Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003054-24 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine in Japanese subjects aged 6 to 64 years who are considered to be at increased risk of pneumococcal disease and who are naive to pneumococcal vaccines.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 13-valent pneumococcal conjugate vaccine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13-valent pneumococcal conjugate vaccine | Biological | A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. 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) for participants aged 6 to <12 years, and as mild (2.5 to 5.0 cm), moderate (>5.0 to 10.0 cm) and, severe (>10.0 cm) for participants aged 12 to <18 years. Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). | Day 1 up to Day 7 |
| Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (2.5 to 5.0 cm), moderate (>5.0 to 10.0 cm) and, severe (>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). | Day 1 up to Day 14 |
| Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Systemic events included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain, and were recorded by using an e-diary. Use of antipyretic or pain medication was also collected by using an e-diary. Fever was graded as 37.5 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (greater than or equals to [>=] 6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (significant, prevented daily activity). |
| Measure | Description | Time Frame |
|---|---|---|
| Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | Antibody-mediated serum OPA against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolony OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). Two (2)-sided 95% CIs were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed based on the Student t distribution. OPA titer was expressed as reciprocal of highest serum dilution. |
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 |
|---|---|---|---|---|---|---|
| Daido Clinic | Nagoya | Aichi-ken | 457-8511 | Japan | ||
| Nippon Kokan Fukuyama Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34563397 | Derived | Yamazaki Y, Ikeda M, Imada T, Furuno K, Mizukami T, de Solom R, Shoji Y, Oe M, Aizawa M, Giardina PC, Schmoele-Thoma B, Scott DA. A phase 3, multicenter, single-arm, open-label study to assess the safety, tolerability, and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine in Japanese participants aged 6-64 years who are considered to be at increased risk of pneumococcal disease and who are naive to pneumococcal vaccines. Vaccine. 2021 Oct 15;39(43):6414-6421. doi: 10.1016/j.vaccine.2021.08.106. Epub 2021 Sep 23. |
| 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
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 13vPnC: 6 to <18 Years | Participants aged between 6 to less than (<) 18 years received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly on Day 1. |
| FG001 | 13vPnC: 18 to <65 Years | Participants aged between 18 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety analysis set included all participants who received 1 dose of study vaccine.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 13vPnC: 6 to <18 Years | Participants aged between 6 to <18 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1. |
| BG001 | 13vPnC: 18 to <65 Years | Participants aged between 18 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1. |
| 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 Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. 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) for participants aged 6 to <12 years, and as mild (2.5 to 5.0 cm), moderate (>5.0 to 10.0 cm) and, severe (>10.0 cm) for participants aged 12 to <18 years. Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). | Safety analysis set included all participants who received 1 dose of study vaccine. Here, "Number analyzed" signifies participants evaluable for each specified category. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 up to Day 7 |
|
signing of informed consent form (Day 1) up to Day 43
Not provided
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 | 13vPnC: 6 to <18 Years | Participants aged between 6 to <18 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | MedDRA 21.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 20, 2018 | Nov 20, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 16, 2018 | Nov 20, 2019 | SAP_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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Day 1 up to Day 7 |
| Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Systemic events included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain, and were recorded by using an e-diary. Use of antipyretic or pain medication was also collected by using an e-diary. Fever was graded as 37.5 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (significant, prevented daily activity). | Day 1 up to Day 14 |
| Percentage of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. 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. | signing of informed consent form (Day 1) up to Day 43 |
| Pre-vaccination and 1 month after vaccination |
| Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination | OPA GMFRs were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. GMFRs were computed as the fold rise in titer value at 1 month after vaccination compared to baseline (pre-vaccination). The CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean difference of the log-transformed assay results before vaccination and 1 month after vaccination. | Pre-vaccination to 1 month after vaccination |
| Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | Pneumococcal IgG antibody against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using direct binding Luminex assay. Results were expressed as IgG concentrations. IgG concentrations were logarithmically transformed for analysis; geometric means calculated and expressed as GMCs. Two (2)-sided 95% CIs were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed based on the Student t distribution. | Pre-vaccination and 1 month after vaccination |
| GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination | IgG GMFRs were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. GMFRs were computed as the fold rise in concentrations at 1 month after vaccination compared to baseline (pre-vaccination). The CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean difference of the log-transformed assay results before vaccination and 1 month after vaccination. | Pre- vaccination to 1 month after vaccination |
| Fukuyama |
| Hiroshima |
| 721-0927 |
| Japan |
| Fukuyama City Hospital | Fukuyama | Hiroshima | 721-8511 | Japan |
| Kawasaki Municipal Hospital | Kawasaki | Kanagawa | 210-0013 | Japan |
| Nagano Prefectural Shinshu Medical Center | Suzaka | Nagano | 382-8577 | Japan |
| Medical Co.LTA PS Clinic | Fukuoka | 812-0025 | Japan |
| Fukuoka Children's Hospital | Fukuoka | 813-0017 | Japan |
| National Hospital Organization Kumamoto Medical Center | Kumamoto | 860-0008 | Japan |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| 13vPnC: 6 to <18 Years |
Participants aged between 6 to <18 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1. |
|
|
| Primary | Percentage of Participants Reporting Pre-Specified Local Reactions Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Local reactions were recorded using an electronic daily diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (2.5 to 5.0 cm), moderate (>5.0 to 10.0 cm) and, severe (>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). | Safety analysis set included all participants who received 1 dose of study vaccine. Here, "Number analyzed" signifies participants evaluable for each specified category. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 up to Day 14 |
|
|
|
| Primary | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 7 Days After Vaccination in Participants Aged Between 6 to <18 Years | Systemic events included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain, and were recorded by using an e-diary. Use of antipyretic or pain medication was also collected by using an e-diary. Fever was graded as 37.5 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (greater than or equals to [>=] 6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (significant, prevented daily activity). | Safety analysis set included all participants who received 1 dose of study vaccine. Here, "Number analyzed" signifies participants evaluable for each specified category. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 up to Day 7 |
|
|
|
| Primary | Percentage of Participants Reporting Systemic Events and Use of Antipyretic or Pain Medication Within 14 Days After Vaccination in Participants Aged Between 18 to <65 Years | Systemic events included fever, vomiting, diarrhea, headache, fatigue, muscle and joint pain, and were recorded by using an e-diary. Use of antipyretic or pain medication was also collected by using an e-diary. Fever was graded as 37.5 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and >40.0 degree C. Vomiting was graded as mild (1-2 times in 24 hours), moderate (>2 times in 24 hours) and severe (required intravenous hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (>=6 loose stools in 24 hours). Headache, fatigue, muscle pain and joint pain were graded as mild (no interference with activity), moderate (some interference with activity) and severe (significant, prevented daily activity). | Safety analysis set included all participants who received 1 dose of study vaccine. Here, "Number analyzed" signifies participants evaluable for each specified category. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 1 up to Day 14 |
|
|
|
| Primary | Percentage of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. 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. | Safety analysis set included all participants who received 1 dose of study vaccine. | Posted | Number | percentage of participants | signing of informed consent form (Day 1) up to Day 43 |
|
|
|
| Secondary | Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at Pre-vaccination and 1 Month After Vaccination | Antibody-mediated serum OPA against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a quantitative functional microcolony OPA (mcOPA) assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). Two (2)-sided 95% CIs were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed based on the Student t distribution. OPA titer was expressed as reciprocal of highest serum dilution. | Evaluable immunogenicity population: eligible participants who received the study vaccine and took no prohibited vaccines, had blood drawn within 1 month after vaccination with at least 1 valid and determinate assay and had no major protocol violations. Here, "Number analyzed" signifies participants evaluable for each specified row. | Posted | Geometric Mean | 95% Confidence Interval | titers | Pre-vaccination and 1 month after vaccination |
|
|
|
| Secondary | Geometric Mean Fold Rises (GMFRs) in Serotype-specific OPA Titers 1 Month After Vaccination | OPA GMFRs were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. GMFRs were computed as the fold rise in titer value at 1 month after vaccination compared to baseline (pre-vaccination). The CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean difference of the log-transformed assay results before vaccination and 1 month after vaccination. | Evaluable immunogenicity set: Eligible participants received study vaccine,took no prohibited vaccine,had blood drawn in specified time frame had atleast 1 valid,determinate OPA titer/IgG concentration result for atleast 1 serotype 1 month after vaccination,no major protocol violation. Number analyzed=participant evaluable for specified row. | Posted | Geometric Mean | 95% Confidence Interval | fold rise | Pre-vaccination to 1 month after vaccination |
|
|
|
| Secondary | Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at Pre-vaccination and 1 Month After Vaccination | Pneumococcal IgG antibody against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using direct binding Luminex assay. Results were expressed as IgG concentrations. IgG concentrations were logarithmically transformed for analysis; geometric means calculated and expressed as GMCs. Two (2)-sided 95% CIs were constructed by back transformation of the CI for the mean of the logarithmically transformed assay results computed based on the Student t distribution. | Evaluable immunogenicity set: Eligible participants received study vaccine, took no prohibited vaccine, had blood drawn in specified time frame had atleast 1 valid, determinate OPA titer/IgG concentration result for atleast 1 serotype 1 month after vaccination, no major protocol violation. | Posted | Geometric Mean | 95% Confidence Interval | microgram per milliliter (mcg/mL) | Pre-vaccination and 1 month after vaccination |
|
|
|
| Secondary | GMFRs in Serotype-specific IgG From Before Vaccination to 1 Month After Vaccination | IgG GMFRs were calculated along with corresponding 2-sided 95% CIs for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. GMFRs were computed as the fold rise in concentrations at 1 month after vaccination compared to baseline (pre-vaccination). The CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean difference of the log-transformed assay results before vaccination and 1 month after vaccination. | Evaluable immunogenicity set: Eligible participants received study vaccine, took no prohibited vaccine, had blood drawn in specified time frame had atleast 1 valid, determinate OPA titer/IgG concentration result for atleast 1 serotype 1 month after vaccination, no major protocol violation. | Posted | Geometric Mean | 95% Confidence Interval | fold rise | Pre- vaccination to 1 month after vaccination |
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| 49 |
| 53 |
| EG001 | 13vPnC: 18 to <65 Years | Participants aged between 18 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1. | 0 | 153 | 0 | 153 | 121 | 153 |
| EG002 | 13vPnC: All Participants | All participants aged between 6 to <65 years received a single 0.5 mL dose of 13vPnC intramuscularly on Day 1. | 0 | 206 | 0 | 206 | 170 | 206 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment | Number of participants at risk = number of participants evaluable for the adverse event. |
|
| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment | Number of participants at risk = number of participants evaluable for the adverse event. |
|
| Fatigue | General disorders | MedDRA 21.1 | Systematic Assessment | Number of participants at risk = number of participants evaluable for the adverse event. |
|
| Redness | General disorders | MedDRA 21.1 | Systematic Assessment | Number of participants at risk = number of participants evaluable for the adverse event. |
|
| Injection site erythema | General disorders | MedDRA 21.1 | Non-systematic Assessment |
|
| Pain at the injection site | General disorders | MedDRA 21.1 | Systematic Assessment | Number of participants at risk = number of participants evaluable for the adverse event. |
|
| Injection site pain | General disorders | MedDRA 21.1 | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 21.1 | Systematic Assessment | Number of participants at risk = number of participants evaluable for the adverse event. |
|
| Pyrexia | General disorders | MedDRA 21.1 | Systematic Assessment | Number of participants at risk = number of participants evaluable for the adverse event. |
|
| Bronchitis | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 21.1 | Non-systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment | Number of participants at risk = number of participants evaluable for the adverse event. |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment | Number of participants at risk = number of participants evaluable for the adverse event. |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 21.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment | Number of participants at risk = number of participants evaluable for the adverse event. |
|
| Middle insomnia | Psychiatric disorders | MedDRA 21.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Non-systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 21.1 | 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 |
|
|
| 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 |
|
|
|
| Fever: 39.0 degree C to 40.0 degree C |
|
|
| Fever: >40.0 degree C |
|
|
| Fatigue: Any |
|
|
| Fatigue: Mild |
|
|
| Fatigue: Moderate |
|
|
| Fatigue: Severe |
|
|
| Headache: Any |
|
|
| Headache: Mild |
|
|
| Headache: Moderate |
|
|
| Headache: Severe |
|
|
| Vomiting: Any |
|
|
| Vomiting: Mild |
|
|
| Vomiting: Moderate |
|
|
| Vomiting: Severe |
|
|
| Diarrhea: Any |
|
|
| Diarrhea: Mild |
|
|
| Diarrhea: Moderate |
|
|
| Diarrhea: Severe |
|
|
| Muscle pain: Any |
|
|
| Muscle pain: Mild |
|
|
| Muscle pain: Moderate |
|
|
| Muscle pain: Severe |
|
|
| Joint pain: Any |
|
|
| Joint pain: Mild |
|
|
| Joint pain: Moderate |
|
|
| Joint pain: Severe |
|
|
| Use of antipyretic or pain medication |
|
|
|
| Fever: 39.0 degree C to 40.0 degree C |
|
|
| Fever: >40.0 degree C |
|
|
| Fatigue: Any |
|
|
| Fatigue: Mild |
|
|
| Fatigue: Moderate |
|
|
| Fatigue: Severe |
|
|
| Headache: Any |
|
|
| Headache: Mild |
|
|
| Headache: Moderate |
|
|
| Headache: Severe |
|
|
| Vomiting: Any |
|
|
| Vomiting: Mild |
|
|
| Vomiting: Moderate |
|
|
| Vomiting: Severe |
|
|
| Diarrhea: Any |
|
|
| Diarrhea: Mild |
|
|
| Diarrhea: Moderate |
|
|
| Diarrhea: Severe |
|
|
| Muscle pain: Any |
|
|
| Muscle pain: Mild |
|
|
| Muscle pain: Moderate |
|
|
| Muscle pain: Severe |
|
|
| Joint pain: Any |
|
|
| Joint pain: Mild |
|
|
| Joint pain: Moderate |
|
|
| Joint pain: Severe |
|
|
| Use of antipyretic or pain medication |
|
|
|
| Pre-vaccination; Serotype 3 |
|
|
| 1 month after vaccination; Serotype 3 |
|
|
| Pre-vaccination; Serotype 4 |
|
|
| 1 month after vaccination; Serotype 4 |
|
|
| Pre-vaccination; Serotype 5 |
|
|
| 1 month after vaccination; Serotype 5 |
|
|
| Pre-vaccination; Serotype 6A |
|
|
| 1 month after vaccination; Serotype 6A |
|
|
| Pre-vaccination; Serotype 6B |
|
|
| 1 month after vaccination; Serotype 6B |
|
|
| Pre-vaccination; Serotype 7F |
|
|
| 1 month after vaccination; Serotype 7F |
|
|
| Pre-vaccination; Serotype 9V |
|
|
| 1 month after vaccination; Serotype 9V |
|
|
| Pre-vaccination; Serotype 14 |
|
|
| 1 month after vaccination; Serotype 14 |
|
|
| Pre-vaccination; Serotype 18C |
|
|
| 1 month after vaccination; Serotype 18C |
|
|
| Pre-vaccination; Serotype 19A |
|
|
| 1 month after vaccination; Serotype 19A |
|
|
| Pre-vaccination; Serotype 19F |
|
|
| 1 month after vaccination; Serotype 19F |
|
|
| Pre-vaccination; Serotype 23F |
|
|
| 1 month after vaccination; Serotype 23F |
|
|
|
| Serotype 4 |
|
|
| Serotype 5 |
|
|
| Serotype 6A |
|
|
| Serotype 6B |
|
|
| Serotype 7F |
|
|
| Serotype 9V |
|
|
| Serotype 14 |
|
|
| Serotype 18C |
|
|
| Serotype 19A |
|
|
| Serotype 19F |
|
|
| Serotype 23F |
|
|
|
| 1 month after vaccination; Serotype 3 |
|
| Pre-vaccination; Serotype 4 |
|
| 1 month after vaccination; Serotype 4 |
|
| Pre-vaccination; Serotype 5 |
|
| 1 month after vaccination; Serotype 5 |
|
| Pre-vaccination; Serotype 6A |
|
| 1 month after vaccination; Serotype 6A |
|
| Pre-vaccination; Serotype 6B |
|
| 1 month after vaccination; Serotype 6B |
|
| Pre-vaccination; Serotype 7F |
|
| 1 month after vaccination; Serotype 7F |
|
| Pre-vaccination; Serotype 9V |
|
| 1 month after vaccination; Serotype 9V |
|
| Pre-vaccination; Serotype 14 |
|
| 1 month after vaccination; Serotype 14 |
|
| Pre-vaccination; Serotype 18C |
|
| 1 month after vaccination; Serotype 18C |
|
| Pre-vaccination; Serotype 19A |
|
| 1 month after vaccination; Serotype 19A |
|
| Pre-vaccination; Serotype 19F |
|
| 1 month after vaccination; Serotype 19F |
|
| Pre-vaccination; Serotype 23F |
|
| 1 month after vaccination; Serotype 23F |
|
| Title | Measurements |
|---|---|
|
| Serotype 5 |
|
| Serotype 6A |
|
| Serotype 6B |
|
| Serotype 7F |
|
| Serotype 9V |
|
| Serotype 14 |
|
| Serotype 18C |
|
| Serotype 19A |
|
| Serotype 19F |
|
| Serotype 23F |
|