Trial · NCT02570126
A Safety and Immune Study of 2 Types of GlaxoSmithKline's Varicella Vaccines Given as a 2-doses Course to Healthy Children 12-23 Months of Age.
NCT02570126, Phase 3, Completed, GlaxoSmithKline; results first posted 2017-10-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Safety and Immune Study of 2 Types of GlaxoSmithKline's Varicella Vaccines Given as a 2-doses Course to Healthy Children 12-23 Months of Age. Trials, record NCT02570126. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02570126
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Immune Study of 2 Types of GlaxoSmithKline's Varicella Vaccines Given as a 2-doses Course to Healthy Children 12-23 Months of Age.
- NCT number
- NCT02570126
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,236 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Chicken-pox Illness (Varicella Virus Disease), Chickenpox
- Interventions
- Varilrix HSA-free, Varilrix™
- First posted
- 2015-10-07
- Last updated
- 2019-11-25
- Other registries' IDs
- eudract:2013-003535-30
- Results first posted
- 2017-10-11
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Reporting Fever | 15-days (Days 0-14) post Dose 1 of varicella vaccination | Fever was defined as axillary temperature above (\>) 39.0 °C (\> 102.2°F) |
| Secondary | Number of Subjects Reporting Fever | 15 days post each dose of varicella vaccination | Fever was defined as axillary temperature greater than or equal to (≥) 38.0°C (≥ 100.4°F) |
| Secondary | Evaluation of Immune Response to Varicella Vaccine With Respect to Anti Varicella Zoster Virus (Anti-VZV) Antibody Concentrations (Immuno-sub Cohort) | At Day 42 and Day 84 post vaccination | Anti-VZY antibody concentrations were expressed in terms of Geometric Mean Concentrations (GMCs) |
| Secondary | Number of Subjects With a Seroresponse to VZV (Immuno Sub Cohort) | At Day 42 and Day 84 post vaccination | For VZV, seroresponse was defined as, post-vaccination anti-VZV antibody concentration ≥ 50 mIU/mL among subjects who were seronegative (antibody concentration below (\< ) 25 mIU/mL) before vaccination |
| Secondary | Number of Subjects Reporting Solicited Local Symptoms | 4-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42) | Solicited local symptoms assessed were pain, injection site redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = subject crying when limb was moved or as spontaneously painful. Grade 3 redness and swelling = above (\>) 20 mm |
| Secondary | Number of Subjects Reporting Fever | 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42) | Any fever (≥ 38°C) = occurrence of any fever regardless of its intensity grade or relationship to vaccination. Grade 3 fever = temperature \> 39.5°C. Related fever = assessed by the investigator as causally related to study vaccination |
| Secondary | Number of Subjects Reporting Rash | 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42) | Any rash = occurrence of the specified solicited general symptom regardless of its intensity. Grade 3 rash = rash which prevented normal, everyday activities. Related rash = assessed by the investigator as causally related to study vaccination |
| Secondary | Number of Subjects Reporting Febrile Convulsions | 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42) | Any febrile convulsion = occurrence of the specified solicited general symptom regardless of its intensity. Grade 3 febrile convulsion = febrile convulsion which prevented normal, everyday activities. Related febrile convulsion = assessed by the investigator as causally related to study vaccination |
| Secondary | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42) | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination |
| Secondary | Number of Subjects Reporting Serious Adverse Events (SAEs) | From Day 0 through the end of study (Day 84) | SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalisation or prolongation of hospitalisation or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination |
Source ClinicalTrials.gov
Outcomes10
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 Fever | 15-days (Days 0-14) post Dose 1 of varicella vaccination | Analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with administration of either Varilrix HSA-free or Varilrix™vaccine documented. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with documented dose 15-days (Days 0-14) post Dose 1 of varicella vaccination | Subjects | NUMBER |
| SECONDARY | Number of Subjects Reporting Fever | 15 days post each dose of varicella vaccination | Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with documented dose 15-days post each dose of varicella vaccination for each of the 2 groups (VAR\_HSA\_F Group and VAR Group) | Subjects | NUMBER |
| SECONDARY | Evaluation of Immune Response to Varicella Vaccine With Respect to Anti Varicella Zoster Virus (Anti-VZV) Antibody Concentrations (Immuno-sub Cohort) | At Day 42 and Day 84 post vaccination | Immunogenicity analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity. Immune response (in terms of GMC) was assessed in sub cohort of the ATP cohort for immunogenicity for each group (immuno sub cohort) who had blood taken and tested for anti-varicella antibodies at Day 0, Day 42, and Day 84 | mIU/mL | GEOMETRIC_MEAN |
| SECONDARY | Number of Subjects With a Seroresponse to VZV (Immuno Sub Cohort) | At Day 42 and Day 84 post vaccination | Immunogenicity analyses were performed on the According-to-protocol (ATP) cohort for immunogenicity. Seropositivity was assessed in sub cohort of the ATP cohort for immunogenicity for each group (immuno sub cohort) who had blood taken and tested for anti-varicella antibodies at Day 0, Day 42, and Day 84 | Subjects | NUMBER |
| SECONDARY | Number of Subjects Reporting Solicited Local Symptoms | 4-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42) | Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with at least one documented dose 4 days following each vaccination and across doses for each of the 2 groups (VAR\_HSA\_F Group and VAR Group) | Subjects | NUMBER |
| SECONDARY | Number of Subjects Reporting Fever | 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42) | Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with the documented dose 43 days following each vaccination and across doses for each of the 2 groups (VAR\_HSA\_F Group and VAR Group) | Subjects | NUMBER |
| SECONDARY | Number of Subjects Reporting Rash | 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42) | Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with at least one documented dose 43 days following each vaccination and across doses for each of the 2 groups (VAR\_HSA\_F Group and VAR Group) | Subjects | NUMBER |
| SECONDARY | Number of Subjects Reporting Febrile Convulsions | 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42) | Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with at least one documented dose 43 days following each vaccination and across doses for each of the 2 groups (VAR\_HSA\_F Group and VAR Group) | Subjects | NUMBER |
| SECONDARY | Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42) | Analysis was performed on the Total Vaccinated cohort. Number of participants analysed corresponds to the subjects in the Total Vaccinated cohort with the administered dose 43 days following each vaccination and across doses for each of the 2 groups (VAR\_HSA\_F Group and VAR Group) | Subjects | NUMBER |
| SECONDARY | Number of Subjects Reporting Serious Adverse Events (SAEs) | From Day 0 through the end of study (Day 84) | Subjects | NUMBER |
Source ClinicalTrials.gov
Results by group198
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 Fever | VAR_HSA_F Group | 24 | Subjects | ||
| Number of Subjects Reporting Fever | VAR Group | 32 | Subjects | ||
| Number of Subjects Reporting Fever | VAR_HSA_F Group | Fever ≥ 38 °C following Dose 1 | 83 | Subjects | |
| Number of Subjects Reporting Fever | VAR Group | Fever ≥ 38 °C following Dose 1 | 92 | Subjects | |
| Number of Subjects Reporting Fever | VAR_HSA_F Group | Fever ≥ 38 °C following Dose 2 | 83 | Subjects | |
| Number of Subjects Reporting Fever | VAR Group | Fever ≥ 38 °C following Dose 2 | 86 | Subjects | |
| Evaluation of Immune Response to Varicella Vaccine With Respect to Anti Varicella Zoster Virus (Anti-VZV) Antibody Concentrations (Immuno-sub Cohort) | VAR_HSA_F Group | Post Dose 1 blood sample at Day 42 | 139.9 | 95% Confidence Interval 126.7 to 154.5 | mIU/mL |
| Evaluation of Immune Response to Varicella Vaccine With Respect to Anti Varicella Zoster Virus (Anti-VZV) Antibody Concentrations (Immuno-sub Cohort) | VAR Group | Post Dose 1 blood sample at Day 42 | 146.0 | 95% Confidence Interval 132.5 to 160.7 | mIU/mL |
| Evaluation of Immune Response to Varicella Vaccine With Respect to Anti Varicella Zoster Virus (Anti-VZV) Antibody Concentrations (Immuno-sub Cohort) | VAR_HSA_F Group | Post Dose 2 blood sample at Day 84 | 931.8 | 95% Confidence Interval 841.1 to 1032.3 | mIU/mL |
| Evaluation of Immune Response to Varicella Vaccine With Respect to Anti Varicella Zoster Virus (Anti-VZV) Antibody Concentrations (Immuno-sub Cohort) | VAR Group | Post Dose 2 blood sample at Day 84 | 1102.4 | 95% Confidence Interval 996.1 to 1220.2 | mIU/mL |
1 to 10 of 198Source ClinicalTrials.gov
See all 198 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | VAR_HSA_F Group | 615 | |
| Overall Study | STARTED | VAR Group | 616 | |
| Overall Study | COMPLETED | VAR_HSA_F Group | 609 | |
| Overall Study | COMPLETED | VAR Group | 607 | |
| Overall Study | NOT COMPLETED | VAR_HSA_F Group | 6 | |
| Overall Study | NOT COMPLETED | VAR Group | 9 |
Source ClinicalTrials.gov
Adverse events66
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 | VAR_HSA_F Group | 57 | 615 | 71 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | VAR Group | 49 | 616 | 59 |
| other | Diarrhoea | Gastrointestinal disorders | VAR_HSA_F Group | 38 | 615 | 44 |
| other | Diarrhoea | Gastrointestinal disorders | VAR Group | 39 | 616 | 53 |
| other | Injection site erythema | General disorders | VAR_HSA_F Group | 224 | 615 | 319 |
| other | Injection site erythema | General disorders | VAR Group | 237 | 616 | 341 |
| other | Injection site pain | General disorders | VAR_HSA_F Group | 101 | 615 | 138 |
| other | Injection site pain | General disorders | VAR Group | 127 | 616 | 167 |
| other | Injection site swelling | General disorders | VAR_HSA_F Group | 92 | 615 | 112 |
| other | Injection site swelling | General disorders | VAR Group | 95 | 616 | 114 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | VAR_HSA_F Group | 0 | 615 |
| Total, all-cause mortality | VAR Group | 0 | 616 |
| Total, other adverse events | VAR_HSA_F Group | 489 | 615 |
| Total, other adverse events | VAR Group | 491 | 616 |
| Total, serious adverse events | VAR_HSA_F Group | 13 | 615 |
| Total, serious adverse events | VAR Group | 15 | 616 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30732648 | BACKGROUND |
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 |
|---|---|
| VAR_HSA_F Group vs VAR Group: deaths from any cause | Trial comparisons |
| VAR_HSA_F Group vs VAR 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/NCT02570126
GET https://conductscience.org/api/trials/v1/NCT02570126/results?page=2