Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003307-35 | 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 and tolerability of 20vPnC in healthy infants.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20-valent pneumococcal conjugate vaccine | Experimental | Pneumococcal conjugate vaccine |
|
| 13-valent pneumococcal conjugate vaccine | Active Comparator | Pneumococcal conjugate vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20-valent pneumococcal conjugate vaccine | Biological | Pneumococcal conjugate vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: greater than (>) 0.0 to 2.0 cm; moderate: >2.0 to 7.0 cm; and severe: >7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement. | Within 7 Days after Dose 1 |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: >0.0 to 2.0 cm; moderate: >2.0 to 7.0 cm; and severe: >7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement. | Within 7 Days after Dose 2 |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: >0.0 to 2.0 cm; moderate: >2.0 to 7.0 cm; and severe: >7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement. | Within 7 Days after Dose 3 |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: >0.0 to 2.0 cm; moderate: >2.0 to 7.0 cm; and severe: >7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eclipse Clinical Research | Tucson | Arizona | 85745 | United States | ||
| Good Samaritan Family Health Team |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Not provided
Not provided
Not provided
A total of 1511 participants were enrolled and randomized to receive 4 doses of 20-valent pneumococcal conjugate vaccine (20vPnC) or 13vPnC of which 7 participants were not vaccinated and 1504 were vaccinated with either 20vPnC or 13vPnC.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 20vPnC | Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 milliliter (mL) 20vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 31, 2022 | May 18, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
| 13-valent pneumococcal conjugate vaccine | Biological | Pneumococcal conjugate vaccine |
|
| Within 7 Days after Dose 4 |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature greater than or equal to (>=) 38.0 degrees Celsius (C) and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). | Within 7 Days after Dose 1 |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature >=38.0 degrees C and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). | Within 7 Days after Dose 2 |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature >=38.0 degrees C and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). | Within 7 Days after Dose 3 |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature >=38.0 degrees C and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). | Within 7 Days after Dose 4 |
| Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. | From Dose 1 to 1 Month after Dose 3 |
| Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. | From Dose 4 to 1 Month after Dose 4 |
| Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 6 Months After Dose 4 | A SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect and other important medical events. | From Dose 1 to 6 Months after Dose 4 |
| Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 6 Months After Dose 4 | An NDCMC was defined as a significant disease or medical condition, not previously identified, that is expected to be persistent or was otherwise long-lasting in its effects. | From Dose 1 to 6 Months after Dose 4 |
| Fullerton |
| California |
| 92831 |
| United States |
| FocilMed | Oxnard | California | 93030 | United States |
| Superior Research, LLC | Sacramento | California | 95831 | United States |
| Carey Chronis, MD | Ventura | California | 93003 | United States |
| Fomat - Robert Nudelman MD | Westlake Village | California | 91361 | United States |
| Ebert Family Clinic | Frisco | Colorado | 80443 | United States |
| Advanced Research for Health Improvement, LLC | Fort Myers | Florida | 33907 | United States |
| Pensacola Pediatrics | Gulf Breeze | Florida | 32563 | United States |
| Y&L Advance Health Care Inc, d/b/a Elite | Miami | Florida | 33144 | United States |
| Advanced Research for Health Improvement, LLC | Naples | Florida | 34102 | United States |
| Citadelle Clinical Research | North Miami Beach | Florida | 33162 | United States |
| Avanza Medical Research Center | Pensacola | Florida | 32503 | United States |
| Pensacola Pediatrics | Pensacola | Florida | 32504 | United States |
| KIDZ Medical Services Pediatric Pulmonary Center | South Miami | Florida | 33143 | United States |
| Teena Hughes/PAS Research | Tampa | Florida | 33613 | United States |
| Idaho Falls Pediatrics | Ammon | Idaho | 83406 | United States |
| Elite Clinical Trials LLLP | Blackfoot | Idaho | 83221 | United States |
| Idaho Falls Pediatrics | Idaho Falls | Idaho | 83402 | United States |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | United States |
| The Pediatric Center | Idaho Falls | Idaho | 83404 | United States |
| Cotton O'Neil Clinical Research Center, Pediatrics | Topeka | Kansas | 66604 | United States |
| All Children Pediatrics | Louisville | Kentucky | 40243 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| MedClinical Research Partners, LLC | East Orange | New Jersey | 07018 | United States |
| Advantage Clinical Trials | The Bronx | New York | 10468 | United States |
| Pediatric Partners, PA | Raleigh | North Carolina | 27609 | United States |
| PMG Research Inc., d/b/a PMG Research of Piedmont HealthCare | Statesville | North Carolina | 28625 | United States |
| Ford Simpson Lively and Rice Pedtrics, PA (Wake Health Network) | Winston-Salem | North Carolina | 27103 | United States |
| PMG Research of Winston-Salem | Winston-Salem | North Carolina | 27103 | United States |
| Omega Medical Research | Warwick | Rhode Island | 02886 | United States |
| Coastal Pediatric Research | Summerville | South Carolina | 29486 | United States |
| The Jackson Clinic, PA | Jackson | Tennessee | 38305 | United States |
| Advent Health Family Medicine Rural Health Clinics, Inc. | Lampasas | Texas | 76550 | United States |
| FMC Science | Lampasas | Texas | 76550 | United States |
| Maximos Ob/Gyn | League City | Texas | 77573 | United States |
| Rio Grande Valley Clinical Research Institute | Pharr | Texas | 78577 | United States |
| Tanner Clinic | Layton | Utah | 84041 | United States |
| Wasatch Pediatrics - St. Marks Office | Salt Lake City | Utah | 84124 | United States |
| CopperView Medical Center | South Jordan | Utah | 84095 | United States |
| PI-Coor Clinical Research LLC | Burke | Virginia | 22015 | United States |
| Clinica Mayo UMCB S.R.L. | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Hospital del Nino Jesus | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Centro Medico Dra. De Salvo | Buenos Aires | C1426ABP | Argentina |
| Aggarwal and Associates Limited | Brampton | Ontario | L6T 0G1 | Canada |
| Dawson Clinical Research Inc. | Guelph | Ontario | N1H 1B1 | Canada |
| Milestone Research , Inc | London | Ontario | N5W 6A2 | Canada |
| Bluewater Clinical Research Group Inc. | Sarnia | Ontario | N7T 4X3 | Canada |
| Dr. Hartley Garfield Medicine Professional Corporation | Toronto | Ontario | M5G 1N8 | Canada |
| Centre hospitalier universitaire (CHU) Sainte-Justine | Montreal | Quebec | H3T 1C5 | Canada |
| McGill University Health Centre, Vaccine Study Centre | Pierrefonds | Quebec | H9H 4Y6 | Canada |
| CHU de Quebec-Universite Laval | Québec | Quebec | G1E 7G9 | Canada |
| CESFAM Colina | Colina, Santiago | Santiago Metropolitan | 9350079 | Chile |
| CESFAM Esmeralda | Colina, Santiago | Santiago Metropolitan | Chile |
| Biocinetic | Santiago | Santiago Metropolitan | 8331143 | Chile |
| Grupo Estudios Clínicos Infectología Respiratoria | Santiago | Santiago Metropolitan | 8380453 | Chile |
| Hospital Padre Hurtado | Santiago | Santiago Metropolitan | 8880465 | Chile |
| Ordinace praktickeho lekare pro deti a dorost | Hradec Králové | 50004 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Jindrichuv Hradec II | 377 01 | Czechia |
| Detska ambulance Petriny spol. s r.o. | Veleslavín | 162 00 | Czechia |
| MeVac - Meilahti Vaccine Research Center | Helsinki | 00290 | Finland |
| SIBAmed GmbH & Co.KG | Leipzig | Saxony | 04103 | Germany |
| Kinderarztpraxis Bramsche | Bramsche | 49565 | Germany |
| Arztpraxis Dr. med. Dr. rer. nat. Helmut Pabel | Herford | 32049 | Germany |
| Praxis fuer Kinderpneumologie und Allergologie Mannheim | Mannheim | 68161 | Germany |
| Kinderarztpraxis Ralph Köllges, Jacek Mossakowski, Dr. med. Martina Meyer-Krott | Mönchengladbach | 41236 | Germany |
| Praxis Dr. med. Joachim Weimer | Reinfeld | 23858 | Germany |
| University General Hospital of Heraklion | Heraklion | Crete | 71110 | Greece |
| General University Hospital of Larissa | Larissa | Thessaly | 41110 | Greece |
| "Aghia Sophia" Children's Hospital | Athens | 11527 | Greece |
| P. and A. Kyriakou Children's Hospital | Athens | 11527 | Greece |
| University General Hospital "ATTIKON" | Athens | 12462 | Greece |
| "Ippokratio" General Hospital of Thessaloniki | Thessaloniki | 54642 | Greece |
| Papp és Tsa Eü és Szolg Bt | Szigetvár | Baranya | 7900 | Hungary |
| Dr Pölöskey Péter Egyéni Cég Házi Gyermekorvosi Szolgálat Szombathely | Szombathely | Vas County | 9700 | Hungary |
| Gyerkőc Med Bt. Házi Gyermekorvosi Rendelő | Budapest | 1042 | Hungary |
| Futurenest Kft. Pestszentimrei Gyermekrendelő | Budapest | 1188 | Hungary |
| Gyorine dr Bari Eszter E. V. 1. sz. Gyermek Haziorvosi Praxis | Csongrád | 6640 | Hungary |
| Futurenest Kft. 16. házi gyermekorvosi rendelő | Debrecen | 4025 | Hungary |
| Mimiped Bt | Győr | 9024 | Hungary |
| Futurenest Kft | Miskolc | 3527 | Hungary |
| Bettimedical BT | Százhalombatta | 2440 | Hungary |
| Ponce Medical School Foundation Inc./ CAIMED Center | Ponce | 00176 | Puerto Rico |
| CHUS - Hospital Clinico Universitario | Santiago de Compostela | A Coruna | 15706 | Spain |
| Hospital Universitari General de Catalunya | Sant Cugat del Vallès | Barcelona | 08195 | Spain |
| Centro de Salud de Burriana II | Burriana | Castellon | 12530 | Spain |
| Hospital Universitario de Burgos | Burgos | Castille and León | 09006 | Spain |
| Hospital Universitario HM Monteprincipe | Boadilla del Monte | Madrid | 28660 | Spain |
| Centro de Salud L'Eliana | L'Eliana | Valencia | 46183 | Spain |
| Centro de Salud de Paiporta | Paiporta | Valencia | 46200 | Spain |
| Clinica Corachan | Barcelona | 08017 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Grupo Pediatrico Uncibay | Málaga | 29015 | Spain |
| Centro de Salud de Malvarrosa | Valencia | 46011 | Spain |
| FISABIO | Valencia | 46020 | Spain |
| Centro de Salud la Serreria II | Valencia | 46022 | Spain |
| 13vPnC |
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age. |
| Dose 1 |
|
| Dose 2 |
|
| Dose 3 |
|
| Dose 4 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received any incorrect study vaccination during the study was excluded.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 20vPnC | Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age. |
| BG001 | 13vPnC | Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 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 | Days |
| |||||||||||||||
| 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 Local Reactions Within 7 Days After Dose 1 | Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: greater than (>) 0.0 to 2.0 cm; moderate: >2.0 to 7.0 cm; and severe: >7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement. | Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. Here, "Number of Participants Analyzed" signifies number of participants with any e-diary data reported after Dose 1. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 Days after Dose 1 |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: >0.0 to 2.0 cm; moderate: >2.0 to 7.0 cm; and severe: >7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement. | Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. Here, "Number of Participants Analyzed" signifies number of participants with any e-diary data reported after Dose 2. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 Days after Dose 2 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Local Reactions Within 7 Days After Dose 3 | Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: >0.0 to 2.0 cm; moderate: >2.0 to 7.0 cm; and severe: >7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement. | Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. Here, "Number of Participants Analyzed" signifies number of participants with any e-diary data reported after Dose 3. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 Days after Dose 3 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Local Reactions Within 7 Days After Dose 4 | Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an e-diary. Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild: >0.0 to 2.0 cm; moderate: >2.0 to 7.0 cm; and severe: >7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if gently touched with crying; severe: limited limb movement. | Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. Here, "Number of Participants Analyzed" signifies number of participants with any e-diary data reported after Dose 4. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 Days after Dose 4 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature greater than or equal to (>=) 38.0 degrees Celsius (C) and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). | Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. Here, "Number of Participants Analyzed" signifies number of participants with any e-diary data reported after Dose 1. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 Days after Dose 1 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature >=38.0 degrees C and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). | Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. Here, "Number of Participants Analyzed" signifies number of participants with any e-diary data reported after Dose 2. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 Days after Dose 2 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Systemic Events Within 7 Days After Dose 3 | Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature >=38.0 degrees C and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). | Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. Here, "Number of Participants Analyzed" signifies number of participants with any e-diary data reported after Dose 3. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 Days after Dose 3 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Systemic Events Within 7 Days After Dose 4 | Systemic events included fever, decreased appetite, drowsiness, and irritability. Fever was defined as temperature >=38.0 degrees C and categorized as >=38.0 to 38.4 degrees C, >38.4 to 38.9 degrees C, >38.9 to 40.0 degrees C and >40.0 degrees C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabling, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable, crying could not be comforted). | Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. Here, "Number of Participants Analyzed" signifies number of participants with any e-diary data reported after Dose 4. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 Days after Dose 4 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Adverse Events (AEs) From Dose 1 to 1 Month After Dose 3 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. | Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Dose 1 to 1 Month after Dose 3 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With AEs From Dose 4 to 1 Month After Dose 4 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. | Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. Here, "Number of Participants Analyzed" signifies number of participants who received Dose 4. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Dose 4 to 1 Month after Dose 4 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 to 6 Months After Dose 4 | A SAE was any untoward medical occurrence that, at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; congenital anomaly/birth defect and other important medical events. | Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Dose 1 to 6 Months after Dose 4 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Dose 1 to 6 Months After Dose 4 | An NDCMC was defined as a significant disease or medical condition, not previously identified, that is expected to be persistent or was otherwise long-lasting in its effects. | Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Dose 1 to 6 Months after Dose 4 |
|
|
Local reactions and systemic events recorded using systematic assessment: within 7 days after Dose 1, 2, 3, 4; SAEs and all-cause mortality recorded using non-systematic assessment: From Dose 1 up to 6 months after Dose 4; other AEs recorded using non-systematic assessment: from Dose 1 up to 1 month after Dose 3 and from Dose 4 up to 1 month after Dose 4
The same event may appear as both AE and SAE. However, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study. Safety population included all participants who received at least 1 dose of the investigational product with safety follow up after any dose. Participant who received incorrect vaccination was excluded from analysis.
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 | 20vPnC | Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age. | 0 | 1,000 | 44 | 1,000 | 960 | 1,000 |
| EG001 | 13vPnC | Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age. | 0 | 503 | 28 | 503 | 481 | 503 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Allergic colitis | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Adverse food reaction | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Gastroenteritis norovirus | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Respiratory syncytial virus bronchitis | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Viraemia | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Foreign body aspiration | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 25.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Infantile spasms | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Breath holding | Psychiatric disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Hypersensitivity vasculitis | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site erythema (REDNESS) | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Injection site pain (PAIN) | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Injection site swelling (SWELLING) | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Pyrexia (FEVER) | General disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Non-systematic Assessment |
| |
| Decreased appetite (DECREASED APPETITE) | Metabolism and nutrition disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Hypersomnia (INCREASED SLEEP) | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
| |
| Irritability (IRRITABILITY) | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 30, 2020 | May 18, 2023 | SAP_001.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
| 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 |
|
| Redness: Severe |
|
| Swelling: Mild |
|
| Swelling: Moderate |
|
| Swelling: Severe |
|
| Pain at injection site: Mild |
|
| Pain at injection site: Moderate |
|
| Pain at injection site: Severe |
|
|
|
|
|
|
|
| 13vPnC |
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age. |
|
|
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age. |
|
|
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age. |
|
|
Infants 42 to 98 days of age were enrolled to receive 4 doses of 0.5 mL 13vPnC intramuscularly. Dose 1 was given at enrollment. Dose 2 was given 42 to 63 days later. Dose 3 was given 42 to 63 days after Dose 2. Dose 4 was administered between 12 to 15 months of age. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Counts |
|---|
| Participants |
|
|