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| ID | Type | Description | Link |
|---|---|---|---|
| B1851057 | Other Identifier | Alias Study Number |
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It is an observational multi-center study to assess the safety profile of Prevenar13 used among Korean children in the routine clinical setting following a licensure and introduction of the vaccine. This study is designed to fulfill regulatory requirement for any new drug authorized by KFDA.
non-randomization, non-probability sampling
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13-valent pneumococcal vaccine | Biological | 0.5mL IM (Intramuscular administration) as per recommended schedule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. | Within 7 days after Vaccination 1 |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. | Within 7 days after Vaccination 2 |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of AE is the total time from onset of adverse event till the event is resolved in participants who had at least 1 AE. | Baseline up to 28 days after last dose of study vaccination (13 Months) |
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Inclusion Criteria:
Exclusion Criteria:
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All infants and children meeting the usual prescribing criteria for Prevenar 13 as per the local product information for usage
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Choi's Pediatric Clinic | Wŏnju | Gangwon-do | 220-956 | South Korea | ||
| Seoul Children's Hospital |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prevenar 13 | Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up.
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| ID | Title | Description |
|---|---|---|
| BG000 | Prevenar 13 | Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination. |
| 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 | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. | Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "number of participants analyzed" (N) signifies those participants who were evaluable for this outcome measure. | Posted | Number | participants | Within 7 days after Vaccination 1 |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
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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 | Prevenar 13 | Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MEDICINE INEFFECTIVE | General disorders | WHO-ART 092 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| INJECTION SITE RASH | Injury, poisoning and procedural complications | WHO-ART 092 | 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
| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
Not provided
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Not provided
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| Within 7 days after Vaccination 3 |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. | Within 28 days after Vaccination 4 |
| Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1 | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Within 7 days after Vaccination 1 |
| Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2 | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Within 7 days after Vaccination 2 |
| Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3 | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Within 7 days after Vaccination 3 |
| Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4 | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Within 28 days after Vaccination 4 |
| Number of Participants With Adverse Events (AEs) by Severity | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event). | Within 7 days after Vaccination 1, 2, 3 and within 28 days after Vaccination 4 |
| Number of Participants With Outcome in Response to Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by those participants who had at least 1 AE: 'Is the adverse event still present?' as 'yes', 'unknown' or 'no-resolved'. | Baseline up to 28 days after last dose of study vaccination (13 Months) |
| Number of Participants Discontinued Due to Adverse Events | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Baseline up to 28 days after last dose of study vaccination (13 Months) |
| Osan |
| Gyeonggi-do |
| 447-804 |
| South Korea |
| Bundang Pediatric Clinic | Seongnam-si | Gyeonggi-do | 463-821 | South Korea |
| Teun Teun Pediatric clinic | Suwon | Gyeonggi-do | 443-471 | South Korea |
| Namujungwon Women's Hospital | Yangju | Gyeonggi-do | 482-050 | South Korea |
| Yonsei Pediatric Clinic | Yongin-si | Gyeonggi-do | 448-508 | South Korea |
| Busan National University Hospital | Busan | 602-739 | South Korea |
| Jaeil Alliance Pediatrics Clinic | Daegu | 701847 | South Korea |
| Teun Teun Pediatric Clinic | Daegu | 702886 | South Korea |
| Eulji University Hospital | Daejeon | 302-799 | South Korea |
| Korea University Ansan Hospital | Gyeonggi-do | 425-707 | South Korea |
| Cha Bundang Medical Center, Cha University | Gyeonggi-do | 463-712 | South Korea |
| Inha University Hospital | Incheon | 400-711 | South Korea |
| Lee Ha Young Pediatrics | Incheon | 402-852 | South Korea |
| Asan Medical Center | Seoul | 138-736 | South Korea |
| Eulji Medical Center | Seoul | 139-711 | South Korea |
| JaMo Women's Hospital | Suyeong-gu | 613-806 | South Korea |
| Ulsan University Hospital | Ulsan | 682-714 | South Korea |
| months |
|
| Gender | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | Prevenar 13 | Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination. |
|
|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. | Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "N" signifies those participants who were evaluable for this outcome measure. | Posted | Number | participants | Within 7 days after Vaccination 2 |
|
|
|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. | Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "N" signifies those participants who were evaluable for this outcome measure. | Posted | Number | participants | Within 7 days after Vaccination 3 |
|
|
|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events. | Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "N" signifies those participants who were evaluable for this outcome measure. | Posted | Number | participants | Within 28 days after Vaccination 4 |
|
|
|
| Primary | Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1 | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "N" signifies those participants who were evaluable for this outcome measure. | Posted | Number | participants | Within 7 days after Vaccination 1 |
|
|
|
| Primary | Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2 | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "N" signifies those participants who were evaluable for this outcome measure. | Posted | Number | participants | Within 7 days after Vaccination 2 |
|
|
|
| Primary | Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3 | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "N" signifies those participants who were evaluable for this outcome measure. | Posted | Number | participants | Within 7 days after Vaccination 3 |
|
|
|
| Primary | Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4 | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "N" signifies those participants who were evaluable for this outcome measure. | Posted | Number | participants | Within 28 days after Vaccination 4 |
|
|
|
| Secondary | Duration of Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of AE is the total time from onset of adverse event till the event is resolved in participants who had at least 1 AE. | Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "N" signifies those participants who had at least 1 adverse event. | Posted | Mean | Standard Deviation | days | Baseline up to 28 days after last dose of study vaccination (13 Months) |
|
|
|
| Secondary | Number of Participants With Adverse Events (AEs) by Severity | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event). | Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "n" signifies those participants who were evaluable at specified time points. | Posted | Number | participants | Within 7 days after Vaccination 1, 2, 3 and within 28 days after Vaccination 4 |
|
|
|
| Secondary | Number of Participants With Outcome in Response to Adverse Events (AEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by those participants who had at least 1 AE: 'Is the adverse event still present?' as 'yes', 'unknown' or 'no-resolved'. | Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. Here, "N" signifies those participants who had at least 1 adverse event. | Posted | Number | participants | Baseline up to 28 days after last dose of study vaccination (13 Months) |
|
|
|
| Secondary | Number of Participants Discontinued Due to Adverse Events | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | Safety analysis set included all participants who recieved at least 1 dose of Prevenar 13 and had the safety assessment through appropriate follow-up. | Posted | Number | participants | Baseline up to 28 days after last dose of study vaccination (13 Months) |
|
|
|
| 3 |
| 649 |
| 165 |
| 649 |
| PHARYNGITIS | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
|
| PNEUMONIA | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
|
| INJECTION SITE REACTION | Injury, poisoning and procedural complications | WHO-ART 092 | Non-systematic Assessment |
|
| CRYING ABNORMAL | General disorders | WHO-ART 092 | Non-systematic Assessment |
|
| FEVER | General disorders | WHO-ART 092 | Non-systematic Assessment |
|
| ANOREXIA | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
|
| ENTERITIS | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
|
| GASTRO-INTESTINAL DISORDER NOS | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
|
| GASTROENTERITIS | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | WHO-ART 092 | Non-systematic Assessment |
|
| EAR ACHE | Ear and labyrinth disorders | WHO-ART 092 | Non-systematic Assessment |
|
| LIGAMENT DISORDER | Musculoskeletal and connective tissue disorders | WHO-ART 092 | Non-systematic Assessment |
|
| NAEVUS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | WHO-ART 092 | Non-systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | WHO-ART 092 | Non-systematic Assessment |
|
| NERVOUSNESS | Psychiatric disorders | WHO-ART 092 | Non-systematic Assessment |
|
| ANAEMIA HYPOCHROMIC | Blood and lymphatic system disorders | WHO-ART 092 | Non-systematic Assessment |
|
| BRONCHITIS | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
|
| CYSTITIS | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
|
| FURUNCULOSIS | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
|
| INFECTION VIRAL | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
|
| OTITIS MEDIA | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
|
| PHARYNGITIS | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
|
| PNEUMONIA | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
|
| PYELONEPHRITIS | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
|
| RHINITIS | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
|
| SINUSITIS | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | WHO-ART 092 | Non-systematic Assessment |
|
| COUGHING | Respiratory, thoracic and mediastinal disorders | WHO-ART 092 | Non-systematic Assessment |
|
| SPUTUM DISORDER | Respiratory, thoracic and mediastinal disorders | WHO-ART 092 | Non-systematic Assessment |
|
| DERMATITIS | Skin and subcutaneous tissue disorders | WHO-ART 092 | Non-systematic Assessment |
|
| DERMATITIS CONTACT | Skin and subcutaneous tissue disorders | WHO-ART 092 | Non-systematic Assessment |
|
| ECZEMA | Skin and subcutaneous tissue disorders | WHO-ART 092 | Non-systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | WHO-ART 092 | Non-systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | WHO-ART 092 | Non-systematic Assessment |
|
| SEBORRHOEA | Skin and subcutaneous tissue disorders | WHO-ART 092 | Non-systematic Assessment |
|
| SKIN DISORDER | Skin and subcutaneous tissue disorders | WHO-ART 092 | Non-systematic Assessment |
|
| URTICARIA | Skin and subcutaneous tissue disorders | WHO-ART 092 | Non-systematic Assessment |
|
| CONJUNCTIVITIS | Eye disorders | WHO-ART 092 | Non-systematic Assessment |
|
| HETEROPHORIA | Eye disorders | WHO-ART 092 | Non-systematic Assessment |
|
| LACRIMAL DUCT OBSTRUCTION | Eye disorders | WHO-ART 092 | 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.
| Title | Measurements |
|---|---|
|
| After Vaccination 2: Mild (n =536) |
|
| After Vaccination 2: Moderate (n =536) |
|
| After Vaccination 2: Severe (n =536) |
|
| After Vaccination 3: Mild (n =489) |
|
| After Vaccination 3: Moderate (n =489) |
|
| After Vaccination 3: Severe (n =489) |
|
| After Vaccination 4: Mild (n =342) |
|
| After Vaccination 4: Moderate (n =342) |
|
| After Vaccination 4: Severe (n =342) |
|
| Title | Measurements |
|---|
|