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The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate vaccine (13vPnC) in infants of Japanese descent.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13vPnC | Biological | "First dose during 2 to 6 months of age Second dose at least 28 days after the first dose Third dose at least 28 days after the second dose Forth dose during 12 to 15 months of age" |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series | Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/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. | one month after 3-dose infant series (at 7 months of age) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series | GMC as measured by enzyme-linked immunosorbent assay (ELISA) 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. | one mone month after 3-dose infant series (at 7 months of age) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Reporting Pre-Specified Local Reactions | Local reactions were collected 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 |
|---|---|---|---|---|---|---|
| Nagoya | Aichi-ken | 466-8650 | Japan | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23538524 | Derived | Togashi T, Yamaji M, Thompson A, Giardina PC, Aizawa M, Patterson S, Gruber WC, Scott DA; 3003 Study Group. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in healthy infants in Japan. Pediatr Infect Dis J. 2013 Sep;32(9):984-9. doi: 10.1097/INF.0b013e318293007e. |
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Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
Participants were recruited in Japan from September 2007 to February 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | 13vPnC | Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series) and 12-15 months of age (toddler dose). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Infant Series |
|
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| Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/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. | one month after the toddler dose (at 12 - 15 months of age) |
| Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | GMC as measured by enzyme-linked immunosorbent assay (ELISA) 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. | one month after the toddler dose (at 12-15 months of age) |
| Within 7 days after each dose |
| Percentage of Participants Reporting Pre-Specified Systemic Events | Systemic events (fever ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category. | Within 7 days after each dose |
| Toyohashi |
| Aichi-ken |
| 441-8570 |
| Japan |
| Chiba | Chiba | 261-0012 | Japan |
| Matsuyama | Ehime | 790-8524 | Japan |
| Fukuoka | Fukuoka | 811-1394 | Japan |
| Fukuoka | Fukuoka | 813-0036 | Japan |
| Fukuoka | Fukuoka | 814-0162 | Japan |
| Fukuoka | Fukuoka | 819-0002 | Japan |
| Maebaru-shi | Fukuoka | 819-1138 | Japan |
| Asahikawa-shi | Hokkaido | 078-8211 | Japan |
| Sapporo | Hokkaido | 006-0831 | Japan |
| Sapporo | Hokkaido | 062-0931 | Japan |
| Sapporo | Hokkaido | 063-0831 | Japan |
| Yokohama | Kanagawa | 240-8555 | Japan |
| Yokosuka-shi | Kanagawa | 238-8558 | Japan |
| Nangoku-shi | Kochi | 783-8505 | Japan |
| Ise-shi | Mie-ken | 516-0805 | Japan |
| Tsu | Mie-ken | 514-025 | Japan |
| Yokkaichi-shi | Mie-ken | 510-8561 | Japan |
| Kurashiki-shi | Okayama-ken | 701-0192 | Japan |
| Meguro-ku | Tokyo | 152-8902 | Japan |
| Setagaya-ku | Tokyo | 154-0002 | Japan |
| Setagaya-ku | Tokyo | 154-0017 | Japan |
| Setagaya-ku | Tokyo | 157-8535 | Japan |
| 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 | Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series) and 12-15 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 | 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 Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the 3-Dose Infant Series | Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/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. | Evaluable immunogenicity population had valid and determinate assay results and had no other major protocol violations. | Posted | Mar 2010 | Number | 95% Confidence Interval | percentage of participants | one month after 3-dose infant series (at 7 months of age) |
|
|
| |||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants Reporting Pre-Specified Local Reactions | Local reactions were collected 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. | The safety population included all participants who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days. | Posted | Mar 2010 | Number | percentage of participants | Within 7 days after each dose |
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants Reporting Pre-Specified Systemic Events | Systemic events (fever ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category. | The safety population included all subjects who received at least 1 dose of vaccine, (n) = number of participants reporting yes for at least 1 day or no for all days. | Posted | Mar 2010 | Number | percentage of participants | Within 7 days after each dose |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the 3-Dose Infant Series | GMC as measured by enzyme-linked immunosorbent assay (ELISA) 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. | Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations. | Posted | Mar 2010 | Geometric Mean | 95% Confidence Interval | μg/mL | one mone month after 3-dose infant series (at 7 months of age) |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving Antibody Level ≥ 0.35 μg/mL in the 13vPnC Group After the Toddler Dose | Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥ 0.35 μg/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. | Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations. | Posted | Number | 95% Confidence Interval | percentage of participants | one month after the toddler dose (at 12 - 15 months of age) |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose | GMC as measured by enzyme-linked immunosorbent assay (ELISA) 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. | Evaluable immunogenicity population had valid and determinate assay results, and had no other major protocol violations. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | one month after the toddler dose (at 12-15 months of age) |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 13vPnC Infant Series | Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series). | 9 | 193 | 192 | 193 | ||
| EG001 | 13vPnC Post-Infant Series | Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series). | 14 | 193 | 19 | 193 | ||
| EG002 | 13vPnC Toddler Dose | Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months (toddler dose). | 1 | 185 | 171 | 185 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adenovirus infection | Infections and infestations | Non-systematic Assessment |
| ||
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Bronchiolitis | Infections and infestations | Non-systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Non-systematic Assessment |
| ||
| Cellulitis staphylococcal | Infections and infestations | Non-systematic Assessment |
| ||
| Enteritis infectious | Infections and infestations | Non-systematic Assessment |
| ||
| Exanthema subitum | Infections and infestations | Non-systematic Assessment |
| ||
| Febrile convulsion | Nervous system disorders | Non-systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
| ||
| Pertussis | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia respiratory syncytial viral | Infections and infestations | Non-systematic Assessment |
| ||
| Respiratory syncytial virus bronchiolitis | Infections and infestations | Non-systematic Assessment |
| ||
| Respiratory syncytial virus infection | Infections and infestations | Non-systematic Assessment |
| ||
| Rotavirus infection | Infections and infestations | Non-systematic Assessment |
| ||
| Staphylococcal sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Subdural haematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Pulmonary valve stenosis | Cardiac disorders | Non-systematic Assessment |
| ||
| Dacryostenosis congenital | Congenital, familial and genetic disorders | Non-systematic Assessment |
| ||
| Cryptorchism | Congenital, familial and genetic disorders | Non-systematic Assessment |
| ||
| Pectus excavatum | Congenital, familial and genetic disorders | Non-systematic Assessment |
| ||
| Cerumen impaction | Ear and labyrinth disorders | Non-systematic Assessment |
| ||
| Conjunctivitis | Eye disorders | Non-systematic Assessment |
| ||
| Eye discharge | Eye disorders | Non-systematic Assessment |
| ||
| Ocular hyperaemia | Eye disorders | Non-systematic Assessment |
| ||
| Keratitis | Eye disorders | Non-systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Anal fissure | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Enterocolitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Haematochezia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Umbilical hernia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Injection site erythema | General disorders | Non-systematic Assessment |
| ||
| Injection site swelling | General disorders | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Irritability | General disorders | Non-systematic Assessment |
| ||
| Injection site pain | General disorders | Non-systematic Assessment |
| ||
| Injection site induration | General disorders | Non-systematic Assessment |
| ||
| Injection site eczema | General disorders | Non-systematic Assessment |
| ||
| Injection site mass | General disorders | Non-systematic Assessment |
| ||
| Injection site irritation | General disorders | Non-systematic Assessment |
| ||
| Injection site warmth | General disorders | Non-systematic Assessment |
| ||
| Swelling | General disorders | Non-systematic Assessment |
| ||
| Vaccination site induration | General disorders | Non-systematic Assessment |
| ||
| Vessel puncture site reaction | General disorders | Non-systematic Assessment |
| ||
| Liver disorder | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Food allergy | Immune system disorders | Non-systematic Assessment |
| ||
| Milk allergy | Immune system disorders | Non-systematic Assessment |
| ||
| Solvent sensitivity | Immune system disorders | Non-systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Non-systematic Assessment |
| ||
| Exanthema subitum | Infections and infestations | Non-systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
| ||
| Influenza | Infections and infestations | Non-systematic Assessment |
| ||
| Pharyngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Varicella | Infections and infestations | Non-systematic Assessment |
| ||
| Rhinitis | Infections and infestations | Non-systematic Assessment |
| ||
| Enteritis infectious | Infections and infestations | Non-systematic Assessment |
| ||
| Otitis media | Infections and infestations | Non-systematic Assessment |
| ||
| Otitis media acute | Infections and infestations | Non-systematic Assessment |
| ||
| Bronchiolitis | Infections and infestations | Non-systematic Assessment |
| ||
| Croup infectious | Infections and infestations | Non-systematic Assessment |
| ||
| Gastroenteritis viral | Infections and infestations | Non-systematic Assessment |
| ||
| Molluscum contagiosum | Infections and infestations | Non-systematic Assessment |
| ||
| Adenovirus infection | Infections and infestations | Non-systematic Assessment |
| ||
| Respiratory syncytial virus infection | Infections and infestations | Non-systematic Assessment |
| ||
| Conjunctivitis bacterial | Infections and infestations | Non-systematic Assessment |
| ||
| Fungal skin infection | Infections and infestations | Non-systematic Assessment |
| ||
| Gastroenteritis rotavirus | Infections and infestations | Non-systematic Assessment |
| ||
| Respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Skin candida | Infections and infestations | Non-systematic Assessment |
| ||
| Viral rash | Infections and infestations | Non-systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Non-systematic Assessment |
| ||
| Enterocolitis viral | Infections and infestations | Non-systematic Assessment |
| ||
| Enterovirus infection | Infections and infestations | Non-systematic Assessment |
| ||
| Herpes simplex | Infections and infestations | Non-systematic Assessment |
| ||
| Impetigo | Infections and infestations | Non-systematic Assessment |
| ||
| Laryngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Omphalitis | Infections and infestations | Non-systematic Assessment |
| ||
| Oral candidiasis | Infections and infestations | Non-systematic Assessment |
| ||
| Paronychia | Infections and infestations | Non-systematic Assessment |
| ||
| Pertussis | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia respiratory syncytial viral | Infections and infestations | Non-systematic Assessment |
| ||
| Respiratory syncytial virus bronchiolitis | Infections and infestations | Non-systematic Assessment |
| ||
| Rotavirus infection | Infections and infestations | Non-systematic Assessment |
| ||
| Subcutaneous abscess | Infections and infestations | Non-systematic Assessment |
| ||
| Viral diarrhoea | Infections and infestations | Non-systematic Assessment |
| ||
| Viral infection | Infections and infestations | Non-systematic Assessment |
| ||
| Herpangina | Infections and infestations | Non-systematic Assessment |
| ||
| Adenoviral upper respiratory infection | Infections and infestations | Non-systematic Assessment |
| ||
| Bronchopneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Enterocolitis infectious | Infections and infestations | Non-systematic Assessment |
| ||
| Gastroenteritis bacterial | Infections and infestations | Non-systematic Assessment |
| ||
| Sinusitis | Infections and infestations | Non-systematic Assessment |
| ||
| Tonsillitis | Infections and infestations | Non-systematic Assessment |
| ||
| Arthropod bite | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Contusion | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Animal bite | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Excoriation | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Joint dislocation | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Joint injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Skin laceration | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Thermal burn | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Clavicle fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Mouth injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Liver function test abnormal | Investigations | Non-systematic Assessment |
| ||
| Decreased appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Lactose intolerance | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypocalcaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Lymphangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Hypersomnia | Nervous system disorders | Non-systematic Assessment |
| ||
| Crying | Nervous system disorders | Non-systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
| ||
| Head banging | Psychiatric disorders | Non-systematic Assessment |
| ||
| Vesicoureteric reflux | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Balanoposthitis | Reproductive system and breast disorders | Non-systematic Assessment |
| ||
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Dysphonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Wheezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Fibrinous bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Dermatitis diaper | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Eczema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Eczema infantile | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Dry skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Heat rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Petechiae | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Dermatitis atopic | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Hyperkeratosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Asteatosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Blister | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Dermatitis contact | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Drug eruption | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Eczema asteatotic | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Rash erythematous | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Dermatitis allergic | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Tenderness (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 1 Infant Series and Toddler Dose |
|
| Tenderness (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 2 Infant Series |
|
| Tenderness (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 3 Infant Series |
|
| Tenderness (Significant) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 1 Infant Series and Toddler Dose |
|
| Tenderness (Significant) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 2 Infant Series |
|
| Tenderness (Significant) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 3 Infant Series |
|
| Induration (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 1 Infant Series and Toddler Dose |
|
| Induration (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 2 Infant Series |
|
| Induration (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 3 Infant Series |
|
| Induration(Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 1 Infant Series and Toddler Dose |
|
| Induration(Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 2 Infant Series |
|
| Induration(Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 3 Infant Series |
|
| Induration (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 1 Infant Series and Toddler Dose |
|
| Induration (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 2 Infant Series |
|
| Induration (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 3 Infant Series |
|
| Induration (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 1 Infant Series and Toddler Dose |
|
| Induration (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 2 Infant Series |
|
| Induration (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 3 Infant Series |
|
| Erythema (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 1 Infant Series and Toddler Dose |
|
| Erythema (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 2 Infant Series |
|
| Erythema (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 3 Infant Series |
|
| Erythema (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 1 Infant Series and Toddler Dose |
|
| Erythema (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 2 Infant Series |
|
| Erythema (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 3 Infant Series |
|
| Erythema (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 1 Infant Series and Toddler Dose |
|
| Erythema (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 2 Infant Series |
|
| Erythema (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 3 Infant Series |
|
| Erythema (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 1 Infant Series and Toddler Dose |
|
| Erythema (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 2 Infant Series |
|
| Erythema (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Dose 3 Infant Series |
|
| Any fever (≥37.5°C) | General disorders | Systemic Events | Systematic Assessment | Dose 1 Infant Series and Toddler Dose |
|
| Any fever (≥37.5°C) | General disorders | Systemic Events | Systematic Assessment | Dose 2 Infant Series |
|
| Any fever (≥37.5°C) | General disorders | Systemic Events | Systematic Assessment | Dose 3 Infant Series |
|
| Fever ≥38°C but ≤39°C (mild) | General disorders | Systemic Events | Systematic Assessment | Dose 1 Infant Series and Toddler Dose |
|
| Fever ≥38°C but ≤39°C (mild) | General disorders | Systemic Events | Systematic Assessment | Dose 2 Infant Series |
|
| Fever ≥38°C but ≤39°C (mild) | General disorders | Systemic Events | Systematic Assessment | Dose 3 Infant Series |
|
| Fever >39°C but ≤40°C (moderate) | General disorders | Systemic Events | Systematic Assessment | Dose 1 Infant Series and Toddler Dose |
|
| Fever >39°C but ≤40°C (moderate) | General disorders | Systemic Events | Systematic Assessment | Dose 2 Infant Series |
|
| Fever >39°C but ≤40°C (moderate) | General disorders | Systemic Events | Systematic Assessment | Dose 3 Infant Series |
|
| Fever >40°C (severe) | General disorders | Systemic Events | Systematic Assessment | Dose 1 Infant Series and Toddler Dose |
|
| Fever >40°C (severe) | General disorders | Systemic Events | Systematic Assessment | Dose 2 Infant Series |
|
| Fever >40°C (severe) | General disorders | Systemic Events | Systematic Assessment | Dose 3 Infant Series |
|
| Decreased appetite | General disorders | Systemic Events | Systematic Assessment | Dose 1 Infant Series and Toddler Dose |
|
| Decreased appetite | General disorders | Systemic Events | Systematic Assessment | Dose 2 Infant Series |
|
| Decreased appetite | General disorders | Systemic Events | Systematic Assessment | Dose 3 Infant Series |
|
| Irritability | General disorders | Systemic Events | Systematic Assessment | Dose 1 Infant Series and Toddler Dose |
|
| Irritability | General disorders | Systemic Events | Systematic Assessment | Dose 2 Infant Series |
|
| Irritability | General disorders | Systemic Events | Systematic Assessment | Dose 3 Infant Series |
|
| Increased sleep | General disorders | Systemic Events | Systematic Assessment | Dose 1 Infant Series and Toddler Dose |
|
| Increased sleep | General disorders | Systemic Events | Systematic Assessment | Dose 2 Infant Series |
|
| Increased sleep | General disorders | Systemic Events | Systematic Assessment | Dose 3 Infant Series |
|
| Decreased sleep | General disorders | Systemic Events | Systematic Assessment | Dose 1 Infant Series and Toddler Dose |
|
| Decreased sleep | General disorders | Systemic Events | Systematic Assessment | Dose 2 Infant Series |
|
| Decreased sleep | General disorders | Systemic Events | Systematic Assessment | Dose 3 Infant Series |
|
| Hives (urticaria) | General disorders | Systemic Events | Systematic Assessment | Dose 1 Infant Series and Toddler Dose |
|
| Hives (urticaria) | General disorders | Systemic Events | Systematic Assessment | Dose 2 Infant Series |
|
| Hives (urticaria) | General disorders | Systemic Events | Systematic Assessment | Dose 3 Infant Series |
|
The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| U. S. Contact Center | Wyeth | clintrialresults@wyeth.com |
|
| Common Serotypes - Serotype 14 |
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| Common Serotypes - Serotype 18C |
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| Common Serotypes - Serotype 19F |
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| Common Serotypes - Serotype 23F |
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| Additional Serotypes - Serotype 1 |
|
| Additional Serotypes - Serotype 3 |
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| Additional Serotypes - Serotype 5 |
|
| Additional Serotypes - Serotype 6A |
|
| Additional Serotypes - Serotype 7F |
|
| Additional Serotypes - Serotype 19A |
|
| OG003 | 13vPnC Toddler Dose | Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months of age (toddler dose). |
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| OG003 | 13vPnC Toddler Dose | Subjects received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months of age (toddler dose). |
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