Trial · NCT01235949
Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A and Prophylactic Antipyretic Treatment
NCT01235949, Phase 4, Completed, GlaxoSmithKline; results first posted 2019-01-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A and Prophylactic Antipyretic Treatment. Trials, record NCT01235949. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01235949
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A and Prophylactic Antipyretic Treatment
- NCT number
- NCT01235949
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 850 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Infections, Streptococcal
- Interventions
- GSK1024850A (SynflorixTM), Infanrix hexa, Infanrix-IPV/Hib, Ibuprofen, Paracetamol
- First posted
- 2010-11-08
- Last updated
- 2019-05-10
- Other registries' IDs
- eudract:2010-019761-28
- Results first posted
- 2019-01-31
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off | One month after primary immunization (At Month 3) | Antibodies against the vaccine 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) have been assessed by 22F-inhibition enzyme-linked immunosorbent assay (ELISA). The cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.2 micrograms per milliliter (μg/mL). |
| Primary | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | One month after primary immunization (At Month 3) | Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL. |
| Primary | Antibody Concentrations Against Protein D (Anti-PD) | One month after primary immunization (At Month 3) | Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units (EL.U) per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. |
| Secondary | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A | One month after primary immunization (At Month 3) | Anti-pneumococcal serotype 6A and 19A antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL. |
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses | Solicited local symptoms assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimeters (mm). |
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Within the 4-day (Days 0-3) period following booster vaccination | Solicited local symptoms assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimeters (mm). |
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses | Solicited general symptoms included drowsiness, irritability, loss of appetite and fever \[rectally, greater than or equal to (≥) 38 degrees Celsius (°C)\]. Any= incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that interfered with normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever above (\>) 40.0°C. Related = symptom assessed by the investigator as related to the vaccination. |
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Within the 4-day (Days 0-3) period following booster vaccination | Solicited general symptoms included drowsiness, irritability, loss of appetite and fever \[rectally, greater than or equal to (≥) 38 degrees Celsius (°C)\]. Any= incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that interfered with normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever above (\>) 40.0°C. Related = symptom assessed by the investigator as related to the vaccination. |
| Secondary | Number of Subjects With Any Serious Adverse Events (SAEs) | During the entire study period (Month 0 to 10) | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity. |
| Secondary | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Within 31-days (Day 0-30) following each primary vaccination dose | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. |
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 | Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off | One month after primary immunization (At Month 3) | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Antibody Concentrations Against Vaccine Pneumococcal Serotypes | One month after primary immunization (At Month 3) | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available. | µg/mL | GEOMETRIC_MEAN |
| PRIMARY | Antibody Concentrations Against Protein D (Anti-PD) | One month after primary immunization (At Month 3) | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available. | EL.U/mL | GEOMETRIC_MEAN |
| SECONDARY | Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A | One month after primary immunization (At Month 3) | The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data and assay results for antibodies against at least one study vaccine antigen component after vaccination were available. | μg/mL | GEOMETRIC_MEAN |
| SECONDARY | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose and had the symptoms sheet filled in. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Within the 4-day (Days 0-3) period following booster vaccination | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose and had the symptoms sheet filled in. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose and had the symptoms sheet filled in. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Within the 4-day (Days 0-3) period following booster vaccination | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose and had the symptoms sheet filled in. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any Serious Adverse Events (SAEs) | During the entire study period (Month 0 to 10) | The analysis was performed on the Total Vaccinated Cohort (TVC), which included all vaccinated subjects who received at least one vaccine dose. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Any Unsolicited Adverse Events (AEs) | Within 31-days (Day 0-30) following each primary vaccination dose | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects who received at least one vaccine dose. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group1,782
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off | IIBU Group | Anti-1 | 144 | Participants | |
| Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off | DIBU Group | Anti-1 | 155 | Participants | |
| Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off | NIBU Group | Anti-1 | 160 | Participants | |
| Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off | IPARA Group | Anti-1 | 52 | Participants | |
| Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off | DPARA Group | Anti-1 | 50 | Participants | |
| Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off | NPARA Group | Anti-1 | 55 | Participants | |
| Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off | IIBU Group | Anti-4 | 145 | Participants | |
| Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off | DIBU Group | Anti-4 | 155 | Participants | |
| Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off | NIBU Group | Anti-4 | 158 | Participants | |
| Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off | IPARA Group | Anti-4 | 53 | Participants |
1 to 10 of 1,782Source ClinicalTrials.gov
See all 1,782 results by groupParticipant flow108
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Primary Phase | STARTED | IIBU Group | 198 | |
| Primary Phase | STARTED | DIBU Group | 198 | |
| Primary Phase | STARTED | NIBU Group | 199 | |
| Primary Phase | STARTED | IPARA Group | 71 | |
| Primary Phase | STARTED | DPARA Group | 72 | |
| Primary Phase | STARTED | NPARA Group | 74 | |
| Primary Phase | STARTED | IIBU-IIBU Group | 0 | |
| Primary Phase | STARTED | IIBU-DIBU Group | 0 | |
| Primary Phase | STARTED | IIBU-NIBU Group | 0 | |
| Primary Phase | STARTED | DIBU-IIBU Group | 0 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 participant flowAdverse events540
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 | Pain | General disorders | IIBU Group | 92 | 198 | 154 |
| other | Pain | General disorders | DIBU Group | 76 | 198 | 145 |
| other | Pain | General disorders | NIBU Group | 107 | 199 | 197 |
| other | Pain | General disorders | IPARA Group | 30 | 71 | 58 |
| other | Pain | General disorders | DPARA Group | 37 | 72 | 71 |
| other | Pain | General disorders | NPARA Group | 44 | 74 | 80 |
| other | Pain | General disorders | IIBU-IIBU Group | 25 | 64 | 25 |
| other | Pain | General disorders | IIBU-DIBU Group | 22 | 60 | 22 |
| other | Pain | General disorders | IIBU-NIBU Group | 15 | 63 | 15 |
| other | Pain | General disorders | DIBU-IIBU Group | 22 | 63 | 22 |
1 to 10 of 540Source ClinicalTrials.gov
See all 540 adverse eventsAdverse event totals54
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IIBU Group | 0 | 198 |
| Total, all-cause mortality | DIBU Group | 0 | 198 |
| Total, all-cause mortality | NIBU Group | 0 | 199 |
| Total, all-cause mortality | IPARA Group | 0 | 71 |
| Total, all-cause mortality | DPARA Group | 0 | 72 |
| Total, all-cause mortality | NPARA Group | 0 | 74 |
| Total, all-cause mortality | IIBU-IIBU Group | 0 | 64 |
| Total, all-cause mortality | IIBU-DIBU Group | 0 | 60 |
| Total, all-cause mortality | IIBU-NIBU Group | 0 | 63 |
| Total, all-cause mortality | DIBU-IIBU Group | 0 | 63 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27541270 | 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 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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Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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