Trial · NCT00383123
Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children
NCT00383123, Phase 3, Completed, GlaxoSmithKline; results first posted 2008-12-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children. Trials, record NCT00383123. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00383123
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children
- NCT number
- NCT00383123
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,327 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Influenza
- Interventions
- Fluarix™, Fluzone
- First posted
- 2006-10-02
- Last updated
- 2018-06-08
- Results first posted
- 2008-12-04
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies | 21 or 28 days after last vaccine dose | GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine. |
| Primary | Number of Seroconverted Subjects | 21 or 28 days after last vaccine dose | Seroconverted subjects are defined as subjects with either a pre-vaccination HI titer \<1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer. Data are presented for all 3 viral strains comprised in the vaccine. |
| Primary | Number of Subjects Reporting Rare Serious Events | Up to 6 months after vaccination | Rare serious event is defined as any untoward medical event with an occurrence rate of ≥1/300 that: * resulted in death, * was life-threatening, * required hospitalization or prolongation of existing hospitalization, * resulted in disability/incapacity, or * was a congenital anomaly/birth defect in the offspring of a study subject. |
| Secondary | Number of Seroprotected Subjects | Before (PRE) and 21 or 28 days after (POST) the last vaccine dose | Seroprotected subjects are defined as vaccinees with a serum HI titer ≥ 1:40. Data are presented for all 3 viral strains comprised in the vaccine. |
| Secondary | Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer | 21 or 28 days after last vaccine dose | Initially unprotected subjects are subjects with a baseline HI titer \< 1:40. Data are presented for all 3 viral strains comprised in the vaccine. |
| Secondary | Number of Subjects Reporting Solicited Local and General Symptoms | During a 4-day follow-up period after each vaccination | Solicited local symptoms assessed include pain, redness, and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, loss of appetite, arthralgia, fatigue, headache, muscle aches, and shivering. Data across doses are presented. Any = at least one symptom irrespective of intensity/relationship to vaccination; Grade 3: symptom that prevented normal everyday activities; Related: considered by the investigator as related to the study vaccination. |
| Secondary | Number of Subjects Reporting Unsolicited Adverse Events | Within 28 days following vaccination | An Adverse Event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any = at least one symptom irrespective of intensity and relationship to vaccination; Grade 3 = preventing normal activity; Related = considered by the investigator to be causally related to the study vaccination. |
| Secondary | Number of Subjects Reporting New Onset Chronic Illnesses and/or Serious Adverse Events (SAE) | Up to 6 months after vaccination | SAE: any untoward medical occurrence that * resulted in death, * was life-threatening, * required hospitalization or prolongation of existing hospitalization, * resulted in disability/incapacity, or * was a congenital anomaly/birth defect in the offspring of a study subject. Examples of possible new onset chronic illnesses include but are not limited to diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies | 21 or 28 days after last vaccine dose | Per protocol, GMTs were assessed only in part of the According-To-Protocol (ATP) cohort for immunogenicity (children aged 6 months to \< 5 years). | Titer | GEOMETRIC_MEAN |
| PRIMARY | Number of Seroconverted Subjects | 21 or 28 days after last vaccine dose | As per protocol, seroconversion was assessed in part of the ATP cohort for immunogenicity: children aged 6 months to \< 5 years for whom post-vaccination results were available. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects Reporting Rare Serious Events | Up to 6 months after vaccination | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Seroprotected Subjects | Before (PRE) and 21 or 28 days after (POST) the last vaccine dose | As per protocol, seroprotection was assessed in part of the ATP cohort for immunogenicity: children aged 6 months to \< 5 years for whom results were available. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer | 21 or 28 days after last vaccine dose | As per protocol, only subjects from the ATP cohort for immunogenicity aged 6 months to \< 5 years and with a baseline titre \< 1:40 were analysed for this Outcome Measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Reporting Solicited Local and General Symptoms | During a 4-day follow-up period after each vaccination | Analysis was performed on vaccinated subjects with available data.~* Pain, redness, swelling and fever were assessed in all age cohorts.~* Drowsiness, irritability and loss of appetite were assessed in the 6 months to \< 5 years cohort only.~* Arthralgia, fatigue, headache, muscle aches and shivering were assessed in the 5 to \< 18 years cohort only. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects Reporting Unsolicited Adverse Events | Within 28 days following vaccination | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Subjects Reporting New Onset Chronic Illnesses and/or Serious Adverse Events (SAE) | Up to 6 months after vaccination | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group138
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies | Fluarix Group | A/New Caledonia [6 to <36 months] | 52.4 | 95% Confidence Interval 43.3 to 63.4 | Titer |
| Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies | Fluzone Group | A/New Caledonia [6 to <36 months] | 101.4 | 95% Confidence Interval 86.9 to 118.2 | Titer |
| Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies | Fluarix Group | A/Wisconsin [6 to <36 months] | 80.5 | 95% Confidence Interval 62.2 to 104.1 | Titer |
| Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies | Fluzone Group | A/Wisconsin [6 to <36 months] | 218.0 | 95% Confidence Interval 185.8 to 255.8 | Titer |
| Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies | Fluarix Group | B/Malaysia [6 to <36 months] | 20.2 | 95% Confidence Interval 15.9 to 25.8 | Titer |
| Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies | Fluzone Group | B/Malaysia [6 to <36 months] | 40.6 | 95% Confidence Interval 32.3 to 51.1 | Titer |
| Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies | Fluarix Group | A/New Caledonia [3 to < 5 years] | 130.3 | 95% Confidence Interval 108.6 to 156.4 | Titer |
| Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies | Fluzone Group | A/New Caledonia [3 to < 5 years] | 168.7 | 95% Confidence Interval 138.7 to 205.2 | Titer |
| Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies | Fluarix Group | A/Wisconsin [3 to < 5 years] | 458.1 | 95% Confidence Interval 365.3 to 574.3 | Titer |
| Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies | Fluzone Group | A/Wisconsin [3 to < 5 years] | 483.4 | 95% Confidence Interval 396.8 to 588.9 | Titer |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fluarix Group | 2,115 | |
| Overall Study | STARTED | Fluzone Group | 1,210 | |
| Overall Study | COMPLETED | Fluarix Group | 2,004 | |
| Overall Study | COMPLETED | Fluzone Group | 1,124 | |
| Overall Study | NOT COMPLETED | Fluarix Group | 111 | |
| Overall Study | NOT COMPLETED | Fluzone Group | 86 |
Source ClinicalTrials.gov
Adverse events72
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 | Pyrexia | General disorders | Fluarix Group | 102 | 2,115 | |
| other | Pyrexia | General disorders | Fluzone Group | 86 | 1,210 | |
| other | Upper respiratory tract infection | Infections and infestations | Fluarix Group | 116 | 2,115 | |
| other | Upper respiratory tract infection | Infections and infestations | Fluzone Group | 74 | 1,210 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Fluarix Group | 100 | 2,115 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Fluzone Group | 81 | 1,210 | |
| other | Pain at the injection site | General disorders | Fluarix Group | 1,072 | 2,115 | |
| other | Pain at the injection site | General disorders | Fluzone Group | 526 | 1,210 | |
| other | Redness at the injection site | General disorders | Fluarix Group | 421 | 2,115 | |
| other | Redness at the injection site | General disorders | Fluzone Group | 233 | 1,210 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fluarix Group | 0 | 0 |
| Total, all-cause mortality | Fluzone Group | 0 | 0 |
| Total, other adverse events | Fluarix Group | 1,480 | 2,115 |
| Total, other adverse events | Fluzone Group | 781 | 1,210 |
| Total, serious adverse events | Fluarix Group | 11 | |
| Total, serious adverse events | Fluzone Group | 11 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Fluarix Group vs Fluzone Group: Number of Subjects Reporting Rare Serious 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/NCT00383123
GET https://conductscience.org/api/trials/v1/NCT00383123/results?page=2