A Study on the Immune Response and Safety of Various Potencies of an Investigational Chickenpox Vaccine Compared With a Marketed Chickenpox Vaccine, Given to Healthy Children 12 to 15 Months of Age

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05084508
• Collaborator: IQVIA, USA (Other)
• Enrollment: 800
• Locations: 46
• Arms: 5
• Anticipated Duration (Months): 25.4
• Patients Per Site: 17.4
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The purpose of this study is to assess immune response and safety of various potencies of an investigational chickenpox vaccine given to healthy children 12 to 15 months of age.

Condition or Disease	Intervention/Treatment	Phase
Chickenpox	Biological: Investigational varicella vaccine low potency; Biological: Investigational varicella vaccine medium potency; Biological: Investigational varicella vaccine high potency; Biological: Marketed varicella vaccine Lot 1; Biological: Marketed varicella vaccine Lot 2; Biological: Measles, mumps, and rubella vaccine; Biological: Hepatitis A vaccine; Biological: 13-valent pneumococcal conjugate vaccine	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 800 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Observer-blind study. Recipients and study evaluators will be unaware of vaccine administered.
• Primary Purpose: Prevention
• Official Title: A Phase II, Observer-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of a Varicella Vaccine at Various Potencies Compared With Varivax, as a First Dose, Administered in Healthy Children in Their Second Year of Life
• Actual Study Start Date: Feb 3, 2022
• Anticipated Primary Completion Date: Oct 25, 2023
• Anticipated Study Completion Date: Mar 18, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VNS_Low Group 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 a 13-valent pneumococcal conjugate vaccine on Day 1.	Biological: Investigational varicella vaccine low potency; 1 dose of a low-potency investigational varicella vaccine administered subcutaneously in the upper arm; Biological: Investigational varicella vaccine medium potency; 1 dose of a medium-potency investigational varicella vaccine administered subcutaneously in the upper arm; Biological: Investigational varicella vaccine high potency; 1 dose of a high-potency investigational varicella vaccine administered subcutaneously in the upper arm; Biological: Marketed varicella vaccine Lot 1; 1 dose of a marketed varicella vaccine of Lot 1 administered subcutaneously in the upper arm; Biological: Marketed varicella vaccine Lot 2; 1 dose of a marketed varicella vaccine of Lot 2 administered subcutaneously in the upper arm; Biological: Measles, mumps, and rubella vaccine; 1 dose of a measles, mumps, and rubella vaccine administered subcutaneously in the upper arm; Biological: Hepatitis A vaccine; 1 dose of a hepatitis A vaccine administered intramuscularly in the anterolateral thigh; Biological: 13-valent pneumococcal conjugate vaccine; 1 dose of a 13-valent pneumococcal conjugate vaccine administered intramuscularly in the anterolateral thigh
Experimental: VNS_Med Group 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.	Biological: Investigational varicella vaccine medium potency; 1 dose of a medium-potency investigational varicella vaccine administered subcutaneously in the upper arm; Biological: Investigational varicella vaccine high potency; 1 dose of a high-potency investigational varicella vaccine administered subcutaneously in the upper arm; Biological: Marketed varicella vaccine Lot 1; 1 dose of a marketed varicella vaccine of Lot 1 administered subcutaneously in the upper arm; Biological: Marketed varicella vaccine Lot 2; 1 dose of a marketed varicella vaccine of Lot 2 administered subcutaneously in the upper arm; Biological: Measles, mumps, and rubella vaccine; 1 dose of a measles, mumps, and rubella vaccine administered subcutaneously in the upper arm; Biological: Hepatitis A vaccine; 1 dose of a hepatitis A vaccine administered intramuscularly in the anterolateral thigh; Biological: 13-valent pneumococcal conjugate vaccine; 1 dose of a 13-valent pneumococcal conjugate vaccine administered intramuscularly in the anterolateral thigh
Experimental: VNS_High Group 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.	Biological: Investigational varicella vaccine medium potency; 1 dose of a medium-potency investigational varicella vaccine administered subcutaneously in the upper arm; Biological: Investigational varicella vaccine high potency; 1 dose of a high-potency investigational varicella vaccine administered subcutaneously in the upper arm; Biological: Marketed varicella vaccine Lot 1; 1 dose of a marketed varicella vaccine of Lot 1 administered subcutaneously in the upper arm; Biological: Marketed varicella vaccine Lot 2; 1 dose of a marketed varicella vaccine of Lot 2 administered subcutaneously in the upper arm; Biological: Measles, mumps, and rubella vaccine; 1 dose of a measles, mumps, and rubella vaccine administered subcutaneously in the upper arm; Biological: Hepatitis A vaccine; 1 dose of a hepatitis A vaccine administered intramuscularly in the anterolateral thigh; Biological: 13-valent pneumococcal conjugate vaccine; 1 dose of a 13-valent pneumococcal conjugate vaccine administered intramuscularly in the anterolateral thigh
Active Comparator: VV_Lot1 Group Healthy children aged 12 to 15 months of age receive 1 dose of a marketed varicella vaccine (VV) of Lot 1, 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.	Biological: Investigational varicella vaccine medium potency; 1 dose of a medium-potency investigational varicella vaccine administered subcutaneously in the upper arm; Biological: Investigational varicella vaccine high potency; 1 dose of a high-potency investigational varicella vaccine administered subcutaneously in the upper arm; Biological: Marketed varicella vaccine Lot 1; 1 dose of a marketed varicella vaccine of Lot 1 administered subcutaneously in the upper arm; Biological: Marketed varicella vaccine Lot 2; 1 dose of a marketed varicella vaccine of Lot 2 administered subcutaneously in the upper arm; Biological: Measles, mumps, and rubella vaccine; 1 dose of a measles, mumps, and rubella vaccine administered subcutaneously in the upper arm; Biological: Hepatitis A vaccine; 1 dose of a hepatitis A vaccine administered intramuscularly in the anterolateral thigh; Biological: 13-valent pneumococcal conjugate vaccine; 1 dose of a 13-valent pneumococcal conjugate vaccine administered intramuscularly in the anterolateral thigh
Active Comparator: VV_Lot2 Group Healthy children aged 12 to 15 months of age receive 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.	Biological: Investigational varicella vaccine medium potency; 1 dose of a medium-potency investigational varicella vaccine administered subcutaneously in the upper arm; Biological: Investigational varicella vaccine high potency; 1 dose of a high-potency investigational varicella vaccine administered subcutaneously in the upper arm; Biological: Marketed varicella vaccine Lot 1; 1 dose of a marketed varicella vaccine of Lot 1 administered subcutaneously in the upper arm; Biological: Marketed varicella vaccine Lot 2; 1 dose of a marketed varicella vaccine of Lot 2 administered subcutaneously in the upper arm; Biological: Measles, mumps, and rubella vaccine; 1 dose of a measles, mumps, and rubella vaccine administered subcutaneously in the upper arm; Biological: Hepatitis A vaccine; 1 dose of a hepatitis A vaccine administered intramuscularly in the anterolateral thigh; Biological: 13-valent pneumococcal conjugate vaccine; 1 dose of a 13-valent pneumococcal conjugate vaccine administered intramuscularly in the anterolateral thigh

Outcome Measures

Primary Outcome Measures

1. Concentrations of anti-glycoprotein E (gE) antibodies [At Day 43]

Secondary Outcome Measures

1. Percentage of participants with seroresponse to gE [At Day 43]

2. Percentage of participants reporting solicited administration site events [During the 4-day period after the administration of study interventions (administered at Day 1)]

   Solicited administration site events include injection site redness, pain and swelling.

3. Percentage of participants reporting solicited systemic events [During the 43-day period after the administration of study interventions (administered at Day 1)]

   Solicited systemic events include fever and varicella-like rash and general rash (not varicella -like) after the administration of all vaccines for each group. Fever is defined as temperature greater than or equal to (≥)38.0 degrees Celsius (°C) (100.4 degrees Fahrenheit [°F]) by any route (the preferred location for measuring temperature is the axilla). A typical varicella-like rash manifests as a rash/lesions that may appear within several weeks after the varicella vaccination. Lesions may contain spots, bumps, blisters, or crusts.

4. Percentage of participants reporting solicited systemic events [During the 15-day period after the administration of study interventions (administered at Day 1)]

   Solicited systemic events include drowsiness, loss of appetite, and irritability after the administration of all vaccines for each group.

5. Percentage of participants reporting unsolicited adverse events [During the 43 days-period after the administration of study interventions (administrated at Day 1)]

   Unsolicited adverse events (AEs) include any AE reported in addition to solicited events during the study, or any "solicited" symptoms with onset outside of the specified period of follow-up for solicited symptoms, are assessed for each group after the administration of all vaccines.

6. Percentage of participants reporting serious adverse events (SAEs) [Throughout the entire study period (From Day 1 to Day 181)]

   A SAE is an AE which is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or other situations that are considered serious per medical or scientific judgment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Months to 15 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy participants as established by medical history and clinical examination before entering into the study.

• 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.

• Written informed consent obtained from the parent(s)/legally authorized representative(s) of the participant prior to performance of any study-specific procedure.

• Participants' parent(s)/legally authorized representative(s), who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g., completion of Electronic Diaries, return for follow-up visits).

• Participants who previously received the primary series of pneumococcal conjugate vaccine in their first year of life with the last dose at least 60 days prior to study entry.

Exclusion Criteria:

Medical Conditions

• History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions including hypersensitivity to neomycin or gelatin.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).

• Hypersensitivity to latex.

• Major congenital defects, as assessed by the investigator.

• History of varicella.

• Recurrent history of or uncontrolled neurological disorders or seizures.

• Participant with history of SARS-CoV-2 infection who is still symptomatic.

• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.

Prior and Concomitant Therapy

• Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study interventions during the period beginning 30 days before the dose of study interventions (Day -29 to Day 1), or planned use during the study period.

• Chronic administration (defined as more than 14 days in total) of immunosuppressants, or other immune-modifying drugs during the period starting 90 days prior to the study interventions administration. For corticosteroids, this will mean prednisone equivalent ≥ 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for pediatric participants, or equivalent. Inhaled and topical steroids are allowed.

• Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 180 days before the dose of study interventions or planned administration during the study period.

• Administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab).

• Previous vaccination against measles, mumps, rubella, hepatitis A, and/or varicella virus.

Medical Conditions

• History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions including hypersensitivity to neomycin or gelatin.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).

• Hypersensitivity to latex.

• Major congenital defects, as assessed by the investigator.

• History of varicella.

• Recurrent history of or uncontrolled neurological disorders or seizures.

• Participant with history of SARS-CoV-2 infection who is still symptomatic.

• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.

Prior and Concomitant Therapy

• Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study interventions during the period beginning 30 days before the dose of study interventions (Day -29 to Day 1), or planned use during the study period.

• Chronic administration (defined as more than 14 days in total) of immunosuppressants, or other immune-modifying drugs during the period starting 90 days prior to the study interventions administration. For corticosteroids, this will mean prednisone equivalent ≥ 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for pediatric participants, or equivalent. Inhaled and topical steroids are allowed.

• Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 180 days before the dose of study interventions or planned administration during the study period.

• Administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab).

• Previous vaccination against measles, mumps, rubella, hepatitis A, and/or varicella virus.

• Previous administration of a booster dose of any pneumococcal conjugate vaccine.

• Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the dose and ending at 43 days after the dose of study interventions administration* (Visit 3) with the exception of inactivated influenza (flu) vaccine which may be given at any time during the study and administered at a different location than the study interventions.

• Any other age appropriate vaccine may be given starting at Visit 3 and anytime thereafter.

• In case of emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced if necessary, for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.

Prior/Concurrent Clinical Study Experience

• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non investigational intervention (drug/invasive medical device).

Other Exclusions

• Child in care.

• Any study personnel's immediate dependents, family, or household members.

• Participants with the following high-risk individuals in their household:

• Immunocompromised individuals.

• Pregnant women without documented history of varicella.

• Newborn infants of mothers without documented history of varicella.

• Newborn infants born <28 weeks of gestation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Bryant	Arkansas	United States	72022
2	GSK Investigational Site	Jonesboro	Arkansas	United States	72401
3	GSK Investigational Site	Bellflower	California	United States	90706
4	GSK Investigational Site	Downey	California	United States	90240
5	GSK Investigational Site	West Covina	California	United States	91790
6	GSK Investigational Site	Jacksonville	Florida	United States	32258
7	GSK Investigational Site	Lake Mary	Florida	United States	32746
8	GSK Investigational Site	Wellington	Florida	United States	33414
9	GSK Investigational Site	Atlanta	Georgia	United States	30310
10	GSK Investigational Site	Idaho Falls	Idaho	United States	83404
11	GSK Investigational Site	Nampa	Idaho	United States	83686
12	GSK Investigational Site	Newton	Kansas	United States	67114
13	GSK Investigational Site	Metairie	Louisiana	United States	70006-5322
14	GSK Investigational Site	Shreveport	Louisiana	United States	71118
15	GSK Investigational Site	Gulfport	Mississippi	United States	39507
16	GSK Investigational Site	Bridgeton	Missouri	United States	63044
17	GSK Investigational Site	Hastings	Nebraska	United States	68901
18	GSK Investigational Site	Hastings	Nebraska	United States	68901
19	GSK Investigational Site	Omaha	Nebraska	United States	68134
20	GSK Investigational Site	Omaha	Nebraska	United States	68134
21	GSK Investigational Site	Omaha	Nebraska	United States	68198
22	GSK Investigational Site	Bronx	New York	United States	10468
23	GSK Investigational Site	Endwell	New York	United States	13760
24	GSK Investigational Site	Syracuse	New York	United States	13210
25	GSK Investigational Site	Cleveland	Ohio	United States	44121
26	GSK Investigational Site	Dayton	Ohio	United States	45406
27	GSK Investigational Site	Erie	Pennsylvania	United States	16505
28	GSK Investigational Site	Barnwell	South Carolina	United States	29812
29	GSK Investigational Site	Cheraw	South Carolina	United States	29520
30	GSK Investigational Site	Tullahoma	Tennessee	United States	37388
31	GSK Investigational Site	Corpus Christi	Texas	United States	78414
32	GSK Investigational Site	Dallas	Texas	United States	75230-2571
33	GSK Investigational Site	Dickinson	Texas	United States	77539
34	GSK Investigational Site	Houston	Texas	United States	77055
35	GSK Investigational Site	Lampasas	Texas	United States	76550
36	GSK Investigational Site	San Antonio	Texas	United States	78218
37	GSK Investigational Site	San Antonio	Texas	United States	78240
38	GSK Investigational Site	San Antonio	Texas	United States	78240
39	GSK Investigational Site	Layton	Utah	United States	84041
40	GSK Investigational Site	Provo	Utah	United States	84604
41	GSK Investigational Site	Roy	Utah	United States	84067
42	GSK Investigational Site	Saint George	Utah	United States	84790
43	GSK Investigational Site	Saint George	Utah	United States	84790
44	GSK Investigational Site	South Jordan	Utah	United States	84095
45	GSK Investigational Site	Syracuse	Utah	United States	84075
46	GSK Investigational Site	Charlottesville	Virginia	United States	22902

Sponsors and Collaborators

• GlaxoSmithKline
• IQVIA, USA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT05084508
• Other Study ID Numbers: 217212
• First Posted: Oct 19, 2021
• Last Update Posted: Jul 18, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by GlaxoSmithKline: Varicella; Chickenpox
• Additional relevant MeSH terms: Chickenpox; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine

Study Results

No Results Posted as of Jul 18, 2022