Candidate varicella vaccine
BiologicalInvestigational varicella vaccine administered intramuscularly.
NCT Number: NCT06855160
This study aims to assess the immune response and safety of GSK's candidate chickenpox and marketed MMR vaccines when given to children 12 to 15 months of age via a muscle injection. It compares the GSK vaccines to Merck's chickenpox vaccine, administered just under the skin. Additionally, the study will evaluate the immune response and safety of giving the GSK vaccines along with other childhood vaccines through a muscle injection.
Interested in participating?
Request Info12 month–15 month
All sexes
Interventional
Phase 3
GSK Investigational Site, Alken, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Prior/Concomitant therapy
Prior/Concurrent clinical study experience
Other exclusion criteria
Investigational varicella vaccine administered intramuscularly.
Marketed varicella vaccine administered subcutaneously.
MMR vaccine administered subcutaneously or intramuscularly.
Hepatitis A vaccine co-administered intramuscularly.
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.
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.
The Vaxneuvance (15-valent pneumococcal conjugate vaccine) co-administered intramuscularly. In some countries Vaxneuvancewill only be administered depending on the availability, country's registration status and national recommendations for pneumococcal vaccination at the time of study conduct.
Time frame: At Day 43
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.
Time frame: At Day 43
Concentrations of anti-VZV gE IgG are presented as GMC and expressed in milli-international units per milliliter (mIU/mL) for each group.
Time frame: At Day 43
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.
Time frame: At Day 43
Time frame: At Day 43
Time frame: At Day 43
Time frame: At Day 43
Time frame: At Day 43
Time frame: Day 1 (post-dose) to Day 4
Solicited administration site events include injection site redness, pain, and swelling.
Time frame: Day 1 (post-dose) to Day 4
Solicited administration site events include injection site redness, pain and swelling.
Time frame: Day 1 (post-dose) to Day 15
Solicited systemic events include drowsiness, loss of appetite and irritability.
Time frame: Day 1 (post-dose) to Day 22
Fever is defined as temperature greater than or equal (>=) 38.0 degrees Celsius (°C) regardless of the location of measurement (the preferred location for measuring temperature is the axilla).
Time frame: Day 1 (post-dose) to Day 43
Solicited administration site events include injection site varicella-like rash.
Time frame: Day 1 (post-dose) to Day 43
Solicited systemic events includes varicella-like rash (non-injection site), measles/rubella-like rash, and general rash (not varicella like and not measles/rubella-like).
Time frame: Day 1 (post-dose) to Day 43
Unsolicited 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. Unsolicited AEs include nonserious and serious AEs.
Time frame: Day 1 (post-dose) to Day 181 (Study end)
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.
Time frame: Day 1 (post-dose) to Day 181 (Study end)
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.
Contact information is provided by the study sponsor or research team.
EU GSK Clinical Trials Call Center
CONTACT
US GSK Clinical Trials Call Center
CONTACT
GlaxoSmithKline
Industry
A Phase 3a, Open-Label, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Intramuscular Administration of an Investigational Varicella Vaccine and Priorix Compared With Subcutaneous Administration of Varivax and Priorix, When Given as a First Dose to Healthy Children 12 to 15 Months of Age
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06806137
Chickenpox, DNA Virus Infections
Salvaleón de Higüey, La Altagracia Province, Dominican Republic
View Trial DetailsNCT05084508
Chickenpox, DNA Virus Infections
Bryant, Arkansas, United States
View Trial DetailsNCT05732337
Chickenpox, DNA Virus Infections
Malbork, Poland
View Trial DetailsNCT04384016
Chickenpox, DNA Virus Infections
Phu Ly, Ha Nam, Vietnam
View Trial Details