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

NCT ID: NCT00226499

Last Updated: 2019-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 5803 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-01
• Study Completion Date: 2006-10-12

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.

Detailed Description

According to treatment group allocation, participants will receive study vaccines and be followed for antibody titres and occurrence of varicella disease.

This study is conducted in 2 phases. Phase A includes the vaccination period and an observation period for efficacy. The efficacy endpoints will be evaluated over at least two years after vaccination. During this period, the immunogenicity endpoints will be evaluated with respect to the immune response 43 days after vaccination and the persistence of antibodies over two years to varicella (for all subjects) and to measles, mumps and rubella (for a subset of subjects). Regarding the safety endpoints, SAEs (including any complicated varicella cases if observed) will be assessed for all subjects during the whole Phase A duration, whereas, solicited (local and general) and unsolicited adverse events will be assessed in a subset of subjects within a 43-day period after vaccination.

Phase B is an extension of Phase A. It is a long-term follow-up until Year 10 to examine the long-term efficacy of the study vaccines against clinical varicella disease as well as the long-term persistence of antibodies to varicella (for all subjects) and to measles, mumps and rubella (in a subset of subjects) after vaccination.

Conditions

Varicella; Chickenpox Vaccines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

MMRV Group

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).

Group Type: EXPERIMENTAL

Priorix-tetra™

Intervention Type: BIOLOGICAL

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

OKAH Group

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.

Group Type: EXPERIMENTAL

Priorix™

Intervention Type: 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

Varilrix™

Intervention Type: BIOLOGICAL

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

MMR Group

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).

Group Type: ACTIVE_COMPARATOR

Priorix™

Intervention Type: 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

Interventions

Priorix-tetra™

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

Intervention Type: BIOLOGICAL

Priorix™

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

Intervention Type: BIOLOGICAL

Varilrix™

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

Intervention Type: BIOLOGICAL

Eligibility 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.

• 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).

• Minimum Eligible Age: 11 Months
• Maximum Eligible Age: 22 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Brno, , Czechia

GSK Investigational Site

Chomutov, , Czechia

GSK Investigational Site

Děčín, , Czechia

GSK Investigational Site

Havlíčkův Brod, , Czechia

GSK Investigational Site

Hradec Králové, , Czechia

GSK Investigational Site

Humpolec, , Czechia

GSK Investigational Site

Jindřichův Hradec, , Czechia

GSK Investigational Site

Kolín, , Czechia

GSK Investigational Site

Liberec, , Czechia

GSK Investigational Site

Moravská Ostrava, , Czechia

GSK Investigational Site

Náchod, , Czechia

GSK Investigational Site

Ostrava, , Czechia

GSK Investigational Site

Pardubice, , Czechia

GSK Investigational Site

Pilsen, , Czechia

GSK Investigational Site

Prague, , Czechia

GSK Investigational Site

Prague, , Czechia

GSK Investigational Site

Prague, , Czechia

GSK Investigational Site

Prague, , Czechia

GSK Investigational Site

Prague, , Czechia

GSK Investigational Site

Znojmo, , Czechia

GSK Investigational Site

Arta, , Greece

GSK Investigational Site

Athens, , Greece

GSK Investigational Site

Athens, , Greece

GSK Investigational Site

Athens, , Greece

GSK Investigational Site

Giannitsá, , Greece

GSK Investigational Site

Karditsa, , Greece

GSK Investigational Site

Komotini, , Greece

GSK Investigational Site

Ptolemaida, , Greece

GSK Investigational Site

Thessaloniki, , Greece

GSK Investigational Site

Tripoli, , Greece

GSK Investigational Site

Véria, , Greece

GSK Investigational Site

Quarto (NA), Campania, Italy

GSK Investigational Site

Ferrara, Emilia-Romagna, Italy

GSK Investigational Site

Udine, Friuli Venezia Giulia, Italy

GSK Investigational Site

Genoa, Liguria, Italy

GSK Investigational Site

Milan, Lombardy, Italy

GSK Investigational Site

Novara, Piedmont, Italy

GSK Investigational Site

Alghero (SS), Sardinia, Italy

GSK Investigational Site

Ozieri (SS), Sardinia, Italy

GSK Investigational Site

Florence, Tuscany, Italy

GSK Investigational Site

Alytus, , Lithuania

GSK Investigational Site

Kaunas, , Lithuania

GSK Investigational Site

Klaipėda, , Lithuania

GSK Investigational Site

Panevezys, , Lithuania

GSK Investigational Site

Šiauliai, , Lithuania

GSK Investigational Site

Vilnius, , Lithuania

GSK Investigational Site

Vilnius, , Lithuania

GSK Investigational Site

Vilnius, , Lithuania

GSK Investigational Site

Bekkestua, , Norway

GSK Investigational Site

Moelv, , Norway

GSK Investigational Site

Paradis, , Norway

GSK Investigational Site

Skien, , Norway

GSK Investigational Site

Trondheim, , Norway

GSK Investigational Site

Bydgoszcz, , Poland

GSK Investigational Site

Dębica, , Poland

GSK Investigational Site

Krakow, , Poland

GSK Investigational Site

Oleśnica, , Poland

GSK Investigational Site

Poznan, , Poland

GSK Investigational Site

Siemianowice Śląskie, , Poland

GSK Investigational Site

Tarnów, , Poland

GSK Investigational Site

Trzebnica, , Poland

GSK Investigational Site

Wesoła, , Poland

GSK Investigational Site

Wroclaw, , Poland

GSK Investigational Site

Brasov, , Romania

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Cluj-Napoca, , Romania

GSK Investigational Site

Constanța, , Romania

GSK Investigational Site

Sibiu, , Romania

GSK Investigational Site

Timișoara, , Romania

GSK Investigational Site

Ivanteevka Moscow Region, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Murmansk, , Russia

GSK Investigational Site

Novokuznetsk, , Russia

GSK Investigational Site

Novosibirsk, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Samara, , Russia

GSK Investigational Site

Saratov, , Russia

GSK Investigational Site

Tomsk, , Russia

GSK Investigational Site

Volgograd, , Russia

GSK Investigational Site

Yekaterinburg, , Russia

GSK Investigational Site

Yekaterinburg, , Russia

GSK Investigational Site

Bratislava, , Slovakia

GSK Investigational Site

Bratislava, , Slovakia

GSK Investigational Site

Dlhá nad Oravou, , Slovakia

GSK Investigational Site

Dolný Kubín, , Slovakia

GSK Investigational Site

Dubnica nad Váhom, , Slovakia

GSK Investigational Site

Nová Dubnica, , Slovakia

GSK Investigational Site

Nové Mesto nad Váhom, , Slovakia

GSK Investigational Site

Nové Zámky, , Slovakia

GSK Investigational Site

Púchov, , Slovakia

GSK Investigational Site

Ružomberok, , Slovakia

GSK Investigational Site

Štúrovo, , Slovakia

GSK Investigational Site

Šurany, , Slovakia

GSK Investigational Site

Trenčín, , Slovakia

GSK Investigational Site

Linköping, , Sweden

GSK Investigational Site

Malmo, , Sweden

GSK Investigational Site

Norrköping, , Sweden

GSK Investigational Site

Örebro, , Sweden

GSK Investigational Site

Umeå, , Sweden

Countries

Czechia; Greece; Italy; Lithuania; Norway; Poland; Romania; Russia; Slovakia; Sweden

References

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.

Reference Type: BACKGROUND

PMID: 29224964 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24485548 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31345639 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33736915 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30765242 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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Other Identifiers

104105 (EXT FU Y2)

Identifier Type: OTHER

Identifier Source: secondary_id

103494 (EXT FU Y1)

Identifier Type: OTHER

Identifier Source: secondary_id

104106 (EXT FU Y4-Y6-Y8-Y10)

Identifier Type: OTHER

Identifier Source: secondary_id

2004-002676-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

100388

Identifier Type: -

Identifier Source: org_study_id