Trial · NCT02242643
Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) Compared to Fluzone® Quadrivalent in Children 6 to 35 Months of Age
NCT02242643, Phase 3, Completed, GlaxoSmithKline; results first posted 2016-04-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) Compared to Fluzone® Quadrivalent in Children 6 to 35 Months of Age. Trials, record NCT02242643. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02242643
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) Compared to Fluzone® Quadrivalent in Children 6 to 35 Months of Age
- NCT number
- NCT02242643
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,432 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Influenza
- Interventions
- FluLaval™ Quadrivalent, Fluzone® Quadrivalent
- First posted
- 2014-09-17
- Last updated
- 2018-09-07
- Results first posted
- 2016-04-12
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains | 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects) | Antibody titers were expressed as Seroconversion rate (SCR) and SCR difference. SCR was defined as the proportion of vaccinees who had either a pre-vaccination titer \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria). |
| Primary | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | At 28 days after the last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects) | HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria). |
| Secondary | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | At Day 0 and 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects) | Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria). |
| Secondary | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | At Day 0 and 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects) | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria). |
| Secondary | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects) | A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria). |
| Secondary | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects) | MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria). |
| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | During a 7-day (Day 0 - Day 6) follow-up period after each vaccination | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity and all subjects reporting 'Yes' for solicited symptom occurred but with missing values for at least one day during the solicited period. Grade 3 pain = Cried when limb is moved/spontaneously painful. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. \>100mm. |
| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | During the 7-day (Days 0-6) follow-up period after each vaccination | Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (\< )38°C but with missing values for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (\>) 39.0°C. |
| Secondary | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | During the 7-day (Days 0-6) follow-up period after each vaccination. | Duration was defined as number of days with any grade of local and general symptoms. |
| Secondary | Number of Subjects Reporting Any Fever Following Each Dose and Across Doses. | During a 2-day (Days 0-1) follow-up period after each vaccination | Any Fever = all subjects with a documented temperature of ≥38.0°C /100.4°F by axillary route and all subjects reporting temperature \< 38.0°C but with missing values for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (\>) 39.0°C. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains | 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects) | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available. | Subjects | NUMBER |
| PRIMARY | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | At 28 days after the last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects) | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available. | Titers | GEOMETRIC_MEAN |
| SECONDARY | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | At Day 0 and 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects) | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available. | Titers | MEAN |
| SECONDARY | Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | At Day 0 and 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects) | The ATP cohort for immunogenicity included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available. | Subjects | NUMBER |
| SECONDARY | Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects) | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available. | Subjects | NUMBER |
| SECONDARY | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects) | The ATP cohort for immunogenicity included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available. | Fold increase | GEOMETRIC_MEAN |
| SECONDARY | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | During a 7-day (Day 0 - Day 6) follow-up period after each vaccination | The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available. | Subjects | NUMBER |
| SECONDARY | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | During the 7-day (Days 0-6) follow-up period after each vaccination | The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available. | Subjects | NUMBER |
| SECONDARY | Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) | During the 7-day (Days 0-6) follow-up period after each vaccination. | The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available. | Days | MEDIAN |
| SECONDARY | Number of Subjects Reporting Any Fever Following Each Dose and Across Doses. | During a 2-day (Days 0-1) follow-up period after each vaccination | The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available. | Subjects | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group1,016
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains | FluLaval™ Quadrivalent Group | H1N1 [N=972,980] | 716 | Subjects | |
| Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains | Fluzone® Quadrivalent Group | H1N1 [N=972,980] | 660 | Subjects | |
| Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains | FluLaval™ Quadrivalent Group | H3N2 [N=972,980] | 740 | Subjects | |
| Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains | Fluzone® Quadrivalent Group | H3N2 [N=972,980] | 680 | Subjects | |
| Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains | FluLaval™ Quadrivalent Group | Victoria [N=973,980] | 631 | Subjects | |
| Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains | Fluzone® Quadrivalent Group | Victoria [N=973,980] | 475 | Subjects | |
| Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains | FluLaval™ Quadrivalent Group | Yamagata [N=974,980] | 833 | Subjects | |
| Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains | Fluzone® Quadrivalent Group | Yamagata [N=974,980] | 723 | Subjects | |
| Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | FluLaval™ Quadrivalent Group | H1N1 | 98.8 | 95% Confidence Interval 90.3 to 108.2 | Titers |
| Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | Fluzone® Quadrivalent Group | H1N1 | 84.4 | 95% Confidence Interval 76.9 to 92.6 | Titers |
1 to 10 of 1,016Source ClinicalTrials.gov
See all 1,016 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FluLaval™ Quadrivalent Group | 1,207 | |
| Overall Study | STARTED | Fluzone® Quadrivalent Group | 1,217 | |
| Overall Study | COMPLETED | FluLaval™ Quadrivalent Group | 1,132 | |
| Overall Study | COMPLETED | Fluzone® Quadrivalent Group | 1,139 | |
| Overall Study | NOT COMPLETED | FluLaval™ Quadrivalent Group | 75 | |
| Overall Study | NOT COMPLETED | Fluzone® Quadrivalent Group | 78 |
Source ClinicalTrials.gov
Adverse events94
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 | Upper respiratory tract infection | Infections and infestations | FluLaval™ Quadrivalent Group | 111 | 1,207 | |
| other | Upper respiratory tract infection | Infections and infestations | Fluzone® Quadrivalent Group | 102 | 1,217 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | FluLaval™ Quadrivalent Group | 70 | 1,207 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Fluzone® Quadrivalent Group | 77 | 1,217 | |
| other | Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | FluLaval™ Quadrivalent Group | 59 | 1,207 | |
| other | Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Fluzone® Quadrivalent Group | 76 | 1,217 | |
| other | Nasopharyngitis | Infections and infestations | FluLaval™ Quadrivalent Group | 66 | 1,207 | |
| other | Nasopharyngitis | Infections and infestations | Fluzone® Quadrivalent Group | 54 | 1,217 | |
| other | Diarrhoea | Gastrointestinal disorders | FluLaval™ Quadrivalent Group | 66 | 1,207 | |
| other | Diarrhoea | Gastrointestinal disorders | Fluzone® Quadrivalent Group | 53 | 1,217 |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FluLaval™ Quadrivalent Group | ||
| Total, all-cause mortality | Fluzone® Quadrivalent Group | ||
| Total, other adverse events | FluLaval™ Quadrivalent Group | 932 | 1,207 |
| Total, other adverse events | Fluzone® Quadrivalent Group | 895 | 1,217 |
| Total, serious adverse events | FluLaval™ Quadrivalent Group | 5 | 1,207 |
| Total, serious adverse events | Fluzone® Quadrivalent Group | 4 | 1,217 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| FluLaval™ Quadrivalent Group vs Fluzone® Quadrivalent Group: serious adverse events |
Source 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.
For software
Read this trial from software.
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