A Phase II, single-blind, randomized, controlled study to evaluate the immunogenicity and safety of a measles, mumps, rubella, varicella vaccine compared with ProQuad, administered in healthy children 4 to 6 years of age - 217715

GlaxoSmithKline Biologicals0 sites890 target enrollmentDecember 5, 2022

ConditionsHealthy volunteers (prevention of measles, mumps, rubella and varicella infections)MedDRA version: 21.1Level: LLTClassification code: 10069545Term: Measles immunization Class: 10042613 MedDRA version: 21.1Level: LLTClassification code: 10069547Term: Mumps immunization Class: 10042613 MedDRA version: 21.1Level: LLTClassification code: 10069564Term: Rubella immunization Class: 10042613 MedDRA version: 21.1Level: LLTClassification code: 10069628Term: Varicella immunization Class: 10042613 Therapeutic area: Diseases [C] - Virus Diseases [C02]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy volunteers (prevention of measles, mumps, rubella and varicella infections)
Sponsor: GlaxoSmithKline Biologicals
Enrollment: 890
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 5, 2022

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Biologicals

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, 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).

Exclusion Criteria

•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 prese