Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Varicella (Varilrix®), Varicella, Investigational varicella vaccine, Investigational varicella vaccine_Lot 1, Candidate varicella vaccine
Varicella vaccine (VNS) · 4 trials · 1 indication
Seroresponse is defined as post-vaccination (Day 43 post Dose 2) anti VZV gE Immunoglobulin (IgG) concentration greater than equal to (\>=) 300 milli-international units per milliliter (mIU/mL).
Concentrations of anti-VZV gE IgG are presented as GMC and expressed in mIU/mL for each group.
The seroresponse rate is defined as the percentage of participants for whom the post-vaccination Day 43 anti VZV gE IgG concentration is above the seroresponse threshold.
Concentrations of anti-VZV gE IgG are presented as GMC and expressed in milli-international units per milliliter (mIU/mL) for each group.
The seroresponse rate is defined as the percentage of participants for whom the post-vaccination Day 43 anti-measles, mumps, and rubella antibody concentrations are above the seroresponse threshold.
Seroresponse is defined as post-vaccination (Day 43) anti-VZV gE IgG antibody concentration greater than or equal to (\>=) 300 milli-international units per milliliter (mIU/mL) among participants who were seronegative \[(antibody concentration less than (\<) LLOQ (Lower limit of quantification)\] before vaccination. A seronegative participant is a participant whose antibody concentration is below the LLOQ of the assay. A seropositive participant is a participant whose antibody concentration is greater than or equal to the LLOQ of the assay.
Concentrations of anti-VZV gE IgG presented as GMCs and expressed in mIU/mL for each group.
Seroresponse is defined as post-vaccination (Day 43) anti-VZV gE IgG concentration \>= 300 mIU/mL among participants who were seronegative (antibody concentration \< LLOQ) before vaccination. A seronegative participant is a participant whose antibody concentration is below the LLOQ of the assay. A seropositive participant is a participant whose antibody concentration is greater than or equal to the LLOQ of the assay.
Concentrations of anti-VZV gE IgG are presented as GMCs and expressed in mIU/mL for each group.
Solicited administration site events include injection site redness, pain and swelling.
Solicited systemic events include drowsiness, loss of appetite and irritability.
Fever is defined as temperature greater than or equal to (\>=) 38.0°C (100.4°F) by any route (the preferred location for measuring temperature is the axilla).
Solicited systemic events includes varicella-like rash (non-injection site), and general rash (not varicella-like).
An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
A MAAE is an AE for which the participant received medical attention including any symptom or illness requiring hospitalization, or an emergency room visit, or visit to/by a healthcare professional.
A SAE is an AE which results in death, 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.
| Arm | Type | Description |
|---|---|---|
| VV-VV Group | ACTIVE_COMPARATOR | Participants receive 2 doses of a VV vaccine on Day 1 and Day 91. 1 dose of measles, mumps, and rubella (MMR) vaccine, 1 dose of hepatitis A vaccine (HAV), and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where a second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule. |
| VNS-VNS Group | EXPERIMENTAL | Participants receive 2 doses of a VNS vaccine on Day 1 and Day 91. 1 doses of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13, Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule. |
| VV-VNS Group | EXPERIMENTAL | Participants receive 1 dose of VV vaccine on Day 1, 1 dose of VNS Vaccine on Day 91. 1 doses of MMR vaccine, 1 dose of HAV, and 1 dose of PCV (either PCV 13, Vaxneuvance or PCV 20) on Day 1. A second dose of MMR vaccine will be co-administered to the participants in countries where second dose of MMR is recommended at 15 to 18 months of age, as per national immunization schedule. |
| VNS+ MMR Vaccine | EXPERIMENTAL | Participants receive 1 dose of the candidate varicella vaccine (VNS vaccine), 1 dose of a measles, mumps, and rubella (MMR) vaccine, 1 dose of a hepatitis A virus (HAV vaccine), and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1. |
| VV+MMR Vaccine | ACTIVE_COMPARATOR | Participants receive 1 dose of a Marketed varicella vaccine (VV), 1 dose of a MMR vaccine, 1 dose of a HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1. |
| VNS_Lot 1 Group | EXPERIMENTAL | Participants receive 1 dose of the investigational VNS vaccine of Lot 1, 1 dose of measles, mumps, and rubella (MMR) vaccine, 1 dose of hepatitis A vaccine (HAV), and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1. |
| VNS_Lot 2 Group | EXPERIMENTAL | Participants receive 1 dose of the investigational VNS vaccine of Lot 2, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1. |
| VNS_Lot 3 Group | EXPERIMENTAL | Participants receive 1 dose of the investigational VNS vaccine of Lot 3, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1. |
| VV_Lot 1 Group | ACTIVE_COMPARATOR | Participants receive 1 dose of a marketed varicella vaccine (VV) of Lot 1, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1. |
| VV_Lot 2 Group | ACTIVE_COMPARATOR | Participants receive 1 dose of a marketed VV of Lot 2, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1. |
| VNS Group | EXPERIMENTAL | Participants receive 1 dose of a VNS vaccine, 1 dose of measles, mumps, and rubella (MMR) vaccine, 1 dose of hepatitis A (HAV) vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1. |
| VV Group | ACTIVE_COMPARATOR | Participants receive 1 dose of a marketed VV, 1 dose of MMR vaccine, 1 dose of HAV vaccine, and 1 dose of PCV (either PCV 13 or Vaxneuvance or PCV 20) on Day 1. |
| Name | Type | Description |
|---|---|---|
| Investigational varicella vaccine | BIOLOGICAL | Investigational varicella vaccine administered subcutaneously. |
| Marketed varicella vaccine | BIOLOGICAL | Marketed varicella vaccine administered subcutaneously. |
| MMR vaccine | BIOLOGICAL | MMR vaccine co-administered subcutaneously or intramuscularly. |
| Hepatitis A vaccine | BIOLOGICAL | Hepatitis A vaccine co-administered intramuscularly. |
| PCV (pneumococcal conjugate vaccine) 13 | BIOLOGICAL | The 13-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct. |
| PCV 20 | BIOLOGICAL | The 20-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct. |
| Vaxneuvance | BIOLOGICAL | The Vaxneuvance (15-valent pneumococcal conjugate vaccine co-administered intramuscularly. In some countries PCV will only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct. |
| Candidate varicella vaccine | BIOLOGICAL | Investigational varicella vaccine administered intramuscularly. |
| Investigational varicella vaccine_Lot 1 | BIOLOGICAL | Investigational varicella vaccine of Lot 1 administered subcutaneously. |
| Investigational varicella vaccine_Lot 2 | BIOLOGICAL | Investigational varicella vaccine of Lot 2 administered subcutaneously. |
| Investigational varicella vaccine_Lot 3 | BIOLOGICAL | Investigational varicella vaccine of Lot 3 administered subcutaneously. |
| Marketed varicella vaccine_Lot 1 | BIOLOGICAL | Marketed varicella vaccine of Lot 1 administered subcutaneously. |
| Marketed varicella vaccine_Lot 2 | BIOLOGICAL | Marketed varicella vaccine of Lot 2 administered subcutaneously. |
| Measles, mumps, and rubella vaccine | BIOLOGICAL | 1 dose of measles, mumps, and rubella vaccine co-administered subcutaneously or intramuscularly. |
Inclusion Criteria: * Participant's parent(s)/Legally acceptable representative (LAR)(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol * Written or witnessed/thumb printed informed consent obtained from the participant's parent(s)/LAR(s) prior t...
The investigational varicella vaccine (VNS) is being developed for the prevention of chickenpox (varicella) in healthy children. It is a vaccine candidate studied in children starting at 12 to 15 months of age. It is not yet approved and remains in clinical development.
The investigational varicella vaccine (VNS) is being developed by GSK plc, which trades under the ticker GSK. GSK is running the Phase 3 clinical program evaluating the vaccine in healthy children across multiple countries.
The investigational varicella vaccine (VNS) is in Phase 3 clinical development. All four of its registered trials are Phase 3 studies, and all four are currently recruiting. The vaccine is investigational and has not been approved for use.
Four Phase 3 trials are evaluating the investigational varicella vaccine (VNS): NCT06855160, NCT06806137, NCT06740630, and NCT06693895. Together they plan to enroll about 4,101 healthy children aged 12 months and older. All are randomized, double-blind, and actively controlled, and all are currently recruiting.
The investigational varicella vaccine (VNS) is also referred to as Varicella (Varilrix) and as a varicella vaccine combined with Haemophilus influenzae Type b conjugate vaccine. It is additionally listed under names such as candidate varicella vaccine and investigational varicella vaccine Lot 1.
The Phase 3 program studies the investigational varicella vaccine (VNS) in healthy children beginning at 12 to 15 months of age. One trial, NCT06806137, evaluates a second dose given three months after the first. The studies assess immune response and safety, with some trials comparing the vaccine against a marketed measles, mumps and rubella vaccine.