2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), will be given to the subjects in this group. The vaccine will be administered subcutaneously in the triceps region of the left arm

2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), will be given to the subjects in this group. The vaccine will be administered subcutaneously in the triceps region of the left arm

2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm

VAR_HSA_F Group

2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), were given to the subjects in this group. The vaccine was administered subcutaneously in the triceps region of the left arm

VAR Group

Total

Sex: Female, Male

Race/Ethnicity, Customized

Fever was defined as axillary temperature above (>) 39.0 °C (> 102.2°F)

Number of Subjects Reporting Fever

Fever was defined as axillary temperature greater than or equal to (≥) 38.0°C (≥ 100.4°F)

Anti-VZY antibody concentrations were expressed in terms of Geometric Mean Concentrations (GMCs)

Evaluation of Immune Response to Varicella Vaccine With Respect to Anti Varicella Zoster Virus (Anti-VZV) Antibody Concentrations (Immuno-sub Cohort)

For VZV, seroresponse was defined as, post-vaccination anti-VZV antibody concentration ≥ 50 mIU/mL among subjects who were seronegative (antibody concentration below (< ) 25 mIU/mL) before vaccination

Number of Subjects With a Seroresponse to VZV (Immuno Sub Cohort)

Solicited local symptoms assessed were pain, injection site redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = subject crying when limb was moved or as spontaneously painful. Grade 3 redness and swelling = above (>) 20 mm

Number of Subjects Reporting Solicited Local Symptoms

Any fever (≥ 38°C) = occurrence of any fever regardless of its intensity grade or relationship to vaccination. Grade 3 fever = temperature > 39.5°C. Related fever = assessed by the investigator as causally related to study vaccination

Any rash = occurrence of the specified solicited general symptom regardless of its intensity. Grade 3 rash = rash which prevented normal, everyday activities. Related rash = assessed by the investigator as causally related to study vaccination

Number of Subjects Reporting Rash

Any febrile convulsion = occurrence of the specified solicited general symptom regardless of its intensity. Grade 3 febrile convulsion = febrile convulsion which prevented normal, everyday activities. Related febrile convulsion = assessed by the investigator as causally related to study vaccination

Number of Subjects Reporting Febrile Convulsions

Unsolicited AE covers 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

Number of Subjects Reporting Unsolicited Adverse Events (AEs)

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

Number of Subjects Reporting Serious Adverse Events (SAEs)

Overall Study

GSK Response Center

Chicken-pox Illness (Varicella Virus Disease)

Chickenpox

2 doses will be administered, one at Day 0 and the other at Day 42

Varilrix HSA-free

Varilrix™

GSK Investigational Site

A Safety and Immune Study of 2 Types of GlaxoSmithKline's Varicella Vaccines Given as a 2-doses Course to Healthy Children 12-23 Months of Age.

Safety and Immunogenicity Study of 2 Formulations of GSK Biologicals' Varicella Vaccines Given as a 2-dose Course in the Second Year of Life.

IPD is available via the Clinical Study Data Request site (click on the link provided below)

GlaxoSmithKline

Patients suffering from uveitis, who have vitrectomy performed for diagnostic purpose

Patients suffering from either "Epiretinal fibrosis" og "Macula hole" who have vitrectomy performed for curative reasons

Corpus vitreum (vitreus body) Aqua from the anterior champer Whole blood in dry container Whole blood in container containing EDTA Whole blood in QuantiFERON test KIT for tuberculosis Urine

Uveitis

Glostrup Hospital

Infectious Causes of Uveitis

Infectious Causes of Uveitis, With Special Focus on Infection With Leptospira

Steen Villumsen

MD, PhD

Statens Serum Institut

Glostrup University Hospital, Copenhagen

University of Copenhagen

Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 at 12 months of age.

Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 at 14 months of age.

Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 at 15 months of age.

Pediatric participants received ProQuad® Dose 1 at 9 months of age and ProQuad® Dose 2 90 days later at 12 months of age.

Arm 1: ProQuad® at 9 and 12 Months

Pediatric participants received ProQuad® Dose 1 at 11 months of age and ProQuad® Dose 2 90 days later at 14 months of age.

Arm 2: ProQuad® at 11 and 14 Months

Pediatric participants received ProQuad® Dose 1 at 12 months of age and ProQuad® Dose 2 90 days later at 15 months of age.

Arm 3: ProQuad® at 12 and 15 Months

Immunogenicity response rates were compared in participants with baseline seronegativity from Arm 2 (received ProQuad® Dose 1 at 11 months) and Arm 3 (received ProQuad® Dose 1 at 12 months). Measles, mumps and rubella antibody levels were determined using enzyme-linked immunosorbent assay (ELISA) and varicella antibody levels were determined with glycoprotein-based ELISA (gpELISA). Response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL.

Percentage of Participants in Arm 2 and Arm 3 Meeting Antibody Immunogenicity Response Criteria Following ProQuad® Dose 2

Immunogenicity response rates were compared in participants with baseline seronegativity from Arm 1 (received ProQuad® Dose 1 at 9 months) and Arm 3 (received ProQuad® Dose 1 at 12 months). Measles, mumps and rubella antibody levels were determined using ELISA and varicella antibody levels were determined with gpELISA. Response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL.

Percentage of Participants in Arm 1 and Arm 3 Meeting Antibody Immunogenicity Response Criteria Following ProQuad® Dose 2

The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 1.

Percentage of Participants With Solicited Injection-site Adverse Reactions

The percentage of participants with unsolicited injection-site reactions after ProQuad® Dose 1 was determined.

Percentage of Participants Experiencing Unsolicited Injection-site Adverse Reactions

The percentage of participants with systemic adverse events after ProQuad® Dose 1 was determined.

Percentage of Participants Experiencing a Systemic Adverse Event After ProQuad® Dose 1

The percentage of participants with a rectal (or rectal equivalent) temperature ≥ 39.4°C after ProQuad® Dose 1 was determined.

Percentage of Participants With Rectal (or Rectal Equivalent) Temperature ≥ 39.4°C

Antibody titres (GMT) to measles, mumps, rubella, and varicella were determined after the first ProQuad® dose in participants with seronegative baseline values. Baseline seronegativity criteria were as follows: measles antibody titre <255 mIU/mL; mumps antibody titre <10 ELISA Ab units mL; rubella antibody titre <10 IU/mL; and varicella antibody titre <1.25 gpELISA units/mL.

Geometric Mean Titres (GMT) to Measles, Mumps, Rubella, and Varicella After ProQuad® Dose 1

Antibody titres (GMT) to measles, mumps, rubella, and varicella were determined after the second ProQuad® dose in participants with seronegative baseline values. Baseline seronegativity criteria were as follows: measles antibody titre <255 mIU/mL; mumps antibody titre <10 ELISA Ab units mL; rubella antibody titre <10 IU/mL; and varicella antibody titre <1.25 gpELISA units/mL.

GMT to Measles, Mumps, Rubella, and Varicella After ProQuad® Dose 2

The percentage of participants with varicella antibody titre ≥ 1.25 gpELISA units/mL 6 weeks after each ProQuad® dose was determined.

Percentage of Participants With Varicella Antibody Titre ≥ 1.25 gpELISA Units/mL

The percentage of baseline seronegative participants meeting measles, mumps, rubella, and varicella antibody response criteria after the first ProQuad® dose was determined. Measles, mumps and rubella antibody levels were determined using ELISA and varicella antibody levels were determined with gpELISA. Response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL.

Percentage of Baseline Seronegative Participants Meeting Antibody Immunogenicity Response Criteria After ProQuad® Dose 1

The percentage of participants with rashes of interest after ProQuad® Dose 1 was determined. Rashes of interest consisted of measles-like rash, rubella-like rash, varicella-like rash, zoster-like rash, and mumps-like rash.

Percentage of Participants With Non-injection Site Rashes of Interest Following ProQuad® Dose 1

The percentage of participants with rashes of interest after receiving ProQuad® Dose 2 was determined. Rashes of interest consisted of measles-like rash, rubella-like rash, varicella-like rash, zoster-like rash, and mumps-like rash.

Percentage of Participants With Non-injection Site Rashes of Interest Following ProQuad® Dose 2

Senior Vice President, Global Clinical Development

Measles

Mumps

Rubella

Varicella

A 2-dose regimen of ProQuad® (0.5 mL per dose) given via subcutaneous injection into the deltoid muscle at a 3-month interval. Each dose contains measles virus Enders' Edmonston strain (live attenuated), mumps virus Jeryl Lynn™ (Level B) strain (live attenuated), rubella virus Wistar RA 27 or 3 strain (live attenuated), and varicella virus Oka or Merck strain (live attenuated).

ProQuad® manufactured with recombinant Human Albumin (rHA)

Comparative Study of Immunogenicity and Safety of a 2-dose Regimen of ProQuad® Manufactured With rHA (V221-038)

An Open-label, Randomised, Comparative, Multi-centre Study of the Immunogenicity and Safety of a 2-dose Regimen of ProQuad® Manufactured With rHA Administered to Healthy Children From 9 Months of Age

chickenpox/albumin

A Safety and Immune Study of 2 Types of GlaxoSmithKline's Varicella Vaccines Given as a 2-doses Course to Healthy Children 12-23 Months of Age.

Infectious Causes of Uveitis

Comparative Study of Immunogenicity and Safety of a 2-dose Regimen of ProQuad® Manufactured With rHA (V221-038)

Vispilnīgākā ārstniecības augu datu bāze, kuru atbalsta zinātne