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The purpose of this study will be to analyze 13-valent pneumococcal vaccine given to healthy infants in Brazil for safety and tolerability, and to determine the immune response to the vaccines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 13vPnC | Experimental | 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). |
|
| 7vPnC | Active Comparator | 7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) | Biological |
| ||
| 7-Valent Pneumococcal Conjugate Vaccine (7vPnc) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% confidence interval (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. | 1 Month after the infant series (7 Months of age) |
| Percentage of Participants Achieving Antibody Level ≥5 Enzyme-linked Immunosorbent Assay (ELISA) Units Per mL (EU/mL) for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Percentage of participants achieving predefined antibody threshold ≥5 enzyme-linked immunosorbent assay (ELISA) units per mL (EU/mL) along with the corresponding 95% CI for concomitant antigen pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], and pertactin [PRN]) are presented. | 1 month after the infant series (7 months of age) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% confidence interval (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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Pre-specified 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 be represented in more than 1 category. |
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Curitiba | 80060-900 | Brazil | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | 13vPnC | 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). |
| FG001 | 7vPnC |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Infant Series |
|
Not provided
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| Biological |
|
| 1 month after the toddler dose (13 months of age) |
| Percentage of Participants Achieving Antibody Level ≥5 EU/mL for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Percentage of participants achieving predefined antibody threshold ≥5 EU/mL along with the corresponding 95% CI for concomitant antigen pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], and pertactin [PRN]) are presented. | 1 month after the toddler dose (13 months of age) |
| Within 4 days after dose 1 (2 months of age) |
| Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Pre-specified 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 be represented in more than 1 category. | Within 4 days after dose 2 (4 months of age) |
| Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Pre-specified 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 be represented in more than 1 category. | Within 4 days after dose 3 (6 months of age) |
| Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Pre-specified 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 be represented in more than 1 category. | Within 4 days after toddler dose (12 months of age) |
| Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category. | Within 4 days after dose 1 (2 months of age) |
| Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category. | Within 4 days after dose 2 (4 months of age) |
| Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category. | Within 4 days after dose 3 (6 months of age) |
| Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category. | Within 4 days after toddler dose (12 months of age) |
| Florianópolis |
| 88025-301 |
| Brazil |
| Sau Paulo | 04020-060 | Brazil |
| Sau Paulo | 04038-001 | Brazil |
7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
| Vaccinated Dose 1 |
|
| Vaccinated Dose 2 |
|
| Vaccinated Dose 3 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| After Infant Series |
|
|
| Toddler Dose |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 13vPnC | 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). |
| BG001 | 7vPnC | 7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | months |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Micrograms Per Milliliter (Mcg/mL) in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% confidence interval (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. | Evaluable immunogenicity population: treatments as randomized at all expected doses, blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations. N=number of participants with a determinate IgG antibody concentration to the given serotype. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 Month after the infant series (7 Months of age) |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants Achieving Antibody Level ≥5 Enzyme-linked Immunosorbent Assay (ELISA) Units Per mL (EU/mL) for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Infant Series | Percentage of participants achieving predefined antibody threshold ≥5 enzyme-linked immunosorbent assay (ELISA) units per mL (EU/mL) along with the corresponding 95% CI for concomitant antigen pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], and pertactin [PRN]) are presented. | Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the given concomitant vaccine component. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month after the infant series (7 months of age) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Serotype Specific IgG Antibody Concentration ≥0.35 Mcg/mL in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% confidence interval (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. | Evaluable immunogenicity population. N=number of participants with a determinate IgG antibody concentration to the given serotype. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month after the toddler dose (13 months of age) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Antibody Level ≥5 EU/mL for Pertussis in the 13vPnC Group Relative to 7vPnC Group 1 Month After the Toddler Dose | Percentage of participants achieving predefined antibody threshold ≥5 EU/mL along with the corresponding 95% CI for concomitant antigen pertussis (pertussis toxoid [PT], filamentous hemagglutinin [FHA], and pertactin [PRN]) are presented. | Evaluable immunogenicity population. N=number of participants with a determinate antibody concentration to the given concomitant vaccine component. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month after the toddler dose (13 months of age) |
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 Months of Age) | Pre-specified 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 be represented in more than 1 category. | Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days. | Posted | Number | percentage of participants | Within 4 days after dose 1 (2 months of age) |
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 Months of Age) | Pre-specified 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 be represented in more than 1 category. | Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days. | Posted | Number | percentage of participants | Within 4 days after dose 2 (4 months of age) |
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 Months of Age) | Pre-specified 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 be represented in more than 1 category. | Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days. | Posted | Number | percentage of participants | Within 4 days after dose 3 (6 months of age) |
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants Reporting Pre-specified Local Reactions: Toddler Dose (12 Months of Age) | Pre-specified 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 be represented in more than 1 category. | Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days. | Posted | Number | percentage of participants | Within 4 days after toddler dose (12 months of age) |
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 1 (2 Months of Age) | Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category. | Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days. | Posted | Number | percentage of participants | Within 4 days after dose 1 (2 months of age) |
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 2 (4 Months of Age) | Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category. | Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days. | Posted | Number | percentage of participants | Within 4 days after dose 2 (4 months of age) |
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants Reporting Pre-specified Systemic Events: Infant Series Dose 3 (6 Months of Age) | Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category. | Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days. | Posted | Number | percentage of participants | Within 4 days after dose 3 (6 months of age) |
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants Reporting Pre-specified Systemic Events: Toddler Dose (12 Months of Age) | Pre-specified systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may be represented in more than 1 category. | Safety population: all participants who received at least 1 dose of study vaccine. N=number of participants reporting yes for at least 1 day or no for all days. | Posted | Number | percentage of participants | Within 4 days after toddler dose (12 months of age) |
|
|
Baseline through 1 Month after last study vaccination (13 Months). Local reactions and systemic events assessed within 4 days of dose: Infant Series Dose 1=2 months of age; Dose 2=4 months of age; Dose 3=6 months of age; Toddler Dose=12 months of age.
Safety population = all randomized subjects with at least 1 dose of study treatment. An Adverse Event (AE) term may be reported as both a serious and non-serious AE, but are distinct events. AE may = serious for 1 subject and = non-serious for another subject or subject may have experienced both a serious and non-serious episode of the same event.
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 | Infant Series 13vPnC | 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series). | 10 | 163 | 140 | 163 | ||
| EG001 | Infant Series 7vPnC | 7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series). | 10 | 162 | 140 | 162 | ||
| EG002 | After the Infant Series 13vPnC | 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age). | 10 | 163 | 18 | 163 | ||
| EG003 | After the Infant Series 7vPnC | 7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 2, 4, and 6 months of age (infant series); assessment 1 month after the infant series (7 months of age). | 5 | 162 | 12 | 162 | ||
| EG004 | Toddler Dose 13vPnC | 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 12 months of age (toddler dose). 7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 12 months of age (toddler dose). Other Adverse Events (non-serious events): the number affected (N) for non-systematic (non-solicited) Other Adverse Events N=69; systematic (solicited) Local Reactions N=81; systematic (solicited) Systemic Events N=84. Total N at Risk=155: 1 participant had no record of safety information during the Toddler dose period and was not included in the Safety population. | 2 | 155 | 84 | 155 | ||
| EG005 | Toddler Dose 7vPnC | 7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered IM at 12 months of age (toddler dose). Other Adverse Events (non-serious events): the number affected (N) for non-systematic (non-solicited) Other Adverse Events N=64; systematic (solicited) Local Reactions N=67; systematic (solicited) Systemic Events N=86. | 3 | 156 | 86 | 156 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Congenital hydrocephalus | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia primary atypical | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Muscle abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Tracheobronchitis viral | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypotonic-hyporesponsive episode | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Breath holding | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Hydrocele | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Ventricular septal defect | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Congenital hydrocephalus | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Glucose-6-phosphate dehydrogenase deficiency | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Cerumen impaction | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Strabismus | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Eye discharge | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Abnormal faeces | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Oral mucosal discolouration | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Regurgitation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA | Non-systematic Assessment |
| |
| Tenderness | General disorders | MedDRA | Non-systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Inflammation | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site exfoliation | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site scar | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Non-systematic Assessment |
| |
| Vaccination site erythema | General disorders | MedDRA | Non-systematic Assessment |
| |
| Vaccination site pain | General disorders | MedDRA | Non-systematic Assessment |
| |
| Vaccination site reaction | General disorders | MedDRA | Non-systematic Assessment |
| |
| Allergy to anthropod sting | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Milk allergy | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Allergy to anthropod bite | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Perineal infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Exanthema subitum | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Viral rash | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Conjunctivitis bacterial | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Asymptomatic bacteriuria | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Conjunctivitis viral | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia primary atypical | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pyoderma | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Conjunctivitis infective | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Herpangina | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Injection site abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Menigitis viral | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pertussis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pharyngitis bacterial | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Roseola | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Skin bacterial infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Viral diarrhoea | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Viral tonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Muscle abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Tracheobronchitis viral | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Tonsillitis bacterial | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Abnormal weight gain | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Weight gain poor | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Lactose intolerance | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Hypotonic-hyporesponsive episode | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Hypokinesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Poor quality sleep | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Psychomotor skills impaired | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Breath holding | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Pyelocaliectasis | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Allergic cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Upper airway obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Pityriasis alba | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Prurigo | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperaemia | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Tenderness (any) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; tenderness (any)=present at site of vaccination |
|
| Tenderness (any) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 2; tenderness (any)=present at site of vaccination |
|
| Tenderness (any) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 3; tenderness (any)=present at site of vaccination |
|
| Tenderness (significant) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Tenderness (significant)=present and interfered with limb movement |
|
| Tenderness (significant) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 2; Tenderness (significant)=present and interfered with limb movement |
|
| Tenderness (significant) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 3; Tenderness (significant)=present and interfered with limb movement |
|
| Swelling (any) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Swelling (any)=present at site of vaccination |
|
| Swelling (any) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 2; Swelling (any)=present at site of vaccination |
|
| Swelling (any) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 3; Swelling (any)=present at site of vaccination |
|
| Swelling (mild) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Swelling (mild)=0.5 to 2.0 centimeters (cm) |
|
| Swelling (mild) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 2; Swelling (mild)=0.5 to 2.0 cm |
|
| Swelling (mild) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 3; Swelling (mild)=0.5 to 2.0 cm |
|
| Swelling (moderate) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Swelling (moderate)=2.5 to 7.0 cm |
|
| Swelling (moderate) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 2; Swelling (moderate)=2.5 to 7.0 cm |
|
| Swelling (moderate) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 3; Swelling (moderate)=2.5 to 7.0 cm |
|
| Swelling (severe) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Swelling (severe) >7.0 cm |
|
| Swelling (severe) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 2; Swelling (severe) >7.0 cm |
|
| Swelling (severe) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 3; Swelling (severe) >7.0 cm |
|
| Redness (any) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Redness (any)=present at site of vaccination. |
|
| Redness (any) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 2; Redness (any)=present at site of vaccination |
|
| Redness (any) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 3; Redness (any)=present at site of vaccination |
|
| Redness (mild) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Redness (mild)=0.5 to 2.0 cm |
|
| Redness (mild) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 2; Redness (mild)=0.5 to 2.0 cm |
|
| Redness (mild) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 3; Redness (mild)=0.5 to 2.0 cm |
|
| Redness (moderate) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Redness (moderate)=2.5 to 7.0 cm |
|
| Redness (moderate) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 2; Redness (moderate)=2.5 to 7.0 cm |
|
| Redness (moderate) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 3; Redness (moderate)=2.5 to 7.0 cm |
|
| Redness (severe) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Redness (severe) >7.0 cm |
|
| Redness (severe) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 2; Redness (severe) >7.0 cm |
|
| Redness (severe) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 3; Redness (severe) >7.0 cm |
|
| Fever ≥ 38 degrees Celsius [C] but ≤ 39 degrees C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Fever ≥ 38 degrees C but ≤ 39 degrees C |
|
| Fever ≥ 38 degrees C but ≤ 39 degrees C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 2; Fever ≥ 38 degrees C but ≤ 39 degrees C |
|
| Fever ≥ 38 degrees C but ≤ 39 degrees C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 3; Fever ≥ 38 degrees C but ≤ 39 degrees C |
|
| Fever > 39 degrees C but ≤ 40 degrees C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Fever > 39 degrees C but ≤ 40 degrees C |
|
| Fever > 39 degrees C but ≤ 40 degrees C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 2; Fever > 39 degrees C but ≤ 40 degrees C |
|
| Fever > 39 degrees C but ≤ 40 degrees C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 3; Fever > 39 degrees C but ≤ 40 degrees C |
|
| Fever > 40 degrees C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Fever > 40 degrees C |
|
| Fever > 40 degrees C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 2; Fever > 40 degrees C |
|
| Fever > 40 degrees C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 3; Fever > 40 degrees C |
|
| Decreased appetite | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Decreased appetite |
|
| Decreased appetite | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 2; Decreased appetite |
|
| Decreased appetite | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 3; Decreased appetite |
|
| Irritability | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Irritability |
|
| Irritability | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 2; Irritability |
|
| Irritability | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 3; Irritability |
|
| Increased sleep | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Increased sleep |
|
| Increased sleep | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 2; Increased sleep |
|
| Increased sleep | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 3; Increased sleep |
|
| Decreased sleep | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Decreased sleep |
|
| Decreased sleep | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 2; Decreased sleep |
|
| Decreased sleep | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 3; Decreased sleep |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D017778 | Vaccines, Combined |
Not provided
Not provided
| Failed to return |
|
| Male |
|
| Common serotypes - serotype 9V |
|
| Common serotypes - serotype 14 |
|
| Common serotypes - serotype 18C |
|
| Common serotypes - serotype 19F |
|
| Common serotypes - serotype 23F |
|
| Additional serotypes - serotype 1 |
|
| Additional serotypes - serotype 3 |
|
| Additional serotypes - serotype 5 |
|
| Additional serotypes - serotype 6A |
|
| Additional serotypes - serotype 7F |
|
| Additional serotypes - serotype 19A |
|
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