Trial · NCT00979602
Safety, Immunogenicity, and Relative Efficacy of H1N1 Vaccines in Adults Aged 18 Years and Older
NCT00979602, Phase 3, Completed, GlaxoSmithKline; results first posted 2017-09-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety, Immunogenicity, and Relative Efficacy of H1N1 Vaccines in Adults Aged 18 Years and Older. Trials, record NCT00979602. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00979602
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Immunogenicity, and Relative Efficacy of H1N1 Vaccines in Adults Aged 18 Years and Older
- NCT number
- NCT00979602
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,048 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Influenza
- Interventions
- GSK2340274A, GSK2340273A
- First posted
- 2009-09-18
- Last updated
- 2018-03-21
- Results first posted
- 2017-09-21
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | At Day 21 | A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer higher than or equal to (≥)1:40 or at least a 4-fold increase of the pre-vaccination titer of ≥ 1:10. The Flu strain assessed was A/California/7/09 (H1N1)v-like (Flu A/CAL/7/09) in subjects of 18-60 years and older and 18-64 years and older, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance. |
| Primary | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | At Day 0 | A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) antibody titer ≥ 1:40 against the tested virus. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. |
| Primary | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | At Day 21 | A seroprotected subject was defined as a vaccinated subject with serum HI antibody titer ≥ 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. |
| Primary | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | At Day 21 | SCF was defined as the fold increase in serum HI geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus, in subjects 18-60 years and older and 18-64 years and older, following the CHMP guidance. |
| Primary | Number of A/California/7/2009 (H1N1)V-like Illness (ILI) Cases | From Day 14 post-vaccination up to study end (at Day 385) | The analysis focused on Quantitative Reverse Transcription Polymerase Chain Reaction Assay (RT-qPCR)-confirmed A/California/7/2009 (H1N1)v-like illness (ILI) cases. |
| Secondary | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | At Days 0 and 21 | Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strains assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. |
| Secondary | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | At Days 0 and 21 | Titers were presented as geometric mean titers (GMTs). The flu strain assessed was /California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. |
| Secondary | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | At Day 42 | Cut-off values assessed were greater than or equal to (≥) 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. |
| Secondary | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | At Day 42 | Titers were presented as geometric mean titers (GMTs). The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. |
| Secondary | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | At Day 182 | Cut-off values assessed were greater than or equal to ≥ 1:10 in the sera of subjects seronegative before vaccination. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) in subjects 18-60 years and older and 18-64 years and older, following the CHMP and the CBER guidance. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | At Day 21 | The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | At Day 0 | The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | At Day 21 | The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Seroconversion Factor (SCF) for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | At Day 21 | The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available. | Fold increase | GEOMETRIC_MEAN |
| PRIMARY | Number of A/California/7/2009 (H1N1)V-like Illness (ILI) Cases | From Day 14 post-vaccination up to study end (at Day 385) | The analysis was performed on the ATP cohort for efficacy, which included all eligible subjects who received the study vaccine according to their treatment assignment and who were successfully contacted at least once during the active influenza surveillance period after completing the Day 21 study visit. | Events | NUMBER |
| SECONDARY | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | At Days 0 and 21 | The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | At Days 0 and 21 | The analysis was performed on the ATP cohort for immunogenicity at Day 21, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 21 were available. | Titers | GEOMETRIC_MEAN |
| SECONDARY | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | At Day 42 | The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Titers for Serum HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | At Day 42 | The analysis was performed on a subset from the ATP cohort for immunogenicity at Day 42, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 42 were available. | Titers | GEOMETRIC_MEAN |
| SECONDARY | Number of Seropositive Subjects for HI Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | At Day 182 | The analysis was performed on the ATP cohort for immunogenicity at Day 182, which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against A/California-like HA antigen for the blood sample taken on Day 182 were available. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group868
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | GSK2340274A (18-60 y) Group | 1210 | Participants | ||
| Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | GSK2340274A (>60 y) Group | 411 | Participants | ||
| Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | GSK2340273A (18-60 y) Group | 1012 | Participants | ||
| Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | GSK2340273A (>60 y) Group | 301 | Participants | ||
| Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | GSK2340274A (18-64 y) Group | 1279 | Participants | ||
| Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | GSK2340274A (>64 y) Group | 342 | Participants | ||
| Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | GSK2340273A (18-64 y) Group | 1055 | Participants | ||
| Number of Seroconverted (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 H1N1 Virus Strain | GSK2340273A (>64 y) Group | 258 | Participants | ||
| Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | GSK2340274A (18-60 y) Group | 337 | Participants | ||
| Number of Seroprotected (SPR) Subjects for HI Antibodies Against the Flu A/CAL/7/09 H1N1 Virus Strain | GSK2340274A (>60 y) Group | 74 | Participants |
1 to 10 of 868Source ClinicalTrials.gov
See all 868 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GSK2340274A Group | 2,025 | |
| Overall Study | STARTED | GSK2340273A Group | 2,023 | |
| Overall Study | COMPLETED | GSK2340274A Group | 1,880 | |
| Overall Study | COMPLETED | GSK2340273A Group | 1,890 | |
| Overall Study | NOT COMPLETED | GSK2340274A Group | 145 | |
| Overall Study | NOT COMPLETED | GSK2340273A Group | 133 |
Source ClinicalTrials.gov
Adverse events318
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 | Arthralgia | Musculoskeletal and connective tissue disorders | GSK2340274A Group | 299 | 2,025 | 302 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | GSK2340273A Group | 165 | 2,023 | 167 |
| other | Chills | General disorders | GSK2340274A Group | 181 | 2,025 | 183 |
| other | Chills | General disorders | GSK2340273A Group | 116 | 2,023 | 116 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | GSK2340274A Group | 78 | 2,025 | 82 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | GSK2340273A Group | 110 | 2,023 | 112 |
| other | Erythema | Skin and subcutaneous tissue disorders | GSK2340274A Group | 114 | 2,025 | 114 |
| other | Erythema | Skin and subcutaneous tissue disorders | GSK2340273A Group | 18 | 2,023 | 18 |
| other | Fatigue | General disorders | GSK2340274A Group | 564 | 2,025 | 573 |
| other | Fatigue | General disorders | GSK2340273A Group | 428 | 2,023 | 435 |
1 to 10 of 318Source ClinicalTrials.gov
See all 318 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GSK2340274A Group | 6 | 2,025 |
| Total, all-cause mortality | GSK2340273A Group | 1 | 2,023 |
| Total, other adverse events | GSK2340274A Group | 1,680 | 2,025 |
| Total, other adverse events | GSK2340273A Group | 1,063 | 2,023 |
| Total, serious adverse events | GSK2340274A Group | 84 | 2,025 |
| Total, serious adverse events | GSK2340273A Group | 73 | 2,023 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23856331 | DERIVED |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| GSK2340274A Group vs GSK2340273A Group: deaths from any cause | Trial comparisons |
| GSK2340274A Group vs GSK2340273A 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/NCT00979602
GET https://conductscience.org/api/trials/v1/NCT00979602/registered?page=2