A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Interchangeability of V114 and Prevnar 13™ With Respect to Safety, Tolerability, and Immunogenicity in Healthy Infants (PNEU-DIRECTION)

Conditions
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Pneumococcal Infections

Intervention / Treatment
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* Biological: Prevnar 13™
* Biological: V114
* Biological: RotaTeq™
* Biological: Pentacel™
* Biological: RECOMBIVAX HB™
* Biological: HIBERIX™
* Biological: M-M-R™ II
* Biological: VARIVAX™


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 42 Days
Maximum Age: 90 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1: Prevnar 13™-Prevnar 13™-Prevnar 13™-Prevnar 13™<br>Participants will receive 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 will concomitantly receive 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. | Biological: Prevnar 13™<br>* 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.<br>Biological: RotaTeq™<br>* RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.<br>* Other names: V260; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;Biological: Pentacel™<br>* 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.<br>* Other names: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;Biological: RECOMBIVAX HB™<br>* RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.<br>* Other names: V232, HEPTAVAX™-II, HBVAXPRO; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;Biological: HIBERIX™<br>* 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.<br>* Other names: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;Biological: M-M-R™ II<br>* 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.<br>* Other names: V205C; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;Biological: VARIVAX™<br>* VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.<br>* Other names: V210; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;|
| Experimental: Group 2: Prevnar 13™-Prevnar 13™-Prevnar 13™-V114<br>Participants will receive 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 will concomitantly receive 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. | Biological: Prevnar 13™<br>* 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.<br>Biological: V114<br>* 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.<br>* Other names: VAXNEUVANCE™;Biological: RotaTeq™<br>* RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.<br>* Other names: V260; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;Biological: Pentacel™<br>* 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.<br>* Other names: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;Biological: RECOMBIVAX HB™<br>* RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.<br>* Other names: V232, HEPTAVAX™-II, HBVAXPRO; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;Biological: HIBERIX™<br>* 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.<br>* Other names: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;Biological: M-M-R™ II<br>* 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.<br>* Other names: V205C; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;Biological: VARIVAX™<br>* VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.<br>* Other names: V210; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;|
| Experimental: Group 3: Prevnar 13™-Prevnar 13™-V114-V114<br>Participants will receive 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 will concomitantly receive 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. | Biological: Prevnar 13™<br>* 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.<br>Biological: V114<br>* 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.<br>* Other names: VAXNEUVANCE™;Biological: RotaTeq™<br>* RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.<br>* Other names: V260; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;Biological: Pentacel™<br>* 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.<br>* Other names: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;Biological: RECOMBIVAX HB™<br>* RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.<br>* Other names: V232, HEPTAVAX™-II, HBVAXPRO; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;Biological: HIBERIX™<br>* 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.<br>* Other names: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;Biological: M-M-R™ II<br>* 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.<br>* Other names: V205C; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;Biological: VARIVAX™<br>* VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.<br>* Other names: V210; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;|
| Experimental: Group 4: Prevnar 13™-V114-V114-V114<br>Participants will receive 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 will concomitantly receive 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. | Biological: Prevnar 13™<br>* 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.<br>Biological: V114<br>* 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.<br>* Other names: VAXNEUVANCE™;Biological: RotaTeq™<br>* RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.<br>* Other names: V260; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;Biological: Pentacel™<br>* 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.<br>* Other names: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;Biological: RECOMBIVAX HB™<br>* RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.<br>* Other names: V232, HEPTAVAX™-II, HBVAXPRO; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;Biological: HIBERIX™<br>* 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.<br>* Other names: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;Biological: M-M-R™ II<br>* 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.<br>* Other names: V205C; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;Biological: VARIVAX™<br>* VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.<br>* Other names: V210; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;|
| Experimental: Group 5: V114-V114-V114-V114<br>Participants will receive 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 will concomitantly receive 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. | Biological: V114<br>* 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.<br>* Other names: VAXNEUVANCE™;Biological: RotaTeq™<br>* RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.<br>* Other names: V260; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;Biological: Pentacel™<br>* 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.<br>* Other names: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;Biological: RECOMBIVAX HB™<br>* RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.<br>* Other names: V232, HEPTAVAX™-II, HBVAXPRO; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;Biological: HIBERIX™<br>* 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.<br>* Other names: Trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;Biological: M-M-R™ II<br>* 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.<br>* Other names: V205C; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;Biological: VARIVAX™<br>* VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.<br>* Other names: V210; trade names of the concomitant vaccines may vary depending on where clinical supplies are sourced.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to  14 days after each vaccination | 
| 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. | Up to  14 days after each vaccination | 
| 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. | Up to  6 months after Vaccination 4 (up to  19 months) | 
| 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. | 30 Days after Vaccination 4 (Months 11-14) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 Days after Vaccination 3 (Month 5) | 
| 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. | 30 Days after Vaccination 3 (Month 5) | 
| 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. | 30 Days after Vaccination 3 (Month 5) | 
| 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. | 30 Days after Vaccination 3 (Month 5) | 
| 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. | 30 Days after Vaccination 4 (Months 11-14) |