Trial · NCT01218308
A Study to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine in Children
NCT01218308, Phase 3, Completed, GlaxoSmithKline; results first posted 2013-04-02
3 sourcestrials-2026-11-12-0.4.0
Download JSON
Cite this record
ConductScience Library. A Study to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine in Children. Trials, record NCT01218308. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01218308
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine in Children
- NCT number
- NCT01218308
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 5,220 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Influenza
- Interventions
- FluLaval® Quadrivalent, Havrix™
- First posted
- 2010-10-11
- Last updated
- 2018-08-01
- Results first posted
- 2013-04-02
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Reporting at Least One Confirmed Occurrence of Influenza A or B. | From Day 14 to Day 180 | To confirm influenza A and/or B disease, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion. |
| Secondary | Number of Subjects Reporting at Least One Moderate to Severe Occurrence of Influenza A or B. | From Day 14 to Day 180 | To confirm influenza A and/or B disease moderate to severe cases, a positive RT-PCR result for influenza A or B virus from a nose and throat swab obtained concurrently with an ILI was required. Moderate to severe influenza was defined as RT-PCR-confirmed ILI with: * Fever \>39°C, and/or at least one of the following manifestations, * Physician-verified shortness of breath, pulmonary congestion, pneumonia, bronchiolitis, bronchitis, wheezing, croup, or acute otitis media, and/or one of the following, * Physician-diagnosed serious extra-pulmonary complication of influenza, including myositis, encephalitis, seizure, or myocarditis |
| Secondary | Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Antigenically Matched Strain. | From Day 14 to Day 180 | To confirm influenza A and/or B disease due to antigenically matched strain, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion. |
| Secondary | Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Any Strain. | From Day 14 to Day 180 | To confirm influenza A and/or B disease due to any strain, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion. |
| Secondary | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST] | Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata). |
| Secondary | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST] | A seroconverted subject was defined as a vaccinated subject 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 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata). |
| Secondary | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST] | A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata). |
| Secondary | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST] | The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata). |
| Secondary | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Strains | On Day 0 and at least 6 months after first vaccination (Month 6) | HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Victoria/210/09 (H3N2), Flu B/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata). |
| Secondary | Number of Seroconverted Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains. | At least 6 months after first vaccination (Month 6) | A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 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/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata). |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Reporting at Least One Confirmed Occurrence of Influenza A or B. | From Day 14 to Day 180 | The analysis was performed on the According-To-Protocol cohort for efficacy - Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination. | subjects | NUMBER |
| SECONDARY | Number of Subjects Reporting at Least One Moderate to Severe Occurrence of Influenza A or B. | From Day 14 to Day 180 | The analysis was performed on the According-To-Protocol cohort for efficacy - Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination. | subjects | NUMBER |
| SECONDARY | Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Antigenically Matched Strain. | From Day 14 to Day 180 | The analysis was performed on the According-To-Protocol cohort for efficacy - Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination. | subjects | NUMBER |
| SECONDARY | Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Any Strain. | From Day 14 to Day 180 | The analysis was performed on the According-To-Protocol cohort for efficacy - Time to event, which included all eligible subjects who met all inclusion criteria and no exclusion criteria, followed their study treatment assignment and were successfully contacted at least once after the first vaccination. | subjects | NUMBER |
| SECONDARY | Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST] | The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available. | titers | GEOMETRIC_MEAN |
| SECONDARY | Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. | At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST] | The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available. | subjects | NUMBER |
| SECONDARY | Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. | At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST] | The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available. | subjects | NUMBER |
| SECONDARY | Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST] | The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects (those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom data concerning immunogenicity outcome measure were available. | fold increase | MEAN |
| SECONDARY | Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Strains | On Day 0 and at least 6 months after first vaccination (Month 6) | The ATP Cohort for persistence included, in terms of antibody response measured by the HI assay, all evaluable subjects for whom data concerning immunogenicity outcome measure were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Titer | GEOMETRIC_MEAN |
| SECONDARY | Number of Seroconverted Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains. | At least 6 months after first vaccination (Month 6) | The ATP Cohort for persistence included, in terms of antibody response measured by the HI assay, all evaluable subjects for whom data concerning immunogenicity outcome measure were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination. | Subjects | NUMBER |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group200
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Reporting at Least One Confirmed Occurrence of Influenza A or B. | FluLaval® Quadrivalent Group | 58 | subjects | ||
| Number of Subjects Reporting at Least One Confirmed Occurrence of Influenza A or B. | Havrix Group | 128 | subjects | ||
| Number of Subjects Reporting at Least One Moderate to Severe Occurrence of Influenza A or B. | FluLaval® Quadrivalent Group | 14 | subjects | ||
| Number of Subjects Reporting at Least One Moderate to Severe Occurrence of Influenza A or B. | Havrix Group | 52 | subjects | ||
| Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Antigenically Matched Strain. | FluLaval® Quadrivalent Group | 31 | subjects | ||
| Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Antigenically Matched Strain. | Havrix Group | 56 | subjects | ||
| Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Any Strain. | FluLaval® Quadrivalent Group | 50 | subjects | ||
| Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Any Strain. | Havrix Group | 112 | subjects | ||
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | FluLaval® Quadrivalent Group | H1N1, PRE [N=457;117] | 15.3 | 95% Confidence Interval 13.6 to 17.3 | titers |
| Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. | Havrix Group | H1N1, PRE [N=457;117] | 16.1 | 95% Confidence Interval 12.6 to 20.5 | titers |
1 to 10 of 200Source ClinicalTrials.gov
See all 200 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 | 2,584 | |
| Overall Study | STARTED | Havrix Group | 2,584 | |
| Overall Study | COMPLETED | FluLaval® Quadrivalent Group | 2,481 | |
| Overall Study | COMPLETED | Havrix Group | 2,464 | |
| Overall Study | NOT COMPLETED | FluLaval® Quadrivalent Group | 103 | |
| Overall Study | NOT COMPLETED | Havrix Group | 120 |
Source ClinicalTrials.gov
Adverse events104
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 | Nasopharyngitis | Infections and infestations | FluLaval® Quadrivalent Group | 213 | 2,584 | |
| other | Nasopharyngitis | Infections and infestations | Havrix Group | 231 | 2,584 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | FluLaval® Quadrivalent Group | 145 | 2,584 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Havrix Group | 137 | 2,584 | |
| other | Pain | General disorders | FluLaval® Quadrivalent Group | 1,215 | 2,546 | |
| other | Pain | General disorders | Havrix Group | 888 | 2,551 | |
| other | Drowsiness | General disorders | FluLaval® Quadrivalent Group | 100 | 899 | |
| other | Drowsiness | General disorders | Havrix Group | 93 | 896 | |
| other | Irritability | General disorders | FluLaval® Quadrivalent Group | 102 | 899 | |
| other | Irritability | General disorders | Havrix Group | 91 | 896 |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 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 | Havrix Group | ||
| Total, other adverse events | FluLaval® Quadrivalent Group | 1,215 | 2,584 |
| Total, other adverse events | Havrix Group | 1,297 | 2,584 |
| Total, serious adverse events | FluLaval® Quadrivalent Group | 36 | 2,584 |
| Total, serious adverse events | Havrix Group | 24 | 2,584 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24328444 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| FluLaval® Quadrivalent Group vs Havrix 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.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01218308
GET https://conductscience.org/api/trials/v1/NCT01218308/results?page=2