Nurminen method
Comparison: Difference in Percentage:Irritability(Group 2 vs1)p-value: =0.17895% CI: [-16.6, 3.1]Miettinen & Nurminen method
Comparison: Difference in Percentage: Drowsiness(Group 5 vs 1)p-value: =0.5295% CI: [-6.8, 13.5]Miettinen & Nurminen method
Comparison: Difference in Percentage: Drowsiness(Group 4 vs 1)p-value: >0.99995% CI: [-10.2, 10.2]Miettinen & Nurminen method
Comparison: Difference in Percentage: Drowsiness(Group 3 vs 1)p-value: =0.96395% CI: [-10.5, 10]Miettinen & Nurminen method
Comparison: Difference in Percentage: Drowsiness(Group 2 vs 1)p-value: =0.82195% CI: [-11.4, 9]Miettinen & Nurminen method
Comparison: Difference in Percentage: Hives(Group 5 vs 1)p-value: =0.83695% CI: [-6.1, 5]Miettinen & Nurminen method
Comparison: Difference in Percentage: Hives(Group 4 vs 1)p-value: =0.56295% CI: [-4.2, 7.6]Miettinen & Nurminen method
Comparison: Difference in Percentage: Hives(Group 3 vs 1)p-value: =0.52795% CI: [-7.1, 3.7]Miettinen & Nurminen method
Comparison: Difference in Percentage: Hives(Group 2 vs 1)p-value: =0.1695% CI: [-8.6, 1.5]Miettinen & Nurminen method
Primary
Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgement. Relatedness of an SAE to the study vaccine was determined by the investigator. Per protocol, the percentage of participants with vaccine-related SAEs was assessed through 6 months following Vaccination 4.
Time frame: Up to ~6 months after Vaccination 4 (up to ~19 months)
Population: All randomized participants who got ≥1 dose of V114 or Prevnar 13™.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) | 0 Percentage of Participants |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) | 0 Percentage of Participants |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) | 0.6 Percentage of Participants |
| Group 4: Prevnar 13™-V114-V114-V114 | Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) | 0 Percentage of Participants |
| Group 5: V114-V114-V114-V114 | Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) | 0 Percentage of Participants |
Comparison: Difference in Percentage (Group 5 vs 1)95% CI: [-2.1, 2.1]
Comparison: Difference in Percentage (Group 4 vs 1)95% CI: [-2.1, 2.1]
Comparison: Difference in Percentage (Group 3 vs 1)95% CI: [-1.6, 3.1]
Comparison: Difference in Percentage (Group 2 vs 1)95% CI: [-2.1, 2.1]
Secondary
GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
The concentration of anti-PnP serotype-specific IgG for 15 serotypes contained in V114 (13 serotypes shared with Prevnar 13™ \[1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F\] and 2 unique serotypes \[22F, 33F\]) was assessed using a PnECL assay. Per protocol, GMC of 15 IgG serotypes was assessed at 30 days post Vaccination 3.
Time frame: 30 Days after Vaccination 3 (Month 5)
Population: All randomized participants who were compliant with the protocol, got scheduled dosing of V114 or Prevnar 13™, had IgG GMC data available for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 22F or 33F in Groups 1, 2, 3, 4 or 5 at 30 Days post Vaccination 3.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 33F | 0.05 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 5 | 1.99 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 19A | 2.17 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 3 | 0.54 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 1 | 1.93 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 6B | 2.03 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 6A | 3.07 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 14 | 6.57 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 23F | 1.32 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 4 | 1.39 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 18C | 1.69 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 19F | 2.83 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 9V | 1.69 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 7F | 3.36 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 22F | 0.05 µg/mL |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 3 | 0.64 µg/mL |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 18C | 2.03 µg/mL |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 33F | 0.05 µg/mL |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 19A | 2.46 µg/mL |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 19F | 2.90 µg/mL |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 4 | 1.47 µg/mL |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 5 | 2.16 µg/mL |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 6A | 3.22 µg/mL |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 22F | 0.05 µg/mL |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 6B | 2.50 µg/mL |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 7F | 3.54 µg/mL |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 9V | 1.81 µg/mL |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 23F | 1.72 µg/mL |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 14 | 6.18 µg/mL |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 1 | 1.99 µg/mL |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 1 | 1.86 µg/mL |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 4 | 1.34 µg/mL |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 14 | 9.32 µg/mL |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 7F | 3.52 µg/mL |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 19A | 2.25 µg/mL |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 23F | 1.22 µg/mL |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 19F | 3.08 µg/mL |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 18C | 2.08 µg/mL |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 6A | 3.26 µg/mL |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 33F | 0.28 µg/mL |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 9V | 1.68 µg/mL |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 22F | 3.63 µg/mL |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 3 | 0.56 µg/mL |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 6B | 2.43 µg/mL |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 5 | 2.15 µg/mL |
| Group 4: Prevnar 13™-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 3 | 0.67 µg/mL |
| Group 4: Prevnar 13™-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 1 | 1.35 µg/mL |
| Group 4: Prevnar 13™-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 33F | 0.89 µg/mL |
| Group 4: Prevnar 13™-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 4 | 1.07 µg/mL |
| Group 4: Prevnar 13™-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 5 | 1.73 µg/mL |
| Group 4: Prevnar 13™-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 6A | 2.05 µg/mL |
| Group 4: Prevnar 13™-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 6B | 2.29 µg/mL |
| Group 4: Prevnar 13™-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 7F | 2.61 µg/mL |
| Group 4: Prevnar 13™-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 9V | 1.47 µg/mL |
| Group 4: Prevnar 13™-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 14 | 6.71 µg/mL |
| Group 4: Prevnar 13™-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 18C | 1.50 µg/mL |
| Group 4: Prevnar 13™-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 19A | 1.64 µg/mL |
| Group 4: Prevnar 13™-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 19F | 2.32 µg/mL |
| Group 4: Prevnar 13™-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 23F | 1.33 µg/mL |
| Group 4: Prevnar 13™-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 22F | 5.94 µg/mL |
| Group 5: V114-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 19F | 2.21 µg/mL |
| Group 5: V114-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 14 | 5.50 µg/mL |
| Group 5: V114-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 9V | 2.01 µg/mL |
| Group 5: V114-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 7F | 2.41 µg/mL |
| Group 5: V114-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 1 | 1.27 µg/mL |
| Group 5: V114-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 23F | 1.46 µg/mL |
| Group 5: V114-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 6B | 2.26 µg/mL |
| Group 5: V114-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 6A | 1.82 µg/mL |
| Group 5: V114-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 5 | 1.91 µg/mL |
| Group 5: V114-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 33F | 2.22 µg/mL |
| Group 5: V114-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 22F | 5.15 µg/mL |
| Group 5: V114-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 4 | 1.40 µg/mL |
| Group 5: V114-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 19A | 1.63 µg/mL |
| Group 5: V114-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 18C | 1.51 µg/mL |
| Group 5: V114-V114-V114-V114 | GMC of Anti-PnP IgG for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 3 | 1.01 µg/mL |
Secondary
Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4
The GMC of anti-PnP serotype-specific IgG for 13 shared serotypes contained in V114 and Prevnar 13™ (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) was assessed using a PnECL assay. Per protocol, GMC of 13 IgG serotypes was analysed by vaccine dosing schedules (Groups 1, 5). Per protocol, 13 IgG serotypes in Group 5 (experimental arm) were compared to Group 1 (comparator arm) at 30 days post Vaccination 4 as a pre-specified secondary outcome analysis; 13 IgG serotypes in Groups 2, 3, 4 (experimental arms) were compared to Group 1 (comparator arm) at 30 days post Vaccination 4, as a separate protocol-specified primary outcome analysis and reported earlier in the record.
Time frame: 30 Days after Vaccination 4 (Months 11-14)
Population: All randomized participants who were compliant with the protocol, got scheduled dosing of V114 or Prevnar 13™, had IgG GMC data available for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F or 23F in Groups 5 or 1 at 30 Days post Vaccination 4. 13 IgG serotypes in Group 5 were compared to Group 1 as a protocol-specified secondary outcome analysis; 13 IgG serotypes in Groups 2, 3, 4 were compared to Group 1 as a separate protocol-specified primary outcome analysis and reported earlier.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 4 | 1.51 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 9V | 2.93 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 6A | 6.42 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 14 | 7.62 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 3 | 0.72 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 18C | 2.57 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 6B | 6.15 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 19A | 5.92 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 5 | 3.66 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 19F | 4.78 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 7F | 5.10 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 23F | 2.89 µg/mL |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 1 | 2.02 µg/mL |
| Group 5: V114-V114-V114-V114 | Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 23F | 2.11 µg/mL |
| Group 5: V114-V114-V114-V114 | Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 1 | 1.46 µg/mL |
| Group 5: V114-V114-V114-V114 | Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 3 | 0.89 µg/mL |
| Group 5: V114-V114-V114-V114 | Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 4 | 1.35 µg/mL |
| Group 5: V114-V114-V114-V114 | Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 5 | 2.90 µg/mL |
| Group 5: V114-V114-V114-V114 | Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 6A | 4.43 µg/mL |
| Group 5: V114-V114-V114-V114 | Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 6B | 5.83 µg/mL |
| Group 5: V114-V114-V114-V114 | Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 7F | 3.43 µg/mL |
| Group 5: V114-V114-V114-V114 | Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 9V | 2.89 µg/mL |
| Group 5: V114-V114-V114-V114 | Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 14 | 6.57 µg/mL |
| Group 5: V114-V114-V114-V114 | Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 18C | 2.65 µg/mL |
| Group 5: V114-V114-V114-V114 | Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 19A | 4.66 µg/mL |
| Group 5: V114-V114-V114-V114 | Group 5 Versus Group 1: GMC of Anti-PnP IgG For 13 Shared Serotypes Contained in V114 and Prevnar 13™ at 30 Days Post Vaccination 4 | Serotype 19F | 4.10 µg/mL |
Comparison: GMC Ratio: Serotype 1 (Group 5 vs 1)95% CI: [0.6, 0.86]
Comparison: GMC Ratio: Serotype 3 (Group 5 vs 1)95% CI: [1.04, 1.44]
Comparison: GMC Ratio: Serotype 4 (Group 5 vs 1)95% CI: [0.73, 1.1]
Comparison: GMC Ratio: Serotype 5 (Group 5 vs 1)95% CI: [0.64, 0.97]
Comparison: GMC Ratio: Serotype 6A (Group 5 vs 1)95% CI: [0.57, 0.84]
Comparison: GMC Ratio: Serotype 6B (Group 5 vs 1)95% CI: [0.78, 1.15]
Comparison: GMC Ratio: Serotype 7F (Group 5 vs 1)95% CI: [0.55, 0.82]
Comparison: GMC Ratio: Serotype 9V (Group 5 vs 1)95% CI: [0.82, 1.18]
Comparison: GMC Ratio: Serotype 14 (Group 5 vs 1)95% CI: [0.7, 1.07]
Comparison: GMC Ratio: Serotype 18C (Group 5 vs 1)95% CI: [0.85, 1.25]
Comparison: GMC Ratio: Serotype 19A (Group 5 vs 1)95% CI: [0.65, 0.95]
Comparison: GMC Ratio: Serotype 19F (Group 5 vs 1)95% CI: [0.72, 1.02]
Comparison: GMC Ratio: Serotype 23F (Group 5 vs 1)95% CI: [0.59, 0.91]
Secondary
Group 5 Versus Group 1 + Group 2: Geometric Mean Titer (GMT) of Anti-Rotavirus Immunoglobulin A (IgA) at 30 Days Post Vaccination 3
The GMT of anti-rotavirus IgA was assessed using a serum IgA enzyme linked immunosorbent assay. The protocol specified analysis of anti-rotavirus IgA GMT at 30 days post vaccination 3 was conducted in participants combined across vaccine dosing schedules (Group 1 + Group 2) as well as in participants separated across vaccine dosing schedules (Group 1, Group 2). Per protocol, GMT of anti-rotavirus IgA in Group 5 was compared to Group 1 + Group 2 at 30 days post Vaccination 3, as a pre-specified secondary outcome analysis. Anti-rotavirus IgA GMT analysis was not planned to be reported in Group 3 and Group 4, per protocol.
Time frame: 30 Days after Vaccination 3 (Month 5)
Population: All randomized participants who were protocol compliant, got scheduled dosing of V114, Prevnar 13™ or background RotaTeq™, had anti-rotavirus data at 30 days post Vaccination 3. Per protocol anti-rotavirus analysis was done in participants combined across dosing schedules (Group 1 + 2) and separated across dosing schedules (Group 1, 2). Per protocol Group 5 was compared to Group 1 + 2 as a secondary outcome analysis. Per protocol anti-rotavirus analysis was not planned or reported in Group 3, 4
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Group 5 Versus Group 1 + Group 2: Geometric Mean Titer (GMT) of Anti-Rotavirus Immunoglobulin A (IgA) at 30 Days Post Vaccination 3 | 286.5 Titers |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Group 5 Versus Group 1 + Group 2: Geometric Mean Titer (GMT) of Anti-Rotavirus Immunoglobulin A (IgA) at 30 Days Post Vaccination 3 | 329.5 Titers |
| Group 5: V114-V114-V114-V114 | Group 5 Versus Group 1 + Group 2: Geometric Mean Titer (GMT) of Anti-Rotavirus Immunoglobulin A (IgA) at 30 Days Post Vaccination 3 | 298.3 Titers |
| Group 1: Prevnar 13™(Vaccinations 1-4) + Group 2: Prevnar 13™(Vaccinations 1-3)-V114 (Vaccination 4) | Group 5 Versus Group 1 + Group 2: Geometric Mean Titer (GMT) of Anti-Rotavirus Immunoglobulin A (IgA) at 30 Days Post Vaccination 3 | 307.0 Titers |
Comparison: GMT Ratio (Group 5 vs Group 1+2)p-value: <0.00195% CI: [0.7, 1.34]ANCOVA
Secondary
Group 5 Versus Group 1 + Group 2: Percentage of Participants With Anti-Hepatitis B Surface Antigen (HBsAg) ≥10 mIU/mL at 30 Days Post Vaccination 3
The concentration of anti-HBsAg was assessed using an enhanced chemiluminescence assay. The protocol-specified analysis of the percentage of participants with anti-HBsAg ≥10 mIU/mL at 30 days post vaccination 3 was conducted in participants combined across vaccine dosing schedules (Group 1 + Group 2) as well as in participants separated across vaccine dosing schedules (Group 1, Group 2). Per protocol, participants with anti-HBsAg ≥10 mIU/mL in Group 5 were compared to Group 1 + Group 2 at 30 days post Vaccination 3, as a pre-specified secondary outcome analysis. Analysis of participants with anti-HBsAg ≥10 mIU/mL was not planned to be reported in Group 3 and Group 4, per protocol.
Time frame: 30 Days after Vaccination 3 (Month 5)
Population: All randomized participants who were protocol compliant, got scheduled dosing of V114, Prevnar 13™ or background RECOMBIVAX HB™, had anti-HBsAg data at 30 days post Vaccination 3. Per protocol anti-HBsAg analysis was done in participants combined across dosing schedules (Group 1 + 2) and separated across dosing schedules (Group 1, 2). Per protocol Group 5 was compared to Group 1 + 2 as a secondary outcome analysis. Per protocol anti-HBsAg analysis was not planned to be reported in Groups 3, 4.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Group 5 Versus Group 1 + Group 2: Percentage of Participants With Anti-Hepatitis B Surface Antigen (HBsAg) ≥10 mIU/mL at 30 Days Post Vaccination 3 | 98.6 Percentage of Participants |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Group 5 Versus Group 1 + Group 2: Percentage of Participants With Anti-Hepatitis B Surface Antigen (HBsAg) ≥10 mIU/mL at 30 Days Post Vaccination 3 | 99.3 Percentage of Participants |
| Group 5: V114-V114-V114-V114 | Group 5 Versus Group 1 + Group 2: Percentage of Participants With Anti-Hepatitis B Surface Antigen (HBsAg) ≥10 mIU/mL at 30 Days Post Vaccination 3 | 98.7 Percentage of Participants |
| Group 1: Prevnar 13™(Vaccinations 1-4) + Group 2: Prevnar 13™(Vaccinations 1-3)-V114 (Vaccination 4) | Group 5 Versus Group 1 + Group 2: Percentage of Participants With Anti-Hepatitis B Surface Antigen (HBsAg) ≥10 mIU/mL at 30 Days Post Vaccination 3 | 98.9 Percentage of Participants |
Comparison: Difference in Percentage (Group 5 vs Group 1+2)p-value: <0.00195% CI: [-3.7, 2]Miettinen & Nurminen method
Secondary
Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3
The concentration of anti-PnP serotype-specific IgG for 15 serotypes contained in V114 (13 serotypes shared with Prevnar 13™ \[1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F\] and 2 unique serotypes \[22F, 33F\]) was assessed using a PnECL assay. Per protocol, percentage of participants with anti-PnP IgG concentrations ≥0.35 µg/mL was assessed at 30 days post Vaccination 3.
Time frame: 30 Days after Vaccination 3 (Month 5)
Population: All randomized participants who were compliant with the protocol, got scheduled dosing of V114 or Prevnar 13™, had IgG concentration ≥0.35µg/mL data available for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 22F or 33F in Groups 1, 2, 3, 4 or 5 at 30 Days post Vaccination 3.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 7F | 100 Percentage of Participants |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 1 | 97.9 Percentage of Participants |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 6B | 91.3 Percentage of Participants |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 5 | 97.9 Percentage of Participants |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 19F | 99.3 Percentage of Participants |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 22F | 2.9 Percentage of Participants |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 19A | 99.3 Percentage of Participants |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 14 | 98.6 Percentage of Participants |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 6A | 99.3 Percentage of Participants |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 3 | 73.2 Percentage of Participants |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 9V | 96.5 Percentage of Participants |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 23F | 91.4 Percentage of Participants |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 33F | 2.1 Percentage of Participants |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 4 | 97.9 Percentage of Participants |
| Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™ | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 18C | 95.8 Percentage of Participants |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 14 | 98.6 Percentage of Participants |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 19F | 99.3 Percentage of Participants |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 18C | 100 Percentage of Participants |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 3 | 73.9 Percentage of Participants |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 19A | 100 Percentage of Participants |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 4 | 98.6 Percentage of Participants |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 5 | 99.3 Percentage of Participants |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 1 | 100 Percentage of Participants |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 22F | 1.4 Percentage of Participants |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 6A | 99.3 Percentage of Participants |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 6B | 94.3 Percentage of Participants |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 7F | 100 Percentage of Participants |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 33F | 2.2 Percentage of Participants |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 23F | 97.9 Percentage of Participants |
| Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 9V | 96.5 Percentage of Participants |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 6B | 96.1 Percentage of Participants |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 33F | 39.4 Percentage of Participants |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 23F | 90.6 Percentage of Participants |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 4 | 93.0 Percentage of Participants |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 19A | 98.4 Percentage of Participants |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 7F | 100 Percentage of Participants |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 19F | 99.2 Percentage of Participants |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 18C | 99.2 Percentage of Participants |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 3 | 79.1 Percentage of Participants |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 14 | 96.9 Percentage of Participants |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 6A | 99.2 Percentage of Participants |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 1 | 99.2 Percentage of Participants |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 5 | 97.7 Percentage of Participants |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 22F | 93.8 Percentage of Participants |
| Group 3: Prevnar 13™-Prevnar 13™-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 9V | 96.1 Percentage of Participants |
| Group 4: Prevnar 13™-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 14 | 100 Percentage of Participants |
| Group 4: Prevnar 13™-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 1 | 97.8 Percentage of Participants |
| Group 4: Prevnar 13™-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 3 | 81.9 Percentage of Participants |
| Group 4: Prevnar 13™-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 4 | 94.2 Percentage of Participants |
| Group 4: Prevnar 13™-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 5 | 97.1 Percentage of Participants |
| Group 4: Prevnar 13™-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 6A | 97.1 Percentage of Participants |
| Group 4: Prevnar 13™-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 6B | 95.7 Percentage of Participants |
| Group 4: Prevnar 13™-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 7F | 100 Percentage of Participants |
| Group 4: Prevnar 13™-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 9V | 95.7 Percentage of Participants |
| Group 4: Prevnar 13™-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 18C | 97.8 Percentage of Participants |
| Group 4: Prevnar 13™-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 19A | 97.1 Percentage of Participants |
| Group 4: Prevnar 13™-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 19F | 100 Percentage of Participants |
| Group 4: Prevnar 13™-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 23F | 92.6 Percentage of Participants |
| Group 4: Prevnar 13™-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 22F | 99.3 Percentage of Participants |
| Group 4: Prevnar 13™-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 33F | 75.9 Percentage of Participants |
| Group 5: V114-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 1 | 96.6 Percentage of Participants |
| Group 5: V114-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 7F | 100 Percentage of Participants |
| Group 5: V114-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 6B | 95.2 Percentage of Participants |
| Group 5: V114-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 19F | 100 Percentage of Participants |
| Group 5: V114-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 23F | 94.6 Percentage of Participants |
| Group 5: V114-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 6A | 98.6 Percentage of Participants |
| Group 5: V114-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 5 | 98.0 Percentage of Participants |
| Group 5: V114-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 4 | 96.6 Percentage of Participants |
| Group 5: V114-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 33F | 93.2 Percentage of Participants |
| Group 5: V114-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 22F | 98.6 Percentage of Participants |
| Group 5: V114-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 3 | 93.9 Percentage of Participants |
| Group 5: V114-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 19A | 97.3 Percentage of Participants |
| Group 5: V114-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 18C | 98.0 Percentage of Participants |
| Group 5: V114-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 14 | 98.6 Percentage of Participants |
| Group 5: V114-V114-V114-V114 | Percentage of Participants With Anti-PnP IgG Concentration ≥0.35 µg/mL for 15 Serotypes Contained in V114 at 30 Days Post Vaccination 3 | Serotype 9V | 98.6 Percentage of Participants |