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Phase 3 N=5,803 Randomized Quadruple-blind Prevention

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

Varicella · Chickenpox Vaccines

Enrolled (actual)
5,803
Serious AEs
26.5%
Results posted
Sep 2019
Primary outcome: Primary: Phase A: Number of Subjects With Confirmed Varicella Case — 37; 243; 201 Participants — p=<0.0001

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Priorix-tetra™ (Biological); Priorix™ (Biological); Varilrix™ (Biological)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
GlaxoSmithKline
Primary completion
Oct 2006

Outcome Measures

OutcomeResultp-value
PRIMARY
Phase A: Number of Subjects With Confirmed Varicella Case
37; 243; 201 <0.0001 sig
SECONDARY
Phase A: Number of Subjects With Moderate or Severe Confirmed Varicella Case
2; 37; 117 0.0001 sig
SECONDARY
Phase A: Number of Subjects With Probable or Confirmed Varicella Case
57; 260; 209 <0.0001 sig
SECONDARY
Phase A: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations
12.8; 12.7; 12.6; 116.1; 13.5; 13.1
SECONDARY
Phase A: Number of Subjects With Seroconversion/Seroresponse to VZV
26; 24; 4; 661; 21; 6
SECONDARY
Phase A: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations in a Subset of Subjects
75.7; 77.9; 77.9; 3961.0; 2602.7; 2817.4
SECONDARY
Phase A: Number of Subjects With Seroconversion/Seroresponse to Measles in a Subset of Subjects
2; 7; 2; 676; 682; 225
SECONDARY
Phase A: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations in a Subset of Subjects
117.5; 119.1; 118.1; 896.6; 925.0; 945.2
SECONDARY
Phase A: Number of Subjects With Seroconversion/Seroresponse to Mumps in a Subset of Subjects
4; 6; 2; 584; 613; 208
SECONDARY
Phase A: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations in a Subset of Subjects
2.1; 2.0; 2.1; 57.6; 74.0; 71.0
SECONDARY
Phase A: Number of Subjects With a Seroconversion/Seroresponse to Rubella in a Subset of Subjects
7; 5; 2; 688; 693; 230
SECONDARY
Phase A: Number of Subjects With Confirmed Cases of Herpes Zoster
0; 0; 0
SECONDARY
Phase A: Number of Subjects Reporting Fever
450; 354; 102; 328; 226; 69
SECONDARY
Phase A: Number of Subjects Reporting Fever
450; 354; 102; 328; 226; 69
SECONDARY
Phase A: Number of Subjects Reporting Solicited Local Symptoms
74; 83; 20; 1; 2; 0
SECONDARY
Phase A: Number of Subjects Reporting Meningism
1; 0; 0; 1; 0; 0
SECONDARY
Phase A: Number of Subjects Reporting Parotitis
4; 5; 1; 2; 1; 0
SECONDARY
Phase A: Number of Subjects Reporting Rash
82; 84; 30; 14; 15; 6
SECONDARY
Phase A: Number of Subjects With Suspected Sign of Meningism Including Febrile Convulsions
1; 0; 0; 0; 1; 0
SECONDARY
Phase A: Number of Subjects Reporting Unsolicited Adverse Events (AEs)
301; 303; 82; 239; 258; 90
SECONDARY
Phase A: Number of Subjects Reporting Serious Adverse Events (SAEs)
473; 480; 148
SECONDARY
Phase A: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness
31.5; 40.5; 48.1; 66.4; 49.5; 54.5
SECONDARY
Phase B: Number of Subjects With Confirmed Varicella Case
38; 225; 149 <0.0001 sig
SECONDARY
Phase B: Number of Subjects With Moderate or Severe Confirmed Varicella Case
6; 67; 176 <0.0001 sig
SECONDARY
Phase B: Number of Subjects With Probable or Confirmed Varicella Case
49; 237; 152 <0.0001 sig
SECONDARY
Phase B: Characteristics of Varicella Cases
38; 223; 148; 0; 2; 1
SECONDARY
Phase B: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations
501.3; 272.7; 32.4; 680.6; 417.6; 91.8
SECONDARY
Phase B: Number of Subjects With Anti-VZV Antibody Concentrations Above the Cut-off Value
1330; 1061; 73; 1289; 986; 97
SECONDARY
Phase B: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations
3290.9; 1803.5; 1724.4; 2795.9; 1727.7; 1369.0
SECONDARY
Phase B: Number of Subjects With Anti-measles Antibody Concentrations Above the Cut-off Value
407; 402; 131; 402; 218; 128
SECONDARY
Phase B: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations
1088.9; 905.3; 1059.1; 999.7; 920.5; 1030.3
SECONDARY
Phase B: Number of Subjects With Anti-mumps Antibody Concentrations Above the Cut-off Value
368; 357; 123; 360; 196; 127
SECONDARY
Phase B: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations
44.4; 50.8; 49.0; 30.1; 34.0; 33.3
SECONDARY
Phase B: Number of Subjects With Anti-rubella Antibody Concentrations Above the Cut-off Value
407; 408; 137; 402; 222; 136
SECONDARY
Phase B: Characteristics of Zoster Cases
4; 2; 0; 0; 0; 0
SECONDARY
Phase B: Number of Subjects Reporting Serious Adverse Events (SAEs)
290; 317; 93
SECONDARY
Phase B: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness
42.8; 44.6; 57.8; 40.7; 48.0; 57.2

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.

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:
  • 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.

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).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00226499). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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