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| ID | Type | Description | Link |
|---|---|---|---|
| V114-027 | Other Identifier | Merck | |
| 2018-001151-12 | EudraCT Number |
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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 13â„¢ in healthy infants switched from Prevnar 13â„¢ to V114 during the four-dose PCV immunization schedule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Prevnar 13â„¢-Prevnar 13â„¢-Prevnar 13â„¢-Prevnar 13â„¢ | Active Comparator | Participants will receive a single 0.5 mL intramuscular (IM) injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
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| Group 2: Prevnar 13â„¢-Prevnar 13â„¢-Prevnar 13â„¢-V114 | Experimental | Participants will receive a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
|
| Group 3: Prevnar 13â„¢-Prevnar 13â„¢-V114-V114 | Experimental | Participants will receive a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevnar 13â„¢ | Biological | Prevnar 13â„¢ 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. |
| 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 13â„¢ at 30 Days Post Vaccination 4 | The GMC of anti-PnP serotype-specific IgG for 13 shared serotypes contained in V114 and Prevnar 13â„¢ (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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Clinical Therapeutics ( Site 0015) | Birmingham | Alabama | 35205 | United States | ||
| Southeastern Pediatric Associates, P.A. ( Site 0002) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36522265 | Result | Bili A, Dobson S, Quinones J, Phongsamart W, Oberdorfer P, Kosalaraksa P, Dagan R, Richmond P, Wilck M, Vallejos W, Nunn C, McFetridge R, Tamms G, Fu R, Lupinacci R, Musey L, Banniettis N, Bickham K; V114-027 PNEU-DIRECTION study group. A phase 3, multicenter, randomized, double-blind study to evaluate the interchangeability of V114, a 15-valent pneumococcal conjugate vaccine, and PCV13 with respect to safety, tolerability, and immunogenicity in healthy infants (PNEU-DIRECTION). Vaccine. 2023 Jan 16;41(3):657-665. doi: 10.1016/j.vaccine.2022.10.072. Epub 2022 Dec 13. |
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Participants were screened at Study Day 1, prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Prevnar 13â„¢-Prevnar 13â„¢-Prevnar 13â„¢-Prevnar 13â„¢ | Participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2018 |
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| Group 4: Prevnar 13â„¢-V114-V114-V114 | Experimental | Participants will receive a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
|
| Group 5: V114-V114-V114-V114 | Experimental | 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
|
| V114 | Biological | 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. |
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| RotaTeqâ„¢ | Biological | RotaTeqâ„¢ live, pentavalent Rotavirus vaccine given as background treatment via oral solution. |
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| Pentacelâ„¢ | Biological | Pentacelâ„¢ 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 13â„¢ administration. |
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| RECOMBIVAX HBâ„¢ | Biological | RECOMBIVAX HBâ„¢ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13â„¢ administration. |
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| HIBERIXâ„¢ | Biological | HIBERIXâ„¢ Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13â„¢ administration. |
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| M-M-Râ„¢ II | Biological | M-M-Râ„¢ II (Measles, Mumps, and Rubella Virus Vaccine Live), given as background treatment via subcutaneous (SC) injection in the opposite limb to V114 and Prevnar 13â„¢ administration. |
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| VARIVAXâ„¢ | Biological | VARIVAXâ„¢ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13â„¢ administration. |
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| 30 Days after Vaccination 4 (Months 11-14) |
| 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 13â„¢ [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 13â„¢ at 30 Days Post Vaccination 4 | The GMC of anti-PnP serotype-specific IgG for 13 shared serotypes contained in V114 and Prevnar 13â„¢ (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) |
| Dothan |
| Alabama |
| 36305 |
| United States |
| Children's Clinic of Jonesboro, PA ( Site 0022) | Jonesboro | Arkansas | 72401 | United States |
| Davita Medical Group ( Site 0012) | Colorado Springs | Colorado | 80922 | United States |
| Suncoast Research Associates, LLC ( Site 0035) | Miami | Florida | 33184 | United States |
| Kentucky Pediatric/Adult Research Inc ( Site 0011) | Bardstown | Kentucky | 40004 | United States |
| Pediatric Associates of Fall River ( Site 0021) | Fall River | Massachusetts | 02721 | United States |
| Midwest Children's Health Research Institute, LLC ( Site 0024) | Lincoln | Nebraska | 68504 | United States |
| Midwest Children's Health Research Institute, LLC ( Site 0003) | Lincoln | Nebraska | 68505 | United States |
| Midwest Children's Health Research Institute, LLC ( Site 0004) | Lincoln | Nebraska | 68516 | United States |
| Midwest Children's Health Research Institute, LLC ( Site 0001) | Lincoln | Nebraska | 68522 | United States |
| Summerwood Pediatrics ( Site 0009) | Liverpool | New York | 13088 | United States |
| University of Rochester Medical Center ( Site 0029) | Rochester | New York | 14642 | United States |
| SUNY Upstate Medical University ( Site 0008) | Syracuse | New York | 13202 | United States |
| Piedmont Healthcare, PA ( Site 0025) | Statesville | North Carolina | 28625 | United States |
| Coastal Pediatric Research ( Site 0006) | Charleston | South Carolina | 29414 | United States |
| Parkside Pediatric ( Site 0007) | Greenville | South Carolina | 29607 | United States |
| Holston Medical Group ( Site 0018) | Kingsport | Tennessee | 37660 | United States |
| Ventavia Research Group LLC ( Site 0017) | Fort Worth | Texas | 76104 | United States |
| University of Texas Medical Branch ( Site 0023) | Galveston | Texas | 77555 | United States |
| Wasatch Pediatrics-Cottonwood Office ( Site 0014) | Murray | Utah | 84107 | United States |
| Multicare ( Site 0019) | Spokane | Washington | 99202 | United States |
| Cooperativa de Facultad Medica Sanacoop ( Site 0057) | Bayamón | 00961 | Puerto Rico |
| Clinical Research of Puerto Rico ( Site 0050) | Guayama | 00784 | Puerto Rico |
| CAIMED Center - Ponce School of Medicine ( Site 0053) | Ponce | 00716 | Puerto Rico |
| San Juan Hospital ( Site 0056) | San Juan | 00935 | Puerto Rico |
| University of Puerto Rico ( Site 0051) | San Juan | 00935 | Puerto Rico |
| Srinagarind Hospital. Khon Kaen University ( Site 0093) | Muang | Changwat Khon Kaen | 40002 | Thailand |
| Chulalongkorn University ( Site 0092) | Bangkok | 10330 | Thailand |
| Siriaj Hospital ( Site 0091) | Bangkok | 10700 | Thailand |
| Maharaj Nakorn Chiang Mai Hospital ( Site 0090) | Chiang Mai | 50200 | Thailand |
| Hacettepe University Faculty of Medicine ( Site 0070) | Ankara | 06230 | Turkey (Türkiye) |
| Eskisehir Osmangazi University Faculty of Medicine ( Site 0071) | Eskişehir | 26480 | Turkey (Türkiye) |
| Ege University Medical Faculty Hospital ( Site 0072) | Izmir | 35040 | Turkey (Türkiye) |
| FG001 | Group 2: Prevnar 13â„¢-Prevnar 13â„¢-Prevnar 13â„¢-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| FG002 | Group 3: Prevnar 13â„¢-Prevnar 13â„¢-V114-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| FG003 | Group 4: Prevnar 13â„¢-V114-V114-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| FG004 | 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| Vaccination 1 (V114 or Prevnar 13â„¢) |
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| Vaccination 2 (V114 or Prevnar 13â„¢) |
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| Vaccination 3 (V114 or Prevnar 13â„¢) |
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| Vaccination 4 (V114 or Prevnar 13â„¢) |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Prevnar 13â„¢-Prevnar 13â„¢-Prevnar 13â„¢-Prevnar 13â„¢ | Participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| BG001 | Group 2: Prevnar 13â„¢-Prevnar 13â„¢-Prevnar 13â„¢-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| BG002 | Group 3: Prevnar 13â„¢-Prevnar 13â„¢-V114-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| BG003 | Group 4: Prevnar 13â„¢-V114-V114-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| BG004 | 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | days |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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. | All randomized participants who got ≥1 dose of V114 or Prevnar 13™. | Posted | Number | Percentage of Participants | Up to ~14 days after each vaccination |
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| 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. | All randomized participants who got ≥1 dose of V114 or Prevnar 13™. | Posted | Number | Percentage of Participants | Up to ~14 days after each vaccination |
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| 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. | All randomized participants who got ≥1 dose of V114 or Prevnar 13™. | Posted | Number | Percentage of Participants | Up to ~6 months after Vaccination 4 (up to ~19 months) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | 30 Days after Vaccination 4 (Months 11-14) |
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| 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. | 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. | Posted | Number | Percentage of Participants | 30 Days after Vaccination 3 (Month 5) |
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| 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. | All randomized participants who were protocol compliant, got scheduled dosing of V114, Prevnar 13â„¢ or background RotaTeqâ„¢, 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 | Posted | Geometric Mean | 95% Confidence Interval | Titers | 30 Days after Vaccination 3 (Month 5) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | 30 Days after Vaccination 3 (Month 5) |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 30 Days after Vaccination 3 (Month 5) |
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| 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | 30 Days after Vaccination 4 (Months 11-14) |
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Non-serious AEs (NSAEs): Up to ~14 days after each vaccination; SAEs and all-cause mortality: Up to ~6 months after Vaccination 4 (up to ~19 months)
All-cause mortality was analyzed in all randomized participants; SAEs and NSAEs were analyzed in all randomized participants who received at least 1 dose of study vaccination V114 or Prevnar 13â„¢.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: Prevnar 13â„¢-Prevnar 13â„¢-Prevnar 13â„¢-Prevnar 13â„¢ | Participants received a single 0.5 mL intramuscular (IM) injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. | 0 | 179 | 21 | 179 | 164 | 179 |
| EG001 | Group 2: Prevnar 13â„¢-Prevnar 13â„¢-Prevnar 13â„¢-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. | 0 | 181 | 24 | 181 | 161 | 181 |
| EG002 | Group 3: Prevnar 13â„¢-Prevnar 13â„¢-V114-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. | 0 | 180 | 15 | 178 | 160 | 178 |
| EG003 | Group 4: Prevnar 13â„¢-V114-V114-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. | 0 | 180 | 18 | 179 | 163 | 179 |
| EG004 | 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. | 0 | 180 | 21 | 179 | 160 | 179 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Enteritis | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Complication associated with device | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Adenoviral upper respiratory infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Exanthema subitum | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Herpangina | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Mycoplasma infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Skin bacterial infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Viral rash | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Foreign body ingestion | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Subdural haemorrhage | Injury, poisoning and procedural complications | MedDRA 23.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hair follicle tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Upper airway obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 23.1 | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA 23.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 23.1 | Systematic Assessment |
|
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Jul 28, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
| C492535 | RotaTeq |
| D022243 | Rotavirus Vaccines |
| C512971 | pentacel |
| C075655 | Recombivax HB |
| D017325 | Hepatitis B Vaccines |
| C514867 | Hiberix |
| D019433 | Chickenpox Vaccine |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D014761 | Viral Hepatitis Vaccines |
| D022283 | Herpesvirus Vaccines |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Induration/Hard lump |
|
| Tenderness/Pain |
|
| Swelling |
|
Difference in Percentage: Erythema(Group 4 vs 1) |
| Miettinen & Nurminen method |
| = 0.396 |
| Difference in Percentage |
| -4.5 |
| 2-Sided |
| 95 |
| -14.7 |
| 5.8 |
| Other |
Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan. |
| Difference in Percentage: Erythema(Group 3 vs 1) | Miettinen & Nurminen method | = 0.097 | Difference in Percentage | -8.7 | 2-Sided | 95 | -18.8 | 1.6 | Other | Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan. |
| Difference in Percentage: Erythema(Group 2 vs 1) | Miettinen & Nurminen method | = 0.057 | Difference in Percentage | -9.9 | 2-Sided | 95 | -19.9 | 0.3 | Other | Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan. |
| Difference in Percentage: Induration(Group 5 vs 1) | Miettinen & Nurminen method | = 0.085 | Difference in Percentage | -8.4 | 2-Sided | 95 | -17.8 | 1.2 | Other | Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan. |
| Difference in Percentage: Induration(Group 4 vs 1) | Miettinen & Nurminen method | = 0.050 | Difference in Percentage | -9.5 | 2-Sided | 95 | -18.9 | -0.0 | Other | Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan. |
| Difference in Percentage: Induration(Group 3 vs 1) | Miettinen & Nurminen method | = 0.183 | Difference in Percentage | -6.5 | 2-Sided | 95 | -16.1 | 3.1 | Other | Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan. |
| Difference in Percentage: Induration(Group 2 vs 1) | Miettinen & Nurminen method | = 0.074 | Difference in Percentage | -8.7 | 2-Sided | 95 | -18.1 | 0.8 | Other | Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan. |
| Difference in Percentage: Tenderness(Group 5 vs 1) | Miettinen & Nurminen method | = 0.525 | Difference in Percentage | 3.4 | 2-Sided | 95 | -7.0 | 13.6 | Other | Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan. |
| Difference in Percentage: Tenderness(Group 4 vs 1) | Miettinen & Nurminen method | = 0.915 | Difference in Percentage | -0.6 | 2-Sided | 95 | -10.8 | 9.7 | Other | Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan. |
| Difference in Percentage: Tenderness(Group 3 vs 1) | Miettinen & Nurminen method | = 0.714 | Difference in Percentage | 1.9 | 2-Sided | 95 | -8.4 | 12.2 | Other | Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan. |
| Difference in Percentage: Tenderness(Group 2 vs 1) | Miettinen & Nurminen method | = 0.926 | Difference in Percentage | -0.5 | 2-Sided | 95 | -10.7 | 9.7 | Other | Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan. |
| Difference in Percentage: Swelling(Group 5 vs 1) | Miettinen & Nurminen method | > 0.999 | Difference in Percentage | 0.0 | 2-Sided | 95 | -8.7 | 8.7 | Other | Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan. |
| Difference in Percentage: Swelling(Group 4 vs 1) | Miettinen & Nurminen method | = 0.609 | Difference in Percentage | -2.2 | 2-Sided | 95 | -10.8 | 6.4 | Other | Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan. |
| Difference in Percentage: Swelling(Group 3 vs 1) | Miettinen & Nurminen method | = 0.688 | Difference in Percentage | 1.8 | 2-Sided | 95 | -7.1 | 10.7 | Other | Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan. |
| Difference in Percentage: Swelling(Group 2 vs 1) | Miettinen & Nurminen method | = 0.336 | Difference in Percentage | -4.1 | 2-Sided | 95 | -12.6 | 4.3 | Other | Estimated differences, CIs, and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan. |
| OG002 | Group 3: Prevnar 13â„¢-Prevnar 13â„¢-V114-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| OG003 | Group 4: Prevnar 13â„¢-V114-V114-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| OG004 | 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
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| OG002 | Group 3: Prevnar 13â„¢-Prevnar 13â„¢-V114-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| OG003 | Group 4: Prevnar 13â„¢-V114-V114-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| OG004 | 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
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| OG001 | Group 2: Prevnar 13â„¢-Prevnar 13â„¢-Prevnar 13â„¢-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| OG002 | Group 3: Prevnar 13â„¢-Prevnar 13â„¢-V114-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| OG003 | Group 4: Prevnar 13â„¢-V114-V114-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| OG004 | 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
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| OG001 | Group 2: Prevnar 13â„¢-Prevnar 13â„¢-Prevnar 13â„¢-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| OG002 | Group 3: Prevnar 13â„¢-Prevnar 13â„¢-V114-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| OG003 | Group 4: Prevnar 13â„¢-V114-V114-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| OG004 | 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| OG005 | Group 1: Prevnar 13â„¢(Vaccinations 1-4) + Group 2: Prevnar 13â„¢(Vaccinations 1-3)-V114 (Vaccination 4) | Group 1 participants who received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3), Months 10-13 (Vaccination 4) and Group 2 participants who received a single 0.5 mL IM injection of Prevnar 13â„¢ 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), were combined across vaccination schedule. Group 1 plus Group 2 participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
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| OG001 | Group 2: Prevnar 13â„¢-Prevnar 13â„¢-Prevnar 13â„¢-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| OG002 | Group 3: Prevnar 13â„¢-Prevnar 13â„¢-V114-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| OG003 | Group 4: Prevnar 13â„¢-V114-V114-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| OG004 | 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| OG005 | Group 1: Prevnar 13â„¢(Vaccinations 1-4) + Group 2: Prevnar 13â„¢(Vaccinations 1-3)-V114 (Vaccination 4) | Group 1 participants who received a single 0.5 mL IM injection of Prevnar 13â„¢ on Day 1 (Vaccination 1), Month 2 (Vaccination 2), Month 4 (Vaccination 3), Months 10-13 (Vaccination 4) and Group 2 participants who received a single 0.5 mL IM injection of Prevnar 13â„¢ 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), were combined across vaccination schedule. Group 1 plus Group 2 participants concomitantly received other licensed background pediatric vaccines as follows: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
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| OG002 | Group 3: Prevnar 13â„¢-Prevnar 13â„¢-V114-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| OG003 | Group 4: Prevnar 13â„¢-V114-V114-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| OG004 | 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
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Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13.
| OG002 | Group 3: Prevnar 13â„¢-Prevnar 13â„¢-V114-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| OG003 | Group 4: Prevnar 13â„¢-V114-V114-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| OG004 | 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
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| OG001 | Group 2: Prevnar 13â„¢-Prevnar 13â„¢-Prevnar 13â„¢-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| OG002 | Group 3: Prevnar 13â„¢-Prevnar 13â„¢-V114-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| OG003 | Group 4: Prevnar 13â„¢-V114-V114-V114 | Participants received a single 0.5 mL IM injection of Prevnar 13â„¢ 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
| OG004 | 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: RotaTeqâ„¢, Pentacelâ„¢, RECOMBIVAX HBâ„¢ on Day 1, Month 2, and on Month 4; HIBERIXâ„¢, M-M-Râ„¢ II, VARIVAXâ„¢ on Months 10-13. |
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