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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505154-18-00 | Registry Identifier | CTIS (EU) |
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The purpose of the study is to learn about the effects of a monovalent (single component) pneumococcal conjugate candidate (mPnC candidate) when given to toddlers between 11 and 15 months of age.
All participants in this study will receive 2 doses of either mPnC candidate or mPnC control at the clinic approximately 8 weeks apart. All participants will also receive their third (toddler) dose of PCV10 at Visit 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mPnC candidate | Experimental | Participants will receive the mPnC candidate at Visit 1 and Visit 3 (approximately 8 weeks apart). PCV10 will also be given at Visit 1. |
|
| mPnC control | Active Comparator | Participants will receive the mPnC control at Visit 1 and Visit 3 (approximately 8 weeks apart). PCV10 will also be given at Visit 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mPnC candidate | Biological | monovalent pneumococcal conjugate candidate |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Local Reactions Within 7 Days After Dose 1 | Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild: > 0 to 2.0 centimeter (cm), moderate: >2.0 to 7.0 cm, severe: >7.0 cm and Grade 4: necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched, with crying, severe: caused limitation of limb movement and Grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain at injection site. Grade 4 assessments were made by the investigator. Any local reaction: any mild, moderate, severe, or Grade 4 redness, swelling, or pain at the injection site. | Day 1 through Day 7, where Day 1 is the day of Dose 1 administration (Visit 1 of study) |
| Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild: > 0 to 2.0 cm, moderate: >2.0 to 7.0 cm, severe: >7.0 cm and Grade 4: necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched, with crying, severe: caused limitation of limb movement and Grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain at injection site. Grade 4 assessments were made by the investigator. Any local reaction: any mild, moderate, severe, or Grade 4 redness, swelling, or pain at the injection site. | Day 1 through Day 7, where Day 1 is the day of Dose 2 administration (Visit 3 of study) |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Fever (oral temperature >= 38 degree Celsius [degC]) was categorized as >=38.0-38.4 degC, >38.4-38.9 degC, >38.9-40.0 degC and >40.0 degC. Decreased appetite was graded as mild: decreased interest in eating, moderate: decreased oral intake, severe: refusal to feed. Drowsiness was graded as mild: increased/prolonged sleeping bouts, moderate: slightly subdued, interfered daily activity, severe: disabled, not interested in daily activity. Irritability was graded as mild: easily consolable, moderate: required increased attention, severe: inconsolable, crying couldn't be comforted. Grade 4 decreased appetite, drowsiness and irritability events led to emergency room visit or hospitalization and were classified by investigator/medically qualified person. Any systemic event: any fever, decreased appetite, drowsiness, irritability. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Concentration (GMCs) of Pneumococcal Immunoglobulin G (IgG) at 1 Month After Dose 1 | GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution). | 1 month after Dose 1 |
| GMCs of Pneumococcal IgG at 1 Month After Dose 2 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FVR, Kokkolan rokotetutkimusklinikka | Kokkola | Keski-Pohjanmaa | 67100 | Finland | ||
| FVR, Oulun rokotetutkimusklinikka |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | mPnC Candidate | Participants who had previously received 2 doses of 10-valent pneumococcal conjugate vaccine (PCV10) primary series as part of their infant routine vaccines were administered 0.5 milliliter (mL) dose of monovalent pneumococcal conjugate (mPnC) candidate intramuscularly at Visit 1 of the study (Day 1 of study; Dose 1) and Visit 3 of the study (56 to 70 days after Visit 1; Dose 2). Participants also received their third (toddler) dose of PCV10 at Visit 1 per childhood vaccine standard of care. |
| FG001 | mPnC Control | Participants who had previously received 2 doses of PCV10 primary series as part of their infant routine vaccines were administered 0.5 mL dose of mPnC control intramuscularly at Visit 1 of the study (Day 1 of study; Dose 1) and Visit 3 of the study (56 to 70 days after Visit 1; Dose 2). Participants also received their third (toddler) dose of PCV10 at Visit 1 per childhood vaccine standard of care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | mPnC Candidate | Participants who had previously received 2 doses of PCV10 primary series as part of their infant routine vaccines were administered 0.5 mL dose of mPnC candidate intramuscularly at Visit 1 of the study (Day 1 of study; Dose 1) and Visit 3 of the study (56 to 70 days after Visit 1; Dose 2). Participants also received their third (toddler) dose of PCV10 at Visit 1 per childhood vaccine standard of care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 redness, swelling and pain at injection site. Redness and swelling were graded as mild: > 0 to 2.0 centimeter (cm), moderate: >2.0 to 7.0 cm, severe: >7.0 cm and Grade 4: necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched, with crying, severe: caused limitation of limb movement and Grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain at injection site. Grade 4 assessments were made by the investigator. Any local reaction: any mild, moderate, severe, or Grade 4 redness, swelling, or pain at the injection site. | Safety analysis set included all participants who received at least 1 dose of the study intervention. Here, ''Overall Number of Participants Analyzed'' signifies participants who received Dose 1 and who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 through Day 7, where Day 1 is the day of Dose 1 administration (Visit 1 of study) |
Local reactions and systemic events (systematic collection): Within 7 days after Dose 1 and Dose 2; AEs, SAEs and all-cause mortality (non-systematic collection): From Dose 1 through 1 month after Dose 2 [up to approximately 3.7 months]
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety analysis set included all participants who received at least 1 dose of study intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | mPnC Candidate | Participants who had previously received 2 doses of PCV10 primary series as part of their infant routine vaccines were administered 0.5 mL dose of mPnC candidate intramuscularly at Visit 1 of the study (Day 1 of study; Dose 1) and Visit 3 of the study (56 to 70 days after Visit 1; Dose 2). Participants also received their third (toddler) dose of PCV10 at Visit 1 per childhood vaccine standard of care. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | MedDRA v27.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 15, 2023 | Apr 21, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 1, 2024 | Apr 21, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| mPnC control |
| Biological |
monovalent pneumococcal conjugate control |
|
| Day 1 through Day 7, where Day 1 is the day of Dose 1 administration (Visit 1 of study) |
| Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Fever (oral temperature >= 38 degC) was categorized as >=38.0-38.4 degC, >38.4-38.9 degC, >38.9-40.0 degC and >40.0 degC. Decreased appetite was graded as mild: decreased interest in eating, moderate: decreased oral intake, severe: refusal to feed. Drowsiness was graded as mild: increased/prolonged sleeping bouts, moderate: slightly subdued, interfered daily activity, severe: disabled, not interested in daily activity. Irritability was graded as mild: easily consolable, moderate: required increased attention, severe: inconsolable, crying couldn't be comforted. Grade 4 decreased appetite, drowsiness and irritability events led to emergency room visit or hospitalization and were classified by investigator/medically qualified person. Any systemic event: any fever, decreased appetite, drowsiness, irritability. | Day 1 through Day 7, where Day 1 is the day of Dose 2 administration (Visit 3 of study) |
| Percentage of Participants With Adverse Events (AEs) From Dose 1 Through 1 Month After Dose 2 | An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data. | From Dose 1 through 1 month after Dose 2 [up to approximately 3.7 months] |
| Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 Through 1 Month After Dose 2 | An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic; other situations as judged by investigator. | From Dose 1 through 1 month after Dose 2 [up to approximately 3.7 months] |
GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution). |
| 1 month after Dose 2 |
| Percentage of Participants With Predefined IgG Concentrations at 1 Month After Dose 1 | Predefined IgG concentrations was >= 0.35 micrograms per milliliter (mcg/mL). | 1 month after Dose 1 |
| Percentage of Participants With Predefined IgG Concentrations at 1 Month After Dose 2 | Predefined level of IgG concentrations was >= 0.35 mcg/mL. | 1 month after Dose 2 |
| Geometric Mean Fold Rise (GMFRs) of Pneumococcal IgG From Before Dose 1 to 1 Month After Dose 1 | GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student-t distribution). | From before Dose 1 to 1 month after Dose 1 |
| GMFRs of Pneumococcal IgG From 1 Month After Dose 1 to 1 Month After Dose 2 | GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student-t distribution). | From 1 month after Dose 1 to 1 month after Dose 2 |
| Geometric Mean Titer (GMTs) of Pneumococcal Opsonophagocytic Activity (OPA) at 1 Month After Dose 1 | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). | 1 month after Dose 1 |
| GMTs of Pneumococcal OPA at 1 Month After Dose 2 | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). | 1 month after Dose 2 |
| GMFRs of Pneumococcal OPA From Before Dose 1 to 1 Month After Dose 1 | GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student-t distribution). | From before Dose 1 to 1 month after Dose 1 |
| GMFRs of Pneumococcal OPA From 1 Month After Dose 1 to 1 Month After Dose 2 | GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student-t distribution). | From 1 month after Dose 1 to 1 month after Dose 2 |
| Oulu |
| North Ostrobothnia |
| 90220 |
| Finland |
| FVR, Tampereen rokotetutkimusklinikka | Tampere | Pirkanmaa | 33100 | Finland |
| FVR, Seinäjoen rokotetutkimusklinikka | Seinäjoki | South Ostrobothnia | 60100 | Finland |
| FVR, Turun rokotetutkimusklinikka | Turku | Southwest Finland | 20520 | Finland |
| FVR, Espoon rokotetutkimusklinikka | Espoo | Uusimaa | 02230 | Finland |
| FVR, Etelä-Helsingin rokotetutkimusklinikka | Helsinki | Uusimaa | 00100 | Finland |
| MeVac - Meilahti Vaccine Research Center | Helsinki | Uusimaa | 00290 | Finland |
| FVR, Järvenpään rokotetutkimusklinikka | Jarvenpaa | Uusimaa | 04400 | Finland |
| Centrum Medyczne Pratia Bydgoszcz | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-796 | Poland |
| NZOZ Praktyka Lekarza Rodzinnego "ESKULAP" | Lublin | Lublin Voivodeship | 20-044 | Poland |
| BG001 | mPnC Control | Participants who had previously received 2 doses of PCV10 primary series as part of their infant routine vaccines were administered 0.5 mL dose of mPnC control intramuscularly at Visit 1 of the study (Day 1 of study; Dose 1) and Visit 3 of the study (56 to 70 days after Visit 1; Dose 2). Participants also received their third (toddler) dose of PCV10 at Visit 1 per childhood vaccine standard of care. |
| BG002 | Total | Total of all reporting groups |
| Months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | mPnC Candidate | Participants who had previously received 2 doses of 10-valent pneumococcal conjugate vaccine (PCV10) primary series as part of their infant routine vaccines were administered 0.5 milliliter (mL) dose of monovalent pneumococcal conjugate (mPnC) candidate intramuscularly at Visit 1 of the study (Day 1 of study; Dose 1) and Visit 3 of the study (56 to 70 days after Visit 1; Dose 2). Participants also received their third (toddler) dose of PCV10 at Visit 1 per childhood vaccine standard of care. |
| OG001 | mPnC Control | Participants who had previously received 2 doses of PCV10 primary series as part of their infant routine vaccines were administered 0.5 mL dose of mPnC control intramuscularly at Visit 1 of the study (Day 1 of study; Dose 1) and Visit 3 of the study (56 to 70 days after Visit 1; Dose 2). Participants also received their third (toddler) dose of PCV10 at Visit 1 per childhood vaccine standard of care. |
|
|
| Primary | Percentage of Participants With Local Reactions Within 7 Days After Dose 2 | Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild: > 0 to 2.0 cm, moderate: >2.0 to 7.0 cm, severe: >7.0 cm and Grade 4: necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched, with crying, severe: caused limitation of limb movement and Grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain at injection site. Grade 4 assessments were made by the investigator. Any local reaction: any mild, moderate, severe, or Grade 4 redness, swelling, or pain at the injection site. | Safety analysis set included all participants who received at least 1 dose of the study intervention. Here, ''Overall Number of Participants Analyzed'' signifies participants who received Dose 2 and who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 through Day 7, where Day 1 is the day of Dose 2 administration (Visit 3 of study) |
|
|
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| Primary | Percentage of Participants With Systemic Events Within 7 Days After Dose 1 | Fever (oral temperature >= 38 degree Celsius [degC]) was categorized as >=38.0-38.4 degC, >38.4-38.9 degC, >38.9-40.0 degC and >40.0 degC. Decreased appetite was graded as mild: decreased interest in eating, moderate: decreased oral intake, severe: refusal to feed. Drowsiness was graded as mild: increased/prolonged sleeping bouts, moderate: slightly subdued, interfered daily activity, severe: disabled, not interested in daily activity. Irritability was graded as mild: easily consolable, moderate: required increased attention, severe: inconsolable, crying couldn't be comforted. Grade 4 decreased appetite, drowsiness and irritability events led to emergency room visit or hospitalization and were classified by investigator/medically qualified person. Any systemic event: any fever, decreased appetite, drowsiness, irritability. | Safety analysis set included all participants who received at least 1 dose of the study intervention. Here, ''Overall Number of Participants Analyzed'' signifies participants who received Dose 1 and who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 through Day 7, where Day 1 is the day of Dose 1 administration (Visit 1 of study) |
|
|
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| Primary | Percentage of Participants With Systemic Events Within 7 Days After Dose 2 | Fever (oral temperature >= 38 degC) was categorized as >=38.0-38.4 degC, >38.4-38.9 degC, >38.9-40.0 degC and >40.0 degC. Decreased appetite was graded as mild: decreased interest in eating, moderate: decreased oral intake, severe: refusal to feed. Drowsiness was graded as mild: increased/prolonged sleeping bouts, moderate: slightly subdued, interfered daily activity, severe: disabled, not interested in daily activity. Irritability was graded as mild: easily consolable, moderate: required increased attention, severe: inconsolable, crying couldn't be comforted. Grade 4 decreased appetite, drowsiness and irritability events led to emergency room visit or hospitalization and were classified by investigator/medically qualified person. Any systemic event: any fever, decreased appetite, drowsiness, irritability. | Safety analysis set included all participants who received at least 1 dose of the study intervention. Here, ''Overall Number of Participants Analyzed'' signifies participants who received Dose 2 and who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 through Day 7, where Day 1 is the day of Dose 2 administration (Visit 3 of study) |
|
|
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| Primary | Percentage of Participants With Adverse Events (AEs) From Dose 1 Through 1 Month After Dose 2 | An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data. | Safety analysis set included all participants who received at least 1 dose of the study intervention. Here, ''Overall Number of Participants Analyzed'' signifies participants who received Dose 1 and who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Dose 1 through 1 month after Dose 2 [up to approximately 3.7 months] |
|
|
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| Primary | Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 Through 1 Month After Dose 2 | An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic; other situations as judged by investigator. | Safety analysis set included all participants who received at least 1 dose of the study intervention. Here, ''Overall Number of Participants Analyzed'' signifies participants who received Dose 1 and who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Dose 1 through 1 month after Dose 2 [up to approximately 3.7 months] |
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| Secondary | Geometric Mean Concentration (GMCs) of Pneumococcal Immunoglobulin G (IgG) at 1 Month After Dose 1 | GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution). | Dose 1 evaluable immunogenicity population included all participants who were eligible and randomized, received the study intervention to which they were randomized, had at least 1 valid immunogenicity result within 27 to 56 days, inclusive, after Dose 1, and had no other major protocol deviations as determined by the clinician up to the 1-month post-Dose 1 visit. | Posted | Geometric Mean | 95% Confidence Interval | Microgram/milliliter (mcg/mL) | 1 month after Dose 1 |
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| Secondary | GMCs of Pneumococcal IgG at 1 Month After Dose 2 | GMCs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution). | Dose 2 evaluable immunogenicity population included all participants who were eligible and randomized, received both doses of study intervention to which they were randomly assigned, had at least 1 valid immunogenicity result within 27 to 56 days, inclusive, after Dose 2, and had no other major protocol deviations as determined by the clinician up to the 1-month post-Dose 2 visit. | Posted | Geometric Mean | 95% Confidence Interval | Microgram/milliliter (mcg/mL) | 1 month after Dose 2 |
|
|
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| Secondary | Percentage of Participants With Predefined IgG Concentrations at 1 Month After Dose 1 | Predefined IgG concentrations was >= 0.35 micrograms per milliliter (mcg/mL). | Dose 1 evaluable immunogenicity population included all participants who were eligible and randomized, received the study intervention to which they were randomized, had at least 1 valid immunogenicity result within 27 to 56 days, inclusive, after Dose 1, and had no other major protocol deviations as determined by the clinician up to the 1-month post-Dose 1 visit. | Posted | Number | 95% Confidence Interval | Percentage of participants | 1 month after Dose 1 |
|
|
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| Secondary | Percentage of Participants With Predefined IgG Concentrations at 1 Month After Dose 2 | Predefined level of IgG concentrations was >= 0.35 mcg/mL. | Dose 2 evaluable immunogenicity population included all participants who were eligible and randomized, received both doses of study intervention to which they were randomly assigned, had at least 1 valid immunogenicity result within 27 to 56 days, inclusive, after Dose 2, and had no other major protocol deviations as determined by the clinician up to the 1-month post-Dose 2 visit. | Posted | Number | 95% Confidence Interval | Percentage of participants | 1 month after Dose 2 |
|
|
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| Secondary | Geometric Mean Fold Rise (GMFRs) of Pneumococcal IgG From Before Dose 1 to 1 Month After Dose 1 | GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student-t distribution). | Dose 1 evaluable immunogenicity population included all participants who were eligible and randomized, received study intervention to which they were randomized, had at least 1 valid immunogenicity result within 27 to 56 days, inclusive, after Dose 1, and had no other major protocol deviations as determined by clinician up to 1-month post-Dose 1 visit. Here, ''Overall Number of Participants Analyzed'' signifies Dose 1 evaluable participants with valid result at both timepoints. | Posted | Geometric Mean | 95% Confidence Interval | Fold rise | From before Dose 1 to 1 month after Dose 1 |
|
|
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| Secondary | GMFRs of Pneumococcal IgG From 1 Month After Dose 1 to 1 Month After Dose 2 | GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student-t distribution). | Dose 2 evaluable immunogenicity population included all participants who were eligible, randomized, received both doses of study intervention to which they were randomly assigned, had at least 1 valid immunogenicity result within 27 to 56 days, inclusive, after Dose 2, had no major protocol deviations as determined by clinician up to 1-month post-Dose 2 visit. Here, ''Overall Number of Participants Analyzed'' signifies Dose 2 evaluable participants with valid result at both timepoints. | Posted | Geometric Mean | 95% Confidence Interval | Fold rise | From 1 month after Dose 1 to 1 month after Dose 2 |
|
|
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| Secondary | Geometric Mean Titer (GMTs) of Pneumococcal Opsonophagocytic Activity (OPA) at 1 Month After Dose 1 | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). | Dose 1 evaluable immunogenicity population included all participants who were eligible and randomized, received study intervention to which they were randomized, had at least 1 valid immunogenicity result within 27 to 56 days, inclusive, after Dose 1, and had no other major protocol deviations as determined by clinician up to 1-month post-Dose 1 visit. Here, ''Overall Number of Participants Analyzed'' signifies Dose 1 evaluable participants with valid OPA titers. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 1 month after Dose 1 |
|
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| Secondary | GMTs of Pneumococcal OPA at 1 Month After Dose 2 | GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on student's t distribution). | Dose 2 evaluable immunogenicity population included all participants who were eligible, randomized, received both doses of study intervention to which they were randomly assigned, had at least 1 valid immunogenicity result within 27 to 56 days, inclusive, after Dose 2, had no major protocol deviations as determined by clinician up to 1-month post-Dose 2 visit. Here, ''Overall Number of Participants Analyzed'' signifies Dose 2 evaluable participants with valid OPA titers. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 1 month after Dose 2 |
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| Secondary | GMFRs of Pneumococcal OPA From Before Dose 1 to 1 Month After Dose 1 | GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student-t distribution). | Dose 1 evaluable immunogenicity population included all participants who were eligible and randomized, received study intervention to which they were randomized, had at least 1 valid immunogenicity result within 27 to 56 days, inclusive, after Dose 1, and had no other major protocol deviations as determined by clinician up to 1-month post-Dose 1 visit. Here, ''Overall Number of Participants Analyzed'' signifies Dose 1 evaluable participants with valid OPA result at both timepoints. | Posted | Geometric Mean | 95% Confidence Interval | Fold rise | From before Dose 1 to 1 month after Dose 1 |
|
|
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| Secondary | GMFRs of Pneumococcal OPA From 1 Month After Dose 1 to 1 Month After Dose 2 | GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the student-t distribution). | Dose 2 evaluable immunogenicity population included all participants who were eligible, randomized, received both doses of study intervention to which they were randomly assigned, had at least 1 valid immunogenicity result within 27 to 56 days, inclusive, after Dose 2, had no major protocol deviations as determined by clinician up to 1-month post-Dose 2 visit. Here, ''Overall Number of Participants Analyzed'' signifies Dose 2 evaluable participants with valid OPA result at both timepoints. | Posted | Geometric Mean | 95% Confidence Interval | Fold rise | From 1 month after Dose 1 to 1 month after Dose 2 |
|
|
|
| 0 |
| 52 |
| 1 |
| 52 |
| 51 |
| 52 |
| EG001 | mPnC Control | Participants who had previously received 2 doses of PCV10 primary series as part of their infant routine vaccines were administered 0.5 mL dose of mPnC control intramuscularly at Visit 1 of the study (Day 1 of study; Dose 1) and Visit 3 of the study (56 to 70 days after Visit 1; Dose 2). Participants also received their third (toddler) dose of PCV10 at Visit 1 per childhood vaccine standard of care. | 0 | 53 | 1 | 53 | 53 | 53 |
| Cytomegalovirus infection | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v27.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v27.0 | Non-systematic Assessment |
|
| Injection site erythema (REDNESS) | General disorders | MedDRA v27.0 | Systematic Assessment |
|
| Injection site pain (PAIN) | General disorders | MedDRA v27.0 | Systematic Assessment |
|
| Injection site swelling (SWELLING) | General disorders | MedDRA v27.0 | Systematic Assessment |
|
| Pyrexia (FEVER) | General disorders | MedDRA v27.0 | Systematic Assessment |
|
| Decreased appetite (DECREASED APPETITE) | Metabolism and nutrition disorders | MedDRA v27.0 | Systematic Assessment |
|
| Hypersomnia (INCREASED SLEEP) | Nervous system disorders | MedDRA v27.0 | Systematic Assessment |
|
| Irritability (IRRITABILITY) | Psychiatric disorders | MedDRA v27.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v27.0 | Non-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.
| D007239 | Infections |
| Redness: Moderate |
|
| Redness: Severe |
|
| Redness: Grade 4 |
|
| Swelling: Any |
|
| Swelling: Mild |
|
| Swelling: Moderate |
|
| Swelling: Severe |
|
| Swelling: Grade 4 |
|
| Pain at the injection site: Any |
|
| Pain at the injection site: Mild |
|
| Pain at the injection site: Moderate |
|
| Pain at the injection site: Severe |
|
| Pain at the injection site: Grade 4 |
|
| Fever: >38.4 deg C to 38.9 deg C |
|
| Fever: >38.9 deg C to 40.0 deg C |
|
| Fever: >40.0 deg C |
|
| Decreased appetite: Any |
|
| Decreased appetite: Mild |
|
| Decreased appetite: Moderate |
|
| Decreased appetite: Severe |
|
| Decreased appetite: Grade 4 |
|
| Drowsiness: Any |
|
| Drowsiness: Mild |
|
| Drowsiness: Moderate |
|
| Drowsiness: Severe |
|
| Drowsiness: Grade 4 |
|
| Irritability: Any |
|
| Irritability: Mild |
|
| Irritability: Moderate |
|
| Irritability: Severe |
|
| Irritability: Grade 4 |
|
| Fever: >38.4 deg C to 38.9 deg C |
|
| Fever: >38.9 deg C to 40.0 deg C |
|
| Fever: >40.0 deg C |
|
| Decreased appetite: Any |
|
| Decreased appetite: Mild |
|
| Decreased appetite: Moderate |
|
| Decreased appetite: Severe |
|
| Decreased appetite: Grade 4 |
|
| Drowsiness: Any |
|
| Drowsiness: Mild |
|
| Drowsiness: Moderate |
|
| Drowsiness: Severe |
|
| Drowsiness: Grade 4 |
|
| Irritability: Any |
|
| Irritability: Mild |
|
| Irritability: Moderate |
|
| Irritability: Severe |
|
| Irritability: Grade 4 |
|