Trial · NCT00980005
Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children
NCT00980005, Phase 3, Completed, GlaxoSmithKline; results first posted 2012-02-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children. Trials, record NCT00980005. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00980005
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children
- NCT number
- NCT00980005
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,116 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Influenza
- Interventions
- GSK investigational vaccine GSK1557482A, Fluzone®
- First posted
- 2009-09-18
- Last updated
- 2018-09-21
- Results first posted
- 2012-02-15
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. | At Day 0 and 28 after last vaccine dose. | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs). |
| Primary | Number of Seroconverted Subjects for HI Antibodies Against the Three Strains. | At Day 28 after last vaccine dose. | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) 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. |
| Secondary | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | At Day 0 and 28 after last vaccine dose. | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Titers were expressed as geometric mean antibody titers (GMTs). Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. |
| Secondary | Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | At Day 28 after last vaccine dose. | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) 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. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. |
| Secondary | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains. | At Day 0 and 28 after last vaccine dose. | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults. |
| Secondary | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | At Day 0 and 28 after last vaccine dose. | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. |
| Secondary | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains. | At Day 0 and at Day 28 after last vaccine dose | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen. |
| Secondary | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata. | At Day 0 and at Day 28 after last vaccine dose | The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008. Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years. |
| Secondary | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | During a 4-day follow-up period (Days 0-3) after vaccination. | The general symptoms solicited from study subjects younger than 5 years of age were drowsiness, irritability, loss of appetite, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness, irritability = symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C. Related = symptom assessed by the investigator as causally related to the vaccination. |
| Secondary | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | During a 4-day follow-up period (Days 0-3) after vaccination. | The general symptoms solicited from study subjects 5 years of age and older were arthralgia (joint pain), fatigue, headache, muscle aches, shivering, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C. Related = symptom assessed by the investigator as causaly related to the vaccination. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. | At Day 0 and 28 after last vaccine dose. | The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. | Titers | GEOMETRIC_MEAN |
| PRIMARY | Number of Seroconverted Subjects for HI Antibodies Against the Three Strains. | At Day 28 after last vaccine dose. | The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata. | At Day 0 and 28 after last vaccine dose. | The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. | Titers | GEOMETRIC_MEAN |
| SECONDARY | Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | At Day 28 after last vaccine dose. | The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains. | At Day 0 and 28 after last vaccine dose. | The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata. | At Day 0 and 28 after last vaccine dose. | The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains. | At Day 0 and at Day 28 after last vaccine dose | The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. | Fold change | MEAN |
| SECONDARY | Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata. | At Day 0 and at Day 28 after last vaccine dose | The According-To-Protocol cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one vaccine strain after vaccination. | Fold change | MEAN |
| SECONDARY | Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | During a 4-day follow-up period (Days 0-3) after vaccination. | The Total Vaccinated cohort included all vaccinated subjects. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs). | During a 4-day follow-up period (Days 0-3) after vaccination. | The Total Vaccinated cohort included all vaccinated subjects. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group280
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. | Flulaval Group | A/Brisbane [at Day 0] | 46.0 | 95% Confidence Interval 41.9 to 50.4 | Titers |
| Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. | Fluzone Group | A/Brisbane [at Day 0] | 45.8 | 95% Confidence Interval 41.8 to 50.2 | Titers |
| Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. | Flulaval Group | A/Brisbane [at Day 28] | 320.9 | 95% Confidence Interval 298.3 to 345.2 | Titers |
| Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. | Fluzone Group | A/Brisbane [at Day 28] | 329.4 | 95% Confidence Interval 306.8 to 353.7 | Titers |
| Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. | Flulaval Group | A/Uruguay [at Day 0] | 57.1 | 95% Confidence Interval 51.8 to 63.0 | Titers |
| Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. | Fluzone Group | A/Uruguay [at Day 0] | 63.9 | 95% Confidence Interval 58.1 to 70.3 | Titers |
| Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. | Flulaval Group | A/Uruguay [at Day 28] | 414.7 | 95% Confidence Interval 386.5 to 444.9 | Titers |
| Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. | Fluzone Group | A/Uruguay [at Day 28] | 451.9 | 95% Confidence Interval 423.8 to 481.8 | Titers |
| Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. | Flulaval Group | B/Brisbane [at Day 0] | 16.6 | 95% Confidence Interval 15.3 to 18.1 | Titers |
| Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains. | Fluzone Group | B/Brisbane [at Day 0] | 16.8 | 95% Confidence Interval 15.4 to 18.3 | Titers |
1 to 10 of 280Source ClinicalTrials.gov
See all 280 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 Group | 1,055 | |
| Overall Study | STARTED | Fluzone Group | 1,061 | |
| Overall Study | COMPLETED | Flulaval Group | 1,008 | |
| Overall Study | COMPLETED | Fluzone Group | 998 | |
| Overall Study | NOT COMPLETED | Flulaval Group | 47 | |
| Overall Study | NOT COMPLETED | Fluzone Group | 63 |
Source ClinicalTrials.gov
Adverse events68
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 | Cough | Respiratory, thoracic and mediastinal disorders | Flulaval Group | 129 | 1,055 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Fluzone Group | 115 | 1,061 | |
| other | Pyrexia | General disorders | Flulaval Group | 62 | 1,055 | |
| other | Pyrexia | General disorders | Fluzone Group | 60 | 1,061 | |
| other | Arthralgia | General disorders | Flulaval Group | 70 | 750 | |
| other | Arthralgia | General disorders | Fluzone Group | 80 | 747 | |
| other | Fatigue | General disorders | Flulaval Group | 138 | 750 | |
| other | Fatigue | General disorders | Fluzone Group | 137 | 747 | |
| other | Headache | General disorders | Flulaval Group | 141 | 750 | |
| other | Headache | General disorders | Fluzone Group | 131 | 747 |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Flulaval Group | ||
| Total, all-cause mortality | Fluzone Group | ||
| Total, other adverse events | Flulaval Group | 742 | 1,055 |
| Total, other adverse events | Fluzone Group | 710 | 1,061 |
| Total, serious adverse events | Flulaval Group | 10 | 1,055 |
| Total, serious adverse events | Fluzone Group | 6 | 1,061 |
Source ClinicalTrials.gov
Papers2
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Flulaval Group vs Fluzone Group: Number of Subjects Reporting Medically Attended Adverse Events (MAEs). | Trial comparisons |
| Flulaval Group vs Fluzone Group: Number of Subjects Reporting Serious Adverse Events (SAEs). | Trial comparisons |
| Flulaval Group vs Fluzone 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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00980005
GET https://conductscience.org/api/trials/v1/NCT00980005/results?page=2