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Virus Vaccine

Investigational Chickenpox Vaccine for Chickenpox

Phase 2
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A male or female between, and including, 12 and 15 months of age (i.e., from his/her 1 year birthday until the day before age of 16 months) at the time of the administration of the study interventions.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the entire study period (from day 1 to day 181)
Awards & highlights

Study Summary

This trial assesses the safety and efficacy of an investigational chickenpox vaccine in young children.

Who is the study for?
This trial is for healthy children aged 12 to 15 months who have received their primary series of pneumococcal conjugate vaccine. They must not have a history of severe allergies, immune conditions, or recent immunosuppressant use. Children with certain household members at risk (like pregnant women without chickenpox immunity) are excluded.Check my eligibility
What is being tested?
The study tests different potencies of an investigational chickenpox vaccine against a marketed one in young children. It also includes other routine vaccines like MMR and Hepatitis A to assess the immune response and safety profile of the new varicella vaccine.See study design
What are the potential side effects?
Potential side effects may include typical reactions at the injection site such as redness, swelling, pain, fever, rash similar to mild chickenpox, irritability or crying more than usual. Severe allergic reactions are rare but possible.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 12 and 15 months old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the entire study period (from day 1 to day 181)
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the entire study period (from day 1 to day 181) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Concentrations of anti-varicella zoster virus (VZV) glycoprotein E (gE) antibodies
Secondary outcome measures
Percentage of participants reporting serious adverse events (SAEs)
Percentage of participants reporting solicited administration site events
Percentage of participants reporting solicited systemic events
+2 more

Side effects data

From 2014 Phase 3 trial • 720 Patients • NCT01411241
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
100%
80%
60%
40%
20%
0%
Study treatment Arm
CYD Dengue Vaccine Group 1
CYD Dengue Vaccine Group 2

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: VNS_Med GroupExperimental Treatment7 Interventions
Healthy children aged 12 to 15 months of age receive 1 dose of an investigational varicella vaccine (VNS) of medium potency, 1 dose of a measles, mumps, and rubella vaccine, 1 dose of a hepatitis A vaccine, and 1 dose of a 13-valent pneumococcal conjugate vaccine on Day 1. The 13 valent pneumococcal conjugate vaccine will only be administered to participants enrolled in the US and in countries where pneumococcal conjugate vaccine is recommended at 12-15 months as per national immunization schedule.
Group II: VNS_Low GroupExperimental Treatment8 Interventions
Healthy children aged 12 to 15 months of age receive 1 dose of an investigational varicella vaccine (VNS) of low potency 1 dose of a measles, mumps, and rubella vaccine, 1 dose of a hepatitis A vaccine and 1 dose of a13 valent pneumococcal conjugate vaccine on Day 1. The 13 valent pneumococcal conjugate vaccine will only be administered to participants enrolled in the US and in countries where pneumococcal conjugate vaccine is recommended at 12-15 months as per national immunization schedule.
Group III: VNS_High GroupExperimental Treatment7 Interventions
Healthy children aged 12 to 15 months of age receive 1 dose of an investigational varicella vaccine (VNS) of high potency 1 dose of a measles, mumps, and rubella vaccine, 1 dose of a hepatitis A vaccine, and 1 dose a 13-valent pneumococcal conjugate vaccine on Day 1. The 13 valent pneumococcal conjugate vaccine will only be administered to participants enrolled in the US and in countries where pneumococcal conjugate vaccine is recommended at 12-15 months as per national immunization schedule.
Group IV: VV_Lot1 and Lot2 Pooled GroupActive Control5 Interventions
Healthy children aged 12 to 15 months of age receive 1 dose of a marketed varicella vaccine (VV) of Lot 1 or 1 dose of a marketed varicella vaccine (VV) of Lot 2, 1 dose of a measles, mumps, and rubella vaccine, 1 dose of a hepatitis A vaccine, and a 1 dose of a 13-valent pneumococcal conjugate vaccine on Day 1. The 13 valent pneumococcal conjugate vaccine will only be administered to participants enrolled in the US and in countries where pneumococcal conjugate vaccine is recommended at 12-15 months as per national immunization schedule.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Marketed varicella vaccine Lot 2
2022
Completed Phase 2
~800
Investigational varicella vaccine low potency
2022
Completed Phase 2
~800
Investigational varicella vaccine high potency
2022
Completed Phase 2
~800
Marketed varicella vaccine Lot 1
2022
Completed Phase 2
~800
Measles, mumps, and rubella vaccine
2011
Completed Phase 3
~2320
Hepatitis A vaccine
2008
Completed Phase 4
~72200
13-valent pneumococcal conjugate vaccine
2010
Completed Phase 4
~12980
Investigational varicella vaccine medium potency
2022
Completed Phase 2
~800

Find a Location

Who is running the clinical trial?

IQVIA, USAUNKNOWN
GlaxoSmithKlineLead Sponsor
4,763 Previous Clinical Trials
8,103,968 Total Patients Enrolled
24 Trials studying Chickenpox
22,681 Patients Enrolled for Chickenpox

Media Library

Investigational varicella vaccine high potency (Virus Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05084508 — Phase 2
Chickenpox Research Study Groups: VNS_High Group, VV_Lot1 and Lot2 Pooled Group, VNS_Low Group, VNS_Med Group
Chickenpox Clinical Trial 2023: Investigational varicella vaccine high potency Highlights & Side Effects. Trial Name: NCT05084508 — Phase 2
Investigational varicella vaccine high potency (Virus Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05084508 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment only include people over 40 in the control group?

"The age range for patients that this study can accept is 12-15 months old."

Answered by AI

What does the Measles, mumps, and rubella vaccine help protect patients from?

"The measles, mumps, and rubella vaccine is not only used to treat mumps, but also other conditions like herpes zoster, typhoid fever, and rubella."

Answered by AI

Could I possibly join this experiment?

"The requirements for this study are that potential participants must have had chickenpox and be between 12 and 15 months old. This particular trial is looking for approximately 800 patients in total."

Answered by AI

Are there any unfilled positions for participants in this research?

"That is correct. The clinical trial is currently ongoing and recruiting patients at 39 different sites. So far, they have admitted 800 people into the study."

Answered by AI

Is it safe for patients to receive the Measles, mumps, and rubella vaccine?

"The Measles, mumps, and rubella vaccine is currently in Phase 2 of clinical trials. While there is some data supporting its safety, more research needs to be done to confirm its efficacy."

Answered by AI

Could you please name a few more examples of research surrounding the MMR vaccine?

"23 different clinical trials are currently underway to study the Measles, mumps, and rubella vaccine. Of these ongoing trials, 7 have reached Phase 3. Although many of the Houston-based studies are for Measles, mumps, and rubella vaccines specifically, 593 locations around the world are running similar investigations."

Answered by AI

How many hospitals are conducting this research project?

"Currently, there are a total of 39 clinical trial sites. These include locations in Erie, Shreveport, Barnwell and 36 other places. If you choose to participate in this trial, it would be convenient for you to select the nearest clinic to cut down on travel time."

Answered by AI

How many people can join this experiment at most?

"That is correct. As of 7/15/2022, this study was still recruiting patients which is evident from the information provided on clinicaltrials.gov. This trial was created on 2/3/2022 and was looking for 800 individuals to participate across 39 different sites."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
Nevada
Texas
What site did they apply to?
GSK Investigational Site
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
~246 spots leftby May 2025