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
Not provided
Not provided
A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants
NOTE: Detailed description has not been entered.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multivalent | Experimental | Pneumococcal conjugate vaccines |
|
| Control | Active Comparator | 13vPnC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multivalent | Biological | Pneumococcal conjugate vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (0.5 to 2.0 centimeter [cm]), moderate (greater than [>] 2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). | Within 7 days after Vaccination 1 |
| Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (0.5 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 example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). | Within 7 days after Vaccination 2 |
| Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (0.5 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 example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). | Within 7 days after Vaccination 3 |
| Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3 | Pre-specified levels of serotypes were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: >=0.35 microgram per milliliter, for serotype 5: >=0.23 microgram per milliliter, for serotype 6B: >=0.10 microgram per milliliter and for serotype 19A: >=0.12 microgram per milliliter. |
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 |
|---|---|---|---|---|---|---|
| Northwest Arkansas Pediatrics | Fayetteville | Arkansas | 72703 | United States | ||
| Premier Health Research Center, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34525007 | Derived | Senders S, Klein NP, Lamberth E, Thompson A, Drozd J, Trammel J, Peng Y, Giardina PC, Jansen KU, Gruber WC, Scott DA, Watson W. Safety and Immunogenicity of a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants in the United States. Pediatr Infect Dis J. 2021 Oct 1;40(10):944-951. doi: 10.1097/INF.0000000000003277. |
| 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 460 participants of age greater than or equal to (>=) 42 to less than or equal to (<=) 98 days at baseline, were enrolled into the study. Out of these 460 participants, 458 participants received study treatment.
Participants were enrolled from 16 April 2018 to 11 February 2020 in the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 20vPnC | Participants were randomized to receive a single 0.5 milliliter (mL) intramuscular injection of 20-valent pneumococcal conjugate vaccine (20vPnC) at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively). |
| FG001 | 13vPnC |
| 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 |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 12, 2018 | Feb 8, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 13vPnC | Biological | Pneumococcal conjugate vaccine |
|
Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (0.5 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 example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). |
| Within 7 days after Vaccination 4 |
| Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as greater than or equal to (>=) 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree 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 (disabled, 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 Vaccination 1 |
| Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as >= 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree 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 (disabled, 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 Vaccination 2 |
| Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as >= 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree 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 (disabled, 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 Vaccination 3 |
| Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as >= 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree 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 (disabled, 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 Vaccination 4 |
| Percentage of Participants With Adverse Events (AEs) From Vaccination 1 to 1 Month After Vaccination 3 | An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship. | From Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) |
| Percentage of Participants With Adverse Events (AEs) From Vaccination 4 to 1 Month After Vaccination 4 | An AE was any untoward medical occurrence in study participant who received study vaccine without regard to possibility of causal relationship. | From Vaccination 4 to 1 month after Vaccination 4 |
| Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination 1 to 6 Months Following Vaccination 4 | An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect. | From Vaccination 1 to 6 months after Vaccination 4 (up to 16 months) |
| Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Vaccination 1 to 6 Months Following Vaccination 4 | An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. | From Vaccination 1 to 6 months after Vaccination 4 (duration of 16 months) |
| 1 month after Vaccination 3 |
| Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3 | IgG GMCs were determined for each of the 20 pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. | 1 month after Vaccination 3 |
| Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4 | IgG GMCs were determined for each of the 20 pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. | 1 Month after Vaccination 4 |
| Downey |
| California |
| 90240 |
| United States |
| St. Joseph Heritage Healthcare | Huntington Beach | California | 92648 | United States |
| Kaiser Permanente Oakland | Oakland | California | 94611 | United States |
| Orange County Research Institute | Ontario | California | 91762 | United States |
| Kaiser Permanente South Sacramento | Sacramento | California | 95823 | United States |
| Kaiser Permanente San Jose | San Jose | California | 95119 | United States |
| Kaiser Permanente Santa Clara | Santa Clara | California | 95051 | United States |
| ACC Pediatric Research | Haughton | Louisiana | 71037 | United States |
| MedPharmics, LLC | Metairie | Louisiana | 70006 | United States |
| LSUHSC Shreveport | Shreveport | Louisiana | 71103 | United States |
| University Health Shreveport | Shreveport | Louisiana | 71103 | United States |
| Children's Physicians, Creighton University Medical Center | Omaha | Nebraska | 68131 | United States |
| Child Health Care Associates | East Syracuse | New York | 13057 | United States |
| Blue Ridge Pediatric and Adolescent Medicine, Inc. | Boone | North Carolina | 28607 | United States |
| Capitol Pediatrics & Adolescent Center PLLC | Raleigh | North Carolina | 27609 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45206 | United States |
| Cincinnati Children's Medical Center | Cincinnati | Ohio | 45206 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45225 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229-3039 | United States |
| Pediatric Associates of Mt. Carmel, Inc. | Cincinnati | Ohio | 45245 | United States |
| Ohio Pediatric Research Association, Inc. | Dayton | Ohio | 45414 | United States |
| Senders Pediatrics | South Euclid | Ohio | 44121 | United States |
| Oklahoma State University - Center for Health Sciences | Tulsa | Oklahoma | 74127 | United States |
| Allegheny Health and Wellness Pavilion | Erie | Pennsylvania | 16506 | United States |
| CCP - Kid's Way | Hermitage | Pennsylvania | 16148 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Coastal Pediatric Associates | Charleston | South Carolina | 29414 | United States |
| Coastal Pediatric Research | Charleston | South Carolina | 29414 | United States |
| Palmetto Pediatrics, PA | North Charleston | South Carolina | 29406-9170 | United States |
| University of Texas Medical Branch | Galveston | Texas | 77555-1115 | United States |
| Tekton Research, Inc. | San Antonio | Texas | 78240 | United States |
| Wee Care Pediatrics | Layton | Utah | 84041 | United States |
| Wasatch Pediatrics, Cottonwood Office | Murray | Utah | 84107 | United States |
| Wee Care Pediatrics | Roy | Utah | 84067 | United States |
| CopperView Medical Center | South Jordan | Utah | 84095 | United States |
| Wee Care Pediatrics | Syracuse | Utah | 84075 | United States |
| Pediatric Associates of Charlottesville, PLC | Charlottesville | Virginia | 22902 | United States |
| Pediatric Research of Charlottesville, LLC | Charlottesville | Virginia | 22902 | United States |
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively). |
| Vaccination 1 |
|
| Vaccination 2 |
|
| Vaccination 3 |
|
| Vaccination 4 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
All randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 20vPnC | Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively). |
| BG001 | 13vPnC | Participants were randomized to receive a single 0.5 mL intramuscular injection of 13vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively). |
| 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 Vaccination 1 | Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (0.5 to 2.0 centimeter [cm]), moderate (greater than [>] 2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). | Dose 1 to Dose 3 safety population included participants who received Dose 1 and had safety follow up between Dose 1 and the blood draw visit 1 month after Dose 3. Here, "Overall Number of Participants Analyzed" =participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 7 days after Vaccination 1 |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (0.5 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 example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). | Dose 1 to Dose 3 safety population included participants who received Dose 1 and had safety follow up between Dose 1 and the blood draw visit 1 month after Dose 3. Here, "Overall Number of Participants Analyzed" =participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 7 days after Vaccination 2 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (0.5 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 example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). | Dose 1 to Dose 3 safety population included participants who received Dose 1 and had safety follow up between Dose 1 and the blood draw visit 1 month after Dose 3. Here, "Overall Number of Participants Analyzed" =participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 7 days after Vaccination 3 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 | Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (0.5 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 example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). | Dose 4 safety population included participants who received Dose 4 and had safety follow up between Dose 4 and 6 months after Dose 4. Here, "Overall Number of Participants Analyzed" =participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 7 days after Vaccination 4 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as greater than or equal to (>=) 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree 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 (disabled, 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). | Dose 1 to Dose 3 safety population included participants who received Dose 1 and had safety follow up between Dose 1 and the blood draw visit 1 month after Dose 3. Here, "Overall Number of Participants Analyzed" =participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 7 days after Vaccination 1 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as >= 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree 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 (disabled, 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). | Dose 1 to Dose 3 safety population included participants who received Dose 1 and had safety follow up between Dose 1 and the blood draw visit 1 month after Dose 3. Here, "Overall Number of Participants Analyzed" =participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 7 days after Vaccination 2 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as >= 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree 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 (disabled, 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). | Dose 1 to Dose 3 safety population included participants who received Dose 1 and had safety follow up between Dose 1 and the blood draw visit 1 month after Dose 3. Here, "Overall Number of Participants Analyzed" =participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 7 days after Vaccination 3 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as >= 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree 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 (disabled, 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). | Dose 4 safety population included participants who received Dose 4 and had safety follow up between Dose 4 and 6 months after Dose 4. Here, "Overall Number of Participants Analyzed" =participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Within 7 days after Vaccination 4 |
| |||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Adverse Events (AEs) From Vaccination 1 to 1 Month After Vaccination 3 | An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship. | Dose 1 to Dose 3 safety population included participants who received Dose 1 and had safety follow up between Dose 1 and the blood draw visit 1 month after Dose 3. | Posted | Number | 95% Confidence Interval | percentage of participants | From Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Adverse Events (AEs) From Vaccination 4 to 1 Month After Vaccination 4 | An AE was any untoward medical occurrence in study participant who received study vaccine without regard to possibility of causal relationship. | Dose 4 safety population included participants who received Dose 4 and had safety follow up between Dose 4 and 6 months after Dose 4. | Posted | Number | 95% Confidence Interval | percentage of participants | From Vaccination 4 to 1 month after Vaccination 4 |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination 1 to 6 Months Following Vaccination 4 | An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect. | Overall safety analysis set included all participants who received at least 1 dose of study vaccine (20vPnC or 13vPnC) and had safety follow up in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | From Vaccination 1 to 6 months after Vaccination 4 (up to 16 months) |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Vaccination 1 to 6 Months Following Vaccination 4 | An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. | Overall safety analysis set included all participants who received at least 1 dose of study vaccine (20vPnC or 13vPnC) and had safety follow up in the study. | Posted | Number | 95% Confidence Interval | percentage of participants | From Vaccination 1 to 6 months after Vaccination 4 (duration of 16 months) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3 | Pre-specified levels of serotypes were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: >=0.35 microgram per milliliter, for serotype 5: >=0.23 microgram per milliliter, for serotype 6B: >=0.10 microgram per milliliter and for serotype 19A: >=0.12 microgram per milliliter. | Dose 3 evaluable immunogenicity population: included all eligible participants, who were randomly assigned to receive the vaccine, aged 42-98 days on the day of first vaccination, received 3 doses of assigned vaccine, had valid determinate IgG concentration for at least 1 serotype from 1 month after Dose 3 visit, had blood collection within 27-56 days, inclusive, after Dose 3, had not received prohibited vaccines before blood draw at 1 month after Dose 3, and had no major protocol deviations. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month after Vaccination 3 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3 | IgG GMCs were determined for each of the 20 pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. | Dose 3 evaluable immunogenicity population: included all eligible participants, who were randomly assigned to receive the vaccine, aged 42-98 days on the day of first vaccination, received 3 doses of assigned vaccine, had valid determinate IgG concentration for at least 1 serotype from 1 month after Dose 3 visit, had blood collection within 27-56 days, inclusive, after Dose 3, had not received prohibited vaccines before blood draw at 1 month after Dose 3, and had no major protocol deviations. | Posted | Geometric Mean | 95% Confidence Interval | microgram per milliliter | 1 month after Vaccination 3 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4 | IgG GMCs were determined for each of the 20 pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. | Dose 4 evaluable immunogenicity population: eligible participants, randomly assigned to receive vaccine, aged 42-98 days on day of first vaccination, received all 4 doses of assigned vaccine, with Dose 4 received in defined window (365-386 days of age), had valid determinate IgG concentration for at least 1 serotype 1 month post dose 4,had blood collection within 27-56 days post Dose 4,had not received prohibited vaccines before blood draw at 1 month post Dose 4,had no major protocol deviations. | Posted | Geometric Mean | 95% Confidence Interval | microgram per milliliter | 1 Month after Vaccination 4 |
|
Local reactions and Systemic events: within 7 days after each vaccination (systematic assessment), Non serious AEs: Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) and Vaccination 4 to 1 month after Vaccination 4, SAEs: up to 16 months after Vaccination 1
Same event may appear as AE and SAE, 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 serious and non-serious event during study. Overall safety analysis set was analyzed.
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 | Participants were randomized to receive a single 0.5 mL intramuscular injection of 20vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4 respectively). | 0 | 231 | 12 | 231 | 225 | 231 |
| EG001 | 13vPnC | Participants were randomized to receive a single 0.5 mL intramuscular injection of 13vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively). | 0 | 227 | 5 | 227 | 224 | 227 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Seizure like phenomena | Nervous system disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Plagiocephaly | Congenital, familial and genetic disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Teething | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Injection site erythema (REDNESS) | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Injection site pain (PAIN) | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Injection site swelling (SWELLING) | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Candida nappy rash | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Conjunctivitis bacterial | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Skin candida | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
| |
| Decreased appetite (DECREASED APPETITE) | Metabolism and nutrition disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Feeding disorder | Metabolism and nutrition disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Acquired plagiocephaly | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Agitation neonatal | Nervous system disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Hypersomnia (INCREASED SLEEP) | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Irritability (IRRITABILITY) | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Eczema infantile | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
| |
| Pyrexia (FEVER) | General disorders | MedDRA 22.1 | 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 |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 11, 2020 | Feb 8, 2021 | Prot_001.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 |
|---|---|
| D017778 | Vaccines, Combined |
| D022242 | Pneumococcal Vaccines |
| ID | Term |
|---|---|
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Redness: Moderate |
|
| Redness: Severe |
|
| Swelling: Any |
|
| Swelling: Mild |
|
| Swelling: Moderate |
|
| Swelling: Severe |
|
| Pain at the injection site: Any |
|
| Pain at the injection site: Mild |
|
| Pain at the injection site: Moderate |
|
| Pain at the injection site: Severe |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Participants were randomized to receive a single 0.5 mL intramuscular injection of 13vPnC at 2, 4, 6, and 12 months of age (Dose/Vaccination 1, 2, 3, and 4, respectively).
|
|
|
|
|
|
|
|
|
|
| Counts |
|---|
| Participants |
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|