Trial · NCT01545375
Evaluation of a Vaccine for Reducing Ear and Lung Infections in Children
NCT01545375, Phase 2, Completed, GlaxoSmithKline; results first posted 2017-09-12
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ConductScience Library. Evaluation of a Vaccine for Reducing Ear and Lung Infections in Children. Trials, record NCT01545375. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01545375
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of a Vaccine for Reducing Ear and Lung Infections in Children
- NCT number
- NCT01545375
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 1,806 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Infections, Streptococcal
- Interventions
- Pneumococcal vaccine GSK2189242A, Placebo, Prevnar 13®, PedvaxHIB®
- First posted
- 2012-03-06
- Last updated
- 2019-12-27
- Other registries' IDs
- eudract:2011-003956-38
- Results first posted
- 2017-09-12
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Occurrence of Any Acute Otitis Media (AOM) Diagnosed and Verified Against American Academic of Pediatrics (AAP) Criteria | Any time from 2 weeks after the administration of dose 3 up to Month 22 | 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). |
| Secondary | Time to Occurrence of Any Episodes of AOM Diagnosed by Healthcare-provider | Any time from 2 weeks after the administration of dose 3 up to Month 22 | 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. |
| Secondary | Time to Occurrence of Any Clinical Acute Otitis Media (AOM) Diagnosed and Verified Against Modified American Academic of Pediatrics (AAP) Criteria | Any time from 2 weeks after the administration of dose 3 up to Month 22 | 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. |
| Secondary | Number of Subjects With Any Recurrent Healthcare Provider Diagnosed Acute Otitis Media (AOM) | From the administration of dose 1 up to Month 22 | 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. |
| Secondary | Time to Occurrence of Any Draining Acute Otitis Media (AOM) | Any time from 2 weeks after the administration of dose 3 up to Month 22 | 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. |
| Secondary | Time to Occurrence of Any Draining Pneumococcal Acute Otitis Media (AOM) | Any time from 2 weeks after the administration of dose 3 up to Month 22 | 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. |
| Secondary | Number of Subjects With Any Acute Otitis Media (AOM) With Temporally Related Carriage | From the administration of dose 1 up to Month 22 | AOM with temporally related carriage was defined as AOM with nasopharyngeal swab taken within 3 days before or after an AOM episode. |
| Secondary | Time to Occurrence of Medically Attended Acute Lower Respiratory Tract Infection (ALRI) | Any time from 2 weeks after the administration of dose 3 up to Month 22 | 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. |
| 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 | Any time from 2 weeks after the administration of dose 3 up to Month 22 | 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. |
| 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. | Any time from 2 weeks after the administration of dose 3 up to Month 22 | 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. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Occurrence of Any Acute Otitis Media (AOM) Diagnosed and Verified Against American Academic of Pediatrics (AAP) Criteria | Any time from 2 weeks after the administration of dose 3 up to Month 22 | 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. | Episodes per person-year | NUMBER |
| SECONDARY | Time to Occurrence of Any Episodes of AOM Diagnosed by Healthcare-provider | Any time from 2 weeks after the administration of dose 3 up to Month 22 | 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. | Episodes per person-year | NUMBER |
| SECONDARY | Time to Occurrence of Any Clinical Acute Otitis Media (AOM) Diagnosed and Verified Against Modified American Academic of Pediatrics (AAP) Criteria | Any time from 2 weeks after the administration of dose 3 up to Month 22 | 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. | Episodes per person-year | NUMBER |
| SECONDARY | Number of Subjects With Any Recurrent Healthcare Provider Diagnosed Acute Otitis Media (AOM) | From the administration of dose 1 up to Month 22 | Analysis was performed on the Total vaccinated cohort which included all subjects who had received at least one vaccination dose. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Occurrence of Any Draining Acute Otitis Media (AOM) | Any time from 2 weeks after the administration of dose 3 up to Month 22 | 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. | Episodes per person-year | NUMBER |
| SECONDARY | Time to Occurrence of Any Draining Pneumococcal Acute Otitis Media (AOM) | Any time from 2 weeks after the administration of dose 3 up to Month 22 | 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. | Episodes per person-year | NUMBER |
| SECONDARY | Number of Subjects With Any Acute Otitis Media (AOM) With Temporally Related Carriage | From the administration of dose 1 up to Month 22 | Analysis was performed on the Total vaccinated cohort which included all subjects who had received at least one vaccination dose. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Occurrence of Medically Attended Acute Lower Respiratory Tract Infection (ALRI) | Any time from 2 weeks after the administration of dose 3 up to Month 22 | 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. | Episodes per person-year | NUMBER |
| 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 | Any time from 2 weeks after the administration of dose 3 up to Month 22 | 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. | Episodes per person-year | NUMBER |
| 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. | Any time from 2 weeks after the administration of dose 3 up to Month 22 | 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. | Episodes per person-year | NUMBER |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group336
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Occurrence of Any Acute Otitis Media (AOM) Diagnosed and Verified Against American Academic of Pediatrics (AAP) Criteria | dPly-PhtD Group | 0.425 | Episodes per person-year | ||
| Time to Occurrence of Any Acute Otitis Media (AOM) Diagnosed and Verified Against American Academic of Pediatrics (AAP) Criteria | Control Group | 0.442 | Episodes per person-year | ||
| Time to Occurrence of Any Episodes of AOM Diagnosed by Healthcare-provider | dPly-PhtD Group | 0.678 | Episodes per person-year | ||
| Time to Occurrence of Any Episodes of AOM Diagnosed by Healthcare-provider | Control Group | 0.699 | Episodes per person-year | ||
| Time to Occurrence of Any Clinical Acute Otitis Media (AOM) Diagnosed and Verified Against Modified American Academic of Pediatrics (AAP) Criteria | dPly-PhtD Group | 0.567 | Episodes per person-year | ||
| Time to Occurrence of Any Clinical Acute Otitis Media (AOM) Diagnosed and Verified Against Modified American Academic of Pediatrics (AAP) Criteria | Control Group | 0.599 | Episodes per person-year | ||
| Number of Subjects With Any Recurrent Healthcare Provider Diagnosed Acute Otitis Media (AOM) | dPly-PhtD Group | 30 | Participants | ||
| Number of Subjects With Any Recurrent Healthcare Provider Diagnosed Acute Otitis Media (AOM) | Control Group | 32 | Participants | ||
| Time to Occurrence of Any Draining Acute Otitis Media (AOM) | dPly-PhtD Group | 0.055 | Episodes per person-year | ||
| Time to Occurrence of Any Draining Acute Otitis Media (AOM) | Control Group | 0.060 | Episodes per person-year |
1 to 10 of 336Source ClinicalTrials.gov
See all 336 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | dPly-PhtD Group | 900 | |
| Overall Study | STARTED | Control Group | 903 | |
| Overall Study | COMPLETED | dPly-PhtD Group | 803 | |
| Overall Study | COMPLETED | Control Group | 813 | |
| Overall Study | NOT COMPLETED | dPly-PhtD Group | 97 | |
| Overall Study | NOT COMPLETED | Control Group | 90 |
Source ClinicalTrials.gov
Adverse events268
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Conjunctivitis | Infections and infestations | dPly/PhtD Group | 12 | 200 | 13 |
| other | Conjunctivitis | Infections and infestations | Control Group | 11 | 200 | 11 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | dPly/PhtD Group | 14 | 200 | 18 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Control Group | 15 | 200 | 17 |
| other | Decreased appetite | Metabolism and nutrition disorders | dPly/PhtD Group | 103 | 200 | 180 |
| other | Decreased appetite | Metabolism and nutrition disorders | Control Group | 98 | 200 | 172 |
| other | Dermatitis diaper | Skin and subcutaneous tissue disorders | dPly/PhtD Group | 11 | 200 | 12 |
| other | Dermatitis diaper | Skin and subcutaneous tissue disorders | Control Group | 5 | 200 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | dPly/PhtD Group | 12 | 200 | 13 |
| other | Diarrhoea | Gastrointestinal disorders | Control Group | 7 | 200 | 8 |
1 to 10 of 268Source ClinicalTrials.gov
See all 268 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | dPly/PhtD Group | 0 | 900 |
| Total, all-cause mortality | Control Group | 0 | 903 |
| Total, other adverse events | dPly/PhtD Group | 191 | 200 |
| Total, other adverse events | Control Group | 189 | 200 |
| Total, serious adverse events | dPly/PhtD Group | 229 | 900 |
| Total, serious adverse events | Control Group | 232 | 903 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31629570 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| dPly-PhtD Group vs Control Group: Number of Subjects With Any Serious Adverse Events (SAEs) | Trial comparisons |
| dPly-PhtD Group vs Control Group: Number of Subjects With Any Unsolicited Adverse Events (AEs) After Booster Vaccination - Immuno/Reacto Sub-cohort | Trial comparisons |
| dPly-PhtD Group vs Control Group: Number of Subjects With Any Acute Otitis Media (AOM) With Temporally Related Carriage | Trial comparisons |
| dPly-PhtD Group vs Control Group: Number of Subjects With Any Recurrent Healthcare Provider Diagnosed Acute Otitis Media (AOM) | Trial comparisons |
| dPly-PhtD Group vs Control Group: Number of Subjects With Any Unsolicited Adverse Events (AEs) After Primary Vaccination - Immuno/Reacto Sub-cohort | Trial comparisons |
| dPly/PhtD Group vs Control Group: deaths from any cause | Trial comparisons |
| dPly/PhtD Group vs Control Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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