Phase 2
N=791
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
Chickenpox
Bottom Line
View on ClinicalTrials.gov: NCT05084508 ↗Enrolled (actual)
791
Serious AEs
2.0%
Results posted
Feb 2025
Primary outcome: Primary: Concentrations of Anti-varicella Zoster Virus (VZV) Glycoprotein E (gE) Antibodies — 960; 1071; 1555; 1284 mlU/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Investigational varicella vaccine low potency (Biological); Investigational varicella vaccine medium potency (Biological); Investigational varicella vaccine high potency (Biological); Licensed varicella vaccine Lot 1 (Biological); Licensed varicella vaccine Lot 2 (Biological); Measles, mumps, and rubella vaccine (Biological); Hepatitis A vaccine (Biological); 13-valent pneumococcal conjugate vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentrations of Anti-varicella Zoster Virus (VZV) Glycoprotein E (gE) Antibodies |
960; 1071; 1555; 1284 | — |
| SECONDARY Percentage of Participants With Seroresponse to VZV gE |
93.6; 96.2; 98.7; 98.1 | — |
| SECONDARY Number of Participants Reporting Each Solicited Administration Site Events |
76; 64; 70; 57; 24; 23 | — |
| SECONDARY Number of Participants Reporting Each Solicited Systemic Events |
86; 68; 93; 80; 69; 57 | — |
| SECONDARY Number of Participants Reporting Each Solicited Systemic Events |
86; 68; 93; 80; 69; 57 | — |
| SECONDARY Number of Participants Reporting Unsolicited Adverse Events |
67; 53; 64; 61 | — |
| SECONDARY Number of Participants Reporting Serious Adverse Events (SAEs) |
2; 4; 4; 6 | — |
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.
Eligibility Criteria
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).
- Only for US participants and participants in countries where pneumococcal conjugate vaccine is recommended at 12-15 months of life as per national immunization schedule: 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 Da
Data sourced from ClinicalTrials.gov (NCT05084508). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.