Clinical Trial Results:
Open, multicenter, randomized, controlled phase IIIb study evaluating the immunogenicity and safety of subcutaneous versus intramuscular administration of GlaxoSmithKline Biologicals’ combined measles mumps rubella varicella vaccine (MeMuRu-OKA) to healthy children aged 11 to 21 months
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Summary
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EudraCT number |
2005-005944-22 |
Trial protocol |
DE |
Global end of trial date |
13 Dec 2006
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Results information
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Results version number |
v1(current) |
This version publication date |
10 Jul 2019
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First version publication date |
10 Jul 2019
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
106670
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00351923 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
GlaxoSmithKline Biologicals
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Sponsor organisation address |
Rue de l'Institut 89, Rixensart, Belgium, B-1330
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Public contact |
Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, +(44) 2089904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, +(44) 2089904466, GSKClinicalSupportHD@gsk.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
07 Feb 2008
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
13 Dec 2006
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Primary Objective: 1. To evaluate geometric mean titer (GMT) and seroconversion rate to varicella zoster virus (VZV) after intramuscular (IM) and subcutaneous (SC) injection of GlaxoSmithKline Biologicals' (GSK’s) combined measles-mumps-rubella-varicella (MeMuRu-OKA) vaccine. Secondary Objectives: 1. To evaluate the cell-mediated immunity (CMI) to varicella and measles after IM and SC injection of GSK’s MeMuRu-OKA vaccine. 2. To quantify the immediate vaccination pain after IM and SC injection of GSK’s MeMuRu-OKA vaccine. 3. To evaluate GMT and seroconversion rate to measles, mumps, and rubella, after IM and SC injection of GSK’s MeMuRu-OKA vaccine. 4. To evaluate incidence, nature and severity of local, general, and serious adverse events after IM and SC injection of GSK’s MeMuRu-OKA vaccine.
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Protection of trial subjects |
The subjects were observed closely for at least 30 minutes, with appropriate medical treatment readily available in case of a rare anaphylactic reaction following vaccine administration.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
23 Mar 2006
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Germany: 328
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Worldwide total number of subjects |
328
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EEA total number of subjects |
328
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
328
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
Out of 328 subjects enrolled in the study, only 318 completed the study. | ||||||||||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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IM Group | ||||||||||||||||||||||||||||||
Arm description |
Healthy male and female subjects aged between 11 and 21 months at the time of first vaccination, who received 2 doses of GlaxoSmithKline Biologicals’ combined measles mumps rubella varicella (MMRV) vaccine by intramuscular (IM) injection in the deltoid region of the left arm at Day 0 and Week 6. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Priorix-Tetra
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Subjects in the IM Group were administered 2 doses of the vaccine intramuscularly in the deltoid region of the left arm at Day 0 and Week 6.
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Arm title
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SC Group | ||||||||||||||||||||||||||||||
Arm description |
Healthy male and female subjects aged between 11 and 21 months at the time of first vaccination, who received 2 doses of GlaxoSmithKline Biologicals’ combined measles mumps rubella varicella (MMRV) vaccine by subcutaneous (SC) injection in the deltoid region of the left arm at Day 0 and Week 6. | ||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Priorix-Tetra
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder and solvent for solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Subjects in the SC Group were administered 2 doses of the vaccine subcutaneously in the deltoid region of the left arm at Day 0 and Week 6.
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Baseline characteristics reporting groups
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Reporting group title |
IM Group
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Reporting group description |
Healthy male and female subjects aged between 11 and 21 months at the time of first vaccination, who received 2 doses of GlaxoSmithKline Biologicals’ combined measles mumps rubella varicella (MMRV) vaccine by intramuscular (IM) injection in the deltoid region of the left arm at Day 0 and Week 6. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
SC Group
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Reporting group description |
Healthy male and female subjects aged between 11 and 21 months at the time of first vaccination, who received 2 doses of GlaxoSmithKline Biologicals’ combined measles mumps rubella varicella (MMRV) vaccine by subcutaneous (SC) injection in the deltoid region of the left arm at Day 0 and Week 6. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
IM Group
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Reporting group description |
Healthy male and female subjects aged between 11 and 21 months at the time of first vaccination, who received 2 doses of GlaxoSmithKline Biologicals’ combined measles mumps rubella varicella (MMRV) vaccine by intramuscular (IM) injection in the deltoid region of the left arm at Day 0 and Week 6. | ||
Reporting group title |
SC Group
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Reporting group description |
Healthy male and female subjects aged between 11 and 21 months at the time of first vaccination, who received 2 doses of GlaxoSmithKline Biologicals’ combined measles mumps rubella varicella (MMRV) vaccine by subcutaneous (SC) injection in the deltoid region of the left arm at Day 0 and Week 6. | ||
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End point title |
Percentage of seroconverted subjects with varicella zoster virus (VZV) antibody titer above or below cut-off value | |||||||||||||||
End point description |
Seroconversion was defined as the appearance of antibodies [i.e., antibody titre greater than or equal to (≥) the cut-off value of 1:4] in the serum of subjects seronegative before vaccination. A seronegative subject was one without detectable serum antibodies.
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End point type |
Primary
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End point timeframe |
At Week 12 (i.e. 42-56 days after administration of 2nd vaccine dose at Week 6)
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Statistical analysis title |
Statistical analysis 1 | |||||||||||||||
Statistical analysis description |
Non-inferiority of IM Group as compared to SC Group in terms of the difference in the percentage of subjects with anti-varicella titer above the specified cut off with its two-sided 95% CI in initially seronegative subjects.
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Comparison groups |
IM Group v SC Group
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Number of subjects included in analysis |
258
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [1] | |||||||||||||||
Method |
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Parameter type |
Difference in seroconversion rate (%) | |||||||||||||||
Point estimate |
0
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Confidence interval |
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level |
95% | |||||||||||||||
sides |
2-sided
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lower limit |
-4.1 | |||||||||||||||
upper limit |
5.04 | |||||||||||||||
| Notes [1] - Lower limit of the two-sided 95% CI for group difference in seroconversion rates for antibodies to varicella virus 42-56 days after the second dose between the IM Group and the SC Group (IM Group minus SC Group) should be equal to or above -5% (clinical limit for non-inferiority). |
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End point title |
Anti-VZV antibody titers | |||||||||||||||
End point description |
Antibody titer against VZV was determined by Immunofluorescence assay (IFA) and expressed as geometric mean titers (GMTs).
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End point type |
Secondary
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End point timeframe |
At Week 12 (i.e. 42-56 days after administration of 2nd vaccine dose at Week 6)
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| No statistical analyses for this end point | ||||||||||||||||
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End point title |
Frequency of varicella-specific Cluster of Differentiation 4 (CD4+) and CD8+ T-cell responses | ||||||||||||||||||||||||||||||||||||||||||
End point description |
Varicella-specific CD4+/CD8+ T-cells frequency was assessed by Flow cytometry in ex vivo stimulated peripheral blood mononuclear cells (PBMC) and expressed as positive cells per 10^6 PBMC. Tested cytokines were CD40 ligand (CD40L), interferon gamma (IFNγ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNFα).
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End point type |
Secondary
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End point timeframe |
At Week 12 (i.e. 42-56 days after administration of 2nd vaccine dose at Week 6)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||
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End point title |
Frequency of measles-specific CD4+ and CD8+ T-cell responses | ||||||||||||||||||||||||||||||||||||||||||
End point description |
Measles-specific CD4+/CD8+ T-cells frequency was assessed by Flow cytometry in ex vivo stimulated PBMC and expressed as positive cells per 10^6 PBMC. Tested cytokines were CD40 ligand (CD40L), interferon gamma (IFNγ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNFα).
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End point type |
Secondary
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End point timeframe |
At Week 12 (i.e. 42-56 days after administration of 2nd vaccine dose at Week 6)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||
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End point title |
Frequency of mumps-specific CD4+ and CD8+ T-cell responses | ||||||||||||||||||||||||||||||||||||||||||
End point description |
Mumps-specific CD4+/CD8+ T-cells frequency was assessed by Flow cytometry in ex vivo stimulated PBMC and expressed as positive cells per 10^6 PBMC. Tested cytokines were CD40 ligand (CD40L), interferon gamma (IFNγ), interleukin-2 (IL-2) and tumor necrosis factor alpha (TNFα).
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End point type |
Secondary
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End point timeframe |
At Week 12 (i.e. 42-56 days after administration of 2nd vaccine dose at Week 6)
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||
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End point title |
Percentage of seroconverted subjects anti-measles, anti-mumps and anti-rubella antibody titers above or below cut-off value | |||||||||||||||||||||
End point description |
Seroconversion was defined as the appearance of antibodies [i.e., antibody titre ≥ the cut-off value] in the serum of subjects seronegative before vaccination. A seronegative subject was one without detectable serum antibodies.
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End point type |
Secondary
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End point timeframe |
At Week 12 (i.e. 42-56 days after administration of 2nd vaccine dose at Week 6)
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Anti-measles, anti-mumps and anti-rubella antibody titers | |||||||||||||||||||||
End point description |
Antibody concentrations against measles, mumps and rubella were determined by Enzyme Linked Immonosorbent Assay (ELISA) and expressed as GMTs.
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End point type |
Secondary
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End point timeframe |
At Week 12 (i.e. 42-56 days after administration of 2nd vaccine dose at Week 6)
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Number of subjects with immediate vaccination pain assessed by scores on the Visual Analogue Scale (VAS) | |||||||||||||||||||||||||||||||||||||||
End point description |
Immediate vaccination pain was recorded by the investigator who administered the vaccine, immediately before each vaccination, on the VAS. Scores ranged from 1 (no pain) to 5 (worst pain).
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End point type |
Secondary
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End point timeframe |
Immediately before vaccination (i.e. at Day 0 and Week 6)
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of subjects with immediate vaccination pain assessed by scores on the VAS | |||||||||||||||||||||||||||||||||||||||
End point description |
Immediate vaccination pain was recorded by the investigator who administered the vaccine, within 30 seconds after each vaccination, on the VAS. Scores ranged from 1 (no pain) to 5 (worst pain).
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End point type |
Secondary
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End point timeframe |
30 seconds after each vaccination (i.e. at Day 0 and Week 6)
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of subjects with any and grade 3 solicited local adverse events (AEs) | |||||||||||||||||||||||||||||||||||||||||||||
End point description |
Assessed solicited local AEs included pain, redness and swelling at the injection site. Any = any solicited local AE irrespective of its intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness, swelling = affected area was >20 mm in diameter.
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End point type |
Secondary
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End point timeframe |
During the 4-day follow-up period after each vaccination
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of subjects with any, grade 3 and vaccine-related solicited general AEs | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Assessed solicited general AEs were fever, rash, parotid/salivary gland swelling and signs of meningism including febrile convulsions. Any = any solicited general AE irrespective of its intensity grade and relationship to vaccination. Any fever = any rectal temperature ≥ 38.0°C. Grade 3 fever = rectal temperature > 39.5°C. Any rash = any kind of skin eruption. Grade 3 rash = > 150 lesions. Grade 3 parotitis = swelling with accompanying general symptoms. Grade 3 febrile convulsions/meningism = febrile convulsions/meningism that prevented normal everyday activities. Related = AE considered by the investigator to have a causal relationship to vaccination.
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End point type |
Secondary
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End point timeframe |
During the 43-day follow-up period after each vaccination
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of subjects with any, grade 3 and vaccine-related unsolicited AEs | |||||||||||||||||||||||||||
End point description |
An unsolicited AE was any AE reported in addition to those solicited during the clinical study. Also, any “solicited” AE with onset outside the specified period of follow-up for solicited AEs was reported as an unsolicited AE. Any = any unsolicited AE irrespective of its intensity grade and relationship to vaccination. Grade 3 AE = AE that prevented normal activity. Related AE = AE considered by the investigator to be causally related to the study vaccination.
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End point type |
Secondary
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End point timeframe |
During the 43-day follow-up period after each vaccination
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||
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End point title |
Number of subjects with any serious adverse events (SAEs) | ||||||||||||
End point description |
SAE was defined as any untoward medical occurrence that resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity, required in-patient hospitalization or prolongation of existing hospitalization or was a congenital anomaly/birth defect in the offspring of a study subject. Any = any SAE irrespective of its intensity grade and relationship to vaccination.
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End point type |
Secondary
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End point timeframe |
Throughout the entire study period (Day 0 up to Week 12)
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Solicited local AEs: During the 4-day follow-up period after each vaccination; Solicited general AEs and unsolicited AEs: During the 43-day follow-up period after each vaccination; SAEs: During the entire study period (Day 0 up to Week 12).
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Adverse event reporting additional description |
Total Number (#) of Participants Affected by Other (non-serious) AEs was analyzed separately for expected & unexpected AEs. Performing consolidated analysis was not technically possible & the relevant data is no longer available. Total #Participants Affected in Other AEs Table is currently populated by the highest value of #Participants affected.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
10.1
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Reporting groups
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Reporting group title |
IM Group
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Reporting group description |
Healthy male and female subjects aged between 11 and 21 months at the time of first vaccination, who received 2 doses of MMRV vaccine by intramuscular (IM) injection in the deltoid region of the left arm at Day 0 and Week 6. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
SC Group
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Reporting group description |
Healthy male and female subjects aged between 11 and 21 months at the time of first vaccination, who received 2 doses of MMRV vaccine by subcutaneous (SC) injection in the deltoid region of the left arm at Day 0 and Week 6. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Notes [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: Assessment for this event was done in subjects with available results. |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
