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| ID | Type | Description | Link |
|---|---|---|---|
| B1841011 |
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This study is planned to monitor the local and/or systemic reactions and compatibility of PCV-7 with routine vaccines in the Russian National immunization schedule. Consistent with the observational nature of this protocol, Prevenar will be administered as standard of care.
The aim of this study is to estimate the incidence of febrile reactions more than 38.0 degrees Celsius, specifically (≥38 to < 39 degrees C; > 39 to < 40 degrees C and > 40 degrees C, and the frequency of other local or systemic reactions following vaccination with Prevenar (PCV-7) co-administered with other routine childhood vaccines under the conditions of routine daily use in the Russian Federation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| healthy children after vaccination | healthy children after vaccination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-interventional observational study | Other | Non-interventional observational study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Febrile Reactions Post-dose 1 | Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of greater than or equal to (>=) 38 degrees Celsius (C). Percentage of participants with febrile reaction of >=38 degrees C to less than or equal to (<=) 39 degrees C, >39 degrees C to <=40 degrees C and >40 degrees C were observed. | Day 1 to Day 3 post-dose 1 |
| Percentage of Participants With Febrile Reactions Post-dose 2 | Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C to <=39 degrees C was observed. | Day 1 to Day 3 post-dose 2 |
| Percentage of Participants With Febrile Reactions Post-dose 3 | Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C to <=39 degrees C was observed. | Day 1 to Day 3 post-dose 3 |
| Percentage of Participants With Febrile Reactions Post-dose 4 | Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C was observed. | Day 1 to Day 3 post-dose 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Pre-Specified Local Reactions Post-dose 1 | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 centimeters [cm]); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth. |
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Inclusion Criteria:
Exclusion Criteria:
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Infants and Children from 3 months to 23 months at enrollment
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Russian State Medical University | Moscow | 119049 | Russia | |||
| Russian Academy of Medical Sciences |
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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 | Primary Cohort (3-6 Months) | Participants in the age group 3-6 months received 4 doses (Dose 1, Dose 2, Dose 3 and Dose 4) of 7-valent pneumococcal conjugate vaccine (PCV7) as standard care as per the Summary of Product Characteristics (SmPC). |
| FG001 | Catch-up Cohort (7-11 Months) | Participants in the age group 7-11 months received 3 doses (Dose 1, Dose 2 and Dose 3) of PCV7 vaccine as standard care as per the SmPC. |
| FG002 | Catch-up Cohort (12-23 Months) | Participants in the age group 12-23 months received 2 doses (Dose 1 and Dose 2) of PCV7 vaccine as standard care as per the SmPC. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Primary Cohort (3-6 Months) | Participants in the age group 3-6 months received 4 doses (Dose 1, Dose 2, Dose 3 and Dose 4) of PCV7 vaccine as standard care as per the SmPC. |
| BG001 | Catch-up Cohort (7-11 Months) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Febrile Reactions Post-dose 1 | Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of greater than or equal to (>=) 38 degrees Celsius (C). Percentage of participants with febrile reaction of >=38 degrees C to less than or equal to (<=) 39 degrees C, >39 degrees C to <=40 degrees C and >40 degrees C were observed. | Safety set (post-dose 1) population included all participants who received Dose 1 and who had safety follow-up data following Dose 1. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 to Day 3 post-dose 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 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 | Dose 1 (Primary Cohort [3-6 Months]) | Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute sinusitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| Day 1 to Day 3 post-dose 1 |
| Percentage of Participants With Pre-Specified Local Reactions Post-dose 2 | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth. | Day 1 to Day 3 post-dose 2 |
| Percentage of Participants With Pre-Specified Local Reactions Post-dose 3 | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth. | Day 1 to Day 3 post-dose 3 |
| Percentage of Participants With Pre-Specified Local Reactions Post-dose 4 | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth. | Day 1 to Day 3 post-dose 4 |
| Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 | Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category. | Day 1 to Day 3 post-dose 1 |
| Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 | Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category. | Day 1 to Day 3 post-dose 2 |
| Percentage of Participants With Pre-Specified Systemic Events Post-dose 3 | Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category. | Day 1 to Day 3 post-dose 3 |
| Percentage of Participants With Pre-Specified Systemic Events Post-dose 4 | Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category. | Day 1 to Day 3 post-dose 4 |
| Moscow |
| 119296 |
| Russia |
| Research Institute of Childhood Infections | Saint Petersburg | 197022 | Russia |
| City Children's Clinical Hospital #8 | Yekaterinburg | 620085 | Russia |
| Lost to Follow-up |
|
Participants in the age group 7-11 months received 3 doses (Dose 1, Dose 2 and Dose 3) of PCV7 vaccine as standard care as per the SmPC.
| BG002 | Catch-up Cohort (12-23 Months) | Participants in the age group 12-23 months received 2 doses (Dose 1 and Dose 2) of PCV7 vaccine as standard care as per the SmPC. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Catch-up Cohort (7-11 Months) | Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC. |
| OG002 | Catch-up Cohort (12-23 Months) | Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC. |
|
|
| Primary | Percentage of Participants With Febrile Reactions Post-dose 2 | Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C to <=39 degrees C was observed. | Safety set (post-dose 2) population included all participants who received Dose 2 and who had safety follow-up data following Dose 2. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 to Day 3 post-dose 2 |
|
|
|
| Primary | Percentage of Participants With Febrile Reactions Post-dose 3 | Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C to <=39 degrees C was observed. | Safety set (post-dose 3) population included all participants who received Dose 3 and who had safety follow-up data following Dose 3. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 to Day 3 post-dose 3 |
|
|
|
| Primary | Percentage of Participants With Febrile Reactions Post-dose 4 | Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C was observed. | Safety set (post-dose 4) population included all participants who received Dose 4 and who had safety follow-up data following Dose 4. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 to Day 3 post-dose 4 |
|
|
|
| Secondary | Percentage of Participants With Pre-Specified Local Reactions Post-dose 1 | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 centimeters [cm]); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth. | Safety set (post-dose 1) population included all participants who received Dose 1 and who had safety follow-up data following Dose 1. | Posted | Number | Percentage of participants | Day 1 to Day 3 post-dose 1 |
|
|
|
| Secondary | Percentage of Participants With Pre-Specified Local Reactions Post-dose 2 | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth. | Safety set (post-dose 2) population included all participants who received Dose 2 and who had safety follow-up data following Dose 2. | Posted | Number | Percentage of participants | Day 1 to Day 3 post-dose 2 |
|
|
|
| Secondary | Percentage of Participants With Pre-Specified Local Reactions Post-dose 3 | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth. | Safety set (post-dose 3) population included all participants who received Dose 3 and who had safety follow-up data following Dose 3. | Posted | Number | Percentage of participants | Day 1 to Day 3 post-dose 3 |
|
|
|
| Secondary | Percentage of Participants With Pre-Specified Local Reactions Post-dose 4 | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth. | Safety set (post-dose 4) population included all participants who received Dose 4 and who had safety follow-up data following Dose 4. | Posted | Number | Percentage of participants | Day 1 to Day 3 post-dose 4 |
|
|
|
| Secondary | Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 | Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category. | Safety set (post-dose 1) population included all participants who received Dose 1 and who had safety follow-up data following Dose 1. | Posted | Number | Percentage of participants | Day 1 to Day 3 post-dose 1 |
|
|
|
| Secondary | Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 | Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category. | Safety set (post-dose 2) population included all participants who received Dose 2 and who had safety follow-up data following Dose 2. | Posted | Number | Percentage of participants | Day 1 to Day 3 post-dose 2 |
|
|
|
| Secondary | Percentage of Participants With Pre-Specified Systemic Events Post-dose 3 | Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category. | Safety set (post-dose 3) population included all participants who received Dose 3 and who had safety follow-up data following Dose 3. | Posted | Number | Percentage of participants | Day 1 to Day 3 post-dose 3 |
|
|
|
| Secondary | Percentage of Participants With Pre-Specified Systemic Events Post-dose 4 | Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category. | Safety set (post-dose 4) population included all participants who received Dose 4 and who had safety follow-up data following Dose 4. | Posted | Number | Percentage of participants | Day 1 to Day 3 post-dose 4 |
|
|
|
| 0 |
| 14 |
| 6 |
| 14 |
| EG001 | Dose 2 (Primary Cohort [3-6 Months]) | Participants in the age group 3-6 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC. | 0 | 13 | 6 | 13 |
| EG002 | Dose 3 (Primary Cohort [3-6 Months]) | Participants in the age group 3-6 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC. | 0 | 13 | 6 | 13 |
| EG003 | Dose 4 (Primary Cohort [3-6 Months]) | Participants in the age group 3-6 months received Dose 4 of PCV7 vaccine as standard care as per the SmPC. | 0 | 7 | 2 | 7 |
| EG004 | Dose 1 (Catch-up Cohort [7-11 Months]) | Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC. | 1 | 31 | 17 | 31 |
| EG005 | Dose 2 (Catch-up Cohort [7-11 Months]) | Participants in the age group 7-11 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC. | 0 | 29 | 8 | 29 |
| EG006 | Dose 3 (Catch-up Cohort [7-11 Months]) | Participants in the age group 7-11 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC. | 0 | 26 | 5 | 26 |
| EG007 | Dose 1 (Catch-up Cohort [12-23 Months]) | Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC. | 1 | 55 | 27 | 55 |
| EG008 | Dose 2 (Catch-up Cohort [12-23 Months]) | Participants in the age group 12-23 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC. | 0 | 54 | 16 | 54 |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Disbacteriosis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Abscess limb | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Enterovirus infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Rotavirus infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
|
| Crying | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Redness | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment |
|
| Swelling | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment |
|
| Tenderness | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment |
|
| Injection site haematoma | General disorders | Local reactions | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | Local reactions | Systematic Assessment |
|
| Injection site induration | General disorders | Local reactions | Systematic Assessment |
|
| Injection site warmth | General disorders | Local reactions | Systematic Assessment |
|
| Decreased appetite | General disorders | Systemic events | Systematic Assessment |
|
| Diarrhea | General disorders | Systemic events | Systematic Assessment |
|
| Fever | General disorders | Systemic events | Systematic Assessment |
|
| Restless sleep | General disorders | Systemic events | Systematic Assessment |
|
| Unusual crying | General disorders | Systemic events | Systematic Assessment |
|
| Unusual fussiness | General disorders | Systemic events | Systematic Assessment |
|
| Unusual irritability | General disorders | Systemic events | Systematic Assessment |
|
| Vomiting | 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 |
|---|---|
|
| Tenderness |
|
| Injection site hematoma |
|
| Injection site hemorrhage |
|
| Injection site induration |
|
| Injection site warmth |
|
| Title | Measurements |
|---|---|
|
| Tenderness |
|
| Injection site hemorrhage |
|
| Injection site induration |
|
| Tenderness |
|
| Injection site induration |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Fever |
|
| Restless sleep |
|
| Unusual crying |
|
| Unusual fussiness |
|
| Unusual irritability |
|
| Vomiting |
|
| Title | Measurements |
|---|---|
|
| Fever |
|
| Restless sleep |
|
| Unusual crying |
|
| Unusual fussiness |
|
| Unusual irritability |
|
| Vomiting |
|
| Fever |
|
| Restless sleep |
|
| Unusual crying |
|
| Unusual fussiness |
|
| Unusual irritability |
|
| Vomiting |
|
| Title | Measurements |
|---|---|
|