Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003956-38 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to 1) demonstrate the protective efficacy against acute otitis media (AOM), 2) assess safety of the GlaxoSmithKline (GSK) Biologicals' pneumococcal vaccine GSK2189242A in Native American infants aged less than 24 months, living in the southwestern US, in and around the Navajo and White Mountain Apache reservations, and 3) evaluate the impact on acute lower respiratory tract infections (ALRI) up to the second year of life.
The study will also evaluate the impact of the pneumococcal vaccine GSK2189242A on nasopharyngeal carriage in a subgroup of children called Carriage subgroup. Immunogenicity and reactogenicity of the pneumococcal vaccine GSK2189242A will be evaluated in another subgroup of children called Immuno/reacto subgroup.
Protocol Posting has been updated following Protocol Amendment 3, April 2012, leading to the addition of a secondary outcome measure.
Protocol Posting has been updated following Protocol Amendment 7, March 2017, to add serological testing for antibodies against the Hib polysaccharide PRP on samples collected 12 months following booster dose (Month 22) in the Immuno/reacto sub-cohort, in order to evaluate the long term persistence of immune responses to co-administered PedvaxHIB vaccine.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 Prevenar13â„¢: 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 Prevenar13â„¢ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13â„¢ 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 Prevenar13â„¢: 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 Prevenar13â„¢ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13â„¢ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumococcal vaccine GSK2189242A | Biological | 4 doses administered intramuscularly |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Occurrence of Any Acute Otitis Media (AOM) Diagnosed and Verified Against American Academic of Pediatrics (AAP) Criteria | 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). | Any time from 2 weeks after the administration of dose 3 up to Month 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Occurrence of Any Episodes of AOM Diagnosed by Healthcare-provider | 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)]). A healthcare-provider-diagnosed clinical AOM case was defined as an AOM event diagnosed by a treating physician or equivalent licensed medical professional with or without clinical symptoms documented in the routine medical record. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
For all infants:
For infants in the Immuno/reacto subgroup only:
• Previous vaccination against H. influenzae type b.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Chinle | Arizona | 86505 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31629570 | Background | Hammitt LL, Campbell JC, Borys D, Weatherholtz RC, Reid R, Goklish N, Moulton LH, Traskine M, Song Y, Swinnen K, Santosham M, O'Brien KL. Efficacy, safety and immunogenicity of a pneumococcal protein-based vaccine co-administered with 13-valent pneumococcal conjugate vaccine against acute otitis media in young children: A phase IIb randomized study. Vaccine. 2019 Dec 3;37(51):7482-7492. doi: 10.1016/j.vaccine.2019.09.076. Epub 2019 Oct 16. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Out of the 1806 subjects enrolled in this study, 1803 were vaccinated and therefore included in the Total Vaccinated Cohort. 3 subjects were excluded for the following reasons: one subject had an invalid Inform Consent form and 2 subjects received subject number but did not receive any vaccine dose.
1806 subjects were enrolled in this study, Three sub-cohorts of subjects were foreseen: Immuno/reacto sub-cohort for assessment of immunogenicity, Carriage sub-cohort for assessment of impact on carriage of S. pneumoniae and "No additional procedures" sub-cohort comprising subjects not included in any of the above sub-cohorts.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | dPly-PhtD Group | 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 Prevenar13â„¢: 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 Prevenar13â„¢ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13â„¢ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate. |
| FG001 | Control Group | 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 Prevenar13â„¢: 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 Prevenar13â„¢ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13â„¢ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | dPly-PhtD Group | 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 Prevenar13â„¢: 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 Prevenar13â„¢ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13â„¢ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate. |
| 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 | Time to Occurrence of Any Acute Otitis Media (AOM) Diagnosed and Verified Against American Academic of Pediatrics (AAP) Criteria | 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). | Analysis was performed on the modified according to protocol cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort. | Posted | Number | Episodes per person-year | Any time from 2 weeks after the administration of dose 3 up to Month 22 |
Solicited symptoms: within the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period; SAEs: during the whole study period (from Day 0 to Month 22).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | dPly/PhtD Group | 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 Prevenar13â„¢: 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 Prevenar13â„¢ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13â„¢ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
| C061964 | Haemophilus influenzae-type b polysaccharide-Neisseria meningitidis outer membrane protein conjugate vaccine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Biological |
4 doses administered intramuscularly |
|
| Prevnar 13® | Biological | 4 doses administered intramuscularly |
|
| PedvaxHIB® | Biological | 4 doses administered intramuscularly |
|
| Any time from 2 weeks after the administration of dose 3 up to Month 22 |
| Time to Occurrence of Any Clinical Acute Otitis Media (AOM) Diagnosed and Verified Against Modified American Academic of Pediatrics (AAP) Criteria | 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 modified AAP criteria required a history of acute disease (i.e. AAP criterion 1) together with abnormal tympanic membrane (i.e. one of the AAP criteria 2 or 3a), as per the judgment of a treating physician or equivalent licensed medical professional: 1. A history of acute (recent, usually abrupt) onset of signs and symptoms of middle-ear inflammation and middle-ear effusion (MEE).AND 2. The presence of MEE that is 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 OR 3. Signs or symptoms of middle-ear inflammation as indicated by: a) Distinct erythema of tympanic membrane. | Any time from 2 weeks after the administration of dose 3 up to Month 22 |
| Number of Subjects With Any Recurrent Healthcare Provider Diagnosed Acute Otitis Media (AOM) | Recurrent AOM was defined as at least 3 AOM episodes diagnosed by a physician or equivalent licensed medical professional and occurring within 6 months or at least 4 episodes within one year, regardless of the etiology. | From the administration of dose 1 up to Month 22 |
| Time to Occurrence of Any Draining Acute Otitis Media (AOM) | 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)]). Draining AOM was defined as AOM with otorrhea or with spontaneously perforated tympanic membrane. In this case, middle ear fluid (MEF) was to be swabbed with no tympanocentesis needed and tested for the presence of S. pneumoniae and other pathogens as part of the routine clinical practice. Draining pneumococcal AOM were defined as draining AOM cases with S. pneumoniae identified in MEF. | Any time from 2 weeks after the administration of dose 3 up to Month 22 |
| Time to Occurrence of Any Draining Pneumococcal Acute Otitis Media (AOM) | 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)]). Draining AOM was defined as AOM with otorrhea or with spontaneously perforated tympanic membrane. In this case, middle ear fluid (MEF) was to be swabbed with no tympanocentesis needed and tested for the presence of S. pneumoniae and other pathogens as part of the routine clinical practice. Draining pneumococcal AOM were defined as draining AOM cases with S. pneumoniae identified in MEF. | Any time from 2 weeks after the administration of dose 3 up to Month 22 |
| Number of Subjects With Any Acute Otitis Media (AOM) With Temporally Related Carriage | AOM with temporally related carriage was defined as AOM with nasopharyngeal swab taken within 3 days before or after an AOM episode. | From the administration of dose 1 up to Month 22 |
| Time to Occurrence of Medically Attended Acute Lower Respiratory Tract Infection (ALRI) | 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)]). ALRI was defined by the presence of tachypnea (respiratory rate >50 amongst children 2 to 12 months of age, and respiratory rate >40 in children over 1 year of age) and at least two of the following signs and symptoms: cough; fever documented at visit or reported within preceding 3 days (Fever was defined as temperature ≥100.4°F (38.0°C) regardless of the route of measurement); increased work of breathing: grunting, nasal flaring, and intercostal and/or subcostal retractions; auscultatory abnormalities: wheezing, crackles, rhonchi, decreased breath sounds. | Any time from 2 weeks after the administration of dose 3 up to Month 22 |
| Time to Occurrence of Medically Attended ALRI With Fever Documented at the Visit or History of Fever Within 3 Days Preceding a Given Episode | 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)]). ALRI was defined by the presence of tachypnea (respiratory rate >50 amongst children 2 to 12 months of age, and respiratory rate >40 in children over 1 year of age) and at least two of the following signs and symptoms: cough; fever documented at visit or reported within preceding 3 days (Fever is defined as temperature ≥100.4°F (38.0°C) regardless of the route of measurement); increased work of breathing: grunting, nasal flaring, and intercostal and/or subcostal retractions; auscultatory abnormalities: wheezing, crackles, rhonchi, decreased breath sounds. | Any time from 2 weeks after the administration of dose 3 up to Month 22 |
| Time to Occurrence of Any Medically Attended Healthcare-provider-diagnosed ALRI With Fever Documented at the Visit or History of Fever Within 3 Days Preceding a Given Episode. | 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)]). A healthcare-provider-diagnosed ALRI with fever case was defined as, but not limited to, chest infection, bronchiolitis, pneumonia, bronchopneumonia, pleural effusion or empyema diagnosed by a treating physician or equivalent licensed medical professional with fever documented at the time of visit or history of fever within 3 days preceding a given episode and with or without other clinical symptoms documented in the routine medical record. | Any time from 2 weeks after the administration of dose 3 up to Month 22 |
| Number of Subjects With S. Pneumoniae (Any and Serotype Specific) in the Nasopharynx - Carriage Sub-cohort | Positive cultures of S. pneumoniae (any and serotype specific) identified in the nasopharynx were analyzed. | At 7 months of age (Month 5), 12-15 months of age (Month 10),18-22 months of age (Month 16) and 24-27 months of age (Month 22) |
| Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Immuno/Reacto Sub-cohort | Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-off of the assay were concentrations equal to (=) 12 EL.U/mL for anti-Ply antibodies and = 17 EL.U/mL for anti-PhtD antibodies. | One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one and twelve months post-booster dose [Post-booster(Month 11) and Post-booster(Month 22)], respectively |
| Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies | Inhibition of Ply hemolysis activity was not evaluated due to assay stability issues. | One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one and twelve months post-booster dose [Post-booster(Month 11) and Post-booster(Month 22)], respectively |
| Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - Immuno/Reacto Sub-cohort | Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL. | 1 month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)], 1 month post-booster dose [Post-booster(Month 11)], 12 months post-booster dose [Post-booster(Month 22)] |
| Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Antibody concentrations were measured by Electro-chemiluminescence assay (ECL), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was a serotype-specific antibody concentration higher than or equal to (≥) LLOQ (Lower Limit of Quantification) expressed in µg/mL: 0.08 for Anti-1; 0.075 for anti-3; 0.061 for Anti-4; 0.198 for Anti-5; 0.111 for Anti-6A and Anti-18C; 0.102 for Anti-6B; 0.063 for Anti-7F; 0.066 for Anti-9V; 0.160 for Anti-14; 0.199 for Anti-19A; 0.163 for Anti-19F; 0.073 for Anti-23F. | One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one month post-booster dose [Post-booster(Month 11)] |
| Antibody Concentrations Against Vaccine-related Serotypes 6C | No analysis was performed on antibody concentrations against vaccine-related serotype 6C as no specific qualified/validated assay was available. | One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one month post-booster dose [Post-booster(Month 11)] |
| Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) LLOQ: 8 for OPA-1, OPA-3 and OPA-6B; 33 for OPA-4, and OPA-14; 50 for OPA-5; 151 for OPA-6A; 330 for OPA-7F; 275 for OPA-9V; 11 for OPA-18C; 143 for OPA-19A; 36 for OPA-19F; 101 for OPA-23F. | One month post-dose 3 [PIII(Month 5)] and one month post-booster dose [Post-booster(Month 11)] |
| Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6C | Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine-related pneumococcal serotypes 6C (OPA-6C). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 145. | One month post-dose 3 [PIII(Month 5)] and one month post-booster dose [Post-booster(Month 11)] |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Primary Vaccination - Immuno/Reacto Sub-cohort | Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group. | Within the 4-day (Days 0-3) post-primary vaccination period following each dose |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Booster Vaccination - Immuno/Reacto Sub-cohort | Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group. | Within the 4-day (Days 0-3) post-booster vaccination period |
| Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort | Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (axillary route - temperature equal or higher than [≥] 38.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (axillary) temperature higher than (>) 40.0°C. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group. | Within the 4-day (Days 0-3) post-primary vaccination period following each dose |
| Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Booster Vaccination - Immuno/Reacto Sub-cohort | Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (axillary route - temperature equal or higher than [≥] 38.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (axillary) temperature higher than (>) 40.0°C. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group. | Within the 4-day (Days 0-3) post-booster vaccination period |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) After Primary Vaccination - Immuno/Reacto Sub-cohort | An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. The Immuno/reacto sub-cohort was composed of 200 vaccinated subjects from each study group. | Within the 31-day (Days 0-30) period post primary vaccination, across doses |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) After Booster Vaccination - Immuno/Reacto Sub-cohort | An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group. | Within the 31-day (Days 0-30) period post booster vaccination |
| Number of Subjects With Any Serious Adverse Events (SAEs) | An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination. | From Day 0 to Month 22 |
| Fort Defiance |
| Arizona |
| 86504 |
| United States |
| GSK Investigational Site | Whiteriver | Arizona | 85941 | United States |
| GSK Investigational Site | Gallup | New Mexico | 87301 | United States |
| GSK Investigational Site | Shiprock | New Mexico | 87420 | United States |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| BG001 | Control Group | 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 Prevenar13â„¢: 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 Prevenar13â„¢ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13â„¢ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate. |
| BG002 | Total | Total of all reporting groups |
| Weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
|
|
| Secondary | Time to Occurrence of Any Episodes of AOM Diagnosed by Healthcare-provider | 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)]). A healthcare-provider-diagnosed clinical AOM case was defined as an AOM event diagnosed by a treating physician or equivalent licensed medical professional with or without clinical symptoms documented in the routine medical record. | Analysis was performed on the modified ATP cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort. | Posted | Number | Episodes per person-year | Any time from 2 weeks after the administration of dose 3 up to Month 22 |
|
|
|
| Secondary | Time to Occurrence of Any Clinical Acute Otitis Media (AOM) Diagnosed and Verified Against Modified American Academic of Pediatrics (AAP) Criteria | 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 modified AAP criteria required a history of acute disease (i.e. AAP criterion 1) together with abnormal tympanic membrane (i.e. one of the AAP criteria 2 or 3a), as per the judgment of a treating physician or equivalent licensed medical professional: 1. A history of acute (recent, usually abrupt) onset of signs and symptoms of middle-ear inflammation and middle-ear effusion (MEE).AND 2. The presence of MEE that is 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 OR 3. Signs or symptoms of middle-ear inflammation as indicated by: a) Distinct erythema of tympanic membrane. | Analysis was performed on the modified ATP cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort. | Posted | Number | Episodes per person-year | Any time from 2 weeks after the administration of dose 3 up to Month 22 |
|
|
|
| Secondary | Number of Subjects With Any Recurrent Healthcare Provider Diagnosed Acute Otitis Media (AOM) | Recurrent AOM was defined as at least 3 AOM episodes diagnosed by a physician or equivalent licensed medical professional and occurring within 6 months or at least 4 episodes within one year, regardless of the etiology. | Analysis was performed on the Total vaccinated cohort which included all subjects who had received at least one vaccination dose. | Posted | Count of Participants | Participants | From the administration of dose 1 up to Month 22 |
|
|
|
| Secondary | Time to Occurrence of Any Draining Acute Otitis Media (AOM) | 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)]). Draining AOM was defined as AOM with otorrhea or with spontaneously perforated tympanic membrane. In this case, middle ear fluid (MEF) was to be swabbed with no tympanocentesis needed and tested for the presence of S. pneumoniae and other pathogens as part of the routine clinical practice. Draining pneumococcal AOM were defined as draining AOM cases with S. pneumoniae identified in MEF. | Analysis was performed on the modified ATP for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort. | Posted | Number | Episodes per person-year | Any time from 2 weeks after the administration of dose 3 up to Month 22 |
|
|
|
| Secondary | Time to Occurrence of Any Draining Pneumococcal Acute Otitis Media (AOM) | 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)]). Draining AOM was defined as AOM with otorrhea or with spontaneously perforated tympanic membrane. In this case, middle ear fluid (MEF) was to be swabbed with no tympanocentesis needed and tested for the presence of S. pneumoniae and other pathogens as part of the routine clinical practice. Draining pneumococcal AOM were defined as draining AOM cases with S. pneumoniae identified in MEF. | Analysis was performed on the modified ATP for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort. | Posted | Number | Episodes per person-year | Any time from 2 weeks after the administration of dose 3 up to Month 22 |
|
|
|
| Secondary | Number of Subjects With Any Acute Otitis Media (AOM) With Temporally Related Carriage | AOM with temporally related carriage was defined as AOM with nasopharyngeal swab taken within 3 days before or after an AOM episode. | Analysis was performed on the Total vaccinated cohort which included all subjects who had received at least one vaccination dose. | Posted | Count of Participants | Participants | From the administration of dose 1 up to Month 22 |
|
|
|
| Secondary | Time to Occurrence of Medically Attended Acute Lower Respiratory Tract Infection (ALRI) | 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)]). ALRI was defined by the presence of tachypnea (respiratory rate >50 amongst children 2 to 12 months of age, and respiratory rate >40 in children over 1 year of age) and at least two of the following signs and symptoms: cough; fever documented at visit or reported within preceding 3 days (Fever was defined as temperature ≥100.4°F (38.0°C) regardless of the route of measurement); increased work of breathing: grunting, nasal flaring, and intercostal and/or subcostal retractions; auscultatory abnormalities: wheezing, crackles, rhonchi, decreased breath sounds. | Analysis was performed on the modified ATP cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort. | Posted | Number | Episodes per person-year | Any time from 2 weeks after the administration of dose 3 up to Month 22 |
|
|
|
| Secondary | Time to Occurrence of Medically Attended ALRI With Fever Documented at the Visit or History of Fever Within 3 Days Preceding a Given Episode | 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)]). ALRI was defined by the presence of tachypnea (respiratory rate >50 amongst children 2 to 12 months of age, and respiratory rate >40 in children over 1 year of age) and at least two of the following signs and symptoms: cough; fever documented at visit or reported within preceding 3 days (Fever is defined as temperature ≥100.4°F (38.0°C) regardless of the route of measurement); increased work of breathing: grunting, nasal flaring, and intercostal and/or subcostal retractions; auscultatory abnormalities: wheezing, crackles, rhonchi, decreased breath sounds. | Analysis was performed on the modified ATP cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort. | Posted | Number | Episodes per person-year | Any time from 2 weeks after the administration of dose 3 up to Month 22 |
|
|
|
| Secondary | Time to Occurrence of Any Medically Attended Healthcare-provider-diagnosed ALRI With Fever Documented at the Visit or History of Fever Within 3 Days Preceding a Given Episode. | 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)]). A healthcare-provider-diagnosed ALRI with fever case was defined as, but not limited to, chest infection, bronchiolitis, pneumonia, bronchopneumonia, pleural effusion or empyema diagnosed by a treating physician or equivalent licensed medical professional with fever documented at the time of visit or history of fever within 3 days preceding a given episode and with or without other clinical symptoms documented in the routine medical record. | Analysis was performed on the modified ATP cohort for efficacy which included all evaluable subjects for whom data concerning efficacy outcome measures were available (efficacy cohort) and for whom non-compliance with the vaccination intervals during primary vaccination was the only elimination criterion from the efficacy cohort. | Posted | Number | Episodes per person-year | Any time from 2 weeks after the administration of dose 3 up to Month 22 |
|
|
|
| Secondary | Number of Subjects With S. Pneumoniae (Any and Serotype Specific) in the Nasopharynx - Carriage Sub-cohort | Positive cultures of S. pneumoniae (any and serotype specific) identified in the nasopharynx were analyzed. | Analysis was performed on the Total vaccinated cohort for carriage which included around 400 subjects not included in the immuno/reacto sub-cohort, who had received at least one vaccination dose and for whom data concerning carriage outcome measures were available. | Posted | Count of Participants | Participants | At 7 months of age (Month 5), 12-15 months of age (Month 10),18-22 months of age (Month 16) and 24-27 months of age (Month 22) |
|
|
|
| Secondary | Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (Ply) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Immuno/Reacto Sub-cohort | Anti-Ply and anti-PhtD antibody concentrations were measured by Enzyme-linked immunosorbent assay (ELISA) immunoassay and expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-off of the assay were concentrations equal to (=) 12 EL.U/mL for anti-Ply antibodies and = 17 EL.U/mL for anti-PhtD antibodies. | Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects from the Immuno/reacto sub-cohort (composed of 200 subjects from each study group) for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one and twelve months post-booster dose [Post-booster(Month 11) and Post-booster(Month 22)], respectively |
|
|
|
| Secondary | Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid (Ply) Haemolysis Activity, or Hem-Ply Antibodies | Inhibition of Ply hemolysis activity was not evaluated due to assay stability issues. | The analysis was to be performed on the according to protocol cohort for immunogenicity. But inhibition of Ply hemolysis activity was not evaluated due to assay stability issues. | Posted | One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one and twelve months post-booster dose [Post-booster(Month 11) and Post-booster(Month 22)], respectively |
|
|
| Secondary | Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - Immuno/Reacto Sub-cohort | Seroprotection rate = Anti-PRP antibody concentrations ≥ 0.15 µg/mL. | Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects from the Immuno/reacto sub-cohort (composed of 200 subjects from each study group) for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | 1 month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)], 1 month post-booster dose [Post-booster(Month 11)], 12 months post-booster dose [Post-booster(Month 22)] |
|
|
|
| Secondary | Antibody Concentrations Against Vaccine Serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F | Antibody concentrations were measured by Electro-chemiluminescence assay (ECL), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was a serotype-specific antibody concentration higher than or equal to (≥) LLOQ (Lower Limit of Quantification) expressed in µg/mL: 0.08 for Anti-1; 0.075 for anti-3; 0.061 for Anti-4; 0.198 for Anti-5; 0.111 for Anti-6A and Anti-18C; 0.102 for Anti-6B; 0.063 for Anti-7F; 0.066 for Anti-9V; 0.160 for Anti-14; 0.199 for Anti-19A; 0.163 for Anti-19F; 0.073 for Anti-23F. | Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects from the Immuno/reacto sub-cohort (composed of 200 subjects from each study group) for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one month post-booster dose [Post-booster(Month 11)] |
|
|
|
| Secondary | Antibody Concentrations Against Vaccine-related Serotypes 6C | No analysis was performed on antibody concentrations against vaccine-related serotype 6C as no specific qualified/validated assay was available. | The analysis was to be performed on the ATP cohort for immunogenicity. But no analysis was performed for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available. | Posted | One month post-dose 3 [PIII(Month 5)], prior to booster dose [PIII(Month 10)] and one month post-booster dose [Post-booster(Month 11)] |
|
|
| Secondary | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) LLOQ: 8 for OPA-1, OPA-3 and OPA-6B; 33 for OPA-4, and OPA-14; 50 for OPA-5; 151 for OPA-6A; 330 for OPA-7F; 275 for OPA-9V; 11 for OPA-18C; 143 for OPA-19A; 36 for OPA-19F; 101 for OPA-23F. | Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects from the Immuno/reacto sub-cohort (composed of 200 subjects from each study group) for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | One month post-dose 3 [PIII(Month 5)] and one month post-booster dose [Post-booster(Month 11)] |
|
|
|
| Secondary | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6C | Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine-related pneumococcal serotypes 6C (OPA-6C). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 145. | Analysis was performed on the ATP cohort for immunogenicity which included all evaluable subjects from the Immuno/reacto sub-cohort (composed of 200 subjects from each study group) for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | One month post-dose 3 [PIII(Month 5)] and one month post-booster dose [Post-booster(Month 11)] |
|
|
|
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Primary Vaccination - Immuno/Reacto Sub-cohort | Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group. | Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom at least one vaccination dose was documented. | Posted | Count of Participants | Participants | Within the 4-day (Days 0-3) post-primary vaccination period following each dose |
|
|
|
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Booster Vaccination - Immuno/Reacto Sub-cohort | Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group. | Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom the booster vaccination dose was documented. | Posted | Count of Participants | Participants | Within the 4-day (Days 0-3) post-booster vaccination period |
|
|
|
| Secondary | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Primary Vaccination - Immuno/Reacto Sub-cohort | Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (axillary route - temperature equal or higher than [≥] 38.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (axillary) temperature higher than (>) 40.0°C. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group. | Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom at least one vaccination dose was documented. | Posted | Count of Participants | Participants | Within the 4-day (Days 0-3) post-primary vaccination period following each dose |
|
|
|
| Secondary | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, After Booster Vaccination - Immuno/Reacto Sub-cohort | Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (axillary route - temperature equal or higher than [≥] 38.0 degrees Celsius [°C]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = (axillary) temperature higher than (>) 40.0°C. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group. | Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom the booster vaccination dose was documented. | Posted | Count of Participants | Participants | Within the 4-day (Days 0-3) post-booster vaccination period |
|
|
|
| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs) After Primary Vaccination - Immuno/Reacto Sub-cohort | An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. The Immuno/reacto sub-cohort was composed of 200 vaccinated subjects from each study group. | Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom at least one vaccination dose was documented. | Posted | Count of Participants | Participants | Within the 31-day (Days 0-30) period post primary vaccination, across doses |
|
|
|
| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs) After Booster Vaccination - Immuno/Reacto Sub-cohort | An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. The Immuno /reacto sub-cohort was composed of 200 vaccinated subjects from each study group. | Analysis was performed on Immuno/reacto sub-cohort which included around 200 subjects from the total vaccinated cohort, for whom the booster vaccination dose was documented. | Posted | Count of Participants | Participants | Within the 31-day (Days 0-30) period post booster vaccination |
|
|
|
| Secondary | Number of Subjects With Any Serious Adverse Events (SAEs) | An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination. | Analysis was performed on the Total vaccinated cohort which included all subjects who had received at least one vaccination dose. | Posted | Count of Participants | Participants | From Day 0 to Month 22 |
|
|
|
| 0 |
| 900 |
| 229 |
| 900 |
| 191 |
| 200 |
| EG001 | Control Group | 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 Prevenar13â„¢: 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 Prevenar13â„¢ and PedvaxHIB vaccines were administered intramuscularly into the left anterolateral thigh and at the booster epoch, the Prevenar13â„¢ and PedvaxHIB vaccines were administered into the left deltoid or anterolateral thigh if the deltoid muscle size was not adequate. | 0 | 903 | 232 | 903 | 189 | 200 |
| Benign familial neonatal convulsions | Congenital, familial and genetic disorders | MedDRA 19.1 | Systematic Assessment |
|
| Haemangioma congenital | Congenital, familial and genetic disorders | MedDRA 19.1 | Systematic Assessment |
|
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA 19.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Sandifer's syndrome | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Developmental delay | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Fever neonatal | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Acute hepatic failure | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
|
| Anaphylactic reaction | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Abscess neck | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Adenovirus infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Bacterial pyelonephritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Bacteriuria | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Campylobacter gastroenteritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Cellulitis staphylococcal | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Coxsackie viral infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Croup infectious | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Dacryocystitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Eczema herpeticum | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Escherichia bacteraemia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Escherichia pyelonephritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Escherichia urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Gastroenteritis salmonella | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Groin abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Haemophilus bacteraemia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Lower respiratory tract infection viral | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Mastoiditis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Meningitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Otitis media acute | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Parainfluenzae virus infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Parotitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Periorbital cellulitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Periumbilical abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Pertussis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Pneumococcal bacteraemia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Pneumococcal sepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Pneumonia influenzal | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Pneumonia pneumococcal | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Pneumonia viral | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Pseudomonal sepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Staphylococcal abscess | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Urinary tract infection enterococcal | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Viral rash | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Accidental exposure to product | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Burns second degree | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Foreign body | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Pulmonary contusion | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Subarachnoid haemorrhage | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| Blood culture positive | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Juvenile idiopathic arthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Clear cell sarcoma of the kidney | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| Neuroblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| Epilepsy | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Febrile convulsion | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Partial seizures | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| Balanoposthitis | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
|
| Apnoeic attack | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Apparent life threatening event | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Status asthmaticus | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
| Kawasaki's disease | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Teething | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Month 10 |
|
|
| Month 16 |
|
|
| Month 22 |
|
|
| Anti-Ply-Pre-booster (Month 10) |
|
|
| Anti-Ply-Post-booster (Month 11) |
|
|
| Anti-Ply-Post-booster (Month 22) |
|
|
| Anti-PhtD-PIII (Month 5) |
|
|
| Anti-PhtD-Pre-booster (Month 10) |
|
|
| Anti-PhtD-Post-booster (Month 11) |
|
|
| Anti-PhtD-Post-booster (Month 22) |
|
|
| Anti-PRP Pre-booster (Month 10) |
|
|
| Anti-PRP Post-booster (Month 11) |
|
|
| Anti-PRP Post-booster (Month 22) |
|
|
| Anti-1 Pre-Booster (Month 10) |
|
|
| Anti-1 Post-Booster (Month 11) |
|
|
| Anti-3 PIII(Month 5) |
|
|
| Anti-3 Pre-Booster (Month 10) |
|
|
| Anti-3 Post-Booster (Month 11) |
|
|
| Anti-4 PIII(Month 5) |
|
|
| Anti-4 Pre-Booster (Month 10) |
|
|
| Anti-4 Post-Booster (Month 11) |
|
|
| Anti-5 PIII(Month 5) |
|
|
| Anti-5 Pre-Booster (Month 10) |
|
|
| Anti-5 Post-Booster (Month 11) |
|
|
| Anti-6A PIII(Month 5) |
|
|
| Anti-6A Pre-Booster (Month 10) |
|
|
| Anti-6A Post-Booster (Month 11) |
|
|
| Anti-6B PIII(Month 5) |
|
|
| Anti-6B Pre-Booster (Month 10) |
|
|
| Anti-6B Post-Booster (Month 11) |
|
|
| Anti-7F PIII(Month 5) |
|
|
| Anti-7F Pre-Booster (Month 10) |
|
|
| Anti-7F Post-Booster (Month 11) |
|
|
| Anti-9V PIII(Month 5) |
|
|
| Anti-9V Pre-Booster (Month 10) |
|
|
| Anti-9V Post-Booster (Month 11) |
|
|
| Anti-14 PIII(Month 5) |
|
|
| Anti-14 Pre-Booster (Month 10) |
|
|
| Anti-14 Post-Booster (Month 11) |
|
|
| Anti-18C PIII(Month 5) |
|
|
| Anti-18C Pre-Booster (Month 10) |
|
|
| Anti-18C Post-Booster (Month 11) |
|
|
| Anti-19A PIII(Month 5) |
|
|
| Anti-19A Pre-Booster (Month 10) |
|
|
| Anti-19A Post-Booster (Month 11) |
|
|
| Anti-19F PIII(Month 5) |
|
|
| Anti-19F Pre-Booster (Month 10) |
|
|
| Anti-19F Post-Booster (Month 11) |
|
|
| Anti-23F PIII(Month 5) |
|
|
| Anti-23F Pre-Booster (Month 10) |
|
|
| Anti-23F Post-Booster (Month 11) |
|
|
| OPA-1 Post-Booster (Month 11) |
|
|
| OPA-3 PIII(Month 5) |
|
|
| OPA-3 Post-Booster (Month 11) |
|
|
| OPA-4 PIII(Month 5) |
|
|
| OPA-4 Post-Booster (Month 11) |
|
|
| OPA-5 PIII(Month 5) |
|
|
| OPA-5 Post-Booster (Month 11) |
|
|
| OPA-6A PIII(Month 5) |
|
|
| OPA-6A Post-Booster (Month 11) |
|
|
| OPA-6B PIII(Month 5) |
|
|
| OPA-6B Post-Booster (Month 11) |
|
|
| OPA-7F PIII(Month 5) |
|
|
| OPA-7F Post-Booster (Month 11) |
|
|
| OPA-9V PIII(Month 5) |
|
|
| OPA-9V Post-Booster (Month 11) |
|
|
| OPA-14 PIII(Month 5) |
|
|
| OPA-14 Post-Booster (Month 11) |
|
|
| OPA-18C PIII(Month 5) |
|
|
| OPA-18C Post-Booster (Month 11) |
|
|
| OPA-19A PIII(Month 5) |
|
|
| OPA-19A Post-Booster (Month 11) |
|
|
| OPA-19F PIII(Month 5) |
|
|
| OPA-19F Post-Booster (Month 11) |
|
|
| OPA-23F PIII(Month 5) |
|
|
| OPA-23F Post-Booster (Month 11) |
|
|
| OPA-6C Post-Booster (Month 11) |
|
|
| Grade 3 Pain, post Dose 1 |
|
|
| Any Redness, post Dose 1 |
|
|
| Grade 3 Redness, post Dose 1 |
|
|
| Any Swelling, post Dose 1 |
|
|
| Grade 3 Swelling, post Dose 1 |
|
|
| Any Pain, post Dose 2 |
|
|
| Grade 3 Pain, post Dose 2 |
|
|
| Any Redness, post Dose 2 |
|
|
| Grade 3 Redness, post Dose 2 |
|
|
| Any Swelling, post Dose 2 |
|
|
| Grade 3 Swelling, post Dose 2 |
|
|
| Any Pain, post Dose 3 |
|
|
| Grade 3 Pain, post Dose 3 |
|
|
| Any Redness, post Dose 3 |
|
|
| Grade 3 Redness, post Dose 3 |
|
|
| Any Swelling, post Dose 3 |
|
|
| Grade 3 Swelling, post Dose 3 |
|
|
| Any Redness |
|
| Grade 3 Redness |
|
| Any Swelling |
|
| Grade 3 Swelling |
|
| Grade 3 Drowsiness, post Dose 1 |
|
|
| Related Drowsiness, post Dose 1 |
|
|
| Any Irr./Fuss., post Dose 1 |
|
|
| Grade 3 Irr./Fuss., post Dose 1 |
|
|
| Related Irr./Fuss., post Dose 1 |
|
|
| Any Loss Appet., post Dose 1 |
|
|
| Grade 3 Loss Appet., post Dose 1 |
|
|
| Related Loss Appet., post Dose 1 |
|
|
| Any Fever, post Dose 1 |
|
|
| Grade 3 Fever, post Dose 1 |
|
|
| Related Fever, post Dose 1 |
|
|
| Any Drowsiness, post Dose 2 |
|
|
| Grade 3 Drowsiness, post Dose 2 |
|
|
| Related Drowsiness, post Dose 2 |
|
|
| Any Irr./Fuss., post Dose 2 |
|
|
| Grade 3 Irr./Fuss., post Dose 2 |
|
|
| Related Irr./Fuss., post Dose 2 |
|
|
| Any Loss Appet., post Dose 2 |
|
|
| Grade 3 Loss Appet., post Dose 2 |
|
|
| Related Loss Appet., post Dose 2 |
|
|
| Any Fever, post Dose 2 |
|
|
| Grade 3 Fever, post Dose 2 |
|
|
| Related Fever, post Dose 2 |
|
|
| Any Drowsiness, post Dose 3 |
|
|
| Grade 3 Drowsiness, post Dose 3 |
|
|
| Related Drowsiness, post Dose 3 |
|
|
| Any Irr./Fuss., post Dose 3 |
|
|
| Grade 3 Irr./Fuss., post Dose 3 |
|
|
| Related Irr./Fuss., post Dose 3 |
|
|
| Any Loss Appet., post Dose 3 |
|
|
| Grade 3 Loss Appet., post Dose 3 |
|
|
| Related Loss Appet., post Dose 3 |
|
|
| Any Fever, post Dose 3 |
|
|
| Grade 3 Fever, post Dose 3 |
|
|
| Related Fever, post Dose 3 |
|
|
| Related Drowsiness |
|
| Any Irr./Fuss. |
|
| Grade 3 Irr./Fuss. |
|
| Related Irr./Fuss. |
|
| Any Loss Appet. |
|
| Grade 3 Loss Appet. |
|
| Related Loss Appet. |
|
| Any Fever |
|
| Grade 3 Fever |
|
| Related Fever |
|