Last updated: 11/11/2021 12:20:05

Evaluate Vaccine against Chickenpox and a Combined Vaccine against 4 Viral Childhood Diseases: Measles, Mumps, Rubella and Chickenpox

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GSK study ID
100388
See study documents
Clinicaltrials.gov ID
NCT00226499
See results summary
EudraCT ID
2004-002676-41
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine
Trial description: An observer-blind study to evaluate GlaxoSmithKline Biologicals’ live attenuated varicella vaccine and GlaxoSmithKline Biologicals’ combined measles-mumps-rubella-varicella vaccine in the prevention of varicella disease in children. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

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

Secondary outcomes:

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

Interventions:
  • Biological/vaccine: Priorix–tetra™
  • Biological/vaccine: Priorix™
  • Biological/vaccine: Varilrix™
    • Enrollment:
    5803
    Primary completion date:
    2006-12-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Henry O et al. (2018) One or two doses of live varicella virus-containing vaccines: Efficacy, persistence of immune responses, and safety six years after administration in healthy children during their second year of life. Vaccine. 36(3):381-387.
    Prymula R et al. (2014) Protection against varicella with two doses of combined measles-mumps-rubella-varicella vaccine versus one dose of monovalent varicella vaccine: a multicentre, observer-blind, randomised, controlled trial. Lancet. 383(9925):1313-1324.
    Carryn S et al. (2019) Long-term immunogenicity of measles, mumps and rubella-containing vaccines in healthy young children: A 10-year follow-up. Vaccine. pii: S0264-410X(19)30940-5. doi: 10.1016/j. [Epub ahead of print].
    Paul Gillard, Michael Povey and Stephane Carryn, et al. Clinically vs. Serologically Identified Varicella: A Hidden Infection Burden. Lessons of 10-Year Follow-up in Varicella Endemic Countries. Open Forum Infect Dis. 2018 Nov; 5(Suppl 1): S701. Published online 2018 Nov 26. doi: 10.1093/ofid/ofy210.2008.
    Md Ahsan Habib, Roman Prymula , Stephane Carryn, Susanna Esposito, Ouzama Henry , Stéphanie Ravault, Vytautas Usonis, Jacek Wysocki, Paul Gillard, Michael Povey Correlation of protection against varicella in a randomized Phase III varicella-containing vaccine efficacy trial in healthy infants. Vaccine. 2021 Mar 15;S0264-410X(21)00265-6. doi: 10.1016/j.vaccine.2021.02.074. Online ahead of print.
    Leyla Namazova-Baranova, Md Ahsan Habib, Michael Povey, Kamilla Efendieva, Olga Fedorova, Marina Fedoseenko, Tatyana Ivleva, Yulia Kovshirina, Julia Levina, Artem Lyamin, Ludmila Ogorodova, Olga Reshetko, Viktor Romanenko, Inna Ryzhenkova, Irina Sidorenko, Yakov Yakovlev, Aleksandr Zhestkov, Vladimir Tatochenko, Michael Scherbakov, Evgeniy L Shpeer, Giacomo Casabona. A randomized trial assessing the efficacy, immunogenicity, and safety of vaccination with live attenuated varicella zoster virus-containing vaccines: ten-year follow-up in Russian children. Hum Vaccin Immunother. 2021 Aug 26;1-12. doi: 10.1080/21645515.2021.1959148.
    Medical condition
    Varicella, Asthma
    Product
    SB208133, SB209762
    Collaborators
    Not applicable
    Study date(s)
    September 2005 to October 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    11 - 22 months
    Accepts healthy volunteers
    Yes
    • 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.
    Inclusion and exclusion criteria
    Inclusion 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.
    • 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.
    Exclusion criteria:
    • 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)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Alghero (SS), Sardegna, Italy, 07041
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Alytus, Lithuania, LT-63164
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Arta, Greece, 471 00
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Athens, Greece, 115 22
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Athens, Greece, 115 27
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Athens, Greece, 25236
    Status
    Study Complete
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    Showing 1 - 6 of 102 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2006-12-10
    Actual study completion date
    2006-12-10

    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.

    Additional information about the trial

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