BridgeMD
A study on the immune response and safety of a combined measles, mumps, rubella, chickenpox vaccine compared to a marketed combined vaccine, given to healthy children 4 to 6 years of age
EU CTIS ID: 2022-501564-18-00
What this study is testing
To evaluate the immune response to the MMRVNS vaccines (formulated with different potencies) and the MMRV vaccine (pooled group) in terms of geometric mean concentration (GMCs) for antibodies to measles, mumps, rubella, and varicella viruses.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Healthy participants as established by medical history and clinical examination before entering into the study.
- A male or female between, and including, 4 years and 6 years of age (i.e., from 4-year birthday until the day before the 7-year birthday) at the time of study intervention administration, and in accordance with local regulations.
- Participant who previously received a first dose of varicella-containing vaccine in the second year of life.
- Participant who previously received a single dose of measles-, mumps-, rubella containing vaccine in the second year of life.
- Written informed consent obtained from the participants’ parent(s)/legally acceptable representative(s) (LAR[s]) prior to performance of any study-specific procedure (participant informed assent will be obtained from participants in line with local rules and regulations).
- Participants’ parent(s)/LAR(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of electronic diaries [eDiaries], return for follow-up visits).
You likely can't join if
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions including hypersensitivity to neomycin or gelatin.
- 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 their 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 intervention administration. For corticosteriods, this will mean prednisone equivalent > 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for pediatric participants. 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 with a second dose of varicella-containing vaccine or measles-, mumps-, rubella-containing vaccine.
See the full eligibility criteria
Who can join
- Healthy participants as established by medical history and clinical examination before entering into the study.
- A male or female between, and including, 4 years and 6 years of age (i.e., from 4-year birthday until the day before the 7-year birthday) at the time of study intervention administration, and in accordance with local regulations.
- Participant who previously received a first dose of varicella-containing vaccine in the second year of life.
- Participant who previously received a single dose of measles-, mumps-, rubella containing vaccine in the second year of life.
- Written informed consent obtained from the participants’ parent(s)/legally acceptable representative(s) (LAR[s]) prior to performance of any study-specific procedure (participant informed assent will be obtained from participants in line with local rules and regulations).
- Participants’ parent(s)/LAR(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of electronic diaries [eDiaries], return for follow-up visits).
What rules you out
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions including hypersensitivity to neomycin or gelatin.
- 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 their 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 intervention administration. For corticosteriods, this will mean prednisone equivalent > 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for pediatric participants. 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 with a second dose of varicella-containing vaccine or measles-, mumps-, rubella-containing vaccine.
- Administration or planned 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 and, − routinely recommended licensed childhood DTPa-containing vaccines which can preferably be co-administered according to the local immunization practices of the participating country. Any other age-appropriate vaccine may be given starting at Visit 3 and anytime thereafter. *In case an 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 government recommendations and that GSK/IQVIA is notified accordingly.
- 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)
- 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 (as defined in Section 5.2.1). − Pregnant women without documented history of varicella. − Newborn infants of mothers without documented history of varicella. − Newborn infants born <28 weeks of gestation.
- 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 measles, mumps, rubella, or varicella disease.
- Recurrent history of or uncontrolled neurological disorders or seizures.
- Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Fever is defined as body temperature ≥38.0°C (100.4 degrees Fahrenheit [°F]) by any age-appropriate route. All study interventions can be administered to participants with a minor illness such as diarrhea, mild upper respiratory infection without fever.
- Participant with history of coronavirus disease 2019 (COVID-19) 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.
The study team makes the final eligibility decision.
Where it's taking place
- Colombia
- United States
- Turkey
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Colombia; United States; Turkey; Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.