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The purposes of this study are to evaluate the safety of 13-valent pneumococcal Conjugate Vaccine (13vPnC) in children who have already been vaccinated with Prevenar. The study will also assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine at 5 and 12 months or 12 months of age. In addition, reactions at the injection site will be assessed during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental |
| |
| Group 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13vPnC | Biological | 13vPnC will be administered by intramuscular injection at approximately 5 and 12 months of age. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. | 1 month after the toddler dose (13 months of age) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose | Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age) | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category. |
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 |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Eskilstuna | SE-63188 | Sweden | |||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Group 1 participants received 1 dose of Prevenar at least 42 days prior to study enrollment. Group 2 participants received 2 doses of Prevenar with the last dose at least 140 days prior to study enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | 13vPnC/13vPnC | Participants received two doses of 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7-valent pneumococcal conjugate vaccine (7vPnC), at approximately 3 months of age prior to enrollment in the study. |
| FG001 | 13vPnC | Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants had received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Infant Series (5 Months of Age) |
| |||||||||||||
| After Infant Dose (6 Months of Age) |
| |||||||||||||
| Toddler Dose (12 Months of Age) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 13vPnC/13vPnC | Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study. |
| BG001 |
| 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 | Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose | Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. | Evaluable Toddler Immunogenicity Population: eligible participants who received study vaccine at the expected dose(s), blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. | Posted | Geometric Mean | 95% Confidence Interval | mcg/mL | 1 month after the toddler dose (13 months of age) |
|
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The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious 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 | 13vPnC/13vPnC at 5 Months | 13vPnC 0.5 mL dose administered IM at 5 months of age (infant dose) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA unspecified | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA unspecified | 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 |
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| 13vPnC | Biological | 13vPnC will be administered by intramuscular injection at approximately 12 months of age. |
|
| 1 Month after the infant series (6 months of age) |
| GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose | Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs calculated using all participants with available data for the specified blood draw. | 1 Month after the infant series (6 months of age) |
| GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) presented. GMC (13vPnC) and corresponding 2-sided 95% CIs evaluated. GMCs calculated using all participants with available data for the specified blood draw. | 12 months of age (prior to toddler dose) |
| Day 1 through Day 7 after vaccination |
| Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category. | Day 1 through Day 7 after vaccination |
| Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age) | Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category. | Day 1 through 7 after vaccination |
| Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age) | Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category. | Day 1 through 7 after vaccination |
| Gothenburg |
| SE-40014 |
| Sweden |
| Pfizer Investigational Site | Malmö | SE-20502 | Sweden |
| Pfizer Investigational Site | Örebro | SE-70185 | Sweden |
| Pfizer Investigational Site | Östersund | SE-83183 | Sweden |
| Pfizer Investigational Site | Uddevalla | SE-45180 | Sweden |
| Pfizer Investigational Site | Umeå | SE-90185 | Sweden |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
|
| 13vPnC |
Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study. |
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex/Gender, Customized | Number | participants |
|
Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study. |
| OG001 | 13vPnC | Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study. |
|
|
| Secondary | Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose | Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. | Evaluable Infant Immunogenicity Population: eligible participants who received study vaccine at the expected dose(s), blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. | Posted | Number | 95% Confidence Interval | Percentage of participants | 1 Month after the infant series (6 months of age) |
|
|
|
| Secondary | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose | Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs calculated using all participants with available data for the specified blood draw. | Evaluable Infant Immunogenicity Population | Posted | Geometric Mean | 95% Confidence Interval | mcg/mL | 1 Month after the infant series (6 months of age) |
|
|
|
| Secondary | GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose | Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) presented. GMC (13vPnC) and corresponding 2-sided 95% CIs evaluated. GMCs calculated using all participants with available data for the specified blood draw. | Evaluable Toddler Immunogenicity Population | Posted | Geometric Mean | 95% Confidence Interval | mcg/mL | 12 months of age (prior to toddler dose) |
|
|
|
| Other Pre-specified | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age) | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category. | Safety Population: all participants who received at least 1 dose of the study vaccine; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic | Posted | Number | Percentage of participants | Day 1 through Day 7 after vaccination |
|
|
|
| Other Pre-specified | Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category. | Safety Population; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic | Posted | Number | Percentage of participants | Day 1 through Day 7 after vaccination |
|
|
|
| Other Pre-specified | Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age) | Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category. | Safety Population; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic | Posted | Number | Percentage of participants | Day 1 through 7 after vaccination |
|
|
|
| Other Pre-specified | Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age) | Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category. | Safety Population; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic | Posted | Number | Percentage of participants | Day 1 through 7 after vaccination |
|
|
|
| 1 |
| 118 |
| 92 |
| 118 |
| EG001 | 13vPnC/13vPnC at 6 Months of Age | 13vPnC 0.5 mL dose administered IM at 5 months of age (infant dose); assessment 1 month after the infant series (6 months of age). | 4 | 118 | 4 | 118 |
| EG002 | 13vPnC/13vPnC at 12 Months | 13vPnC 0.5 mL dose administered IM at 5 months (infant dose) and 12 months of age (toddler dose). | 1 | 116 | 91 | 116 |
| EG003 | 13vPnC at 12 Months | 13vPnC 0.5 mL dose administered IM at 12 months of age (toddler dose). | 0 | 116 | 86 | 116 |
| Intussusception | Gastrointestinal disorders | MedDRA unspecified | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA unspecified | Non-systematic Assessment |
|
| Foreign body | Injury, poisoning and procedural complications | MedDRA unspecified | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA unspecified | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA unspecified | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA unspecified | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA unspecified | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA unspecified | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA unspecified | Non-systematic Assessment |
|
| Exanthema subitum | Infections and infestations | MedDRA unspecified | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA unspecified | Non-systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA unspecified | Non-systematic Assessment |
|
| Crying | Nervous system disorders | MedDRA unspecified | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA unspecified | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA unspecified | Non-systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA unspecified | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA unspecified | Non-systematic Assessment |
|
| Mastitis | Infections and infestations | MedDRA unspecified | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA unspecified | Non-systematic Assessment |
|
| Teething | Gastrointestinal disorders | MedDRA unspecified | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA unspecified | Non-systematic Assessment |
|
| Irritability | General disorders | MedDRA unspecified | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA unspecified | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA unspecified | Non-systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA unspecified | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA unspecified | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA unspecified | Non-systematic Assessment |
|
| Croup infectious | Infections and infestations | MedDRA unspecified | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA unspecified | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA unspecified | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA unspecified | Non-systematic Assessment |
|
| Foreign body | Injury, poisoning and procedural complications | MedDRA unspecified | Non-systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA unspecified | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA unspecified | Non-systematic Assessment |
|
| Lower extremity mass | Musculoskeletal and connective tissue disorders | MedDRA unspecified | Non-systematic Assessment |
|
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA unspecified | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA unspecified | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA unspecified | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA unspecified | Non-systematic Assessment |
|
| Tenderness (Any) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment |
|
| Tenderness (Significant) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment |
|
| Swelling (Any) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment |
|
| Swelling (Mild) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment |
|
| Swelling (Moderate) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment |
|
| Swelling (Severe) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment |
|
| Redness (Any) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment |
|
| Redness (Mild) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment |
|
| Redness (Moderate) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment |
|
| Redness (Severe) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment |
|
| Fever ≥38°C but ≤39°C | General disorders | Systemic Events | Systematic Assessment |
|
| Fever >39°C but ≤40°C | General disorders | Systemic Events | Systematic Assessment |
|
| Fever >40°C | General disorders | Systemic Events | Systematic Assessment |
|
| Decreased appetite | General disorders | Systemic Events | Systematic Assessment |
|
| Irritability | General disorders | Systemic Events | Systematic Assessment |
|
| Increased sleep | General disorders | Systemic Events | Systematic Assessment |
|
| Decreased sleep | General disorders | Systemic Events | 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 |
|---|---|
|
| Common Serotype 14 |
|
| Common Serotype 18C |
|
| Common Serotype 19F |
|
| Common Serotype 23F |
|
| Additional Serotype 1 |
|
| Additional Serotype 3 |
|
| Additional Serotype 5 |
|
| Additional Serotype 6A |
|
| Additional Serotype 7F |
|
| Additional Serotype 19A |
|
| Title | Measurements |
|---|---|
|
| Common Serotype 14 |
|
| Common Serotype 18C |
|
| Common Serotype 19F |
|
| Common Serotype 23F |
|
| Additional Serotype 1 |
|
| Additional Serotype 3 |
|
| Additional Serotype 5 |
|
| Additional Serotype 6A |
|
| Additional Serotype 7F |
|
| Additional Serotype 19A |
|
| Common Serotype 9V |
|
| Common Serotype 14 |
|
| Common Serotype 18C |
|
| Common Serotype 19F |
|
| Common Serotype 23F |
|
| Additional Serotype 1 |
|
| Additional Serotype 3 |
|
| Additional Serotype 5 |
|
| Additional Serotype 6A |
|
| Additional Serotype 7F |
|
| Additional Serotype 19A |
|
| Title | Measurements |
|---|---|
|
| Swelling: Mild (n=104) |
|
| Swelling: Moderate (n=101) |
|
| Swelling: Severe (n=99) |
|
| Redness: Any (n=107) |
|
| Redness: Mild (n=107) |
|
| Redness: Moderate (n=99) |
|
| Redness: Severe (n=99) |
|
| Swelling: Any (n=104,110) |
|
| Swelling: Mild (n=104,109) |
|
| Swelling: Moderate (n=100,105) |
|
| Swelling: Severe (n=95,101) |
|
| Redness: Any (n=104,113) |
|
| Redness: Mild (n=103,113) |
|
| Redness: Moderate (n=98,106) |
|
| Redness: Severe (n=95,101) |
|
| Title | Measurements |
|---|---|
|
| Decreased appetite (n=107) |
|
| Irritability (n=114) |
|
| Increased sleep (n=106) |
|
| Decreased sleep (n=112) |
|
| Fever >40 degrees C (n=95,101) |
|
| Decreased appetite (n=103,109) |
|
| Irritability (n=111,113) |
|
| Increased sleep (n=101,108) |
|
| Decreased sleep (n=105,106) |
|