AzTrials
AzTrials

VaricellaPhase 3NCT00226499

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

A Phase 3 study testing Priorix-tetra™, Priorix™ and Varilrix™ in people with Varicella and Chickenpox Vaccines, run by GlaxoSmithKline at 104 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 11 to 22 monthsHealthy volunteers can take part
Conditions the study is for
Varicella, Chickenpox Vaccines
What is being tested?
Priorix-tetra™, Priorix™ and Varilrix™
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,803 participants
Where
104 sitesin 10 countries
Study dates
1 Sep 2005to 12 Oct 2006
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 22 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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 locations and contacts

104 sites in 10 countries.

104 sites in 10 countries

Czechia20 sites

  • GSK Investigational Site

    Brno, 628 00

  • GSK Investigational Site

    Chomutov, 43003

  • GSK Investigational Site

    Děčín, 405 01

  • GSK Investigational Site

    Havlíčkův Brod, 580 22

  • GSK Investigational Site

    Hradec Králové, 500 01

  • GSK Investigational Site

    Humpolec, 396 01

  • GSK Investigational Site

    Jindřichův Hradec, 377 01

  • GSK Investigational Site

    Kolín, 28002

  • GSK Investigational Site

    Liberec, 46015

  • GSK Investigational Site

    Moravská Ostrava, 702 00

  • GSK Investigational Site

    Náchod, 547 01

  • GSK Investigational Site

    Ostrava, 728 92

  • GSK Investigational Site

    Pardubice, 532 03

  • GSK Investigational Site

    Pilsen, 305 99

  • GSK Investigational Site

    Prague, 140 00

  • GSK Investigational Site

    Prague, 14200

  • GSK Investigational Site

    Prague, 150 00

  • GSK Investigational Site

    Prague, 160 00

  • GSK Investigational Site

    Prague, 190 00

  • GSK Investigational Site

    Znojmo

Other trials in Czechia

Russia14 sites

  • GSK Investigational Site

    Ivanteevka Moscow Region, 141280

  • GSK Investigational Site

    Moscow, 115 478

  • GSK Investigational Site

    Moscow, 115446

  • GSK Investigational Site

    Moscow, 119991

  • GSK Investigational Site

    Murmansk, 183046

  • GSK Investigational Site

    Novokuznetsk, 654063

  • GSK Investigational Site

    Novosibirsk, 630112

  • GSK Investigational Site

    Saint Petersburg, 191123

  • GSK Investigational Site

    Samara, 443079

  • GSK Investigational Site

    Saratov, 410010

  • GSK Investigational Site

    Tomsk, 634001

  • GSK Investigational Site

    Volgograd, 400130

  • GSK Investigational Site

    Yekaterinburg, 620085

  • GSK Investigational Site

    Yekaterinburg, 620109

Other trials in Russia

Slovakia13 sites

  • GSK Investigational Site

    Bratislava, 841 08

  • GSK Investigational Site

    Bratislava, 851 05

  • GSK Investigational Site

    Dlhá nad Oravou, 027 55

  • GSK Investigational Site

    Dolný Kubín, 026 01

  • GSK Investigational Site

    Dubnica nad Váhom, 018 41

  • GSK Investigational Site

    Nová Dubnica, 018 51

  • GSK Investigational Site

    Nové Mesto nad Váhom, 915 01

  • GSK Investigational Site

    Nové Zámky, 940 01

  • GSK Investigational Site

    Púchov, 020 01

  • GSK Investigational Site

    Ružomberok, 034 01

  • GSK Investigational Site

    Štúrovo, 943 01

  • GSK Investigational Site

    Šurany, 942 18

  • GSK Investigational Site

    Trenčín, 911 01

Other trials in Slovakia

Greece11 sites

  • GSK Investigational Site

    Arta, 471 00

  • GSK Investigational Site

    Athens, 115 22

  • GSK Investigational Site

    Athens, 115 27

  • GSK Investigational Site

    Athens, 25236

  • GSK Investigational Site

    Giannitsá, 581 00

  • GSK Investigational Site

    Karditsa, 43100

  • GSK Investigational Site

    Komotini, 69 100

  • GSK Investigational Site

    Ptolemaida, 50200

  • GSK Investigational Site

    Thessaloniki, 54636

  • GSK Investigational Site

    Tripoli, 22100

  • GSK Investigational Site

    Véria, 591 00

Other trials in Greece

Poland10 sites

  • GSK Investigational Site

    Bydgoszcz, 85-021

  • GSK Investigational Site

    Dębica, 39-200

  • GSK Investigational Site

    Krakow, 31-202

  • GSK Investigational Site

    Oleśnica, 56-400

  • GSK Investigational Site

    Poznan, 61-709

  • GSK Investigational Site

    Siemianowice Śląskie, 41-103

  • GSK Investigational Site

    Tarnów, 33-100

  • GSK Investigational Site

    Trzebnica, 55-100

  • GSK Investigational Site

    Wesoła, 05-077

  • GSK Investigational Site

    Wroclaw, 52-312

Other trials in Poland

Italy9 sites

  • GSK Investigational Site

    Alghero (SS), Sardinia, 07041

  • GSK Investigational Site

    Ferrara, Emilia-Romagna, 44100

  • GSK Investigational Site

    Florence, Tuscany, 50139

  • GSK Investigational Site

    Genoa, Liguria, 16132

  • GSK Investigational Site

    Milan, Lombardy, 20122

  • GSK Investigational Site

    Novara, Piedmont, 28100

  • GSK Investigational Site

    Ozieri (SS), Sardinia, 07014

  • GSK Investigational Site

    Quarto (NA), Campania, 80010

  • GSK Investigational Site

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Romania9 sites

  • GSK Investigational Site

    Brasov

  • GSK Investigational Site

    Bucharest, 050098

  • GSK Investigational Site

    Bucharest, 077190

  • GSK Investigational Site

    Bucharest, 20395

  • GSK Investigational Site

    Bucharest, 22102

  • GSK Investigational Site

    Cluj-Napoca, 400217

  • GSK Investigational Site

    Constanța, 900709

  • GSK Investigational Site

    Sibiu

  • GSK Investigational Site

    Timișoara, 300593

Other trials in Romania

Lithuania8 sites

  • GSK Investigational Site

    Alytus, LT-63164

  • GSK Investigational Site

    Kaunas, LT-48259

  • GSK Investigational Site

    Klaipėda, LT-94007

  • GSK Investigational Site

    Panevezys, LT-37355

  • GSK Investigational Site

    Šiauliai, LT-76346

  • GSK Investigational Site

    Vilnius, LT -10207

  • GSK Investigational Site

    Vilnius, LT-02169

  • GSK Investigational Site

    Vilnius, LT-11200

Other trials in Lithuania

Norway5 sites

  • GSK Investigational Site

    Bekkestua, 1319

  • GSK Investigational Site

    Moelv, N-2390

  • GSK Investigational Site

    Paradis, 5231

  • GSK Investigational Site

    Skien, N-03730

  • GSK Investigational Site

    Trondheim, N-7036

Other trials in Norway

Sweden5 sites

  • GSK Investigational Site

    Linköping, SE-581 85

  • GSK Investigational Site

    Malmö, 205 02

  • GSK Investigational Site

    Norrköping, SE-602 39

  • GSK Investigational Site

    Örebro, SE-702 11

  • GSK Investigational Site

    Umeå, SE-901 85

Other trials in Sweden

About this study

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

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.

Read the 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.

Being tested
Priorix-tetra™, Priorix™, Varilrix™
Medical subject headings
Chickenpox

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Priorix-tetra™Biological

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

  • Varilrix™Biological

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

Study groups in NCT00226499
Study groupRoleWhat they receive
MMRV GroupExperimentalSubjects 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).
Receives: Biological: Priorix-tetra™
OKAH GroupExperimentalSubjects 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.
Receives: Biological: Priorix™; Biological: Varilrix™
MMR GroupActive comparatorSubjects 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).
Receives: Biological: Priorix™

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (36)

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

    Confirmed varicella case: A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test [PCR (+)] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked [Epi (+)] to a valid index case. Moderately severe disease: 8-15 points; severe disease: ≥ 16 points (scored by IDMC using the modified Vázquez scale).

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

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

    Probable or confirmed varicella case = A case that met the clinical case definition (as determined by the IDMC) but was not laboratory confirmed [PCR (-)] AND was not epidemiologically linked [Epi (-)] to another probable or confirmed case.

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

  3. Phase A: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations

    Anti-VZV antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).

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

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

    Seronegative (S-) = Subjects with antibody concentration less than (<) 25 mIU/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration greater than or equal to (≥) 25 mIU/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.

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

  5. Phase A: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations in a Subset of Subjects

    Anti-measles antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).

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

  6. Phase A: Number of Subjects With Seroconversion/Seroresponse to Measles in a Subset of Subjects

    Seronegative (S-) = Subjects with antibody concentration < 150 mIU/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration ≥ 150 mIU/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.

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

  7. Phase A: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations in a Subset of Subjects

    Anti-mumps antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in units per milliliter (U/mL).

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

  8. Phase A: Number of Subjects With Seroconversion/Seroresponse to Mumps in a Subset of Subjects

    Seronegative (S-) = Subjects with antibody concentration < 231 U/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration ≥ 231 U/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.

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

  9. Phase A: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations in a Subset of Subjects

    Anti-rubella antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in International Units per milliliter (IU/mL).

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

  10. Phase A: Number of Subjects With a Seroconversion/Seroresponse to Rubella in a Subset of Subjects

    Seronegative (S-) = Subjects with antibody concentration < 4 IU/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration ≥ 4 IU/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.

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

  11. Phase A: Number of Subjects With Confirmed Cases of Herpes Zoster

    The number of subjects with confirmed cases of herpes zoster is reported.

    Measured: From Day 0 until the end of Phase A (Year 2)

  12. Phase A: Number of Subjects Reporting Fever

    All fever = Occurrence of any fever (measured rectally) regardless of its intensity grade or relationship to vaccination. Related = fever (measured rectally) assessed by the investigator to be causally related to the study vaccination. Medical Advice = seek for medical advice.

    Measured: Within 43 days (Day 0-42) post-vaccination period following each dose

  13. Phase A: Number of Subjects Reporting Fever

    All fever = Occurrence of any fever (measured rectally) regardless of its intensity grade or relationship to vaccination. Related fever = fever (measured rectally) assessed by the investigator to be causally related to the study vaccination. Medical Advice = seek for medical advice.

    Measured: Within 15 days (Day 0-14) post-vaccination period following each dose

  14. Phase A: Number of Subjects Reporting Solicited Local Symptoms

    Solicited local symptoms assessed were pain, redness and swelling. Any solicited local symptom = Occurrence of any local symptom regardless of their intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than (>) 20 mm.

    Measured: 4 days post-vaccination period following each dose

  15. Phase A: Number of Subjects Reporting Meningism

    Any = Occurrence of meningism regardless of its intensity grade. Grade 3 meningism = Prevented normal, everyday activities. Related = Assessed by the investigator to be causally related to the study vaccination.

    Measured: Within 43 days (Day 0-42) post-vaccination period following each dose

  16. Phase A: Number of Subjects Reporting Parotitis

    Any = Occurrence of parotitis regardless of its intensity grade. Grade 3 parotitis = Swelling with accompanying general symptoms. Related = Assessed by the investigator to be causally related to the study.

    Measured: Within 43 days (Day 0-42) post-vaccination period following each dose

  17. Phase A: Number of Subjects Reporting Rash

    Any = Occurrence of rash regardless of its intensity grade. Grade 3 rash = 101-500 lesions. Grade 4 rash = > 500 lesions. Related rash = Assessed by the investigator to be causally related to the study vaccination.

    Measured: Within 43 days (Day 0-42) post-vaccination period following each dose

  18. Phase A: Number of Subjects With Suspected Sign of Meningism Including Febrile Convulsions

    Any = Occurrence of meningism including febrile convulsions regardless of intensity grade.

    Measured: Within 43 days (Day 0-42) post-vaccination period following each dose

  19. Phase A: Number of Subjects Reporting Unsolicited Adverse Events (AEs)

    Unsolicited AE assessed included any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.

    Measured: Within 43 days (Day 0-42) post-vaccination period following each dose

  20. Phase A: Number of Subjects Reporting Serious Adverse Events (SAEs)

    SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalisation or prolongation of hospitalisation or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination.

    Measured: From Day 0 until the end of Phase A (Year 2)

  21. Phase A: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness

    Parameters assessed: 1. Number of hours lost from work by parents/guardians as a result of taking care of their child due to varicella. 2. Number of hours the child lost attendance in: day care/childminder, school, or in any extra-curricular activities (e.g. sports or recreation or any type of organised leisure activities) due to varicella. 3. Number of hours spent by a nurse, a babysitter or any type of existing paid caregiver to look after the child (if applicable).

    Measured: During Phase A (from Day 0 up to Year 2)

  22. Phase B: Number of Subjects With Confirmed Varicella Case

    Confirmed varicella case = A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test [PCR (+)] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked [Epi (+)] to a valid index case.

    Measured: From the beginning of Phase B (Year 2) up to study end (Year 10)

  23. Phase B: Number of Subjects With Moderate or Severe Confirmed Varicella Case

    Confirmed varicella case = A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test [PCR (+)] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked [Epi (+)] to a valid index case. Moderately severe disease = 8-15 points; severe disease: ≥ 16 points (scored by IDMC using the modified Vázquez scale).

    Measured: From the beginning of Phase B (Year 2) up to study end (Year 10)

  24. Phase B: Number of Subjects With Probable or Confirmed Varicella Case

    Probable or confirmed varicella = A case that met the clinical case definition (as determined by the IDMC) but was not laboratory confirmed [PCR (-)] AND was not epidemiologically linked [Epi (-)] to another probable or confirmed case.

    Measured: From the beginning of Phase B (Year 2) up to study end (Year 10)

  25. Phase B: Characteristics of Varicella Cases

    Varicella cases were characterized by type, number and character of lesions, duration of rash, incidence of fever, systemic signs, the assessment by investigator, complications, treatment, outcome and intensity of severity.

    Measured: From the beginning of Phase B (Year 2) up to study end (Year 10)

  26. Phase B: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations

    Anti-VZV antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).

    Measured: At Year 4, Year 6, Year 8 and Year 10 time points

  27. Phase B: Number of Subjects With Anti-VZV Antibody Concentrations Above the Cut-off Value

    The anti-VZV antibody concentration cut-off value assessed was greater than or equal to (≥) 25 mIU/mL, in the sera of subjects seronegative before vaccination.

    Measured: At Year 4, Year 6, Year 8 and Year 10 time points

  28. Phase B: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations

    Anti-measles antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).

    Measured: At Year 4, Year 6, Year 8 and Year 10 time points

  29. Phase B: Number of Subjects With Anti-measles Antibody Concentrations Above the Cut-off Value

    The anti-measles antibody concentration cut-off value assessed was ≥ 150 mIU/mL, in the sera of subjects seronegative before vaccination.

    Measured: At Year 4, Year 6, Year 8 and Year 10 time points

  30. Phase B: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations

    Anti-mumps antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in units per milliliter (U/mL).

    Measured: At Year 4, Year 6, Year 8 and Year 10 time points

  31. Phase B: Number of Subjects With Anti-mumps Antibody Concentrations Above the Cut-off Value

    The anti-mumps antibody concentration cut-off value assessed was ≥ 231 U/mL, in the sera of subjects seronegative before vaccination.

    Measured: At Year 4, Year 6, Year 8 and Year 10 time points

  32. Phase B: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations

    Anti-rubella antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in international units per milliliter (IU/mL).

    Measured: At Year 4, Year 6, Year 8 and Year 10 time points

  33. Phase B: Number of Subjects With Anti-rubella Antibody Concentrations Above the Cut-off Value

    The anti-rubella antibody concentration cut-off value assessed was ≥ 4 IU/mL, in the sera of subjects seronegative before vaccination.

    Measured: At Year 4, Year 6, Year 8 and Year 10 time points

  34. Phase B: Characteristics of Zoster Cases

    Zoster cases were characterized by number and character of lesions, duration of rash, incidence of fever, systemic signs, the assessment by investigator, complications, treatment, outcome and intensity of severity.

    Measured: From 6 weeks after Dose 2 until study end (Year 10)

  35. Phase B: Number of Subjects Reporting Serious Adverse Events (SAEs)

    SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalisation or prolongation of hospitalisation or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination.

    Measured: From the beginning of Phase B (Year 2) up to study end (Year 10)

  36. Phase B: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness

    Parameters assessed: 1. Number of hours lost from work by parents/guardians as a result of taking care of their child due to varicella. 2. Number of hours the child lost attendance in: day care/childminder, school, or in any extra-curricular activities (e.g. sports or recreation or any type of organised leisure activities) due to varicella. 3. Number of hours spent by a nurse, a babysitter or any type of existing paid caregiver to look after the child (if applicable).

    Measured: During Phase B

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2005 (estimated)
  2. Study start1 Sep 2005
  3. Primary completion12 Oct 2006
  4. Study completion12 Oct 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
5,803 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00226499
Sponsor's protocol ID
100388
Other IDs
104105 (EXT FU Y2), 103494 (EXT FU Y1), 104106 (EXT FU Y4-Y6-Y8-Y10), 2004-002676-41, 2004
Status last verified
Aug 2019
First submitted
23 Sep 2005
Last updated
23 Sep 2019
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

  • 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.

    PubMed 29224964

  • 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.

    PubMed 24485548

  • 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.

    PubMed 31345639

  • 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.

    PubMed 33736915

  • 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.

    PubMed 30765242

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Priorix-tetra™, Priorix™ and Varilrix™ in people with Varicella and Chickenpox Vaccines, run by GlaxoSmithKline at 104 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 104 sites in Czechia, Russia, Slovakia, Greece, Poland and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase A: Number of Subjects With Confirmed Varicella Case (time frame: From 42 days post dose 2 until the end of Phase A). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00226499, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.

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