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The purpose of this study is to assess the safety, tolerability and immunogenicity of manufacturing scale 13-valent pneumococcal conjugate (13vPnC) vaccine compared to pilot scale 13vPnC in healthy infants when given with routine pediatric vaccines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 13-valent Pneumococcal Conjugate Vaccine | Biological | 1 dose at 2,3,4 and 12 months of age |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Percentages of participants achieving 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. | One month after 3-dose infant series (5 months of age) |
| Percentage of Participants Reporting Pre-Specified Local Reactions | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant(Sig) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. | During the 4-day period after each dose |
| Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds)to prevent symptoms (sx), and use of medication to treat symptoms) were collected using an electronic diary. Participants may be represented in more than 1 category. | During the 4-day period after each dose |
| Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C), decreased appetite, irritability, increased sleep, decreased sleep, use of medication to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary. 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 |
|---|---|---|---|---|---|---|
| Torun | Bydgoszcz | 87-100 | Poland | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21335032 | Derived | Gadzinowski J, Albrecht P, Hasiec B, Konior R, Dziduch J, Witor A, Mellelieu T, Tansey SP, Jones T, Sarkozy D, Emini EA, Gruber WC, Scott DA. Phase 3 trial evaluating the immunogenicity, safety, and tolerability of manufacturing scale 13-valent pneumococcal conjugate vaccine. Vaccine. 2011 Apr 5;29(16):2947-55. doi: 10.1016/j.vaccine.2011.02.002. Epub 2011 Feb 16. |
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Participants were enrolled into the study according to inclusion/exclusion criteria without a screening period.
Participants were recruited in Poland from June 2007 to August 2007.
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| ID | Title | Description |
|---|---|---|
| FG000 | 13vPnC Manufacturing | Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose). |
| FG001 | 13vPnC Pilot | Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) 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 Manufacturing | Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) 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 Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Percentages of participants achieving 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 consisting of eligible participants who adhered to protocol requirements, 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 (5 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 Manufacturing Infant Series | Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| U. S. Contact Center | Wyeth | clintrialresults@wyeth.com |
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| During the 4-day period after toddler dose |
| Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Antibody concentration/geometric mean concentration (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 3-dose infant series (5 months of age) |
| Krakow |
| Krakow |
| 30-663 |
| Poland |
| Krakow | Krakow | 31-442 | Poland |
| Siemianowice Śląskie | Krakow | 41-103 | Poland |
| Lubartowie | Lublin Voivodeship | 21-100 | Poland |
| Lublin | Lublin Voivodeship | 20-044 | Poland |
| Warsaw | Warszawa | 01-184 | Poland |
| Lodz | Łódź Voivodeship | 91-347 | Poland |
| Lodz | Łódź Voivodeship | 93-338 | Poland |
| Lost to Follow-up |
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
| BG001 | 13vPnC Pilot | Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose). |
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 13vPnC Pilot | Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose). |
|
|
|
| Primary | Percentage of Participants Reporting Pre-Specified Local Reactions | Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant(Sig) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (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 | During the 4-day period after each dose |
|
|
|
| Primary | Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) | Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds)to prevent symptoms (sx), and use of medication to treat symptoms) were collected using an electronic diary. Participants may be represented in more than 1 category. | The safety population included all participants (268) 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 | During the 4-day period after each dose |
|
|
|
| Primary | Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) | Systemic events (fever ≥ 38 degrees Celsius [C] but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C), decreased appetite, irritability, increased sleep, decreased sleep, use of medication to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary. 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 | Number | percentage of participants | During the 4-day period after toddler dose |
|
|
|
| Primary | Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series | Antibody concentration/geometric mean concentration (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 (per protocol) population were participants 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 | One month after 3-dose infant series (5 months of age) |
|
|
|
|
| 4 |
| 134 |
| 70 |
| 134 |
| EG001 | 13vPnC Pilot Infant Series | Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). | 2 | 134 | 68 | 134 |
| EG002 | 13vPnC Manufacturing Post-Infant Series | Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Assessment done at 5 months of age, 1 month after infant series. | 10 | 134 | 3 | 134 |
| EG003 | 13vPnC Pilot Post-Infant Series | Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Assessment done at 5 months of age, 1 month after infant series. | 11 | 134 | 7 | 134 |
| EG004 | 13vPnC Manufacturing Toddler Series | Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose). | 0 | 131 | 48 | 131 |
| EG005 | 13vPnC Pilot Toddler Series | Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose). | 1 | 131 | 55 | 131 |
| Bronchitis | Infections and infestations | Non-systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | Non-systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | Non-systematic Assessment |
|
| Crying | Psychiatric disorders | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Enterocolitis infectious | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
|
| Infectious mononucleosis | Infections and infestations | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia primary atypical | Infections and infestations | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Rotavirus infection | Infections and infestations | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Lymphadenitis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Hip dysplasia | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Atrial septal defect | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Dacryostenosis congenital | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Hydrocele | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Plagiocephaly | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | Non-systematic Assessment |
|
| Dacryostenosis acquired | Eye disorders | Non-systematic Assessment |
|
| Eyelid oedema | Eye disorders | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Enlarged uvula | Gastrointestinal disorders | Non-systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | Non-systematic Assessment |
|
| Infantile colic | Gastrointestinal disorders | Non-systematic Assessment |
|
| Infrequent bowel movements | Gastrointestinal disorders | Non-systematic Assessment |
|
| Teething | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| Irritability | General disorders | Non-systematic Assessment |
|
| Malaise | General disorders | Non-systematic Assessment |
|
| Food allergy | Immune system disorders | Non-systematic Assessment |
|
| Milk allergy | Immune system disorders | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | 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 |
|
| Candidiasis | Infections and infestations | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | Non-systematic Assessment |
|
| Exanthema subitum | Infections and infestations | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | Non-systematic Assessment |
|
| Bronchopneumonia | Infections and infestations | Non-systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | Non-systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
|
| Laryngitis | Infections and infestations | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Otitis media acute | Infections and infestations | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Corneal abrasion | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Rickets | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Posture abnormal | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Hypertonia | Nervous system disorders | Non-systematic Assessment |
|
| Hypotonia | Nervous system disorders | Non-systematic Assessment |
|
| Poor quality sleep | Nervous system disorders | Non-systematic Assessment |
|
| Crying | Psychiatric disorders | Non-systematic Assessment |
|
| Psychomotor retardation | Psychiatric disorders | Non-systematic Assessment |
|
| Posthitis | 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 |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Rash | 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 |
|
| Eczema | 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 Serie |
|
| 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 |
|
| Fever ≥38°C but ≤39°C | General disorders | Systemic Events | Systematic Assessment | Dose 1 Infant Series and Toddler Dose |
|
| Fever ≥38°C but ≤39°C | General disorders | Systemic Events | Systematic Assessment | Dose 2 Infant Series |
|
| Fever ≥38°C but ≤39°C | General disorders | Systemic Events | Systematic Assessment | Dose 3 Infant Series |
|
| Fever >39°C but ≤40°C | General disorders | Systemic Events | Systematic Assessment | Dose 1 Infant Series and Toddler Dose |
|
| Fever >39°C but ≤40°C | General disorders | Systemic Events | Systematic Assessment | Dose 2 Infant Series |
|
| Fever >39°C but ≤40°C | General disorders | Systemic Events | Systematic Assessment | Dose 3 Infant Series |
|
| Fever >40°C | General disorders | Systemic Events | Systematic Assessment | Dose 1 Infant Series and Toddler Dose |
|
| Fever >40°C | General disorders | Systemic Events | Systematic Assessment | Dose 2 Infant Series |
|
| Fever >40°C | 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 |
|
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.
| Tenderness-Sig (n=131,129,128,128,124,119,112,114) |
|
| Swelling-Any (n=132,130,129,129,126,122,113,115) |
|
| Swelling-Mild (n=132,130,129,129,126,121,113,115) |
|
| Swelling-Mod (n=132,129,128,128,124,120,113,114) |
|
| Swelling-Severe(n=131,129,128,128,124,119,112,113) |
|
| Redness-Any (n=132,131,129,131,125,123,115,116) |
|
| Redness-Mild (n=132,131,129,131,125,123,115,115) |
|
| Redness-Mod (n=131,129,128,128,124,119,113,114) |
|
| Redness-Severe(n=131,129,128,128,124,119,112,113) |
|
| Fever >39°C but ≤40°C (n=131,129,128,128,124,119) |
|
| Fever >40°C (n=131,129,128,128,124,119) |
|
| Decreased appetite (n=133,129,129,128,125,121) |
|
| Irritability (n=134,131,130,131,127,123) |
|
| Increased sleep (n=132,129,128,129124,121) |
|
| Decreased sleep (n=132,130,129,129,124,123) |
|
| Meds to treat sx (n=132,130,128,128,124,123) |
|
| Meds to prevent sx (n=132,130,128,129124,121) |
|
| Fever >40°C (n=112,113) |
|
| Decreased appetite (n=115,117) |
|
| Irritability (n=119,123) |
|
| Increased sleep (n=114,119) |
|
| Decreased sleep (n=116,117) |
|
| Medication to treat symptoms (n=113,115) |
|
| Medication to prevent symptoms (n=114,114) |
|
| Common Serotypes - Serotype 9V |
|
| Common Serotypes - Serotype 14 |
|
| Common Serotypes - Serotype 18C |
|
| Common Serotypes - Serotype 19F |
|
| Common Serotypes - Serotype 23F |
|
| Additional Serotypes - Serotype 1 |
|
| Additional Serotypes - Serotype 3 |
|
| Additional Serotypes - Serotype 5 |
|
| Additional Serotypes - Serotype 6A |
|
| Additional Serotypes - Serotype 7F |
|
| Additional Serotypes - Serotype 19A |
|
| Ratio |
| 0.96 |
| 95 |
| 0.70 |
| 1.31 |
| No |
| Superiority or Other |
| For serotype 9V the GMC ratio was calculated | Ratio | 1.05 | 95 | 0.89 | 1.24 | No | Superiority or Other |
| For serotype 14 the GMC ratio was calculated | Ratio | 0.93 | 95 | 0.71 | 1.22 | No | Superiority or Other |
| For serotype 18C the GMC ratio was calculated | Ratio | 1.06 | 95 | 0.86 | 1.30 | No | Superiority or Other |
| For serotype 19F the GMC ratio was calculated | Ratio | 0.98 | 95 | 0.81 | 1.17 | No | Superiority or Other |
| For serotype 23F the GMC ratio was calculated | Ratio | 0.90 | 95 | 0.70 | 1.15 | No | Superiority or Other |
| For serotype 1 the GMC ratio was calculated | Ratio | 1.10 | 95 | 0.88 | 1.37 | No | Superiority or Other |
| For serotype 3 the GMC ratio was calculated | Ratio | 1.00 | 95 | 0.83 | 1.20 | No | Superiority or Other |
| For serotype 5 the GMC ratio was calculated | Ratio | 0.95 | 95 | 0.79 | 1.16 | No | Superiority or Other |
| For serotype 6A the GMC ratio was calculated | Ratio | 0.83 | 95 | 0.66 | 1.05 | No | Superiority or Other |
| For serotype 7F the GMC ratio was calculated | Ratio | 0.93 | 95 | 0.79 | 1.11 | No | Superiority or Other |
| For serotype 19A the GMC ratio was calculated | Ratio | 0.95 | 95 | 0.79 | 1.13 | No | Superiority or Other |