Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01545375 | Evaluation of a Vaccine for Reducing Ear and Lung Infections in Children | PHASE2 | COMPLETED | 1,806 | — | — | May 21, 2012 | Jul 26, 2016 | Dec 27, 2019 | 5 | United States |
| NCT00985751 | Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination | PHASE2 | COMPLETED | 257 | — | — | Nov 24, 2009 | Mar 2, 2011 | Nov 5, 2020 | 10 | Czechia |
| NCT00896064 | Evaluation of a Booster Dose of Pneumococcal Vaccine Formulations in Young Adults | PHASE2 | COMPLETED | 43 | — | — | May 18, 2009 | Aug 5, 2009 | Aug 17, 2018 | 1 | Belgium |
| NCT00707798 | Evaluation of Pneumococcal Vaccine Formulations in Young Adults | PHASE1 | COMPLETED | 157 | — | — | Jun 30, 2008 | Jan 15, 2009 | May 10, 2017 | 1 | Belgium |
Time to occurrence of any episode of AOM is expressed in terms of rate: Person-year rate = number of episodes (n)/sum of follow-up expressed in years (T\[year)\]). Definition of clinical AOM diagnosed and verified against AAP criteria required meeting three criteria based on the guidelines from the AAP \[AAP, 2004\], as per the judgment of a treating physician or equivalent licensed medical professional: A history of acute (recent, usually abrupt) onset of signs and symptoms of middle-ear inflammation and middle-ear effusion (MEE).AND The presence of MEE indicated by any of the following: a) Bulging of tympanic membrane; b) Limited or absent mobility of tympanic membrane; c) Air-fluid level behind tympanic membrane; d) Otorrhea AND Signs or symptoms of middle-ear inflammation as indicated by either: a) Distinct erythema of tympanic membrane or b) Distinct otalgia (discomfort clearly referable to the ear\[s\] that resulted in interference with or precluded normal activity or sleep).
The number of subjects with rectal temperature higher (\>) than 40.0 degrees Celsius (°C) is reported.
Assessed solicited local symptoms were pain, redness and swelling. Grade 3 pain = significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, malaise, myalgia and fever \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = general symptom assessed by the investigator to be casually related to the study vaccination.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Among haematological or biochemical abnormalities assessed were: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Cholesterol, Creatine Phosphokinase (CRP), Hemoglobin decrease, Haemoglobin, Lactate dehydrogenase (LDH), Neutrophils, Red blood cells (RBC), Reticulocytes, White blood cells (WBC) and Overall parameters. Assessment of intensity: Grading of the haematological and biochemical parameters was performed using the standard Food and Drug Administration (FDA) Toxicity Grading Scale. Changes compared to normal reference ranges were graded: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening
| Arm | Type | Description |
|---|---|---|
| dPly-PhtD Group | EXPERIMENTAL | Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving GSK2189242A (dPly-PhtD) vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the dPly-PhtD vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the dPly-PhtD vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate. |
| Control Group | PLACEBO_COMPARATOR | Healthy Native American infants between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, receiving Placebo vaccine co-administered with Prevenar13™: 3 primary doses at 2, 4, 6 months of age and a booster dose at 12-15 months of age. PedvaxHIB was given as study vaccine to a subset of subjects at 2, 4 and 12-15 months. At the primary epoch, the Placebo vaccine was administered intramuscularly into the right anterolateral thigh and at the booster epoch, the Placebo vaccine was administered into the right deltoid or anterolateral thigh if the deltoid muscle size was not adequate. At the primary epoch, the co-administered Prevenar13™ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13™ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate. |
| Group 1 | EXPERIMENTAL | - |
| Group 2 | EXPERIMENTAL | - |
| Group 3 | EXPERIMENTAL | - |
| Group 4 | EXPERIMENTAL | - |
| Formulation 1 | EXPERIMENTAL | - |
| Formulation 2 | EXPERIMENTAL | - |
| Formulation 3 | EXPERIMENTAL | - |
| Formulation 4 | EXPERIMENTAL | - |
| Formulation 5 | EXPERIMENTAL | - |
| Formulation 6 | EXPERIMENTAL | - |
| 23 valent pneumococcal vaccine | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Pneumococcal vaccine GSK2189242A | BIOLOGICAL | 4 doses administered intramuscularly |
| Placebo | BIOLOGICAL | 4 doses administered intramuscularly |
| Prevnar 13® | BIOLOGICAL | 4 doses administered intramuscularly |
| PedvaxHIB® | BIOLOGICAL | 4 doses administered intramuscularly |
| Pneumococcal vaccine GSK2189242A (formulation 1) | BIOLOGICAL | Three doses will be administered intramuscularly, at Month 0, 2 and 6. |
| Pneumococcal vaccine GSK2189242A (formulation 2) | BIOLOGICAL | Three doses will be administered intramuscularly, at Month 0, 2 and 6 |
| Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3) | BIOLOGICAL | Three doses will be administered intramuscularly, at Month 0, 2 and 6 |
| Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4) | BIOLOGICAL | Three doses will be administered intramuscularly, at Month 0, 2 and 6 |
| Pneumococcal vaccine GSK1024850A | BIOLOGICAL | Three doses will be administered intramuscularly, at Month 0, 2 and 6 |
| Pneumo 23™ | BIOLOGICAL | One dose of 0.5 ml will be administered intramuscularly at Month 0, and a placebo dose to keep the blinding at Month 2 |
Inclusion Criteria: * Subject who the investigator believes that their parent(s)/Legally Authorized Representative(s) (LARs) can and will comply with the requirements of the protocol. * A male or female American Indian infant between, and including, 6 and 12 weeks (42-90 days) of age at the time of...