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The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent Pneumococcal conjugate vaccine (13vPnC) in older infants and children who have not previously been immunized with Pneumococcal vaccine.
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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 Antibody Level ≥0.35μg/mL After Vaccination | Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/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. | 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age). |
| Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | 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. | 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| Trial Manager | For Poland: WPWZMED@wyeth.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bydgoszcz | 85-168 | Poland | ||||
Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
Participants were recruited in Poland from July 2007 to September 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | 13vPnC 7 to <12 Months of Age | Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| During the 4-day period 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. | During the 4-day period after each dose |
| Bydgoszcz |
| 85-316 |
| Poland |
| Dębica | 39-200 | Poland |
| Krakow | 31-503 | Poland |
| Lodz | 91-738 | Poland |
| Oborniki Salskie | 55-120 | Poland |
| Proznan | 61-709 | Poland |
| Trzebnica | 55-100 | Poland |
| Łęczna | 21-010 | Poland |
| FG001 | 13vPnC 12 to <24 Months of Age | Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart. |
| FG002 | 13vPnC 24 to < 72 Months of Age | Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC. |
| Vaccinated Dose 1 |
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| Vaccinated Dose 2 |
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| Vaccinated Dose 3 |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 13vPnC 7 to <12 Months of Age | Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose. |
| BG001 | 13vPnC 12 to <24 Months of Age | Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart. |
| BG002 | 13vPnC 24 to < 72 Months of Age | Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC. |
| BG003 | 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 Antibody Level ≥0.35μg/mL After Vaccination | Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold ≥0.35μg/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 (per protocol) population who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations; (n) = number of participants with a determinate immunoglobulin G (IgG) antibody concentration to the given serotype. | Posted | Mar 2010 | Number | 95% Confidence Interval | percentage of participants | 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 months of age). |
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| Secondary | 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. | Posted | Mar 2010 | Number | percentage of participants | During the 4-day period after each dose |
| |||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mar 2010 | Number | percentage of participants | During the 4-day period after each dose |
| |||||||||||||||||||||||||||||||||
| Primary | Geometric Mean Antibody Concentration (GMC) After Vaccination in 13vPnC Groups | 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. | The evaluable immunogenicity (per protocol) population was the primary analysis population consisting of eligible subjects who adhered to the protocol requirements, had valid and determinate assay results, and had no other major protocol violations. | Posted | Mar 2010 | Geometric Mean | 95% Confidence Interval | μg/mL | 28 to 42 days after vaccination 3 for Group 1 (13 to <17 months of age), after vaccination 2 for Group 2 (14 to <26 months of age), and after vaccination 1 for Group 3 (26 to <73 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 7 to <12 Months of Age | Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose. | 5 | 90 | 55 | 90 | ||
| EG001 | 13vPnC 12 to <24 Months of Age | Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart. | 2 | 112 | 77 | 112 | ||
| EG002 | 13vPnC 24 to < 72 Months of Age | Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC. | 2 | 152 | 74 | 152 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | General disorders | MedDRA | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Exanthema subitum | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chalazion | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Teething | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site nodule | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA | Non-systematic Assessment |
| |
| Allergy to animal | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Allergy to arthropod sting | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Exanthema subitum | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Laryngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Urological examination abnormal | Investigations | MedDRA | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Heat rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Swelling face | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Tenderness (any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1; Tenderness (any)=present at site of vaccination. |
|
| Tenderness (any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 2; Tenderness (any) |
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| Tenderness (any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 3; Tenderness (any) |
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| Tenderness (significant) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1; 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) |
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| Tenderness (significant) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 3; Tenderness (significant) |
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| Induration (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1; Induration (any)=present at site of vaccination. |
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| Induration (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 2; Induration (Any) |
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| Induration (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 3; Induration (Any) |
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| Induration (mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1; Induration (mild)=0.5 centimeters (cm) to 2.0 cm. |
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| Induration (mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 2; Induration (mild) |
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| Induration (mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 3; Induration (mild) |
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| Induration (moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1; Induration (moderate)=2.5 cm to 7.0 cm. |
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| Induration (moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 2; Induration (moderate) |
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| Induration (moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 3; Induration (moderate) |
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| Induration (severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1; Induration (severe) >7.0 cm. |
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| Induration (severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 2; Induration (severe) |
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| Induration (severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 3; Induration (severe) |
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| Erythema (any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1; Erythema (any)=present at site of vaccination. |
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| Erythema (any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 2; Erythema (any) |
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| Erythema (any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 3; Erythema (any) |
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| Erythema (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1; Erythema (mild)=0.5 centimeters (cm) to 2.0 cm. |
|
| Erythema (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 2; Erythema (Mild) |
|
| Erythema (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 3; Erythema (Mild) |
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| Erythema (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1; Erythema(moderate)=2.5 cm to 7.0 cm. |
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| Erythema (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 2; Erythema (Moderate) |
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| Erythema (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 3; Erythema (Moderate) |
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| Erythema (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1; Erythema (severe) >7.0 cm. |
|
| Erythema (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 2; Erythema (Severe) |
|
| Erythema (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 3; Erythema (Severe) |
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| Fever ≥38°C but ≤39°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 1; Fever ≥38°C but ≤39°C |
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| 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 |
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| Fever >39°C but ≤40°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 1; 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; Fever >40°C |
|
| Fever >40°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 2; Fever >40°C |
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| 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; 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; 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; 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; 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 |
|
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 |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| Male |
|
| Common Serotypes - Serotype 6B (n=83,110,150) |
|
| Common Serotypes - Serotype 9V (n= 83,104,148) |
|
| Common Serotypes - Serotype 14 (n= 84,108,135) |
|
| Common Serotypes - Serotype 18C (n= 83,109,151) |
|
| Common Serotypes - Serotype 19F (n=84,110,147) |
|
| Common Serotypes - Serotype 23F (n= 84,110,151) |
|
| Additional Serotypes - Serotype 1 (n= 83,108,149) |
|
| Additional Serotypes - Serotype 3 (n= 83,108,149) |
|
| Additional Serotypes - Serotype 5 (n= 84,107,152) |
|
| Additional Serotypes - Serotype 6A (n= 84,110,150) |
|
| Additional Serotypes - Serotype 7F (n= 84,108,142) |
|
| Additional Serotypes - Serotype 19A (n=84,110,150 |
|
| OG003 | 13vPnC Group 1 - Dose 2 | Participants 7 to less than (<) 12 months of age received a second single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days after the first (infant series). |
| OG004 | 13vPnC Group 2 - Dose 2 | Participants 12 to < 24 months of age received a second single IM 0.5 mL doses of 13vPnC at least 56 days from the first (infant series). |
| OG005 | 13vPnC Group 1 - Dose 3 | Participants received a third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose. |
|
|
| OG003 | 13vPnC Group 1 - Dose 2 | Participants 7 to less than (<) 12 months of age received a second single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days after the first (infant series). |
| OG004 | 13vPnC Group 2 - Dose 2 | Participants 12 to < 24 months of age received a second single IM 0.5 mL doses of 13vPnC at least 56 days from the first (infant series). |
| OG005 | 13vPnC Group 1 - Dose 3 | Participants received a third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose. |
|
|
| OG002 | 13vPnC 24 to < 72 Months of Age | Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC. |
|
|