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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-006624-41 | EudraCT Number |
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The purpose of this study is to understand the safety and effects of a study vaccine (20vPnC) in toddlers who had 2 prior doses of Prevnar 13.
This study is being conducted in children who:
Participants in this study will receive either 1 dose or 2 doses of the study vaccine or 1 dose of Prevnar 13 as a shot in the muscle. During the study, participants will have to come to the study clinic to receive the vaccines and have blood sample collected. The study team will work with participants' parents or legal guardians to monitor any unwanted reactions to the vaccines. Participants are expected to take part in this study for about 1 or 3 months, for 1 dose or 2 dose schedules, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2-Dose 20vPnC Group | Experimental | Pneumococcal conjugate vaccine (2 doses approximately 2 months apart) |
|
| 1-Dose 20vPnC Group | Experimental | Pneumococcal conjugate vaccine |
|
| 13vPnC Group | Active Comparator | Pneumococcal conjugate vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20-valent pneumococcal conjugate vaccine | Biological | 20-valent pneumococcal conjugate vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Local Reactions Within 7 Days After Last Vaccination | Local reactions included redness, swelling, and pain at the injection site, recorded by parents/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 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). 95 percent (%) confidence interval (CI) was based on Clopper and Pearson method. | Within 7 days after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1) |
| Percentage of Participants With Systemic Events Within 7 Days After Last Vaccination | Systemic events included fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: temperature >=38.0 degree Celsius (C) and categorized as >=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/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). 95% CI was based on Clopper & Pearson method. | Within 7 days after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1) |
| Percentage of Participants With Adverse Events (AEs) From Last Vaccination to 1 Month After Last Vaccination | 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. 95% CI was based on the Clopper and Pearson method. AEs reported in this endpoint excluded local reactions and systemic events collected from an e-diary. |
| Measure | Description | Time Frame |
|---|---|---|
| Serotype-specific IgG Geometric Mean Concentrations (GMC) 1 Month After Last Vaccination | Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F and 7 additional serotypes: 8, 10A, 11A, 12F, 15B, 22F, 33F. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ. GMC and corresponding 2-sided 95% CIs were calculated by exponentiating mean logarithm of concentration, corresponding 2-sided 95% CIs (based on Student's t distribution). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gyerkőc- Med Szolgáltató és Kereskedelmi Betéti Társaság | Budapest | 1042 | Hungary | |||
| Lurko-Med Kft Hazi Gyermekorvosi Rendelo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40081152 | Derived | Martinon-Torres F, Martinez SN, Kline MJ, Drozd J, Trammel J, Peng Y, Giardina PC, Gruber WC, Watson W, Bickham K, Tamimi N. A phase 3 study of 20-valent pneumococcal conjugate vaccine in healthy toddlers previously vaccinated in infancy with 13-valent pneumococcal conjugate vaccine. Vaccine. 2025 Apr 19;53:126931. doi: 10.1016/j.vaccine.2025.126931. Epub 2025 Mar 12. |
| 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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A total of 356 participants were enrolled and randomized to receive either 2 dose of 20-valent pneumococcal conjugate vaccine (20vPnC), 1 dose of 20vPnC or 1 dose of 13vPnC.
Participants included in this study were toddlers greater than or equal to (>=) 12 to less than (<) 24 months of age who had received 2 doses of 13-valent pneumococcal conjugate vaccine (13vPnC) (Prevenar 13) in infancy (prior to 12 months of age).
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| ID | Title | Description |
|---|---|---|
| FG000 | 2-Dose 20vPnC | Toddlers >=12 to <24 months of age were randomized to receive 2 doses of 0.5 milliliter (mL) 20vPnC intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit) and Dose 2 was administered 56 to 70 days later (Dose 2 Visit). |
| FG001 | 1-Dose 20vPnC |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 10, 2021 | May 14, 2024 |
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The study is partially masked. Participants randomized to receive 2 doses of 20vPnC will not have treatment masking. Participants randomized to receive 1 dose of 20vPnC or 13vPnC will have treatment masking.
| 13-valent pneumococcal conjugate vaccine | Biological | 13-valent pneumococcal conjugate vaccine |
|
| From last vaccination to 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1) |
| Percentage of Participants With Serious Adverse Events (SAEs) From Last Vaccination to 1 Month After Last Vaccination | A SAE was any untoward medical occurrence that: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, was considered serious and other important medical events. 95% CI was based on the Clopper and Pearson method. | From last vaccination to 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1) |
| Percentage of Participants With Predefined Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes 1 Month After Last Vaccination | Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 7 additional serotypes: 8, 10A, 11A, 12F, 15B, 22F, 33F. The predefined level was 0.35 microgram per milliliter (mcg/mL) for all 7 additional serotypes. 95% CI was based on the Clopper and Pearson method. | 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1) |
| 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1) |
| Percentage of Participants With Predefined IgG Concentrations for the 13 Matched Serotypes 1 Month After Last Vaccination | Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes:1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C,19A,19F, 23F. Predefined level was 0.35 mcg/mL for all 13vPnC serotypes except serotypes 5, 6B, and 19A, which had predefined levels of 0.23, 0.10, and 0.12 mcg/mL, respectively. 95% CI was based on the Clopper and Pearson method. | 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1) |
| Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Last Vaccination | OPA titers for 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) were determined in randomly selected subsets of participants at 1 month after last vaccination received. OPA titers below the LLOQ were set to 0.5*LLOQ. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the Student's t distribution. | 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1) |
| Budapest |
| 1048 |
| Hungary |
| Elitance Duo Kft. | Budapest | 1188 | Hungary |
| Private practice - Dr. Várhelyiné Dr. Torday Judit | Debrecen | 4025 | Hungary |
| Zsebibaba 2004 Bt. 8. Sz Gyermekkorzet | Eger | 3300 | Hungary |
| Mimiped Betéti Társaság | Győr | 9024 | Hungary |
| Futurenest Klinikai Kutató Kft. | Miskolc | 3527 | Hungary |
| Papp és Társa Egészségügyi és Szolgaltató Betéti Társaság | Szigetvár | 7900 | Hungary |
| Rodzinne Centrum Medyczne LUBMED | Luboń | Greater Poland Voivodeship | 62-030 | Poland |
| MICS Centrum Medyczne Toruń | Torun | Kuyavian-Pomeranian Voivodeship | 87-100 | Poland |
| Przylądek Zdrowia | Krakow | Lesser Poland Voivodeship | 30-644 | Poland |
| SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym | Łomianki | Masovian Voivodeship | 05-092 | Poland |
| IN-VIVO Bydgoszcz | Bydgoszcz | 85-048 | Poland |
| SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym | Dziekanów Leśny | 05-092 | Poland |
| Pro Familia Altera Sp. z o.o. | Katowice | 40-648 | Poland |
| NZOZ Vita Longa Sp. z o.o. | Katowice | 40-748 | Poland |
| Przylądek Zdrowia | Krakow | 30-644 | Poland |
| Krakowski Szpital Specjalistyczny im. Jana Pawła II | Krakow | 31-202 | Poland |
| Specjalistyczny Zespol Opieki Zdrowotnej nad Matka i Dzieckiem w Poznaniu | Poznan | 60-663 | Poland |
| Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem w Poznaniu | Poznan | 60-663 | Poland |
| Centrum Medyczne Pratia Poznan | Skorzewo | 60-185 | Poland |
| MICS Centrum Medyczne Toruń | Torun | 87-100 | Poland |
| Szpital Bielanski im. Ks. Jerzego Popieluszki SPZOZ w Warszawie | Warsaw | 01-809 | Poland |
| Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu | Wroclaw | 50-368 | Poland |
| CHUS - Hospital Clinico Universitario | Santiago de Compostela | A Coruña [LA Coruña] | 15706 | Spain |
| Hospital Germans Trias i Pujol | Badalona | Barcelona [barcelona] | 08916 | Spain |
| Hospital Sant Joan de Déu | Esplugues de Llobregat | Barcelona [barcelona] | 08950 | Spain |
| Hospital Sant Joan de Déu | Esplugues de Llobregat | Barcelona | 08950 | Spain |
| Hospital Universitari General de Catalunya | Sant Cugat del Vallès | Barcelona | 08195 | Spain |
| EAP Osona Sud - Alt Congost S.L.P | Centelles | Catalunya [cataluña] | 08500 | Spain |
| Hospital Clinico Universitario Santiago de Compostela | Santiago de Compostela | LA Coruña | 15706 | Spain |
| CHUS - Hospital Clinico Universitario | Santiago de Compostela | LA Coruña | 15760 | Spain |
| Hospital Universitario HM Monteprincipe | Boadilla del Monte | Madrid | 28660 | Spain |
| Hospital Universitario HM Puerta del Sur | Madrid | Madrid, Comunidad de | 28938 | Spain |
| Grupo Pediatrico Uncibay | Málaga | Málaga | 29015 | Spain |
| Hospital de Nens de Barcelona | Barcelona | 08009 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28009 | Spain |
| Hospital General Universitario Gregorio Marañón | Madrid | 28009 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario HM Sanchinarro | Madrid | 28050 | Spain |
| Grupo Pediatrico Uncibay | Málaga | 29015 | Spain |
| Instituto Hispalense de Pediatria | Seville | 41012 | Spain |
| Instituto Hispalense de Pediatria | Seville | 41014 | Spain |
Toddlers >=12 to <24 months of age were randomized to receive 1 dose of 0.5 mL 20vPnC intramuscularly on Day 1 (Dose 1 Visit). |
| FG002 | 13vPnC Control | Toddlers >=12 to <24 months of age were randomized to receive 1 dose of 0.5 mL 13vPnC intramuscularly on Day 1 (Dose 1 Visit). |
| COMPLETED |
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| NOT COMPLETED |
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Safety population included all participants who receive at least 1 dose of the study intervention and have safety data reported after any dose.
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| ID | Title | Description |
|---|---|---|
| BG000 | 2-Dose 20vPnC | Toddlers >=12 to <24 months of age were randomized to receive 2 doses of 0.5 milliliter (mL) 20vPnC intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit) and Dose 2 was administered 56 to 70 days later (Dose 2 Visit). |
| BG001 | 1-Dose 20vPnC | Toddlers >=12 to <24 months of age were randomized to receive 1 dose of 0.5 mL 20vPnC intramuscularly on Day 1 (Dose 1 Visit). |
| BG002 | 13vPnC Control | Toddlers >=12 to <24 months of age were randomized to receive 1 dose of 0.5 mL 13vPnC intramuscularly on Day 1 (Dose 1 Visit). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | months |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||
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| Primary | Percentage of Participants With Local Reactions Within 7 Days After Last Vaccination | Local reactions included redness, swelling, and pain at the injection site, recorded by parents/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 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). 95 percent (%) confidence interval (CI) was based on Clopper and Pearson method. | Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data reported after any dose. Here, "Number of Participants Analyzed" signifies the number of participants with any e-diary data reported after the last vaccination. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 days after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1) |
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| Primary | Percentage of Participants With Systemic Events Within 7 Days After Last Vaccination | Systemic events included fever, decreased appetite, drowsiness/increased sleep and irritability, recorded by parents/legal guardians of participants using an e-diary. Fever: temperature >=38.0 degree Celsius (C) and categorized as >=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/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). 95% CI was based on Clopper & Pearson method. | Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose. Here, "Number of Participants Analyzed" signifies number of participants with any e-diary data reported after the last vaccination. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 7 days after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1) |
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| Primary | Percentage of Participants With Adverse Events (AEs) From Last Vaccination to 1 Month After Last Vaccination | 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. 95% CI was based on the Clopper and Pearson method. AEs reported in this endpoint excluded local reactions and systemic events collected from an e-diary. | Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose. Here, "Number of Participants Analyzed" signifies the number of participants in the specified group who received the last vaccination. | Posted | Number | 95% Confidence Interval | Percentage of participants | From last vaccination to 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1) |
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| Primary | Percentage of Participants With Serious Adverse Events (SAEs) From Last Vaccination to 1 Month After Last Vaccination | A SAE was any untoward medical occurrence that: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/ incapacity; was a congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, was considered serious and other important medical events. 95% CI was based on the Clopper and Pearson method. | Safety analysis set included all participants who received at least 1 dose of 20vPnC or 13vPnC and had safety data assessed after any dose. Here, "Number of Participants Analyzed" signifies the number of participants in the specified group who received the last vaccination. | Posted | Number | 95% Confidence Interval | Percentage of participants | From last vaccination to 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1) |
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| Primary | Percentage of Participants With Predefined Serotype-Specific Immunoglobulin G (IgG) Concentrations for the 7 Additional Serotypes 1 Month After Last Vaccination | Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 7 additional serotypes: 8, 10A, 11A, 12F, 15B, 22F, 33F. The predefined level was 0.35 microgram per milliliter (mcg/mL) for all 7 additional serotypes. 95% CI was based on the Clopper and Pearson method. | Evaluable immunogenicity population (EIP) included all participants who were eligible, received vaccinations to which they were randomized, had at least 1 valid immunogenicity result from 1 month after the last assigned vaccination collected within 27 to 56 days after the dose, had no other major protocol deviations as determined by clinician. "Number of Participants analyzed"= participants in EIP. "Number analyzed"= participants with valid IgG results for specified serotype. | Posted | Number | 95% Confidence Interval | Percentage of participants | 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1) |
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| Secondary | Serotype-specific IgG Geometric Mean Concentrations (GMC) 1 Month After Last Vaccination | Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F and 7 additional serotypes: 8, 10A, 11A, 12F, 15B, 22F, 33F. Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ. GMC and corresponding 2-sided 95% CIs were calculated by exponentiating mean logarithm of concentration, corresponding 2-sided 95% CIs (based on Student's t distribution). | EIP included all participants who were eligible, received vaccinations to which they were randomized, had at least 1 valid immunogenicity result from 1 month after the last assigned vaccination collected within 27 to 56 days after the dose, had no other major protocol deviations as determined by clinician. Here, Number of Participants Analyzed= participants in EIP. "Number Analyzed"= participants with valid IgG assay results for specified serotype. | Posted | Geometric Mean | 95% Confidence Interval | mcg/mL | 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1) |
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| Secondary | Percentage of Participants With Predefined IgG Concentrations for the 13 Matched Serotypes 1 Month After Last Vaccination | Pneumococcal serotype-specific IgG concentrations were measured for serum samples for 13vPnC serotypes:1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C,19A,19F, 23F. Predefined level was 0.35 mcg/mL for all 13vPnC serotypes except serotypes 5, 6B, and 19A, which had predefined levels of 0.23, 0.10, and 0.12 mcg/mL, respectively. 95% CI was based on the Clopper and Pearson method. | EIP included all participants who were eligible, received vaccinations to which they were randomized, had at least 1 valid immunogenicity result from 1 month after last assigned vaccination collected within 27 to 56 days after dose, had no other major protocol deviations. Here, Number of Participants Analyzed= participants in EIP. "Number Analyzed"=participants with valid IgG results for specified serotype. | Posted | Number | 95% Confidence Interval | Percentage of participants | 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1) |
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| Secondary | Serotype-Specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Last Vaccination | OPA titers for 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) were determined in randomly selected subsets of participants at 1 month after last vaccination received. OPA titers below the LLOQ were set to 0.5*LLOQ. GMTs and 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs based on the Student's t distribution. | EIP: eligible participants who received vaccinations as randomized, had at least 1 valid immunogenicity result from 1 month after last dose collected within 27-56 days after dose, had no other major protocol deviation. Number of Participants Analyzed = participants in EIP. OPA titers from randomly selected participants were measured for a subset of the 20 serotypes. Number Analyzed = participants with valid OPA assay result for specified serotype. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 1 Month after last vaccination (for reporting arm 2-Dose 20vPnC last vaccination was Dose 2 and for 1-dose 20vPnC and 13vPnC Control it was Dose 1) |
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Local reactions and systemic events (systematic assessment): Within 7 days after Dose 1 and 2; All-cause mortality, SAEs and non-SAEs (non-systematic assessment): from Dose 1 to 1 month after Dose 1 (1-dose groups) or Dose 2 (2-dose group)
Same event may appear as both SAE and non-SAE. But what is presented are distinct events. Event may be classified as serious in 1 participant and non-serious in another, or 1 participant may have experienced both during study. Safety analysis set analyzed. Results are summarized by: 2-Dose 20vPnC Dose1 to Dose 2, 2-Dose 20vPnC (Dose 2 to 1 month after Dose 2), 1-Dose 20vPnC and 13vPnC Control.
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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 | 2-Dose 20vPnC (Dose 1 to Dose 2) | Toddlers >=12 to <24 months of age were randomized to receive 2 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit) and Dose 2 was administered 56 to 70 days later (Dose 2 Visit). This arm reports data from Dose 1 to Dose 2. | 0 | 121 | 4 | 121 | 93 | 121 |
| EG001 | 2-Dose 20vPnC (Dose 2 to 1 Month After Dose 2) | Toddlers >=12 to <24 months of age were randomized to receive 2 doses of 0.5 mL 20vPnC intramuscularly. Dose 1 was administered at Day 1 (Dose 1 Visit) and Dose 2 was administered 56 to 70 days later (Dose 2 Visit). This arm reports data From Dose 2 to 1 month after Dose 2. | 0 | 116 | 1 | 116 | 91 | 116 |
| EG002 | 1-Dose 20vPnC (Dose 1 to 1 Month After Dose 1) | Toddlers >=12 to <24 months of age were randomized to receive 1 dose of 0.5 mL 20vPnC intramuscularly on Day 1 (Dose 1 Visit). This arm reports data from dose 1 to 1 month after Dose 1. | 0 | 118 | 1 | 118 | 90 | 118 |
| EG003 | 13vPnC Control (Dose 1 to 1 Month After Dose 1) | Toddlers >=12 to <24 months of age were randomized to receive 1 dose of 0.5 mL 20vPnC intramuscularly on Day 1 (Dose 1 Visit). This arm reports data from dose 1 to 1 month after Dose 1. | 0 | 117 | 1 | 117 | 98 | 117 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile convulsion | Nervous system disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 26.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypersomnia (INCREASED SLEEP) | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Decreased appetite (DECREASED APPETITE) | Metabolism and nutrition disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Non-systematic Assessment |
| |
| Injection site erythema (REDNESS) | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site pain (PAIN) | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Injection site swelling (SWELLING) | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Pyrexia (FEVER) | General disorders | MedDRA 26.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 26.0 | 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 | May 4, 2022 | May 14, 2024 | 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: Mild |
|
| Redness: Moderate |
|
| Redness: Severe |
|
| Swelling: Any |
|
| Swelling: Mild |
|
| Swelling: Moderate |
|
| Swelling: Severe |
|
| Pain at Injection Site: Any |
|
| Pain at Injection Site: Mild |
|
| Pain at Injection Site: Moderate |
|
| Pain at Injection Site: Severe |
|
| OG001 | 1-Dose 20vPnC | Toddlers >=12 to <24 months of age were randomized to receive 1 dose of 0.5 mL 20vPnC intramuscularly on Day 1 (Dose 1 Visit). |
| OG002 | 13vPnC Control | Toddlers >=12 to <24 months of age were randomized to receive 1 dose of 0.5 mL 13vPnC intramuscularly on Day 1 (Dose 1 Visit). |
|
|
| OG002 |
| 13vPnC Control |
Toddlers >=12 to <24 months of age were randomized to receive 1 dose of 0.5 mL 13vPnC intramuscularly on Day 1 (Dose 1 Visit). |
|
|
| OG002 | 13vPnC Control | Toddlers >=12 to <24 months of age were randomized to receive 1 dose of 0.5 mL 13vPnC intramuscularly on Day 1 (Dose 1 Visit). |
|
|
| OG002 | 13vPnC Control | Toddlers >=12 to <24 months of age were randomized to receive 1 dose of 0.5 mL 13vPnC intramuscularly on Day 1 (Dose 1 Visit). |
|
|
Toddlers >=12 to <24 months of age were randomized to receive 1 dose of 0.5 mL 20vPnC intramuscularly on Day 1 (Dose 1 Visit). |
| OG002 | 13vPnC Control | Toddlers >=12 to <24 months of age were randomized to receive 1 dose of 0.5 mL 13vPnC intramuscularly on Day 1 (Dose 1 Visit). |
|
|
| OG002 | 13vPnC Control | Toddlers >=12 to <24 months of age were randomized to receive 1 dose of 0.5 mL 13vPnC intramuscularly on Day 1 (Dose 1 Visit). |
|
|
Toddlers >=12 to <24 months of age were randomized to receive 1 dose of 0.5 mL 20vPnC intramuscularly on Day 1 (Dose 1 Visit).
| OG002 | 13vPnC Control | Toddlers >=12 to <24 months of age were randomized to receive 1 dose of 0.5 mL 13vPnC intramuscularly on Day 1 (Dose 1 Visit). |
|
|