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The purpose of this study will be to evaluate safety, tolerability and immunogenicity of 13-valent pneumococcal vaccine in healthy infants given with routine pediatric vaccinations in Mexico.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13-valent pneumococcal conjugate vaccine | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series | Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95 percent confidence interval (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. | 1 month after the infant series (7 months of age) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series | Percentage of participants achieving predefined antibody threshold ≥0.35mcg/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 |
|---|---|---|
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series | 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) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. |
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 |
|---|---|---|---|---|---|---|
| Guadalajara | Jalisco | 44080 | Mexico | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23965217 | Derived | Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinon-Torres F, Gruber WC, Patterson S, Thompson A, Gurtman A, Paradiso P, Scott DA. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-74. doi: 10.1016/j.vaccine.2013.08.009. Epub 2013 Aug 16. |
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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) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Infant Series |
|
| |||||||||||||||||||||||||||||||||
| 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (Mcg/mL), 1 Month After the Infant Series | Percentage of participants achieving predefined antibody threshold ≥0.35mcg/mL, along with the corresponding 95 percent confidence interval (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 3-Dose Infant Immunogenicity population: eligible participants who received treatments as assigned at all 3 doses, 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 (7 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.
The same event may appear as both an 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 | Infant Series 13vPnC | 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5mL dose administered intramuscularly (IM) at 2, 4, and 6 months of age (infant series). Other Adverse Events (AEs) (non-serious events): the number affected (n) for non-systematic (non-solicited) Other Adverse Events n=79; systematic (solicited) Any Local Reaction n=154, 139, and 112 for Dose 1, 2,and 3 of infant series, respectively; systematic (solicited) Any Systemic Event n=182, 144, and 126 for Dose 1, 2,and 3 of infant series, respectively. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocarditis | Cardiac disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer Clinical Trials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquires@Pfizer.com |
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| 1 month after dose 2 of the infant series (5 months of age) |
| Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose | Percentage of participants achieving predefined antibody threshold ≥0.35mcg/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. | 1 month after the toddler dose (13 months of age) |
| Dose 2 of infant series (4 months of age) |
| GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series | Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. | Dose 3 of infant series (6 months of age) |
| GMC for Serotype-specific Pneumococcal IgG Antibody After 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 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data after the toddler dose and after the third dose of the infant series. | Toddler Dose (12 months of age) |
| Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 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 2.0cm); Moderate (2.5 to 7.0cm); Severe (greater than [>] 7.0cm). Participants may be represented in more than 1 category. | Within 4 days after dose 1 of Infant Series (2 months of age) |
| Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 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 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category. | Within 4 days after dose 2 of Infant Series (4 months of age) |
| Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 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 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). 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) | 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 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). 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) | 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 of Infant Series (2 months of age) |
| Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 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 be represented in more than 1 category. | Within 4 days after dose 2 of Infant Series (4 months of age) |
| Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 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 be represented in more than 1 category. | Within 4 days after dose 3 of Infant Series (6 months of age) |
| Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 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 be represented in more than 1 category. | Within 4 days after toddler dose (12 months of age) |
| Distrio Federal |
| Mexico |
| 14080 |
| Mexico |
| Distrio Federal | Mexico | 4530 | Mexico |
| Morelia | Michoacán | 58070 | Mexico |
| Cuernavaca | Morelos | 62508 | Mexico |
| Monterrey | Nuevo León | 64460 | Mexico |
| Oaxaca City | Oaxaca | 71220 | Mexico |
| Puebla City | Puebla | 72190 | Mexico |
| Mérida | Yucatán | 9700 | Mexico |
| Parent/legal guardian request |
|
| Failed to return |
|
| Other |
|
|
|
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 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) |
|
|
| Secondary | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35mcg/mL, 1 Month After Dose 2 of the Infant Series | Percentage of participants achieving predefined antibody threshold ≥0.35mcg/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 2-Dose Infant Immunogenicity population: eligible participants who received treatments as assigned at dose 1 and dose 2, 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 dose 2 of the infant series (5 months of age) |
|
|
|
| Secondary | Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Concentration ≥0.35mcg/mL, 1 Month After the Toddler Dose | Percentage of participants achieving predefined antibody threshold ≥0.35mcg/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 Toddler Immunogenicity population: eligible participants who received treatments as assigned at all 3 doses of the infant series and at the toddler dose, 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 toddler dose (13 months of age) |
|
|
|
| Other Pre-specified | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal IgG Antibody After Dose 2 of the Infant Series | 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) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. | Evaluable 2-Dose Infant Immunogenicity population | Posted | Geometric Mean | 95% Confidence Interval | mcg/mL | Dose 2 of infant series (4 months of age) |
|
|
|
| Other Pre-specified | GMC for Serotype-specific Pneumococcal IgG Antibody After Dose 3 of the Infant Series | Antibody GMC for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data for the specified blood draw. | Evaluable 3-Dose Infant Immunogenicity population | Posted | Geometric Mean | 95% Confidence Interval | mcg/mL | Dose 3 of infant series (6 months of age) |
|
|
|
| Other Pre-specified | GMC for Serotype-specific Pneumococcal IgG Antibody After 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 7vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CIs were evaluated. GMCs were calculated using all participants with available data after the toddler dose and after the third dose of the infant series. | Evaluable Toddler Immunogenicity population subset where the number of participants analyzed (N) equals (=) those who had a valid and determinate assay result for antibody GMC at both the infant dose 3 and toddler dose. | Posted | Geometric Mean | 95% Confidence Interval | mcg/mL | Toddler Dose (12 months of age) |
|
|
|
| Other Pre-specified | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (2 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 2.0cm); Moderate (2.5 to 7.0cm); Severe (greater than [>] 7.0cm). Participants may be represented in more than 1 category. | Safety population: All participants who received at least 1 dose of the study vaccine; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction. | Posted | Number | Percentage of participants | Within 4 days after dose 1 of Infant Series (2 months of age) |
|
|
|
| Other Pre-specified | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 2 (4 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 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category. | Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction. | Posted | Number | Percentage of participants | Within 4 days after dose 2 of Infant Series (4 months of age) |
|
|
|
| Other Pre-specified | Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 3 (6 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 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category. | Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction. | 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) | 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 to 2.0cm); Moderate (2.5 to 7.0cm); Severe (>7.0cm). Participants may be represented in more than 1 category. | Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any local reaction. | 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) | 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; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event. | Posted | Number | Percentage of participants | Within 4 days after dose 1 of Infant Series (2 months of age) |
|
|
|
| Other Pre-specified | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 2 (4 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 be represented in more than 1 category. | Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event. | Posted | Number | Percentage of participants | Within 4 days after dose 2 of Infant Series (4 months of age) |
|
|
|
| Other Pre-specified | Percentage of Participants Reporting Pre-Specified Systemic Events: Infant Series Dose 3 (6 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 be represented in more than 1 category. | Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event. | Posted | Number | Percentage of participants | Within 4 days after dose 3 of Infant Series (6 months of age) |
|
|
|
| Other Pre-specified | Percentage of Participants Reporting Pre-Specified Systemic Events: Toddler Dose (12 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 be represented in more than 1 category. | Safety population; Number of participants analyzed (N) = those reporting yes for at least 1 day or no for all days for any systemic event. | Posted | Number | Percentage of participants | Within 4 days after toddler dose (12 months of age) |
|
|
|
| 3 |
| 223 |
| 182 |
| 223 |
| EG001 | 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). | 3 | 223 | 3 | 223 |
| EG002 | Toddler Dose 13vPnC | 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 mL dose administered IM at 12 months of age (toddler dose). Other AEs (non-serious events): the number affected (n) for non-systematic (non-solicited) Other AEs n=50; systematic (solicited) Any Local Reaction n=73; systematic (solicited) Any Systemic Event n=96. | 2 | 191 | 96 | 191 |
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Kawasaki's disease | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Breath holding | Psychiatric disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Seizure anoxic | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Deficiency Anaemia | Blood and lymphatic system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Mucous stools | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vaccination site pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vaccination site erythema | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Vaccination site swelling | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Irritability | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Allergy to arthropod bite | Immune system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Viral rhinitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Viral pharyngitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Acarodermatitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Body tinea | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Conjunctivitis viral | 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 |
|
| Oral candidiasis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pyoderma | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Acute sinusitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Pharyngotonsillitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Varicella | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Grand mal convulsion | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cephalhaematoma | Pregnancy, puerperium and perinatal conditions | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Rash morbilliform | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
| Prurigo | 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 | Infant Series Dose 1 and Toddler Dose; tenderness (any)=present at site of vaccination |
|
| Tenderness (any) | Skin and subcutaneous tissue disorders | Local reaction | 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)=present at site of vaccination |
|
| Swelling (mild) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 2; swelling (mild)=present at site of vaccination |
|
| Swelling (mild) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 3; swelling (mild)=present at site of vaccination |
|
| Swelling (moderate) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; swelling (moderate)=present at site of vaccination |
|
| Swelling (moderate) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 2; swelling (moderate)=present at site of vaccination |
|
| Swelling (moderate) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 3; swelling (moderate)=present at site of vaccination |
|
| Swelling (severe) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; swelling (severe)=present at site of vaccination |
|
| Swelling (severe) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 2; swelling (severe)=present at site of vaccination |
|
| Swelling (severe) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 3; swelling (severe)=present at site of vaccination |
|
| 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)=present at site of vaccination |
|
| Redness (mild) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 2; redness (mild)=present at site of vaccination |
|
| Redness (mild) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 3; redness (mild)=present at site of vaccination |
|
| Redness (moderate) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; redness (moderate)=present at site of vaccination |
|
| Redness (moderate) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 2; redness (moderate)=present at site of vaccination |
|
| Redness (moderate) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 3; redness (moderate)=present at site of vaccination |
|
| Redness (severe) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; redness (severe)=present at site of vaccination |
|
| Redness (severe) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 2; redness (severe)=present at site of vaccination |
|
| Redness (severe) | Skin and subcutaneous tissue disorders | Local reactions | Systematic Assessment | Infant Series Dose 3; redness (severe)=present at site of vaccination |
|
| Fever ≥38°C but ≤39°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Fever ≥38°C but ≤39°C |
|
| Fever ≥38°C but ≤39°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 2; Fever ≥38°C but ≤39°C |
|
| Fever ≥38°C but ≤39°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 3; Fever ≥38°C but ≤39°C |
|
| Fever >39°C but ≤40°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Fever >39°C but ≤40°C |
|
| Fever >39°C but ≤40°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 2; Fever >39°C but ≤40°C |
|
| Fever >39°C but ≤40°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 3; Fever >39°C but ≤40°C |
|
| Fever >40°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Fever >40°C |
|
| Fever >40°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 2; Fever >40°C |
|
| Fever >40°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 3; Fever >40°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.
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
|
| 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 |
|
| Title | Measurements |
|---|---|
|
| Swelling: Mild |
|
| Swelling: Moderate |
|
| Swelling: Severe |
|
| Redness: Any |
|
| Redness: Mild |
|
| Redness: Moderate |
|
| Redness: Severe |
|
| Title | Measurements |
|---|---|
|
| Swelling: Mild |
|
| Swelling: Moderate |
|
| Swelling: Severe |
|
| Redness: Any |
|
| Redness: Mild |
|
| Redness: Moderate |
|
| Redness: Severe |
|
| Title | Measurements |
|---|---|
|
| Swelling: Mild |
|
| Swelling: Moderate |
|
| Swelling: Severe |
|
| Redness: Any |
|
| Redness: Mild |
|
| Redness: Moderate |
|
| Redness: Severe |
|
| Title | Measurements |
|---|---|
|
| Swelling: Mild |
|
| Swelling: Moderate |
|
| Swelling: Severe |
|
| Redness: Any |
|
| Redness: Mild |
|
| Redness: Moderate |
|
| Redness: Severe |
|
| Title | Measurements |
|---|---|
|
| Decreased appetite |
|
| Irritability |
|
| Increased sleep |
|
| Decreased sleep |
|
| Title | Measurements |
|---|---|
|
| Decreased appetite |
|
| Irritability |
|
| Increased sleep |
|
| Decreased sleep |
|
| Title | Measurements |
|---|---|
|
| Decreased appetite |
|
| Irritability |
|
| Increased sleep |
|
| Decreased sleep |
|
| Title | Measurements |
|---|---|
|
| Decreased appetite |
|
| Irritability |
|
| Increased sleep |
|
| Decreased sleep |
|