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The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine manufactured with Polysorbate 80 compared to a 13-valent pneumococcal conjugate (13vPnC) manufactured without Polysorbate 80 when given concomitantly with routine paediatric vaccinations.
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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 with Polysorbate 80 | Biological |
| ||
| 13 valent pneumococcal conjugate vaccine without Polysorbate 80 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | 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. | One month after 3-dose infant series (at 5 months of age) |
| Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group 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 month after 3-dose infant series (at 5 months of age) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants Reporting Pre-Specified Local Reactions | Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (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 (Mod) (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 |
| Trial Manager | For Poland, WPWZMED@wyeth.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bydgoszcz | 85-168 | Poland | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25126854 | Derived | Gadzinowski J, Tansey SP, Wysocki J, Kopinska E, Majda-Stanislawska E, Czajka H, Korbal P, Pietrzyk JJ, Baker SA, Giardina PC, Gruber WC, Emini EA, Scott DA. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine manufactured with and without polysorbate 80 given to healthy infants at 2, 3, 4 and 12 months of age. Pediatr Infect Dis J. 2015 Feb;34(2):180-5. doi: 10.1097/INF.0000000000000511. |
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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 November 2006 to December 2006.
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| ID | Title | Description |
|---|---|---|
| FG000 | 13vPnC With (+) Polysorbate 80 | Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) with (+) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Infant Series |
|
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| Biological |
|
| one month after the toddler dose (at 13 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 13 months of age) |
| Within 4-days after each dose |
| Percentage of Participants Reporting Pre-Specified Systemic Events | Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (decr)appetite, irritability, increased (incr)sleep, decreased sleep, hives, use of medication (meds) to treat symptoms (sx), and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category. | Within 4-days after each dose |
| Dębica |
| 39-200 |
| Poland |
| Krakow | 30-663 | Poland |
| Krakow | 31-202 | Poland |
| Krakow | 31-422 | Poland |
| Lodz | 91-347 | Poland |
| Lubartów | 21-100 | Poland |
| Lublin | 20-044 | Poland |
| Oborniki ÅšlÄ…skie | 55-120 | Poland |
| Poznan | 60-535 | Poland |
| Poznan | 61-709 | Poland |
| Siemianowice ÅšlÄ…skie | 41-103 | Poland |
| Torun | 87-100 | Poland |
| Trzebnica | 55-100 | Poland |
| FG001 | 13vPnC Without (-) Polysorbate 80 | Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) without (-) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose). |
| Vaccinated Dose 1 |
|
| Vaccinated Dose 2 |
|
| Vaccinated Dose 3 |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| After Infant Series |
|
|
| Toddler Dose |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 13vPnC With (+) Polysorbate 80 | Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) with (+) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose). |
| BG001 | 13vPnC Without (-) Polysorbate 80 | Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) without (-) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | months |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series | 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 population 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 | One month after 3-dose infant series (at 5 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, (n) = number of participants with a determinate IgG antibody concentration to the given serotype. | Posted | Number | 95% Confidence Interval | percentage of participants | one month after the toddler dose (at 13 months of age) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percent of Participants Reporting Pre-Specified Local Reactions | Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (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 (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 | Within 4-days after each dose |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants Reporting Pre-Specified Systemic Events | Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (decr)appetite, irritability, increased (incr)sleep, decreased sleep, hives, use of medication (meds) to treat symptoms (sx), 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 4-days after each dose |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group 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, (n) = number of participants with a determinate antibody concentration for the specified serotype. | Posted | Mar 2010 | Geometric Mean | 95% Confidence Interval | μg/mL | One month after 3-dose infant series (at 5 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, (n) = number of participants with a determinate IgG antibody concentration for the specified serotype. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | one month after the toddler dose (at 13 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 + P80 Infant Series | Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose). | 15 | 249 | 132 | 249 | ||
| EG001 | 13vPnC - P 80 Infant Series | Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose). | 21 | 250 | 132 | 250 | ||
| EG002 | 13vPnC + P80 Post-Infant Series | Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose). | 24 | 249 | 15 | 249 | ||
| EG003 | 13vPnC - P80 Post-Infant Series | Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose). | 16 | 250 | 9 | 250 | ||
| EG004 | 13vPnC + P80 Toddler Dose | Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose). | 3 | 239 | 91 | 239 | ||
| EG005 | 13vPnC - P80 Toddler Dose | Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose). | 2 | 244 | 111 | 244 | ||
| EG006 | 13vPnC + P80 6-Month Follow-up | Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose). | 13 | 249 | 0 | 249 | ||
| EG007 | 13vPnC - P80 6-Month Follow-up | Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose). | 14 | 250 | 1 | 250 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alloimmunisation | Immune system disorders | Non-systematic Assessment |
| ||
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Balance disorder | Nervous system disorders | Non-systematic Assessment |
| ||
| Breath holding | Psychiatric disorders | Non-systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Non-systematic Assessment |
| ||
| Bronchopneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Calculus urinary | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Febrile convulsion | Nervous system disorders | Non-systematic Assessment |
| ||
| Fibrosis | General disorders | Non-systematic Assessment |
| ||
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
| ||
| Gastroenteritis rotavirus | Infections and infestations | Non-systematic Assessment |
| ||
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Head injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Hepatitis | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Hydrocephalus | Nervous system disorders | Non-systematic Assessment |
| ||
| Hydronephrosis | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Hypercalciuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Hypersensitivity | Immune system disorders | Non-systematic Assessment |
| ||
| Infectious mononucleosis | Infections and infestations | Non-systematic Assessment |
| ||
| Inguinal hernia, obstructive | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Laryngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Limbic traumatic amputation | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Meningitis meningococcal | Infections and infestations | Non-systematic Assessment |
| ||
| Meningococcal sepsis | 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 aspiration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pneumonia primary atypical | Infections and infestations | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Radius fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Renal tubular disorder | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Rhinitis | Infections and infestations | Non-systematic Assessment |
| ||
| Sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Splenomegaly | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Staphylococcal bacteraemia | Infections and infestations | Non-systematic Assessment |
| ||
| Thermal burn | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Ultrasound kidney abnormal | Investigations | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Viral infection | Infections and infestations | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Iron deficiency anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Aortic valve incompetence | Cardiac disorders | Non-systematic Assessment |
| ||
| Tricuspid valve incompetence | Cardiac disorders | Non-systematic Assessment |
| ||
| Craniotabes | Congenital, familial and genetic disorders | Non-systematic Assessment |
| ||
| Dacryostenosis congenital | Congenital, familial and genetic disorders | Non-systematic Assessment |
| ||
| Brachycephaly | Congenital, familial and genetic disorders | Non-systematic Assessment |
| ||
| Cryptorchism | Congenital, familial and genetic disorders | Non-systematic Assessment |
| ||
| Ventricular septal defect | Congenital, familial and genetic disorders | Non-systematic Assessment |
| ||
| Conjunctivitis | Eye disorders | Non-systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Haematochezia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Abdominal distension | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Aphthous stomatitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Infantile colic | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Umbilical hernia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Stomatitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pyrexia | General disorders | Non-systematic Assessment |
| ||
| Irritability | General disorders | Non-systematic Assessment |
| ||
| Injection site induration | General disorders | Non-systematic Assessment |
| ||
| Injection site nodule | General disorders | Non-systematic Assessment |
| ||
| Injection site swelling | General disorders | Non-systematic Assessment |
| ||
| Food allergy | Immune system disorders | Non-systematic Assessment |
| ||
| Bronchitis | Infections and infestations | 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 |
| ||
| Respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Bronchopneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Viral infection | Infections and infestations | Non-systematic Assessment |
| ||
| Ear infection | Infections and infestations | Non-systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
| ||
| Laryngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Otitis media | Infections and infestations | Non-systematic Assessment |
| ||
| Exanthema subitum | Infections and infestations | Non-systematic Assessment |
| ||
| Viral upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Candidiasis | Infections and infestations | Non-systematic Assessment |
| ||
| Conjunctivitis infective | Infections and infestations | Non-systematic Assessment |
| ||
| Gastroenteritis staphylococcal | Infections and infestations | Non-systematic Assessment |
| ||
| Oral candidiasis | Infections and infestations | Non-systematic Assessment |
| ||
| Perianal abscess | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia primary atypical | Infections and infestations | Non-systematic Assessment |
| ||
| Tinea cruris | Infections and infestations | Non-systematic Assessment |
| ||
| Tonsillitis | Infections and infestations | Non-systematic Assessment |
| ||
| Varicella | Infections and infestations | Non-systematic Assessment |
| ||
| Viral diarrhoea | Infections and infestations | Non-systematic Assessment |
| ||
| Viral rash | Infections and infestations | Non-systematic Assessment |
| ||
| Hordeolum | Infections and infestations | Non-systematic Assessment |
| ||
| Acute tonsillitis | Infections and infestations | Non-systematic Assessment |
| ||
| Influenza | Infections and infestations | Non-systematic Assessment |
| ||
| Cardiac murmur functional | Investigations | Non-systematic Assessment |
| ||
| Cardiac murmur | Investigations | Non-systematic Assessment |
| ||
| Weight gain poor | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hypertonia | Nervous system disorders | Non-systematic Assessment |
| ||
| Hypotonia | Nervous system disorders | Non-systematic Assessment |
| ||
| Decreased activity | Psychiatric disorders | Non-systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Dermatitis atopic | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Dermatitis allergic | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Dermatitis diaper | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Heat rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Dermatitis contact | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Hyperhidrosis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Skin inflammation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Tenderness (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Tenderness (any)=present at site of vaccination. |
|
| Tenderness (any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 2; Tenderness (any) |
|
| Tenderness (any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 3; Tenderness (any) |
|
| Tenderness (significant) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Tenderness (significant)=present and interfered with limb movement. |
|
| Tenderness (significant) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 2; Tenderness (significant) |
|
| Tenderness (significant) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 3; Tenderness (significant) |
|
| Induration (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Induration (Any)=present at site of vaccination. |
|
| Induration (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 2; Induration (Any) |
|
| Induration (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 3; Induration (Any) |
|
| Induration (mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Induration (mild)=0.5 centimeters (cm) to 2.0 cm. |
|
| Induration (mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 2; Induration (mild) |
|
| Induration (mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 3;Induration (mild) |
|
| Induration (moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Induration (moderate)=2.5 cm to 7.0 cm. |
|
| Induration (moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 2; Induration (moderate) |
|
| Induration (moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 3; Induration (moderate) |
|
| Induration (severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Induration (severe) >7.0 cm. |
|
| Induration (severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 2; Induration (severe) |
|
| Induration (severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 3; Induration (severe) |
|
| Erythema (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Erythema (Any)=present at site of vaccination. |
|
| Erythema (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 2; Erythema (Any) |
|
| Erythema (Any) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 3; Erythema (Any) |
|
| Erythema (Mild) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; 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) |
|
| Erythema (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Erythema (moderate)=2.5 cm to 7.0 cm. |
|
| Erythema (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 2; Erythema (Moderate) |
|
| Erythema (Moderate) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 3; Erythema (Moderate) |
|
| Erythema (Severe) | Skin and subcutaneous tissue disorders | Local Reactions | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; 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) |
|
| Fever ≥38°C but ≤39°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Fever ≥38°C but ≤39°C |
|
| Fever ≥38°C but ≤39°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 2; Fever ≥38°C but ≤39°C |
|
| Fever ≥38°C but ≤39°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 3; Fever ≥38°C but ≤39°C |
|
| Fever >39°C but ≤40°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Fever >39°C but ≤40°C |
|
| Fever >39°C but ≤40°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 2; Fever >39°C but ≤40°C |
|
| Fever >39°C but ≤40°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 3; Fever >39°C but ≤40°C |
|
| Fever >40°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Fever >40°C |
|
| Fever >40°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 2; Fever >40°C |
|
| Fever >40°C | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 3; Fever >40°C |
|
| Decreased appetite | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Decreased appetite |
|
| Decreased appetite | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 2; Decreased appetite |
|
| Decreased appetite | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 3; Decreased appetite |
|
| Decreased sleep | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Decreased sleep |
|
| Decreased sleep | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 2; Decreased sleep |
|
| Decreased sleep | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 3; Decreased sleep |
|
| Increased sleep | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Increased sleep |
|
| Increased sleep | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 2; Increased sleep |
|
| Increased sleep | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 3; Increased sleep |
|
| Irritability | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 1 and Toddler Dose; Irritability |
|
| Irritability | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 2; Irritability |
|
| Irritability | General disorders | Systemic Events | Systematic Assessment | Infant Series Dose 3; Irritability |
|
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 |
|---|---|
| D011136 | Polysorbates |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
Not provided
Not provided
| Lost to Follow-up |
|
| Male |
|
| Common Serotypes - Serotype 9V (n=231,232) |
|
| Common Serotypes - Serotype 14 (n=225,232) |
|
| Common Serotypes - Serotype 18C (n=233,233) |
|
| Common Serotypes - Serotype 19F (n=228,234) |
|
| Common Serotypes - Serotype 23F (n=205,220) |
|
| Additional Serotypes - Serotype 1 (n=228,220) |
|
| Additional Serotypes - Serotype 3 (n=233,236) |
|
| Additional Serotypes - Serotype 5 (n=224,220) |
|
| Additional Serotypes - Serotype 6A (n=206,205) |
|
| Additional Serotypes - Serotype 7F (n=235,237) |
|
| Additional Serotypes - Serotype 19A (n=235,238) |
|
For serotype 6B the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated |
| Difference |
| -5.5 |
| 95 |
| -14.2 |
| 3.3 |
| Yes |
| Non-Inferiority or Equivalence |
Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%. |
| For serotype 9V the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | -0.4 | 95 | -3.7 | 2.8 | Yes | Non-Inferiority or Equivalence | Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%. |
| For serotype 14 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | -2.9 | 95 | -6.9 | 0.7 | Yes | Non-Inferiority or Equivalence | Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%. |
| For serotype 18C the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | 0.0 | 95 | -3.0 | 3.0 | Yes | Non-Inferiority or Equivalence | Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%. |
| For serotype 19F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | -2.5 | 95 | -6.1 | 0.6 | Yes | Non-Inferiority or Equivalence | Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%. |
| For serotype 23F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | -6.3 | 95 | -12.1 | -0.7 | Yes | Non-Inferiority or Equivalence | Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%. |
| For serotype 1 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | 3.4 | 95 | -0.9 | 7.9 | Yes | Non-Inferiority or Equivalence | Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%. |
| For serotype 3 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | -1.3 | 95 | -4.1 | 1.1 | Yes | Non-Inferiority or Equivalence | Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%. |
| For serotype 5 the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | 1.7 | 95 | -3.0 | 6.4 | Yes | Non-Inferiority or Equivalence | Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%. |
| For serotype 6A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | 0.4 | 95 | -5.8 | 6.7 | Yes | Non-Inferiority or Equivalence | Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%. |
| For serotype 7F the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | -0.8 | 95 | -3.2 | 1.2 | Yes | Non-Inferiority or Equivalence | Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%. |
| For serotype 19A the difference in percentages between the two groups (13vPnC - 7vPnC) was calculated | Difference | -1.3 | 95 | -3.6 | 0.3 | Yes | Non-Inferiority or Equivalence | Non-inferiority for each common serotype was declared if the lowest limit of the 2-sided 95% CI for the difference between the 2 groups > -10%. |
| Units | Counts |
|---|---|
| Participants |
|
|
|
| OG003 | 13vPnC - P80 Dose 2 Infant Series | Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2). |
| OG004 | 13vPnC + P80 Dose 3 Infant Series | Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3). |
| OG005 | 13vPnC - P80 Dose 3 Infant Series | Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3). |
| OG006 | 13vPnC + P80 Toddler Dose | Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series), and Priorix at 12 months of age (toddler dose). |
| OG007 | 13vPnC - P80 Toddler Dose | Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series), and Priorix at 12 months of age (toddler dose). |
|
|
| OG003 | 13vPnC - P80 Dose 2 Infant Series | Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2). |
| OG004 | 13vPnC + P80 Dose 3 Infant Series | Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3). |
| OG005 | 13vPnC - P80 Dose 3 Infant Series | Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3). |
| OG006 | 13vPnC + P80 Toddler Dose | Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose). |
| OG007 | 13vPnC - P80 Toddler Dose | Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose). |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|