Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001117-25 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is designed to evaluate the safety, tolerability, and immunogenicity of two different lots of V114 in healthy infants 6 to 12 weeks (>=42 days to <=90 days) of age. The primary hypothesis of the study is that the proportion of participants receiving V114 who have serotype specific IgG >=0.35 mcg/mL for each of pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F at 1 month after Dose 3 is non-inferior to that for recipients of Prevnar 13â„¢.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V114 Lot 1 | Experimental | Infants will receive a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13) |
|
| V114 Lot 2 | Experimental | Infants will receive a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13) |
|
| Prevnar 13â„¢ | Active Comparator | Infants will receive a 0.5 mL intramuscular injection of Prevnar 13â„¢ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V114 Lot 1 | Biological | Lot 1: 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Serotype-specific pneumococcal IgG antibody was measured using the Meso-Scale Discovery (MSD) Pneumococcal electrochemiluminescence assay (Pn ECL). The percentage of participants with serotype-specific IgG ≥0.35 µg/mL was summarized for each serotype. | 1 month post vaccination 3 (Month 5) |
| Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13â„¢ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Serotype-specific pneumococcal IgG antibody will be assayed using the Meso-Scale Discovery (MSD) Pn electrochemiluminescence assay. The geometric mean concentration (GMC) of serotype-specific IgG will be assessed. | 1 month post Vaccination 3 (Month 5) |
| Percentage of Participants Who Experience at Least 1 Adverse Event | An adverse event (AE) is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with one or more AEs was assessed. | Up to 1 month post Vaccination 4 (up to 14 months) |
| Percentage of Participants Who Discontinued From the Study Due to an Adverse Event | The percentage of participants who discontinued the study because of an AE (as defined above) was assessed. | Up to 1 month post Vaccination 4 (up to 14 months) |
| Percentage of Participants With a Solicited Injection-site Adverse Event |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay. | Before Vaccination 4 (Month 10 to 13) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Pediatric Research ( Site 0043) | Birmingham | Alabama | 35205 | United States | ||
| Southeastern Pediatric Associates, P.A. ( Site 0079) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32639460 | Derived | Platt HL, Greenberg D, Tapiero B, Clifford RA, Klein NP, Hurley DC, Shekar T, Li J, Hurtado K, Su SC, Nolan KM, Acosta CJ, McFetridge RD, Bickham K, Musey LK; V114-008 Study Group. A Phase II Trial of Safety, Tolerability and Immunogenicity of V114, a 15-Valent Pneumococcal Conjugate Vaccine, Compared With 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants. Pediatr Infect Dis J. 2020 Aug;39(8):763-770. doi: 10.1097/INF.0000000000002765. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | V114 Lot 1 | Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13) |
| FG001 | V114 Lot 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| 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 | Sep 15, 2016 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| V114 Lot 2 | Biological | Lot 2: 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 |
|
|
| Prevnar 13â„¢ | Biological | Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose |
|
Injection-site AEs solicited on the Vaccine Report Card were redness, swelling, hard lump, and pain/tenderness. The percentage of participants with 1 or more solicited injection-site AEs was assessed. |
| Up to 14 days post any vaccination |
| Percentage of Participants With a Solicited Systemic Adverse Event | Systemic AEs solicited on the Vaccine Report Card were fever, irritability, drowsiness, hive/welts, and appetite loss. The percentage of participants with 1 or more solicited systemic AEs was assessed. | Up to 14 days post any vaccination |
| Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 |
Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay. |
| 1 month post vaccination 4 (Month 11-14) |
| Dothan |
| Alabama |
| 36305 |
| United States |
| Children's Clinic of Jonesboro, PA ( Site 0054) | Jonesboro | Arkansas | 72401 | United States |
| Premier Health Research Center, LLC ( Site 0035) | Downey | California | 90241 | United States |
| Sherif Khamis MD, Inc. ( Site 0044) | Palmdale | California | 93550 | United States |
| Kaiser Permanente - Roseville ( Site 0045) | Roseville | California | 95661 | United States |
| Kaiser Permanente Clinical Trial - Sacramento ( Site 0076) | Sacramento | California | 95815 | United States |
| Kentucky Pediatric/Adult Research Inc ( Site 0037) | Bardstown | Kentucky | 40004 | United States |
| University of Louisville: Pediatric Clinical Trials Unit ( Site 0049) | Louisville | Kentucky | 40202 | United States |
| ACC Pediatric Research ( Site 0039) | Haughton | Louisiana | 71037 | United States |
| Woburn Pediatric Associates ( Site 0046) | Woburn | Massachusetts | 01801 | United States |
| Dundee Clinic ( Site 0063) | Omaha | Nebraska | 68132 | United States |
| Child Health Care Associates ( Site 0064) | East Syracuse | New York | 13057 | United States |
| State University of New York Upstate Medical University ( Site 0065) | Syracuse | New York | 13210 | United States |
| Pediatric Associates of Mt. Carmel, Inc. ( Site 0052) | Cincinnati | Ohio | 45245 | United States |
| Senders Pediatrics ( Site 0058) | Cleveland | Ohio | 44121 | United States |
| Ohio Pediatric Research Association ( Site 0060) | Dayton | Ohio | 45414 | United States |
| Pediatric Medical Associates ( Site 0059) | East Norriton | Pennsylvania | 19401 | United States |
| Kid's Way Pediatrics ( Site 0036) | Hermitage | Pennsylvania | 16148 | United States |
| Thomas Jefferson University ( Site 0067) | Philadelphia | Pennsylvania | 19107 | United States |
| Coastal Pediatric Research ( Site 0070) | Charleston | South Carolina | 29414 | United States |
| Holston Medical Group [Kingsport, TN] ( Site 0048) | Kingsport | Tennessee | 37660 | United States |
| University of Texas Medical Branch at Galveston ( Site 0056) | Galveston | Texas | 77555 | United States |
| University of Texas Medical Branch at Galveston ( Site 0068) | League City | Texas | 77573 | United States |
| Wee Care Pediatrics ( Site 0042) | Layton | Utah | 84041 | United States |
| Cottonwood Pediatrics ( Site 0041) | Murray | Utah | 84107 | United States |
| Copperview Medical Center ( Site 0062) | South Jordan | Utah | 84095 | United States |
| Pediatric Research of Charlottesville, LLC ( Site 0066) | Charlottesville | Virginia | 22902 | United States |
| Huguenot Pediatrics ( Site 0057) | Midlothian | Virginia | 23113 | United States |
| Family Health Care of Ellensburg ( Site 0077) | Ellensburg | Washington | 98926 | United States |
| CHU Ste-Justine ( Site 0084) | Montreal | Quebec | H9H 4M7 | Canada |
| McGill University Health Centre - Vaccine Study Centre ( Site 0030) | Pierrefonds | Quebec | H9H 4M7 | Canada |
| CHU de Quebec Universite de Laval ( Site 0031) | Québec | Quebec | H9H 4M7 | Canada |
| Aarhus Universitetshospital-Skejby-Forskningsklinikken for Kvindesygdomme ( Site 0025) | Aarhus N | Denmark |
| OUH Klinisk Forsk center Gyn Obs D. ( Site 0024) | Odense | Denmark |
| Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007) | Espoo | Finland |
| Tampereen yliopisto Etela-Helsingin rokotetutkimusklinikka ( Site 0005) | Helsinki | Finland |
| Tampereen yliopisto Ita-Helsingin rokotetutkimusklinikka ( Site 0006) | Helsinki | Finland |
| Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003) | Jarvenpaa | Finland |
| Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004) | Oulu | Finland |
| Tampereen yliopisto Porin rokotetutkimusklinikka ( Site 0008) | Pori | Finland |
| Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001) | Tampere | Finland |
| Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002) | Turku | Finland |
| Soroka University Medical Center ( Site 0019) | Beersheba | Israel |
| Soroka University Medical Center - Rahat Family health center ( Site 0020) | Beersheba | Israel |
| Soroka University Medical Center - Ramot Family health center ( Site 0021) | Beersheba | Israel |
| Soroka University Medical Center - Vav Family health center ( Site 0022) | Beersheba | Israel |
| Hospital Clinico Universitario de Santiago ( Site 0016) | Santiago de Compostela | Spain |
| Unidad de Estudios e Investigacion IHP ( Site 0017) | Seville | Spain |
Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13)
| FG002 | Prevnar 13â„¢ | Infants received a 0.5 mL intramuscular injection of Prevnar 13â„¢ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13) |
| Vaccination 1 |
|
| Vaccination 2 |
|
| Vaccination 3 |
|
| Vaccination 4 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | V114 Lot 1 | Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13) |
| BG001 | V114 Lot 2 | Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13) |
| BG002 | Prevnar 13â„¢ | Infants received a 0.5 mL intramuscular injection of Prevnar 13â„¢ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13) |
| BG003 | 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, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity | 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 Achieving the Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Threshold Value of ≥0.35 µg/mL for the 13 Common Serotypes in V114 and Prevnar 13™: 1 Month Post Vaccination 3 | Serotype-specific pneumococcal IgG antibody was measured using the Meso-Scale Discovery (MSD) Pneumococcal electrochemiluminescence assay (Pn ECL). The percentage of participants with serotype-specific IgG ≥0.35 µg/mL was summarized for each serotype. | Participants not considered as protocol violators and had data available for endpoint. Violations could include but were not limited to: failure to receive the scheduled correct doses within scheduled timeframe and lack of valid serology results available from 28 to 42 days following the dose being analyzed. | Posted | Number | 95% Confidence Interval | Percentage of Participants | 1 month post vaccination 3 (Month 5) |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar 13™ and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 3 | Serotype-specific pneumococcal IgG antibody will be assayed using the Meso-Scale Discovery (MSD) Pn electrochemiluminescence assay. The geometric mean concentration (GMC) of serotype-specific IgG will be assessed. | Participants not considered as protocol violators and had data available for endpoint. Violations could include but were not limited to: failure to receive the scheduled correct doses within scheduled timeframe and lack of valid serology results available from 28 to 42 days following the dose being analyzed. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | 1 month post Vaccination 3 (Month 5) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Experience at Least 1 Adverse Event | An adverse event (AE) is defined as any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with one or more AEs was assessed. | All participants that received at least 1 vaccination and had data available for endpoint. | Posted | Number | Percentage of Participants | Up to 1 month post Vaccination 4 (up to 14 months) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Discontinued From the Study Due to an Adverse Event | The percentage of participants who discontinued the study because of an AE (as defined above) was assessed. | All participants that received at least 1 vaccination and had data available for endpoint. | Posted | Number | Percentage of Participants | Up to 1 month post Vaccination 4 (up to 14 months) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With a Solicited Injection-site Adverse Event | Injection-site AEs solicited on the Vaccine Report Card were redness, swelling, hard lump, and pain/tenderness. The percentage of participants with 1 or more solicited injection-site AEs was assessed. | All participants that received at least 1 vaccination and had data available for endpoint. | Posted | Number | Percentage of Participants | Up to 14 days post any vaccination |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With a Solicited Systemic Adverse Event | Systemic AEs solicited on the Vaccine Report Card were fever, irritability, drowsiness, hive/welts, and appetite loss. The percentage of participants with 1 or more solicited systemic AEs was assessed. | All participants that received at least 1 vaccination and had data available for endpoint. | Posted | Number | Percentage of Participants | Up to 14 days post any vaccination |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: Pre-vaccination 4 | Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay. | Participants not considered as protocol violators and had data available for endpoint. Violations could include but were not limited to: failure to receive the scheduled correct doses within scheduled timeframe and lack of valid serology results available from 28 to 42 days following the dose being analyzed. | Posted | Mean | 95% Confidence Interval | µg/mL | Before Vaccination 4 (Month 10 to 13) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Concentration of Serotype-specific Pneumococcal IgG Antibody for the 13 Common Serotypes in V114 and Prevnar and the 2 Serotypes Unique to V114: 1 Month Post Vaccination 4 | Serotype-specific pneumococcal IgG antibody was assayed using the MSD Pn electrochemiluminescence assay. | Participants not considered as protocol violators and had data available for endpoint. Violations could include but were not limited to: failure to receive the scheduled correct doses within scheduled timeframe and lack of valid serology results available from 28 to 42 days following the dose being analyzed. | Posted | Mean | 95% Confidence Interval | µg/mL | 1 month post vaccination 4 (Month 11-14) |
|
Up to approximately 1-month (28 to 42 days) post Vaccination 4 (up to 15 months)
All enrolled participants that received at least 1 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 Lot 1 | Infants received a 0.5 mL intramuscular injection of V114 Lot 1 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13) | 1 | 350 | 18 | 350 | 333 | 350 |
| EG001 | V114 Lot 2 | Infants received a 0.5 mL intramuscular injection of V114 Lot 2 at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13) | 0 | 347 | 19 | 347 | 337 | 347 |
| EG002 | Prevnar 13â„¢ | Infants received a 0.5 mL intramuscular injection of Prevnar 13â„¢ at 2, 4, 6, and 12-15 months of age (Study Day 1, Month 2, Month 4, and Month 10-13) | 0 | 347 | 15 | 347 | 330 | 347 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Infantile colic | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Leukoplakia oral | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pylorospasm | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Milk allergy | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Serum sickness | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| H1N1 influenza | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Haemophilus bacteraemia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Salmonellosis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Burns second degree | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Fontanelle bulging | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Infantile spasms | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Testicular atrophy | Reproductive system and breast disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Apparent life threatening event | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Obliterative bronchiolitis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Purpura | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Teething | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Oct 2, 2019 |
| 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 |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not Hispanic Or Latino |
|
| Not Reported |
|
| Unknown |
|
| Type 3 |
|
|
| Type 4 |
|
|
| Type 5 |
|
|
| Type 6A |
|
|
| Type 6B |
|
|
| Type 7F |
|
|
| Type 9V |
|
|
| Type 14 |
|
|
| Type 18C |
|
|
| Type 19A |
|
|
| Type 19F |
|
|
| Type 23F |
|
|
| Type 3 | Miettinen and Nurminen | < 0.001 | Difference in Percentages | 24.2 | 2-Sided | 95 | 18.7 | 30.0 | Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar | Non-Inferiority | Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13â„¢) being greater than -0.15 for each of the 13 shared serotypes. |
| Type 4 | Miettinen and Nurminen | < 0.001 | Difference in Percentages | 3.0 | 2-Sided | 95 | 0.0 | 6.4 | Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13â„¢ | Non-Inferiority | Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13â„¢) being greater than -0.15 for each of the 13 shared serotypes. |
| Type 5 | Miettinen and Nurminen | < 0.001 | Difference in Percentages | -0.5 | 2-Sided | 95 | -3.9 | 2.8 | Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13â„¢ | Non-Inferiority | Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13â„¢) being greater than -0.15 for each of the 13 shared serotypes. |
| Type 6A | Miettinen and Nurminen | < 0.001 | Difference in Percentages | -5.6 | 2-Sided | 95 | -10.0 | -1.6 | Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13â„¢ | Non-Inferiority | Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13â„¢) being greater than -0.15 for each of the 13 shared serotypes. |
| Type 6B | Miettinen and Nurminen | < 0.001 | Difference in Percentages | -0.8 | 2-Sided | 95 | -5.7 | 4.0 | Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13â„¢ | Non-Inferiority | Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13â„¢) being greater than -0.15 for each of the 13 shared serotypes. |
| Type 7F | Miettinen and Nurminen | < 0.001 | Difference in Percentages | 0.7 | 2-Sided | 95 | -1.1 | 2.7 | Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13â„¢ | Non-Inferiority | Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13â„¢) being greater than -0.15 for each of the 13 shared serotypes. |
| Type 9V | Miettinen and Nurminen | < 0.001 | Difference in Percentages | 1.3 | 2-Sided | 95 | -1.9 | 4.6 | Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13â„¢ | Non-Inferiority | Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13â„¢) being greater than -0.15 for each of the 13 shared serotypes. |
| Type 14 | Miettinen and Nurminen | < 0.001 | Difference in Percentages | 2.0 | 2-Sided | 95 | -0.2 | 4.7 | Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13â„¢ | Non-Inferiority | Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13â„¢) being greater than -0.15 for each of the 13 shared serotypes. |
| Type 18C | Miettinen and Nurminen | < 0.001 | Difference in Percentages | 1.2 | 2-Sided | 95 | -2.1 | 4.7 | Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13â„¢ | Non-Inferiority | Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13â„¢) being greater than -0.15 for each of the 13 shared serotypes. |
| Type 19A | Miettinen and Nurminen | < 0.001 | Difference in Percentages | 0.3 | 2-Sided | 95 | -1.9 | 2.6 | Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13â„¢ | Non-Inferiority | Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13â„¢) being greater than -0.15 for each of the 13 shared serotypes. |
| Type 19F | Miettinen and Nurminen | < 0.001 | Difference in Percentages | 0.3 | 2-Sided | 95 | -1.0 | 1.9 | Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13â„¢ | Non-Inferiority | Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13â„¢) being greater than -0.15 for each of the 13 shared serotypes. |
| Type 23F | Miettinen and Nurminen | < 0.001 | Difference in Percentages | 1.8 | 2-Sided | 95 | -2.9 | 6.5 | Difference in Response Rate calculated as Percentage V114 Lot 1 minus Percentage Prevnar 13â„¢ | Non-Inferiority | Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13â„¢) being greater than -0.15 for each of the 13 shared serotypes. |
| Type 1 | Miettinen and Nurminen | < 0.001 | Difference in Percentages | 0.9 | 2-Sided | 95 | -2.0 | 3.9 | Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13â„¢ | Non-Inferiority | Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13â„¢) being greater than -0.15 for each of the 13 shared serotypes. |
| Type 3 | Miettinen and Nurminen | < 0.001 | Difference in Percentages | 22.3 | 2-Sided | 95 | 16.5 | 28.3 | Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13â„¢ | Non-Inferiority | Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13â„¢) being greater than -0.15 for each of the 13 shared serotypes. |
| Type 4 | Miettinen and Nurminen | < 0.001 | Difference in Percentages | 1.9 | 2-Sided | 95 | -1.4 | 5.4 | Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13â„¢ | Non-Inferiority | Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13â„¢) being greater than -0.15 for each of the 13 shared serotypes. |
| Type 5 | Miettinen and Nurminen | < 0.001 | Difference in Percentages | -0.6 | 2-Sided | 95 | -4.1 | 2.7 | Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13â„¢ | Non-Inferiority | Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13â„¢) being greater than -0.15 for each of the 13 shared serotypes. |
| Type 6A | Miettinen and Nurminen | < 0.001 | Difference in Percentages | -0.6 | 2-Sided | 95 | -4.2 | 2.8 | Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13â„¢ | Non-Inferiority | Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13â„¢) being greater than -0.15 for each of the 13 shared serotypes. |
| Type 6B | Miettinen and Nurminen | < 0.001 | Difference in Percentages | 0.9 | 2-Sided | 95 | -3.7 | 5.6 | Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13â„¢ | Non-Inferiority | Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13â„¢) being greater than -0.15 for each of the 13 shared serotypes. |
| Type 7F | Miettinen and Nurminen | < 0.001 | Difference in Percentages | 0.3 | 2-Sided | 95 | -1.7 | 2.4 | Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13â„¢ | Non-Inferiority | Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13â„¢) being greater than -0.15 for each of the 13 shared serotypes. |
| Type 9V | Miettinen and Nurminen | < 0.001 | Difference in Percentages | 2.0 | 2-Sided | 95 | -1.1 | 5.2 | Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13â„¢ | Non-Inferiority | Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13â„¢) being greater than -0.15 for each of the 13 shared serotypes. |
| Type 14 | Miettinen and Nurminen | < 0.001 | Difference in Percentages | 0.2 | 2-Sided | 95 | -2.8 | 3.1 | Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13â„¢ | Non-Inferiority | Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13â„¢) being greater than -0.15 for each of the 13 shared serotypes. |
| Type 18C | Miettinen and Nurminen | < 0.001 | Difference in Percentages | 2.6 | 2-Sided | 95 | -0.3 | 5.9 | Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13â„¢ | Non-Inferiority | Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13â„¢) being greater than -0.15 for each of the 13 shared serotypes. |
| Type 19A | Miettinen and Nurminen | < 0.001 | Difference in Percentages | -0.1 | 2-Sided | 95 | -2.5 | 2.2 | Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13â„¢ | Non-Inferiority | Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13â„¢) being greater than -0.15 for each of the 13 shared serotypes. |
| Type 19F | Miettinen and Nurminen | < 0.001 | Difference in Percentages | -0.8 | 2-Sided | 95 | -2.9 | 0.9 | Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13â„¢ | Non-Inferiority | Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13â„¢) being greater than -0.15 for each of the 13 shared serotypes. |
| Type 23F | Miettinen and Nurminen | < 0.001 | Difference in Percentages | 4.2 | 2-Sided | 95 | -0.1 | 8.7 | Difference in Response Rate calculated as Percentage V114 Lot 2 minus Percentage Prevnar 13â„¢ | Non-Inferiority | Statistical criterion for non-inferiority corresponds to the lower bound of the adjusted 95% CI of the proportion difference (V114 minus Prevnar 13â„¢) being greater than -0.15 for each of the 13 shared serotypes. |
|
|
|
|
|
|
| Participants |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|