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

NCT00226499 | Completed Phase 3 Results

• 5 other identifiers: 100388104105 (EXT FU Y2)103494 (EXT FU Y1)104106 (EXT FU Y4-Y6-Y8-Y10)2004-002676-41
• Study Type: interventional
• Target: 5,803
• Locations: 10 countries
• Sites: 104

Brief Summary

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.

Conditions

Varicella; Chickenpox Vaccines

Outcome Measures

Primary Outcomes (1)

• Phase A: Number of Subjects With Confirmed Varicella Case

  Confirmed varicella case = A case that met the clinical case definition \[an illness with acute onset of diffuse, generalized maculopapulovesicular rash (i.e. spots, papules and/or vesicles) without other apparent cause\] at least in the opinion of the investigator and was confirmed by laboratory test \[Polymerase Chain Reaction (PCR) (+)\] OR a case that met the clinical definition confirmed by the Independent Data Monitoring Committee (IDMC) and was epidemiologically linked \[Epi (+)\] to a valid index case.

  From 42 days post dose 2 until the end of Phase A

Secondary Outcomes (36)

• Phase A: Number of Subjects With Moderate or Severe Confirmed Varicella Case

  From 42 days post dose 2 until the end of Phase A

• Phase A: Number of Subjects With Probable or Confirmed Varicella Case

  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

  At Day 0, Day 42, Day 84, Year 1 and Year 2 time points

• Phase A: Number of Subjects With Seroconversion/Seroresponse to VZV

  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

  At Day 0, Day 42, Day 84, Year 1 and Year 2 time points

Study Arms (3)

MMRV Group

EXPERIMENTAL

Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Biological: Priorix-tetra™

OKAH Group

EXPERIMENTAL

Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.

Biological: Priorix™; Biological: Varilrix™

MMR Group

ACTIVE COMPARATOR

Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Biological: Priorix™

Interventions

Priorix-tetra™ BIOLOGICAL

2 doses administered subcutaneously, one at Day 0 and the other at Day 42 to subjects in MMRV Group

MMRV Group

Priorix™ BIOLOGICAL

2 doses administered subcutaneously, one at Day 0 and the other at Day 42 to subjects in MMR Group and one dose administered subcutaneously at Day 0 to subjects in OKAH Group

MMR Group; OKAH Group

Varilrix™ BIOLOGICAL

1 dose administered subcutaneously at Day 42 to subjects in OKAH Group

OKAH Group

Eligibility Criteria

• Age: 11 Months - 22 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• with at least one sibling (with negative history of varicella disease/vaccination) at home, or
• attending day care center, or
• attending childminders, i.e. someone taking care of several children, or
• 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.

You may not qualify if:

• 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.
• \- 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).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (104)

GSK Investigational Site

Brno, 628 00, Czechia

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GSK Investigational Site

Chomutov, 43003, Czechia

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GSK Investigational Site

Děčín, 405 01, Czechia

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GSK Investigational Site

Havlíčkův Brod, 580 22, Czechia

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GSK Investigational Site

Hradec Králové, 500 01, Czechia

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GSK Investigational Site

Humpolec, 396 01, Czechia

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GSK Investigational Site

Jindřichův Hradec, 377 01, Czechia

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GSK Investigational Site

Kolín, 28002, Czechia

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GSK Investigational Site

Liberec, 46015, Czechia

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GSK Investigational Site

Moravská Ostrava, 702 00, Czechia

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GSK Investigational Site

Náchod, 547 01, Czechia

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GSK Investigational Site

Ostrava, 728 92, Czechia

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GSK Investigational Site

Pardubice, 532 03, Czechia

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GSK Investigational Site

Pilsen, 305 99, Czechia

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GSK Investigational Site

Prague, 140 00, Czechia

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GSK Investigational Site

Prague, 14200, Czechia

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GSK Investigational Site

Prague, 150 00, Czechia

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GSK Investigational Site

Prague, 160 00, Czechia

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GSK Investigational Site

Prague, 190 00, Czechia

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GSK Investigational Site

Znojmo, Czechia

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GSK Investigational Site

Arta, 471 00, Greece

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GSK Investigational Site

Athens, 115 22, Greece

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GSK Investigational Site

Athens, 115 27, Greece

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GSK Investigational Site

Athens, 25236, Greece

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GSK Investigational Site

Giannitsá, 581 00, Greece

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GSK Investigational Site

Karditsa, 43100, Greece

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GSK Investigational Site

Komotini, 69 100, Greece

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GSK Investigational Site

Ptolemaida, 50200, Greece

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GSK Investigational Site

Thessaloniki, 54636, Greece

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GSK Investigational Site

Tripoli, 22100, Greece

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GSK Investigational Site

Véria, 591 00, Greece

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GSK Investigational Site

Quarto (NA), Campania, 80010, Italy

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GSK Investigational Site

Ferrara, Emilia-Romagna, 44100, Italy

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GSK Investigational Site

Udine, Friuli Venezia Giulia, 33100, Italy

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GSK Investigational Site

Genoa, Liguria, 16132, Italy

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GSK Investigational Site

Milan, Lombardy, 20122, Italy

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GSK Investigational Site

Novara, Piedmont, 28100, Italy

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GSK Investigational Site

Alghero (SS), Sardinia, 07041, Italy

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GSK Investigational Site

Ozieri (SS), Sardinia, 07014, Italy

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GSK Investigational Site

Florence, Tuscany, 50139, Italy

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GSK Investigational Site

Alytus, LT-63164, Lithuania

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GSK Investigational Site

Kaunas, LT-48259, Lithuania

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GSK Investigational Site

Klaipėda, LT-94007, Lithuania

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GSK Investigational Site

Panevezys, LT-37355, Lithuania

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GSK Investigational Site

Šiauliai, LT-76346, Lithuania

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GSK Investigational Site

Vilnius, LT -10207, Lithuania

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GSK Investigational Site

Vilnius, LT-02169, Lithuania

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GSK Investigational Site

Vilnius, LT-11200, Lithuania

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GSK Investigational Site

Bekkestua, 1319, Norway

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GSK Investigational Site

Moelv, N-2390, Norway

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GSK Investigational Site

Paradis, 5231, Norway

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GSK Investigational Site

Skien, N-03730, Norway

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GSK Investigational Site

Trondheim, N-7036, Norway

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GSK Investigational Site

Bydgoszcz, 85-021, Poland

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GSK Investigational Site

Dębica, 39-200, Poland

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GSK Investigational Site

Krakow, 31-202, Poland

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GSK Investigational Site

Oleśnica, 56-400, Poland

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GSK Investigational Site

Poznan, 61-709, Poland

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GSK Investigational Site

Siemianowice Śląskie, 41-103, Poland

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GSK Investigational Site

Tarnów, 33-100, Poland

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GSK Investigational Site

Trzebnica, 55-100, Poland

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GSK Investigational Site

Wesoła, 05-077, Poland

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GSK Investigational Site

Wroclaw, 52-312, Poland

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GSK Investigational Site

Brasov, Romania

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GSK Investigational Site

Bucharest, 050098, Romania

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GSK Investigational Site

Bucharest, 077190, Romania

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GSK Investigational Site

Bucharest, 20395, Romania

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GSK Investigational Site

Bucharest, 22102, Romania

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GSK Investigational Site

Cluj-Napoca, 400217, Romania

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GSK Investigational Site

Constanța, 900709, Romania

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GSK Investigational Site

Sibiu, Romania

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GSK Investigational Site

Timișoara, 300593, Romania

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GSK Investigational Site

Ivanteevka Moscow Region, 141280, Russia

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GSK Investigational Site

Moscow, 115 478, Russia

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GSK Investigational Site

Moscow, 115446, Russia

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GSK Investigational Site

Moscow, 119991, Russia

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GSK Investigational Site

Murmansk, 183046, Russia

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GSK Investigational Site

Novokuznetsk, 654063, Russia

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GSK Investigational Site

Novosibirsk, 630112, Russia

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GSK Investigational Site

Saint Petersburg, 191123, Russia

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GSK Investigational Site

Samara, 443079, Russia

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GSK Investigational Site

Saratov, 410010, Russia

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GSK Investigational Site

Tomsk, 634001, Russia

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GSK Investigational Site

Volgograd, 400130, Russia

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GSK Investigational Site

Yekaterinburg, 620085, Russia

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GSK Investigational Site

Yekaterinburg, 620109, Russia

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GSK Investigational Site

Bratislava, 841 08, Slovakia

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GSK Investigational Site

Bratislava, 851 05, Slovakia

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GSK Investigational Site

Dlhá nad Oravou, 027 55, Slovakia

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GSK Investigational Site

Dolný Kubín, 026 01, Slovakia

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GSK Investigational Site

Dubnica nad Váhom, 018 41, Slovakia

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GSK Investigational Site

Nová Dubnica, 018 51, Slovakia

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GSK Investigational Site

Nové Mesto nad Váhom, 915 01, Slovakia

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GSK Investigational Site

Nové Zámky, 940 01, Slovakia

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GSK Investigational Site

Púchov, 020 01, Slovakia

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GSK Investigational Site

Ružomberok, 034 01, Slovakia

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GSK Investigational Site

Štúrovo, 943 01, Slovakia

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GSK Investigational Site

Šurany, 942 18, Slovakia

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GSK Investigational Site

Trenčín, 911 01, Slovakia

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GSK Investigational Site

Linköping, SE-581 85, Sweden

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GSK Investigational Site

Malmo, 205 02, Sweden

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GSK Investigational Site

Norrköping, SE-602 39, Sweden

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GSK Investigational Site

Örebro, SE-702 11, Sweden

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GSK Investigational Site

Umeå, SE-901 85, Sweden

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Related Publications (5)

• Henry O, Brzostek J, Czajka H, Leviniene G, Reshetko O, Gasparini R, Pazdiora P, Plesca D, Desole MG, Kevalas R, Gabutti G, Povey M, Innis B. 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. 2018 Jan 8;36(3):381-387. doi: 10.1016/j.vaccine.2017.11.081. Epub 2017 Dec 7.

  PMID: 29224964 BACKGROUND

• Prymula R, Bergsaker MR, Esposito S, Gothefors L, Man S, Snegova N, Stefkovicova M, Usonis V, Wysocki J, Douha M, Vassilev V, Nicholson O, Innis BL, Willems P. 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. 2014 Apr 12;383(9925):1313-1324. doi: 10.1016/S0140-6736(12)61461-5. Epub 2014 Jan 29.

  PMID: 24485548 BACKGROUND

• Carryn S, Feyssaguet M, Povey M, Di Paolo E. Long-term immunogenicity of measles, mumps and rubella-containing vaccines in healthy young children: A 10-year follow-up. Vaccine. 2019 Aug 23;37(36):5323-5331. doi: 10.1016/j.vaccine.2019.07.049. Epub 2019 Jul 22.

  PMID: 31345639 BACKGROUND

• Habib MA, Prymula R, Carryn S, Esposito S, Henry O, Ravault S, Usonis V, Wysocki J, Gillard P, Povey M. Correlation of protection against varicella in a randomized Phase III varicella-containing vaccine efficacy trial in healthy infants. Vaccine. 2021 Jun 8;39(25):3445-3454. doi: 10.1016/j.vaccine.2021.02.074. Epub 2021 Mar 16.

  PMID: 33736915 DERIVED

• Povey M, Henry O, Riise Bergsaker MA, Chlibek R, Esposito S, Flodmark CE, Gothefors L, Man S, Silfverdal SA, Stefkovicova M, Usonis V, Wysocki J, Gillard P, Prymula R. Protection against varicella with two doses of combined measles-mumps-rubella-varicella vaccine or one dose of monovalent varicella vaccine: 10-year follow-up of a phase 3 multicentre, observer-blind, randomised, controlled trial. Lancet Infect Dis. 2019 Mar;19(3):287-297. doi: 10.1016/S1473-3099(18)30716-3. Epub 2019 Feb 11.

  PMID: 30765242 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Chickenpox

Interventions

Priorix-Tetra vaccine; Measles-Mumps-Rubella Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Measles Vaccine; Viral Vaccines; Mumps Vaccine; Rubella Vaccine

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2005
• First Posted: September 27, 2005
• Study Start: September 1, 2005
• Primary Completion: October 12, 2006
• Study Completion: October 12, 2006
• Last Updated: September 23, 2019
• Results First Posted: September 23, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

RO (9); RU (14); IT (9); PL (10); LI (8); GR (11); SE (5); SL (13); CZ (20); NO (5)