Study Summary
This trial assesses the safety and efficacy of an investigational chickenpox vaccine in young children.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 6 Secondary · Reporting Duration: Throughout the entire study period (From Day 1 to Day 181)
At Day 43
Concentrations of anti-glycoprotein E (gE) antibodies
Concentrations of anti-varicella zoster virus (VZV) glycoprotein E (gE) antibodies
Percentage of participants with seroresponse to VZV gE
Percentage of participants with seroresponse to gE
Day 1
Percentage of participants reporting solicited systemic events
Day 1
Percentage of participants reporting solicited administration site events
Day 43
Percentage of participants reporting unsolicited adverse events
Day 181
Percentage of participants reporting serious adverse events (SAEs)
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
CYD Dengue Vaccine Group 1
47%Irritability; Post-injection 1
36%Crying abnormal; Post-injection 1
35%Nasopharyngitis
32%Appetite lost; Post-injection 1
30%Injection site Tenderness; Post-injection 1
25%Fever; Post-injection 1
24%Drowsiness; Post-injection 1
19%Vomiting; Post-injection 1
18%Gastroenteritis
16%Pharyngitis
14%Injection site Erythema; Post-injection 1
11%Diarrhoea
8%Pharyngotonsillitis
8%Rhinitis
5%Injection site Swelling; Post-injection 1
2%Febrile convulsion
1%Asthmatic crisis
Trial Design
6 Treatment Groups
VV_Lot1 and Lot2 Pooled Group
1 of 6
VV_Lot2 Group
1 of 6
VV_Lot1 Group
1 of 6
VNS_Low Group
1 of 6
VNS_High Group
1 of 6
VNS_Med Group
1 of 6
Active Control
Experimental Treatment
800 Total Participants · 6 Treatment Groups
Primary Treatment: Measles, mumps, and rubella vaccine · No Placebo Group · Phase 2
VNS_Low GroupExperimental Group · 8 Interventions: Marketed varicella vaccine Lot 1, Measles, mumps, and rubella vaccine, Hepatitis A vaccine, Investigational varicella vaccine high potency, Investigational varicella vaccine low potency, Marketed varicella vaccine Lot 2, Investigational varicella vaccine medium potency, 13-valent pneumococcal conjugate vaccine · Intervention Types: Biological, Biological, Biological, Biological, Biological, Biological, Biological, Biological
VNS_High GroupExperimental Group · 7 Interventions: Marketed varicella vaccine Lot 1, Measles, mumps, and rubella vaccine, Hepatitis A vaccine, Investigational varicella vaccine high potency, Marketed varicella vaccine Lot 2, Investigational varicella vaccine medium potency, 13-valent pneumococcal conjugate vaccine · Intervention Types: Biological, Biological, Biological, Biological, Biological, Biological, Biological
VNS_Med GroupExperimental Group · 7 Interventions: Marketed varicella vaccine Lot 1, Measles, mumps, and rubella vaccine, Hepatitis A vaccine, Investigational varicella vaccine high potency, Marketed varicella vaccine Lot 2, Investigational varicella vaccine medium potency, 13-valent pneumococcal conjugate vaccine · Intervention Types: Biological, Biological, Biological, Biological, Biological, Biological, Biological
VV_Lot1 and Lot2 Pooled GroupActiveComparator Group · 5 Interventions: Marketed varicella vaccine Lot 1, Measles, mumps, and rubella vaccine, Hepatitis A vaccine, Marketed varicella vaccine Lot 2, 13-valent pneumococcal conjugate vaccine · Intervention Types: Biological, Biological, Biological, Biological, Biological
VV_Lot2 GroupActiveComparator Group · 7 Interventions: Marketed varicella vaccine Lot 1, Measles, mumps, and rubella vaccine, Hepatitis A vaccine, Investigational varicella vaccine high potency, Marketed varicella vaccine Lot 2, Investigational varicella vaccine medium potency, 13-valent pneumococcal conjugate vaccine · Intervention Types: Biological, Biological, Biological, Biological, Biological, Biological, Biological
VV_Lot1 GroupActiveComparator Group · 7 Interventions: Marketed varicella vaccine Lot 1, Measles, mumps, and rubella vaccine, Hepatitis A vaccine, Investigational varicella vaccine high potency, Marketed varicella vaccine Lot 2, Investigational varicella vaccine medium potency, 13-valent pneumococcal conjugate vaccine · Intervention Types: Biological, Biological, Biological, Biological, Biological, Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rubella virus vaccine
FDA approved
Hepatitis A Vaccine
FDA approved
13-valent pneumococcal conjugate vaccine
2012
Completed Phase 4
~12490
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: throughout the entire study period (from day 1 to day 181)
Who is running the clinical trial?
IQVIA, USAUNKNOWN
GlaxoSmithKlineLead Sponsor
4,650 Previous Clinical Trials
7,949,266 Total Patients Enrolled
24 Trials studying Chickenpox
22,680 Patients Enrolled for Chickenpox
Eligibility Criteria
Age 12 - 15 · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are medically fit and have been examined prior to entering the study.
You are a male or female between 12 and 15 months old at the time of receiving study interventions.
Prior to any study-specific procedure, written permission must be provided by the participant's parent(s) or legally authorized representative(s).
Parents or legal representatives who, in the investigator's estimation, can and will abide by protocol requirements (e.g., Electronic Diary completion and follow-up visits) are eligible to participate.
Participants from the United States and countries where pneumococcal conjugate vaccine is recommended at 12-15 months of life, who have completed a primary series of doses within their first year with the last dose taken at least 60 days ago.
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Conditions
Cancer Related
Treatments