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| ID | Type | Description | Link |
|---|---|---|---|
| V114-033 | Other Identifier | Merck | |
| 205287 | Registry Identifier | JAPIC-CTI | |
| 2019-003644-68 | EudraCT Number |
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The purpose of this clinical study is to evaluate the safety and immunogenicity of a 4-dose schedule (3-dose primary series followed by a toddler dose) of V114 compared with Pneumococcal 13-valent Conjugate Vaccine (PCV13). The hypotheses are that: 1) V114 is non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13 based on the response rates at 30 days following dose 3; 2) V114 is non-inferior to PCV13 for the 2 unique V114 serotypes based on the response rate of the 2 unique V114 serotypes at 30 days following dose 3; 3) V114 is non-inferior to PCV13 for the 13 shared serotypes between V114 and PCV13 based on anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days following dose 3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V114 | Experimental | Participants will receive a single 0.5 mL subcutaneous injection of V114 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age. |
|
| Pneumococcal 13-valent Conjugate Vaccine (PCV13) | Active Comparator | Participants will receive a single 0.5 mL subcutaneous injection of PCV13 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V114 | Biological | 15-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in PCV13 plus 2 additional serotypes (22F, 33F) in each subcutaneous 0.5 mL single dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Solicited Injection-Site Adverse Events | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any injection with either V114 or PCV13 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, induration, pain, and swelling. | Day 1 to Day 14 post any vaccination, up to a total of 13.5 months |
| Percentage of Participants With Solicited Systemic Adverse Events | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any of the injections with either V114 or PCV13, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were decreased appetite, irritability, somnolence, and urticaria. | Day 1 to Day 14 post any vaccination, up to a total of 13.5 months |
| Percentage of Participants With Vaccine-Related Serious Adverse Events | A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following dose 1 (with either V114 or PCV13) was reported. Vaccine-related SAEs were counted starting after vaccine dose 1 through completion of study. | ~1 month after Dose 4, up to a total of 14 months |
| Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | The anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin G (IgG) response rates (percentage of participants meeting serotype-specific IgG threshold value of ≥0.35 μg/mL of participants administered V114 versus participants administered PCV13) for the 15 serotypes contained in V114 were determined using an electrochemiluminescence assay. |
| Measure | Description | Time Frame |
|---|---|---|
| GMC of Serotype-Specific IgG for the 2 Unique V114 Serotypes After Dose 3 | The anti-PnPs serotype-specific IgG GMCs of participants administered V114 versus participants administered PCV13 for the 2 unique V114 serotypes was determined using an electrochemiluminescence assay. | 30 days after Dose 3, up to a total of 11 months |
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Inclusion Criteria:
- Japanese male or female
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Morinaga Maternity Clinic ( Site 3345) | Kasugai | Aichi-ken | 486-0836 | Japan | ||
| Social Medical Corporation Koujunkai Daido Clinic ( Site 3326) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37344262 | Result | Suzuki H, Fujita H, Iwai K, Kuroki H, Taniyama K, Shizuya T, Kishino H, Igarashi R, Shirakawa M, Sawata M. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine in Japanese healthy infants: A phase III study (V114-033). Vaccine. 2023 Jul 31;41(34):4933-4940. doi: 10.1016/j.vaccine.2023.05.064. Epub 2023 Jun 19. |
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694 infants were randomized in a 1:1 ratio with stratification into 3 categories by age category (2 months, 3 months and 4 to 6 months of age), to receive either V114 or Pneumococcal 13-valent Conjugate Vaccine (PCV13).
This study enrolled healthy Japanese infants at 2 to 6 months of age.
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| ID | Title | Description |
|---|---|---|
| FG000 | V114 | Participants received a single 0.5 ml subcutaneous injection of V114 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age. |
| FG001 | PCV13 |
| 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 | Yes | No | No | Study Protocol | Aug 7, 2020 | Oct 26, 2022 |
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|
| PCV13 | Biological | 13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in each subcutaneous 0.5 mL single dose. |
|
|
| 30 Days after Dose 3, up to a total of 11 months |
| Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | The anti-PnPs serotype-specific IgG Geometric Mean Concentrations (GMCs) of participants administered V114 versus participants administered PCV13 for the 13 serotypes shared in V114 and PCV13 were determined using an electrochemiluminescence assay. | 30 Days after Dose 3, up to a total of 11 months |
| Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 |
The anti-PnPs serotype-specific IgG response rates (percentage of participants meeting serotype-specific IgG threshold value of ≥0.35 μg/mL of participants administered V114 versus participants administered PCV13) for the 15 serotypes contained in V114 were determined using an electrochemiluminescence assay. |
| 30 Days after Dose 4, up to a total of 14 months |
| GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | The anti-PnPs serotype-specific IgG GMCs of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using an electrochemiluminescence assay. | 30 Days after Dose 4, up to a total of 14 months |
| Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | The anti-PnPs serotype-specific opsonophagocytic activity (OPA) and geometric mean titers (GMTs) of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using a multiplexed opsonophagocytic assay. | 30 Days after Dose 3, up to a total of 11 months |
| GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | The anti-PnPs serotype-specific opsonophagocytic activity (OPA) and geometric mean titers (GMTs) of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using a multiplexed opsonophagocytic assay. | 30 Days after Dose 4, up to a total of 14 months |
| Nagoya |
| Aichi-ken |
| 457-8511 |
| Japan |
| Kyoritsu Narashinodai Hospital ( Site 3332) | Funabashi | Chiba | 274-0063 | Japan |
| Sotobo Children's Clinic ( Site 3323) | Isumi | Chiba | 299-4503 | Japan |
| Yokoyama Children's Clinic ( Site 3309) | Kasuga | Fukuoka | 816-0801 | Japan |
| Chugoku Rosai Hospital ( Site 3340) | Kure | Hiroshima | 737-0193 | Japan |
| Tsuchiura Kyodo General Hospital ( Site 3327) | Tsuchiura | Ibaraki | 300-0028 | Japan |
| Kagoshima Children's Hospital ( Site 3342) | Hioki | Kagoshima-ken | 899-2503 | Japan |
| Kawasaki Municipal Hospital ( Site 3302) | Kawasaki | Kanagawa | 210-0013 | Japan |
| National Hospital Organization Sagamihara National Hospital ( Site 3303) | Sagamihara | Kanagawa | 252-0392 | Japan |
| JOHAS Yokohama Rosai Hospital ( Site 3343) | Yokohama | Kanagawa | 222-0036 | Japan |
| National Hospital Organization Mie Chuo Medical Center ( Site 3308) | Tsu | Mie-ken | 514-1101 | Japan |
| National Hospital Organization Sendai Medical Center ( Site 3311) | Sendai | Miyagi | 983-8520 | Japan |
| Ina Central Hospital ( Site 3346) | Ina | Nagano | 396-8555 | Japan |
| Aizawa Hospital ( Site 3313) | Matsumoto | Nagano | 390-8510 | Japan |
| Taniguchi Hospital ( Site 3310) | Izumisano | Osaka | 598-0043 | Japan |
| Medical corporation Waffle GunGunkids Clinic ( Site 3329) | Sakai | Osaka | 591-8023 | Japan |
| Suita Municipal Hospital ( Site 3338) | Suita | Osaka | 564-8567 | Japan |
| Takatsuki General Hospital ( Site 3318) | Takatsuki | Osaka | 569-1192 | Japan |
| Aiwa Hospital ( Site 3336) | Kawagoe | Saitama | 350-0001 | Japan |
| Saiseikai Kawaguchi General Hospital ( Site 3304) | Kawaguchi | Saitama | 332-8558 | Japan |
| Hara Children's Clinic ( Site 3339) | Tokorozawa | Saitama | 359-1141 | Japan |
| National Hospital Organization Saitama Hospital ( Site 3312) | Wako | Saitama | 351-0102 | Japan |
| Saiseikai Shiga Hospital ( Site 3349) | Rittō | Shiga | 520-3046 | Japan |
| Kobayashi Pediatric Clinic ( Site 3301) | Fujieda | Shizuoka | 426-0067 | Japan |
| Saiwai Kodomo Clinic ( Site 3331) | Tachikawa | Tokyo | 190-0002 | Japan |
| Nishida Kodomo Clinic ( Site 3306) | Tama | Tokyo | 206-0025 | Japan |
| Fukui Aiiku Hospital ( Site 3315) | Fukui | 910-0833 | Japan |
| Fukui-ken Saiseikai Hospital ( Site 3314) | Fukui | 918-8503 | Japan |
| Shindo Children's Clinic ( Site 3325) | Fukuoka | 814-0121 | Japan |
| Kurokawa Michiko Pediatric Clinic ( Site 3319) | Fukuoka | 815-0033 | Japan |
| Shimomura Pediatrics Clinic ( Site 3320) | Fukuoka | 819-0002 | Japan |
| INAMITSU Children's Clinic ( Site 3321) | Fukuoka | 819-0041 | Japan |
| Nagamine Soyokaze Clinic ( Site 3348) | Kumamoto | 862-0920 | Japan |
| Minaminagano Medical Center Shinonoi General Hospital ( Site 3344) | Nagano | 388-8004 | Japan |
| Saiseikai Noe Hospital ( Site 3330) | Osaka | 536-0001 | Japan |
| Kubota Children's Clinic ( Site 3334) | Osaka | 544-0033 | Japan |
| Sano Kids Clinic ( Site 3341) | Osaka | 553-0001 | Japan |
| Aizenbashi Hospital ( Site 3317) | Osaka | 556-0005 | Japan |
| Japanese Red Cross Shizuoka Hospital ( Site 3322) | Shizuoka | 420-0853 | Japan |
| Shizuoka City Shimizu Hospital ( Site 3347) | Shizuoka | 424-8636 | Japan |
| Hosaka Children's Clinic ( Site 3307) | Tokyo | 112-0001 | Japan |
| The Fraternity Memorial Hospital ( Site 3333) | Tokyo | 130-8587 | Japan |
| Okawa Children & Family Clinic ( Site 3305) | Tokyo | 146-0095 | Japan |
| Toyama City Hospital ( Site 3328) | Toyama | 939-8511 | Japan |
Participants received a single 0.5 mL subcutaneous injection of PCV13 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age. |
| Dose 1 |
|
| Dose 2 |
|
| Dose 3 |
|
| Dose 4 |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | V114 | Participants received a single 0.5 ml subcutaneous injection of V114 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age. |
| BG001 | PCV13 | Participants received a single 0.5 mL subcutaneous injection of PCV13 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | months |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Solicited Injection-Site Adverse Events | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any injection with either V114 or PCV13 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs were erythema, induration, pain, and swelling. | All randomized participants who received at least 1 dose of study vaccination were analyzed. | Posted | Number | Percentage of Participants | Day 1 to Day 14 post any vaccination, up to a total of 13.5 months |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Solicited Systemic Adverse Events | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Following any of the injections with either V114 or PCV13, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were decreased appetite, irritability, somnolence, and urticaria. | All randomized participants who received at least 1 dose of study vaccination were analyzed. | Posted | Number | Percentage of Participants | Day 1 to Day 14 post any vaccination, up to a total of 13.5 months |
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| Primary | Percentage of Participants With Vaccine-Related Serious Adverse Events | A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following dose 1 (with either V114 or PCV13) was reported. Vaccine-related SAEs were counted starting after vaccine dose 1 through completion of study. | All randomized participants who received at least 1 dose of the relevant study vaccination for the timepoint of interest were analyzed. | Posted | Number | Percentage of Participants | ~1 month after Dose 4, up to a total of 14 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Meeting the Serotype Specific Immunoglobulin G Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 3 | The anti-pneumococcal polysaccharide (PnPs) serotype-specific immunoglobulin G (IgG) response rates (percentage of participants meeting serotype-specific IgG threshold value of ≥0.35 μg/mL of participants administered V114 versus participants administered PCV13) for the 15 serotypes contained in V114 were determined using an electrochemiluminescence assay. | All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity outcome measure and who had sufficient data to perform the analyses were analyzed. | Posted | Number | Percentage of Participants | 30 Days after Dose 3, up to a total of 11 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Geometric Mean Concentration of Serotype-Specific IgG for the 13 Shared Serotypes in V114 and PCV13 After Dose 3 | The anti-PnPs serotype-specific IgG Geometric Mean Concentrations (GMCs) of participants administered V114 versus participants administered PCV13 for the 13 serotypes shared in V114 and PCV13 were determined using an electrochemiluminescence assay. | All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity outcome measure and who had sufficient data to perform the analyses were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | 30 Days after Dose 3, up to a total of 11 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | GMC of Serotype-Specific IgG for the 2 Unique V114 Serotypes After Dose 3 | The anti-PnPs serotype-specific IgG GMCs of participants administered V114 versus participants administered PCV13 for the 2 unique V114 serotypes was determined using an electrochemiluminescence assay. | All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity outcome measure and who had sufficient data to perform the analyses were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | 30 days after Dose 3, up to a total of 11 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Meeting the Serotype Specific IgG Threshold Value of ≥0.35 μg/mL for Each Serotype in V114 After Dose 4 | The anti-PnPs serotype-specific IgG response rates (percentage of participants meeting serotype-specific IgG threshold value of ≥0.35 μg/mL of participants administered V114 versus participants administered PCV13) for the 15 serotypes contained in V114 were determined using an electrochemiluminescence assay. | All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity outcome measure and who had sufficient data to perform the analyses were analyzed. | Posted | Number | Percentage of Participants | 30 Days after Dose 4, up to a total of 14 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | GMC of Serotype-Specific IgG for Each Serotype in V114 After Dose 4 | The anti-PnPs serotype-specific IgG GMCs of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using an electrochemiluminescence assay. | All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity outcome measure and who had sufficient data to perform the analyses were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | 30 Days after Dose 4, up to a total of 14 months |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titer of Serotype-Specific Opsonophagocytic Activity for Each Serotype in V114 After Dose 3 | The anti-PnPs serotype-specific opsonophagocytic activity (OPA) and geometric mean titers (GMTs) of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using a multiplexed opsonophagocytic assay. | All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity outcome measure and who had sufficient data to perform the analyses were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 30 Days after Dose 3, up to a total of 11 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | GMT of Serotype-Specific OPA for Each Serotype in V114 After Dose 4 | The anti-PnPs serotype-specific opsonophagocytic activity (OPA) and geometric mean titers (GMTs) of participants administered V114 versus participants administered PCV13 for the 15 serotypes contained in V114 was determined using a multiplexed opsonophagocytic assay. | The first 50% of all participants with sufficient serum volume after dose 3 to evaluate OPA responses were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 30 Days after Dose 4, up to a total of 14 months |
|
|
Non-serious adverse events: Up to 14 days after each vaccination, up to a total of 13.5 months; Serious adverse events: Approximately 1 month after Dose 4 (Up to 14 months); All-cause mortality: Up to 17 months
The analysis population for deaths (all-causes) included all randomized participants. The analysis population for AEs included all randomized participants who received at least 1 dose of study vaccination.
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 | V114 | Participants received a single 0.5 ml subcutaneous injection of V114 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age. | 0 | 347 | 24 | 347 | 340 | 347 |
| EG001 | PCV13 | Participants received a single 0.5 ml subcutaneous injection of PCV13 administered at 2 to 6 months of age, and second and third dose is administered at an interval of ≥27 days from the prior dose. The fourth dose is administered at 12 to 15 months of age. | 0 | 347 | 23 | 346 | 340 | 346 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hamartoma | Congenital, familial and genetic disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Milk allergy | Immune system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Lymphadenitis bacterial | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Nephritis bacterial | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Respiratory syncytial virus bronchitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Viral rash | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Kawasaki's disease | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Eczema infantile | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
| |
| Skin induration | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
|
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 LLC | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 8, 2021 | Oct 26, 2022 | SAP_002.pdf |
Not provided
| 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 |
Not provided
Not provided
Not provided
| Newborns (0-27 days) |
|
| Infants and toddlers (28 days-23 months) |
|
| Children (2-11 years) |
|
| Adolescents (12-17 years) |
|
| Adults (18-64 years) |
|
| From 65-84 years |
|
| 85 years and over |
|
| 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 |
|
| Injection site pain |
|
| Injection site swelling |
|
Injection site induration |
| Miettinen & Nurminen |
| = 0.937 |
| Difference in Percent |
| -0.2 |
| 2-Sided |
| 95 |
| -6.1 |
| 5.6 |
| Other |
Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan. |
| Injection site pain | Miettinen & Nurminen | = 0.036 | Difference in Percent | 7.1 | 2-Sided | 95 | 0.5 | 13.8 | Other | Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan. |
| Injection site swelling | Miettinen & Nurminen | = 0.208 | Difference in Percent | -4.0 | 2-Sided | 95 | -10.2 | 2.2 | Other | Estimated differences, confidence intervals (CIs), and p-values are calculated based on the Miettinen & Nurminen method and are provided in accordance with the statistical analysis plan. |
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