Trial · NCT00496015
Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Conjugate Vaccine GSK1024850A
NCT00496015, Phase 3, Completed, GlaxoSmithKline; results first posted 2019-01-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Conjugate Vaccine GSK1024850A. Trials, record NCT00496015. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00496015
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Conjugate Vaccine GSK1024850A
- NCT number
- NCT00496015
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 750 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Infections, Streptococcal
- Interventions
- Pneumococcal conjugate vaccine GSK1024850A., Infanrix hexa., Meningococcal vaccine GSK134612., Paracetamol.
- First posted
- 2007-07-04
- Last updated
- 2019-01-18
- Results first posted
- 2019-01-18
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than or Equal to (≥) the Cut-off | Within 4 days (Day 0-3) after primary vaccine dose. | The cut-off for core fever was 38.0 degrees Celsius (ºC). |
| Secondary | Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off | Within 4 days (Day 0-3) after primary vaccination dose | The cut-off value for core fever (rectal temperature) was 39.0ºC. |
| Secondary | Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms. | During the 4-day (Days 0-3) post-primary vaccination period | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any occurrence of the specified symptom regardless of intensity. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling \> 30 millimeters (mm) from injection site. |
| Secondary | Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms | During the 4-day (Day 0-3) post-vaccination period | Solicited general symptoms assessed were drowsiness, fever (rectal temperature ≥ 38.5°C), irritability and loss of appetite. Any was defined as any occurrence of the specified symptom regardless of intensity and relation to vaccination. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Grade 3 fever was defined as rectal temperature \>40.0°C. Grade 3 irritability was defined as crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Related was defined as solicited symptoms assessed by the investigator as causally related to the study vaccination. |
| Secondary | Number of Subjects Reported With Unsolicited Adverse Events (AEs) | Within 31 days (Days 0-30) after primary vaccine dose. | The outcome measure was not reporting statistics for all the arms in the baseline period. Results were tabulated on baseline groups except for the Synforix PRE and Synforix POST groups, for which results were presented for the Pooled Synforix PRE and POST Group. An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Secondary | Number of Subjects Reported With Serious Adverse Events (SAEs) | Throughout the entire study period (Month 0-Month 12) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Secondary | Number of Subjects Reported With AEs Resulting in Rash, New Onset of Chronic Illness (NOCI), Emergency Room (ER) Visits and Non-routine Physician Office Visits. | Up to 6 months after vaccination with Mencevax™ | Results were tabulated only on Mencevax + Infanrix Hexa Group, according to the outcome measure specification of the protocol. |
| Secondary | Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off | Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination | Certain pneumococcal serotypes includes pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA). The seroprotection cut-off for the assay was ≥ 0.2 microgram per milliliter (μg/mL). |
| Secondary | Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off. | Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination | Certain pneumococcal serotypes included pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA). Seropositivity cut-off for the assay was ≥ 0.05 microgram per milliliter (μg/mL). |
| Secondary | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination | OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than or Equal to (≥) the Cut-off | Within 4 days (Day 0-3) after primary vaccine dose. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off | Within 4 days (Day 0-3) after primary vaccination dose | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Reported With Any and Grade 3 Solicited Local Symptoms. | During the 4-day (Days 0-3) post-primary vaccination period | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Reported With Any, Grade 3 and Related Solicited General Symptoms | During the 4-day (Day 0-3) post-vaccination period | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Reported With Unsolicited Adverse Events (AEs) | Within 31 days (Days 0-30) after primary vaccine dose. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Reported With Serious Adverse Events (SAEs) | Throughout the entire study period (Month 0-Month 12) | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Reported With AEs Resulting in Rash, New Onset of Chronic Illness (NOCI), Emergency Room (ER) Visits and Non-routine Physician Office Visits. | Up to 6 months after vaccination with Mencevax™ | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with the symptom sheet filled in. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off | Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination | The analysis were performed on the According-To-Protocol (ATP) cohort for persistence, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Antibody Concentrations Against Certain Pneumococcal Serotypes ≥ the Cut Off. | Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination | The analysis were performed on the ATP cohort for persistence, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination | The analysis were performed on the ATP cohort for persistence, which included all subjects of the pneumococcal conjugate primed groups for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination. | Titers | GEOMETRIC_MEAN |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group862
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than or Equal to (≥) the Cut-off | Synflorix I Group | 64 | Participants | ||
| Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than or Equal to (≥) the Cut-off | Synflorix II Group | 14 | Participants | ||
| Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than or Equal to (≥) the Cut-off | Synflorix PRE Group | 100 | Participants | ||
| Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than or Equal to (≥) the Cut-off | Synflorix POST Group | 16 | Participants | ||
| Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than or Equal to (≥) the Cut-off | Mencevax + Infanrix Hexa Group | 146 | Participants | ||
| Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off | Synflorix I Group | 4 | Participants | ||
| Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off | Synflorix II Group | 0 | Participants | ||
| Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off | Synflorix PRE Group | 14 | Participants | ||
| Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off | Synflorix POST Group | 1 | Participants | ||
| Number of Subjects Reported With Core Fever (Rectal Temperature) Greater Than (>) the Cut-off | Mencevax + Infanrix Hexa Group | 16 | Participants |
1 to 10 of 862Source ClinicalTrials.gov
See all 862 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Synflorix I Group | 178 | |
| Overall Study | STARTED | Synflorix II Group | 27 | |
| Overall Study | STARTED | Synflorix PRE Group | 172 | |
| Overall Study | STARTED | Synflorix POST Group | 37 | |
| Overall Study | STARTED | Mencevax + Infanrix Hexa Group | 336 | |
| Overall Study | COMPLETED | Synflorix I Group | 177 | |
| Overall Study | COMPLETED | Synflorix II Group | 27 | |
| Overall Study | COMPLETED | Synflorix PRE Group | 172 | |
| Overall Study | COMPLETED | Synflorix POST Group | 36 | |
| Overall Study | COMPLETED | Mencevax + Infanrix Hexa Group | 336 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events225
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 | Bronchitis | Infections and infestations | Synflorix I Group | 3 | 178 | 3 |
| other | Bronchitis | Infections and infestations | Synflorix II Group | 0 | 27 | 0 |
| other | Bronchitis | Infections and infestations | Synflorix PRE Group | 2 | 172 | 2 |
| other | Bronchitis | Infections and infestations | Synflorix POST Group | 2 | 37 | 2 |
| other | Bronchitis | Infections and infestations | Mencevax + Infanrix Hexa Group | 12 | 336 | 12 |
| other | Decreased appetite | Metabolism and nutrition disorders | Synflorix I Group | 47 | 178 | 47 |
| other | Decreased appetite | Metabolism and nutrition disorders | Synflorix II Group | 8 | 27 | 8 |
| other | Decreased appetite | Metabolism and nutrition disorders | Synflorix PRE Group | 46 | 172 | 46 |
| other | Decreased appetite | Metabolism and nutrition disorders | Synflorix POST Group | 10 | 37 | 10 |
| other | Decreased appetite | Metabolism and nutrition disorders | Mencevax + Infanrix Hexa Group | 88 | 336 | 88 |
1 to 10 of 225Source ClinicalTrials.gov
See all 225 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Synflorix I Group | 0 | 178 |
| Total, all-cause mortality | Synflorix II Group | 0 | 27 |
| Total, all-cause mortality | Synflorix PRE Group | 0 | 172 |
| Total, all-cause mortality | Synflorix POST Group | 0 | 37 |
| Total, all-cause mortality | Mencevax + Infanrix Hexa Group | 0 | 336 |
| Total, other adverse events | Synflorix I Group | 153 | 178 |
| Total, other adverse events | Synflorix II Group | 23 | 27 |
| Total, other adverse events | Synflorix PRE Group | 154 | 172 |
| Total, other adverse events | Synflorix POST Group | 35 | 37 |
| Total, other adverse events | Mencevax + Infanrix Hexa Group | 290 | 336 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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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