Evaluate Vaccine against Chickenpox and a Combined Vaccine against 4 Viral Childhood Diseases: Measles, Mumps, Rubella and Chickenpox
Trial overview
Phase A: Number of subjects with confirmed varicella case
Timeframe: From 42 days post dose 2 until the end of Phase A
Phase A: Vaccine efficacy in subjects with confirmed varicella case
Timeframe: From 42 days post dose 2 until the end of Phase A
Phase A: Number of subjects with moderate or severe confirmed varicella case
Timeframe: From 42 days post dose 2 until the end of Phase A
Phase A: Vaccine efficacy in subjects with moderate or severe confirmed varicella case
Timeframe: From 42 days post dose 2 until the end of Phase A
Phase A: Number of subjects with probable or confirmed varicella case
Timeframe: From 42 days post dose 2 until the end of Phase A
Phase A: Vaccine efficacy in subjects with probable or confirmed varicella case
Timeframe: From 42 days post dose 2 until the end of Phase A
Phase A: Immune response to varicella vaccine with respect to anti-Varicella Zoster Virus (anti-VZV) antibody concentrations
Timeframe: At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
Phase A: Number of subjects with seroconversion/seroresponse to VZV
Timeframe: At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
Phase A: Immune response to measles with respect to anti-measles antibody concentrations in a subset of subjects
Timeframe: At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
Phase A: Number of subjects with seroconversion/seroresponse to measles in a subset of subjects
Timeframe: At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
Phase A: Immune response to mumps with respect to anti-mumps antibody concentrations in a subset of subjects
Timeframe: At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
Phase A: Number of subjects with seroconversion/seroresponse to mumps in a subset of subjects
Timeframe: At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
Phase A: Immune response to rubella with respect to anti-rubella antibody concentrations in a subset of subjects
Timeframe: At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
Phase A: Number of subjects with a seroconversion/seroresponse to rubella in a subset of subjects
Timeframe: At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
Phase A: Number of subjects with confirmed cases of herpes zoster
Timeframe: From Day 0 until the end of Phase A (Year 2)
Phase A: Number of subjects reporting fever
Timeframe: Within 43 days (Day 0-42) post-vaccination period following each dose
Phase A: Number of subjects reporting fever
Timeframe: Within 15 days (Day 0-14) post-vaccination period following each dose
Phase A: Number of subjects reporting solicited local symptoms
Timeframe: 4 days post-vaccination period following each dose
Phase A: Number of subjects reporting meningism
Timeframe: Within 43 days (Day 0-42) post-vaccination period following each dose
Phase A: Number of subjects reporting parotitis
Timeframe: Within 43 days (Day 0-42) post-vaccination period following each dose
Phase A: Number of subjects reporting rash
Timeframe: Within 43 days (Day 0-42) post-vaccination period following each dose
Phase A: Number of subjects with suspected sign of meningism including febrile convulsions
Timeframe: Within 43 days (Day 0-42) post-vaccination period following each dose
Phase A: Number of subjects reporting unsolicited Adverse Events (AEs)
Timeframe: Within 43 days (Day 0-42) post-vaccination period following each dose
Phase A: Number of subjects reporting Serious Adverse Events (SAEs)
Timeframe: From Day 0 until the end of Phase A (Year 2)
Phase A: Health Economics analysis of factors leading to indirect costs due to varicella illness
Timeframe: During Phase A (from Day 0 up to Year 2)
Phase B: Number of subjects with confirmed varicella case
Timeframe: From the beginning of Phase B (Year 2) up to study end (Year 10)
Phase B: Vaccine efficacy in subjects with confirmed varicella case
Timeframe: From the beginning of Phase B (Year 2) up to study end (Year 10)
Phase B: Number of subjects with moderate or severe confirmed varicella case
Timeframe: From the beginning of Phase B (Year 2) up to study end (Year 10)
Phase B: Vaccine efficacy in subjects with moderate or severe confirmed varicella case
Timeframe: From the beginning of Phase B (Year 2) up to study end (Year 10)
Phase B: Number of subjects with probable or confirmed varicella case
Timeframe: From the beginning of Phase B (Year 2) up to study end (Year 10)
Phase B: Vaccine efficacy in subjects with probable or confirmed varicella case
Timeframe: From the beginning of Phase B (Year 2) up to study end (Year 10)
Phase B: Characteristics of varicella cases
Timeframe: From the beginning of Phase B (Year 2) up to study end (Year 10)
Phase B: Immune response to varicella vaccine with respect to anti-Varicella Zoster Virus (anti-VZV) antibody concentrations
Timeframe: At Year 4, Year 6, Year 8 and Year 10 time points
Phase B: Number of subjects with anti-VZV antibody concentrations above the cut-off value
Timeframe: At Year 4, Year 6, Year 8 and Year 10 time points
Phase B: Immune response to measles with respect to anti-measles antibody concentrations
Timeframe: At Year 4, Year 6, Year 8 and Year 10 time points
Phase B: Number of subjects with anti-measles antibody concentrations above the cut-off value
Timeframe: At Year 4, Year 6, Year 8 and Year 10 time points
Phase B: Immune response to mumps with respect to anti-mumps antibody concentrations
Timeframe: At Year 4, Year 6, Year 8 and Year 10 time points
Phase B: Number of subjects with anti-mumps antibody concentrations above the cut-off value
Timeframe: At Year 4, Year 6, Year 8 and Year 10 time points
Phase B: Immune response to rubella with respect to anti-rubella antibody concentrations
Timeframe: At Year 4, Year 6, Year 8 and Year 10 time points
Phase B: Number of subjects with anti-rubella antibody concentrations above the cut-off value
Timeframe: At Year 4, Year 6, Year 8 and Year 10 time points
Phase B: Characteristics of zoster cases
Timeframe: From 6 weeks after Dose 2 until study end (Year 10)
Phase B: Number of subjects reporting Serious Adverse Events (SAEs)
Timeframe: From the beginning of Phase B (Year 2) up to study end (Year 10)
Phase B: Health Economics analysis of factors leading to indirect costs due to varicella illness
Timeframe: During Phase B
Participation criteria
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol for the whole duration of the study.
- Male or female subject between 12 and 22 months of age at the time of the first vaccination.
- Previous vaccination against measles, mumps, rubella and/or varicella.
- History of previous measles, mumps, rubella and/or varicella/ herpes zoster diseases.
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol for the whole duration of the study.
- Male or female subject between 12 and 22 months of age at the time of the first vaccination.
- Subjects free of obvious health problems, as established by medical history and physical examination before entering the study.
- Written informed consent obtained from the parents/guardians of the subject after they have been informed on the risks and benefits of the study, in a language they clearly understand and before performance of any study procedure.
- Subjects whose parents/guardians have direct access to telephone/mobile phone.
- Subjects: (1) with at least one sibling (with negative history of varicella disease/vaccination) at home, or (2) attending day care center, or (3) attending childminders, i.e. someone taking care of several children, or (4) who are in contact for at least once a week with other children without a known positive history of varicella disease/vaccination, while playing in close physical contact for more than 5 minutes.
- Previous vaccination against measles, mumps, rubella and/or varicella.
- History of previous measles, mumps, rubella and/or varicella/ herpes zoster diseases.
- Known exposure to measles, mumps, rubella and/or varicella/herpes zoster within 30 days prior to the start of the study.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Administration of immunoglobulins and/or any blood products within three months prior to the first vaccine dose or planned administration during the study period.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical.
- Family history of congenital or hereditary immunodeficiency.
- History of allergic diseases or reactions likely to be exacerbated by any component of the vaccines, including systemic allergy to egg proteins or neomycin.
- Major congenital defects or serious chronic illness.
- Residence in the same household as newborns (0-4 weeks of age), pregnant women who are varicella-susceptible, persons with a known immunodeficiency or any other persons at high risk for varicella.
- History of any neurologic disorders or seizures.
- Use of any investigational or non-registered product (drug/vaccine other than the study vaccines) within 14 days prior to vaccination and planned use during the study period. Additional exclusion criteria for subjects included in the subset:
- Administration of a licensed vaccine within 14 days prior to vaccination and planned use until approximately 42 days after the last study vaccine dose (Day 84) with the exception of oral polio vaccine (OPV).
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.