2025-523274-17-00招募中3 期
A Phase 3a, observer blind, randomized, controlled study to evaluate the immunogenicity and safety of intramuscular administration of an investigational combined measles, mumps, rubella, and varicella vaccine compared with intramuscular administration of ProQuad when administered as a second dose to healthy children aged 15 months to 6 years of age
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 65
- 试验地点
- 4
- 主要终点
- Seroresponse of Immunoglobulin G (IgG) concentrations against measles at day 43.
研究概览
简要总结
To demonstrate immunological non-inferiority of the intramuscular administration of MMRVNS as compared to the intramuscular administration of MMRV in terms of seroresponse rates and geometric mean concentrations (GMCs) for antibodies to the measles, mumps, rubella, and varicella viruses.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Participants’ parent(s)/legally acceptable representative(s) (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 participants parent(s)/LAR(s) prior to performance of any study specific procedure.
- •Informed assent obtained from the participants in line with local rules and regulations.
- •Healthy participants as established by medical history and clinical examination at screening.
- •For countries where the second dose of measles, mumps, rubella, and varicella vaccination is administered between 4 and 6 years of age: •A male or female participant between and including 4 and 6 years of age at the time of the 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 first dose of measles, mumps, rubella-containing vaccine in the second year of life.
- •For other countries: •A male or female participant between and including 15 months to 6 years of age 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, or earlier at 11 months of age in accordance with national vaccination schedule following official recommendation, at least 3 months before study entry. •Participant who previously received a first dose of measles, mumps, rubella-containing vaccine in the second year of life, or earlier at 11 months of age in accordance with national vaccination schedule following official recommendation, at least 1 month before study entry.
排除标准
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, including hypersensitivity to neomycin or, gelatin.
- •Condition that, in the judgement of the investigator, would make intramuscular injection unsafe.
- •Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the clinical study.
- •Use of any investigational or non-registered product other than the study interventions during the period beginning 30 days before the dose of study intervention, or their planned use during the study period.
- •Administration of immunoglobulins or other blood products or plasma derivates during the period starting 90 days before the study intervention or planned administration during the study period.
- •Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune-modifying treatments at any time up to the end of the study. -Up to 90 days prior to the study interventions administration: systemic corticosteroid. -Up to 180 days prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy, monoclonal antibodies, antitumoral medication.
- •Previous vaccination with a second dose of varicella containing vaccine or measles, mumps, rubella-containing vaccine.
- •Use of salicylates or salicylate-containing products or its planned use during the period of 6 weeks following study intervention administration.
- •Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the dose and ending 43 days after the dose of study intervention administration* (Visit 2), with the exception of: • Influenza vaccines: • Inactivated influenza vaccine must not be administered in the period starting 28 days before the dose and ending 28 days after the dose of study intervention administration. It must be given at a different location than the study intervention. • Live attenuated influenza vaccine must not be administered during the period starting 30 days before the dose and ending 43 days after the dose of study intervention administration (Visit 2). • Diphtheria, tetanus, pertussis-containing vaccines: • Only the following diphtheria, tetanus, acellular pertussis-containing vaccines (DTaP) may be administered, per local immunization practice: Daptacel, Infanrix, Kinrix, Pediarix, Pentacel, Quadracel, or Vaxelis). They must be given on the same day as the study intervention, but at a different location. • Other DTaP brand and diphtheria, tetanus, whole cell pertussis-containing vaccines (DTwP) must not be administered during the period starting 30 days before the dose and ending at 43 days after the dose of study intervention administration (Visit 2).
- •Concurrently participating in another clinical study, at any time during the study period.
- •Any study personnel’s immediate dependents, family, or household members.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Child in care.
- •Participants with the following high-risk individuals in their household: • Immunocompromised individuals. • Pregnant women without documented history of varicella. • Newborn infants of mothers without documented history of varicella. • Newborn infants born <28 weeks of gestation.
- •Hypersensitivity to latex.
- •Unstable chronic conditions as determined by medical history and physical examination.
- •Major congenital defects, as assessed by the investigator.
- •History of measles, mumps, rubella, or varicella/zoster disease, as evaluated by the investigator.
- •Recurrent history or uncontrolled neurological disorders or any neuroinflammatory, congenital neurological conditions, encephalopathies, or seizures.
- •History of febrile seizures, for participant under 4 years of age.
- •Active untreated tuberculosis.
结局指标
主要结局
Seroresponse of Immunoglobulin G (IgG) concentrations against measles at day 43.
Seroresponse of Immunoglobulin G (IgG) concentrations against measles at day 43.
Seroresponse of IgG concentrations against mumps at day 43.
Seroresponse of IgG concentrations against mumps at day 43.
Seroresponse of IgG concentrations against rubella at day 43.
Seroresponse of IgG concentrations against rubella at day 43.
Seroresponse of IgG concentrations against Varicella zoster virus (VZV) at day 43.
Seroresponse of IgG concentrations against Varicella zoster virus (VZV) at day 43.
IgG concentrations against measles at day 43.
IgG concentrations against measles at day 43.
IgG concentrations against mumps at day 43.
IgG concentrations against mumps at day 43.
IgG concentrations against rubella at day 43.
IgG concentrations against rubella at day 43.
IgG concentrations against VZV at day 43.
IgG concentrations against VZV at day 43.
次要结局
- Number of participants with any solicited administration site events from Day 1 to Day 4 for injection site redness, pain/tenderness and swelling; and from Day 1 to Day 43 for injection site varicella-like rash.
- Number of participants with any solicited systemic events from Day 1 to Day 15 for somnolence and loss of appetite; Day 1 to Day 22 for fever; and Day 1 to Day 43 for varicella-like rash, measles/rubella-like rash and other rash.
- Number of participants with any unsolicited adverse events (AEs) from Day 1 up to Day 43 (during the 43 days following study intervention administration).
- Number of participants with any medically attended adverse events (MAAEs) from Day 1 up to Day 181 (during the 181 days following study intervention administration).
- Number of participants with any serious AEs (SAEs), fatal SAEs, related SAEs from Day 1 up to study end (Day 181).
研究者
EU GSK Clinical Trials Call Center
Scientific
GlaxoSmithKline Biologicals
研究点 (4)
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