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Valganciclovir Therapy in Infants and Children With Congenital CMV Infection and Hearing Loss

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01649869
Recruitment Status : Completed
First Posted : July 25, 2012
Results First Posted : June 2, 2021
Last Update Posted : June 2, 2021
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Cytomegalovirus Infection
Interventions Other: Placebo
Drug: Valganciclovir
Enrollment 54
Recruitment Details For this study, subjects were enrolled once they signed the informed consent form (ICF). It was not until after hearing loss was confirmed by audiology testing and confirmation of congenital CMV by dried blood spot that a subject was randomized and started on study drug. This reduced protocol enrollment from 54 to 35.
Pre-assignment Details  
Arm/Group Title Placebo Active
Hide Arm/Group Description

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks

Placebo: Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive valganciclovir HCl 16.0 mg/kg orally twice a day for 6 weeks

Valganciclovir: Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks.

Period Title: Overall Study
Started 18 17
Completed 16 16
Not Completed 2 1
Reason Not Completed
Family member illness             1             0
Required treatment outside protocol             1             0
Severe hearing loss borderline eligible             0             1
Arm/Group Title Placebo Active Total
Hide Arm/Group Description

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks

Placebo: Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive valganciclovir HCl 16.0 mg/kg orally twice a day for 6 weeks

Valganciclovir: Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 18 17 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  MONTHS
Number Analyzed 18 participants 17 participants 35 participants
19.5  (13.1) 17.8  (15.8) 18.7  (14.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 35 participants
Female
8
  44.4%
6
  35.3%
14
  40.0%
Male
10
  55.6%
11
  64.7%
21
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 35 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
17
  94.4%
15
  88.2%
32
  91.4%
Unknown or Not Reported
1
   5.6%
2
  11.8%
3
   8.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 35 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   5.6%
2
  11.8%
3
   8.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  11.1%
2
  11.8%
4
  11.4%
White
15
  83.3%
12
  70.6%
27
  77.1%
More than one race
0
   0.0%
1
   5.9%
1
   2.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants 17 participants 35 participants
United States 7 4 11
United Kingdom 11 13 24
1.Primary Outcome
Title Number of Ears That Had (1) Improved Hearing or no Change in Hearing (2) Worsened Hearing.
Hide Description A single, independent study audiologist who is masked (blinded) to treatment assignment will assess the audiology test battery for each subject and assign the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications will be assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. At the analyses stage, the "best ear" classification for the subject at that study visit will be determined; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification will be mild hearing loss. Not both ears are evaluable for all subjects. In some subjects, only one ear is evaluable.
Time Frame Day 1 through Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active
Hide Arm/Group Description:

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks

Placebo: Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive valganciclovir HCl 16.0 mg/kg orally twice a day for 6 weeks

Valganciclovir: Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks.

Overall Number of Participants Analyzed 16 15
Overall Number of Units Analyzed
Type of Units Analyzed: Ears
28 26
Measure Type: Number
Unit of Measure: Ears
Improve + no change 27 20
Worsened 1 6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0859
Comments [Not Specified]
Method Generalized linear model
Comments Generalized linear model for binary outcome based on generalized estimating equations.
2.Secondary Outcome
Title Number of Best Ear That Had (1) Improved Hearing or no Change in Hearing (2) Worsened Hearing [ex. Improved+ no Change (Normal to Normal) Versus Other].
Hide Description A single, independent study audiologist who is masked (blinded) to treatment assignment will assess the audiology test battery for each subject and assign the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications will be assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. At the analyses stage, the "best ear" classification for the subject at that study visit will be determined; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification will be mild hearing loss. For this outcome, we combine the improved hearing and no change for the special case only of normal to normal. Other category include worsened and no change from (1) mild to mild hearing loss, (2) moderate to moderate hearing loss, or (3) severe to severe hearing loss.
Time Frame Day 1 through Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active
Hide Arm/Group Description:

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks

Placebo: Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive valganciclovir HCl 16.0 mg/kg orally twice a day for 6 weeks

Valganciclovir: Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks.

Overall Number of Participants Analyzed 15 12
Measure Type: Number
Unit of Measure: Participants
Improved + normal to normal 9 6
No change abnormal or worsened 6 6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7068
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Change in Best Ear Hearing Assessments [Improved Versus Other] Between Baseline and Study Month 6.
Hide Description A single, independent study audiologist who is masked (blinded) to treatment assignment will assess the audiology test battery for each subject and assign the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications will be assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. At the analyses stage, the "best ear" classification for the subject at that study visit will be determined; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification will be mild hearing loss.
Time Frame Day 1 through Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active
Hide Arm/Group Description:

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks

Placebo: Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive valganciclovir HCl 16.0 mg/kg orally twice a day for 6 weeks

Valganciclovir: Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks.

Overall Number of Participants Analyzed 15 12
Measure Type: Number
Unit of Measure: Participants
Improved 0 0
No change or worsened 15 12
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Change in Best Ear Hearing Assessments [Worse + no Change (Abnormal to Abnormal) Versus Other] Between Baseline and Study Month 6.
Hide Description A single, independent study audiologist who is masked (blinded) to treatment assignment will assess the audiology test battery for each subject and assign the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications will be assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. At the analyses stage, the "best ear" classification for the subject at that study visit will be determined; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification will be mild hearing loss.
Time Frame Day 1 through Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active
Hide Arm/Group Description:

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks

Placebo: Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive valganciclovir HCl 16.0 mg/kg orally twice a day for 6 weeks

Valganciclovir: Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks.

Overall Number of Participants Analyzed 15 12
Measure Type: Number
Unit of Measure: Participants
No change abnormal to abnormal + worsened 6 6
Improved + normal to normal 9 6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7068
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Change in Best Ear Hearing Assessments [Worse Versus Other] Between Baseline and Study Month 6.
Hide Description A single, independent study audiologist who is masked (blinded) to treatment assignment will assess the audiology test battery for each subject and assign the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications will be assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. At the analyses stage, the "best ear" classification for the subject at that study visit will be determined; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification will be mild hearing loss.
Time Frame Day 1 through Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active
Hide Arm/Group Description:

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks

Placebo: Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive valganciclovir HCl 16.0 mg/kg orally twice a day for 6 weeks

Valganciclovir: Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks.

Overall Number of Participants Analyzed 15 12
Measure Type: Number
Unit of Measure: Participants
Worsened 0 3
Other 15 9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0752
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
6.Secondary Outcome
Title Change in Total Ear Hearing Assessments [Improved Versus Other] Between Baseline and Study Month 6.
Hide Description A single, independent study audiologist who is masked (blinded) to treatment assignment will assess the audiology test battery for each subject and assign the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications will be assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. At the analyses stage, the "best ear" classification for the subject at that study visit will be determined; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification will be mild hearing loss.
Time Frame Day 1 through Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active
Hide Arm/Group Description:

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks

Placebo: Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive valganciclovir HCl 16.0 mg/kg orally twice a day for 6 weeks

Valganciclovir: Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks.

Overall Number of Participants Analyzed 16 15
Overall Number of Units Analyzed
Type of Units Analyzed: Ears
28 26
Measure Type: Number
Unit of Measure: Ears
Improved 0 0
Other 28 26
7.Secondary Outcome
Title Change in Total Ear Hearing Assessments [Worse+ no Change (Abnormal to Abnormal) Versus Other] Between Baseline and Study Month 6.
Hide Description A single, independent study audiologist who is masked (blinded) to treatment assignment will assess the audiology test battery for each subject and assign the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications will be assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. At the analyses stage, the "best ear" classification for the subject at that study visit will be determined; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification will be mild hearing loss.
Time Frame Day 1 through Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active
Hide Arm/Group Description:

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks

Placebo: Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive valganciclovir HCl 16.0 mg/kg orally twice a day for 6 weeks

Valganciclovir: Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks.

Overall Number of Participants Analyzed 16 15
Overall Number of Units Analyzed
Type of Units Analyzed: Ears
28 26
Measure Type: Number
Unit of Measure: Ears
worse + no change (abnormal to abnormal) 19 20
Other 9 6
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4823
Comments [Not Specified]
Method Generalized linear model
Comments Generalized linear model for binary outcome using generalized estimating equations.
8.Secondary Outcome
Title Change in Total Ear Hearing Assessments [Worse Versus Other] Between Baseline and Study Month 6.
Hide Description A single, independent study audiologist who is masked (blinded) to treatment assignment will assess the audiology test battery for each subject and assign the classifications of normal hearing, mild hearing loss, moderate hearing loss, or severe hearing loss based upon their hearing thresholds (in decibels). The classifications will be assigned by ear (one for the left ear and one for the right ear), giving "total ear" classifications. At the analyses stage, the "best ear" classification for the subject at that study visit will be determined; for example, if a subject had mild hearing loss in their left ear and severe hearing loss in their right ear, then the "best ear" classification will be mild hearing loss.
Time Frame Day 1 through Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active
Hide Arm/Group Description:

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks

Placebo: Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive valganciclovir HCl 16.0 mg/kg orally twice a day for 6 weeks

Valganciclovir: Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks.

Overall Number of Participants Analyzed 16 15
Overall Number of Units Analyzed
Type of Units Analyzed: Ears
28 26
Measure Type: Number
Unit of Measure: Ears
Worsened 1 6
Other 27 20
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0859
Comments [Not Specified]
Method Generalized linear model
Comments Generalized linear model for binary outcome using generalized estimating equations.
9.Secondary Outcome
Title Association of Change in Viral Load (Blood) With Change in Total Ear Hearing at 6 Months
Hide Description Analysis of actual viral load was done using log base 10 transformation. Undetectable viral load value was replaced by a value of 10. A summary measure of the viral load over time considers all time points available by calculating the average area under the curve (AUC) (trapezoidal rule) applied to the log base 10 viral load. Average is based on the maximum period of time with viral load data for a given subject. The average or standardize AUC units is therefore the original AUC units of log 10 copies/ml*days divided by days in study which equals log 10 copies/ml.
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was stratified by hearing outcome--total analyzed is the sum of the number analyzed for 2 rows below
Arm/Group Title Randomized Group
Hide Arm/Group Description:
Randomized children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks
Overall Number of Participants Analyzed 31
Overall Number of Units Analyzed
Type of Units Analyzed: Ears
54
Mean (Standard Deviation)
Unit of Measure: log 10 copies/ml
Improved + normal to normal Number Analyzed 15 Ears
1.396  (0.542)
No change abnormal + worsened Number Analyzed 39 Ears
1.326  (0.566)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Randomized Group
Comments [Not Specified]
Type of Statistical Test Other
Comments Association of binary outcome and continuous outcome
Statistical Test of Hypothesis P-Value 0.8212
Comments [Not Specified]
Method Generalized linear model
Comments For binary outcome using generalized estimating equations
10.Secondary Outcome
Title Association of Change in Viral Load (Saliva) With Change in Total Ear Hearing at 6 Months
Hide Description Analysis of actual viral load was done using log base 10 transformation. Undetectable viral load value was replaced by a value of 10. A summary measure of the viral load over time considers all time points available by calculating the average area under the curve (AUC) (trapezoidal rule) applied to the log base 10 viral load. Average is based on the maximum period of time with viral load data for a given subject. The average or standardize AUC units is therefore the original AUC units or log 10 copies/ml*days divided by days in study which equals log 10 copies/ml.
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis stratified by hearing outcome--total analyzed is the sum of the number analyzed for 2 rows belos
Arm/Group Title Randomized Group
Hide Arm/Group Description:
Randomized children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks
Overall Number of Participants Analyzed 31
Overall Number of Units Analyzed
Type of Units Analyzed: Ears
54
Mean (Standard Deviation)
Unit of Measure: log 10 copies/ml
Improved + normal to normal Number Analyzed 15 Ears
2.447  (1.715)
No change abnormal + worsened Number Analyzed 39 Ears
2.290  (1.349)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Randomized Group
Comments [Not Specified]
Type of Statistical Test Other
Comments Association of binary outcome and continuous outcome and continuous outcome
Statistical Test of Hypothesis P-Value 0.8356
Comments [Not Specified]
Method Generalized linear model
Comments Generalized linear model for binary outcome using generalized estimating equations.
11.Secondary Outcome
Title Association of Change in Viral Load (Urine) With Change in Total Ear Hearing at 6 Months
Hide Description Analysis of actual viral load was done using log base 10 transformation. Undetectable viral load value was replaced by a value of 10. A summary measure of the viral load over time considers all time points available by calculating the average area under the curve (AUC) (trapezoidal rule) applied to the log base 10 viral load. Average is based on the maximum period of time with viral load data for a given subject. The average or standardize AUC units is therefore the original AUC units of log 10 copies/ml*days divided by days in study which equals log 10 copies/ml.
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis stratified by hearing outcome--total analyzed is the sum of the number analyzed for 2 rows below
Arm/Group Title Randomized Group
Hide Arm/Group Description:
Randomized children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks
Overall Number of Participants Analyzed 29
Overall Number of Units Analyzed
Type of Units Analyzed: Ears
50
Mean (Standard Deviation)
Unit of Measure: log 10 copies/ml
Improved + normal to normal Number Analyzed 15 Ears
3.562  (1.139)
No change abnormal + worsened Number Analyzed 35 Ears
3.583  (1.370)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Randomized Group
Comments [Not Specified]
Type of Statistical Test Other
Comments Association of binary outcome and continuous outcome
Statistical Test of Hypothesis P-Value 0.7961
Comments [Not Specified]
Method Generalized linear model
Comments Generalized linear model for binary outcome using generalized estimating equations
12.Secondary Outcome
Title Association of Change in Viral Load (Blood) With Change in Best Ear Hearing at 6 Months
Hide Description Analysis of actual viral load was done using log base 10 transformation. Undetectable viral load value was replaced by a value of 10. A summary measure of the viral load over time considers all time points available by calculating the average area under the curve (AUC) (trapezoidal rule) applied to the log base 10 viral load. Average is based on the maximum period of time with viral load data for a given subject. The average or standardize AUC units is therefore the original AUC units of log 10 copies/ml*days divided by days in study which equals log 10 copies/ml.
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis stratified by hearing outcome--total analyzed is the sum of the number analyzed for 2 rows below
Arm/Group Title Randomized Group
Hide Arm/Group Description:
Randomized children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks
Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: log 10 copies/ml
Improved + normal to normal Number Analyzed 15 participants
1.396  (0.542)
No change abnormal + worsened Number Analyzed 12 participants
1.359  (0.668)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Randomized Group
Comments [Not Specified]
Type of Statistical Test Other
Comments Association of binary outcome and continuous outcome
Statistical Test of Hypothesis P-Value 0.8675
Comments [Not Specified]
Method Generalized linear model
Comments Generalized linear model for binary outcome
13.Secondary Outcome
Title Association of Change in Viral Load (Saliva) With Change in Best Ear Hearing at 6 Months
Hide Description Analysis of actual viral load was done using log base 10 transformation. Undetectable viral load value was replaced by a value of 10. A summary measure of the viral load over time considers all time points available by calculating the average area under the curve (AUC) (trapezoidal rule) applied to the log base 10 viral load. Average is based on the maximum period of time with viral load data for a given subject. The average or standardize AUC units is therefore the original AUC units of log 10 copies/ml*days divided by days in study which equals log 10 copies/ml.
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis stratified by hearing outcome--total analyzed is the sum of the number analyzed for 2 rows below
Arm/Group Title Randomized Group
Hide Arm/Group Description:
Randomized children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks
Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: log 10 copies/ml
Improved + normal to normal Number Analyzed 15 participants
2.447  (1.715)
No change abnormal + worsened Number Analyzed 12 participants
2.423  (1.484)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Randomized Group
Comments [Not Specified]
Type of Statistical Test Other
Comments Association of binary outcome and continuous outcome
Statistical Test of Hypothesis P-Value 0.9682
Comments [Not Specified]
Method Generalized linear model
Comments Generalized linear model for binary outcome
14.Secondary Outcome
Title Association of Change in Viral Load (Urine) With Change in Best Ear Hearing at 6 Months
Hide Description Analysis of actual viral load was done using log base 10 transformation. Undetectable viral load value was replaced by a value of 10. A summary measure of the viral load over time considers all time points available by calculating the average area under the curve (AUC) (trapezoidal rule) applied to the log base 10 viral load. Average is based on the maximum period of time with viral load data for a given subject. The average or standardize AUC units is therefore the original AUC units of log 10 copies/ml*days divided by days in study which equals log 10 copies/ml.
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis stratified by hearing outcome--total analyzed is the sum of the number of analyzed for 2 rows below
Arm/Group Title Randomized Group
Hide Arm/Group Description:
Randomized children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: log 10 copies/ml
Improved + normal to normal Number Analyzed 15 participants
3.562  (1.139)
No change abnormal + worsened Number Analyzed 10 participants
3.831  (1.570)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Randomized Group
Comments [Not Specified]
Type of Statistical Test Other
Comments Association of binary outcome and continuous outcome
Statistical Test of Hypothesis P-Value 0.6063
Comments [Not Specified]
Method Generalized linear model
Comments Generalized linear model for binary outcome
15.Secondary Outcome
Title Detection of Viruria (Urine) by PCR Six Weeks After Trial Entry
Hide Description Each subject either has positive or negative PCR results. Virus is detected if the PCR is positive.
Time Frame At 6 weeks (Day 42)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active
Hide Arm/Group Description:

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks

Placebo: Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive valganciclovir HCl 16.0 mg/kg orally twice a day for 6 weeks

Valganciclovir: Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks.

Overall Number of Participants Analyzed 12 12
Measure Type: Number
Unit of Measure: Participants
Positive 11 1
Negative 1 11
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
16.Secondary Outcome
Title Detection of Viruria (Urine) by PCR Six Month After Trial Entry
Hide Description Each subject either has positive or negative PCR results. Virus is detected if the PCR is positive.
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active
Hide Arm/Group Description:

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks

Placebo: Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive valganciclovir HCl 16.0 mg/kg orally twice a day for 6 weeks

Valganciclovir: Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks.

Overall Number of Participants Analyzed 11 14
Measure Type: Number
Unit of Measure: Participants
Positive 10 11
Negative 1 3
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6043
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
17.Secondary Outcome
Title Detection of Viremia (Blood) by PCR Six Weeks After Trial Entry
Hide Description Each subject either has positive or negative PCR results. Virus is detected if the PCR is positive.
Time Frame At 6 weeks (Day 42)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active
Hide Arm/Group Description:

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks

Placebo: Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive valganciclovir HCl 16.0 mg/kg orally twice a day for 6 weeks

Valganciclovir: Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks.

Overall Number of Participants Analyzed 15 14
Measure Type: Number
Unit of Measure: Participants
Positive 4 2
Negative 11 12
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6513
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
18.Secondary Outcome
Title Detection of Viremia (Blood) by PCR Six Month After Trial Entry
Hide Description Each subject either has positive or negative PCR results. Virus is detected if the PCR is positive.
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active
Hide Arm/Group Description:

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks

Placebo: Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive valganciclovir HCl 16.0 mg/kg orally twice a day for 6 weeks

Valganciclovir: Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks.

Overall Number of Participants Analyzed 15 15
Measure Type: Number
Unit of Measure: Participants
Positive 4 3
Negative 11 12
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
19.Secondary Outcome
Title Detection of CMV in Saliva by PCR Six Weeks After Trial Entry
Hide Description Each subject either has positive or negative PCR results. Virus is detected if the PCR is positive.
Time Frame At 6 weeks (Day 42)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active
Hide Arm/Group Description:

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks

Placebo: Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive valganciclovir HCl 16.0 mg/kg orally twice a day for 6 weeks

Valganciclovir: Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks.

Overall Number of Participants Analyzed 16 16
Measure Type: Number
Unit of Measure: Participants
Positive 9 3
Negative 7 13
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0659
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
20.Secondary Outcome
Title Detection of CMV in Saliva PCR Six Month After Trial Entry
Hide Description Each subject either has positive or negative PCR results. Virus is detected if the PCR is positive.
Time Frame At 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Active
Hide Arm/Group Description:

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks

Placebo: Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive valganciclovir HCl 16.0 mg/kg orally twice a day for 6 weeks

Valganciclovir: Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks.

Overall Number of Participants Analyzed 16 16
Measure Type: Number
Unit of Measure: Participants
Positive 8 7
Negative 8 9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Active
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
21.Secondary Outcome
Title The Quantitative Log Change in Viremia From Baseline to Month 6.
Hide Description The quantitative change (Month 6 minus baseline) in viremia (blood) Quantitative viral load by PCR in log 10 units measured in urine after 6 weeks of therapy; if undetectable, viral load is assigned a value of 10 (1 in log 10 units).
Time Frame Baseline to month 6
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed=34: 17 active and 17 placebo
Arm/Group Title Randomized Group
Hide Arm/Group Description:
Randomized children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks
Overall Number of Participants Analyzed 34
Least Squares Mean (95% Confidence Interval)
Unit of Measure: log10 IU/ml
Active Number Analyzed 17 participants
0.4908
(0.08108 to 0.9005)
Placebo Number Analyzed 17 participants
-0.1528
(-0.5721 to 0.2664)
22.Secondary Outcome
Title The Quantitative Log Reduction in Viruria Detected After 6 Weeks of Therapy
Hide Description The quantitative log reduction in viruria (urine) detected after 6 weeks of therapy. Quantitative viral load by PCR in log 10 units measured in urine after 6 weeks of therapy; if undetectable, viral load is assigned a value of 10 (1 in log 10 units)
Time Frame Baseline thru months 6
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed=28: 15 active and 13 placebo
Arm/Group Title Randomized Group
Hide Arm/Group Description:
Randomized children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks
Overall Number of Participants Analyzed 28
Least Squares Mean (95% Confidence Interval)
Unit of Measure: log10 IU/ml
Active Number Analyzed 15 participants
1.2152
(0.5274 to 1.9029)
Placebo Number Analyzed 13 participants
0.8390
(-0.05057 to 1.7286)
23.Secondary Outcome
Title The Quantitative Log Reduction in CMV in Saliva Detected After 6 Weeks of Therapy
Hide Description The quantitative log reduction in CMV in saliva (urine) detected after 6 weeks of therapy. Quantitative viral load by PCR in log 10 units measured in urine after 6 weeks of therapy; if undetectable, viral load is assigned a value of 10 (1 in log 10 units)
Time Frame Baseline thru months 6
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed=34
Arm/Group Title Randomized Group
Hide Arm/Group Description:
Randomized children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks
Overall Number of Participants Analyzed 34
Least Squares Mean (95% Confidence Interval)
Unit of Measure: log10 IU/ml
Active Number Analyzed 17 participants
1.3202
(0.6894 to 1.9509)
Placebo Number Analyzed 17 participants
0.0057
(-0.6395 to 0.6508)
24.Secondary Outcome
Title Number of Adverse Events in the Active Group That Resulted in Discontinuation of Valganciclovir
Hide Description AE resulting in discontinuation of valganciclovir (active group only). This outcome summarizes the number of adverse events (AEs) that resulted in the discontinuation of valganciclovir in the active group only.
Time Frame Day 1 thru day 70
Hide Outcome Measure Data
Hide Analysis Population Description
No participants in the active group were discontinued due to adverse event.
Arm/Group Title Randomized Group
Hide Arm/Group Description:
Randomized children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive valganciclovir orally twice a day for 6 weeks
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: Participants
No 17
Yes 0
25.Secondary Outcome
Title Adverse Event (AE) Resulting in Unresolved Outcome
Hide Description Adverse event resulting in unresolved outcome. This outcome summarizes the number of adverse events (AEs) that resulted in unresolved outcome of that AE.
Time Frame Day 1 thru day 70
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed=18
Arm/Group Title Placebo Active
Hide Arm/Group Description:

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks

Placebo: Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive valganciclovir HCl 16.0 mg/kg orally twice a day for 6 weeks

Valganciclovir: Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks.

Overall Number of Participants Analyzed 18 17
Measure Type: Number
Unit of Measure: Participants
No 18 17
Yes 0 0
26.Secondary Outcome
Title Adverse Event (AE) Resulting in Unanticipated Medically Attended Visit
Hide Description Adverse event resulting in unanticipated medically attended visit. This outcome summarizes the number of adverse events (AEs) that resulted in the unanticipated medically attended visit.
Time Frame Day 1 thru day 70
Hide Outcome Measure Data
Hide Analysis Population Description
Overall number of participants analyzed=18
Arm/Group Title Placebo Active
Hide Arm/Group Description:

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks

Placebo: Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive valganciclovir HCl 16.0 mg/kg orally twice a day for 6 weeks

Valganciclovir: Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks.

Overall Number of Participants Analyzed 18 17
Measure Type: Number
Unit of Measure: Participants
No 15 17
Yes 3 0
Time Frame All AEs and SAEs from Study Day 1 through four weeks following the last dose of study drug. All AEs and SAEs will be followed until resolution, even if this extends beyond the study reporting period. Resolution of an AE is defined as the return to pretreatment status or stabilization of the condition with the expectation that it will remain chronic.
Adverse Event Reporting Description Any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of medicinal (investigational) product whether or not considered drug related. The occurrence of an AE may come to the attention of study personnel during study visits and interviews of a study recipient presenting for medical care, or upon review by a study monitor.
 
Arm/Group Title Placebo Active
Hide Arm/Group Description

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive placebo orally twice a day for 6 weeks

Placebo: Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks

27 Children between 1 month and 3 years of age (up to 4th birthday) with sensoneural hearing loss and documented CMV infection will receive valganciclovir HCl 16.0 mg/kg orally twice a day for 6 weeks

Valganciclovir: Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks.

All-Cause Mortality
Placebo Active
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)      0/17 (0.00%)    
Hide Serious Adverse Events
Placebo Active
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      1/17 (5.88%)    
Respiratory, thoracic and mediastinal disorders     
Respiratory Distress  1  0/18 (0.00%)  0 1/17 (5.88%)  1
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Active
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/35 (51.43%)      17/35 (48.57%)    
Blood and lymphatic system disorders     
Decrease in hemoglobin  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Neutropenia  1  2/18 (11.11%)  4 1/17 (5.88%)  1
Monocytopenia  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Ear and labyrinth disorders     
Bilateral ear infection  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Otitis Media  1  1/18 (5.56%)  1 1/17 (5.88%)  1
Ear Infection  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Gastrointestinal disorders     
Constipation  1  2/18 (11.11%)  3 1/17 (5.88%)  1
Diarrhoea  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Emesis  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Gastroenteritis  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Loose stools  1  1/18 (5.56%)  2 0/17 (0.00%)  0
Reduced Appetite  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Reflux  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Teething  1  2/18 (11.11%)  2 2/17 (11.76%)  2
Viral Gastroenteritis  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Vomiting  1  2/18 (11.11%)  5 4/17 (23.53%)  4
Weight Loss  1  0/18 (0.00%)  0 1/17 (5.88%)  1
General disorders     
Fall on chin  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Fever  1  3/18 (16.67%)  3 1/17 (5.88%)  1
Hyperkalemia  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Long Sighted  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Nose Bleed  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Pyrexia  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Raised Temperature  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Infections and infestations     
Chicken Pox  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Hand, Foot and Mouth Disease  1  1/18 (5.56%)  1 1/17 (5.88%)  1
Infection at Surgical Incision Site  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Rhinitis  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Tonsillitis  1  1/18 (5.56%)  1 1/17 (5.88%)  1
Viral Illness  1  2/18 (11.11%)  3 1/17 (5.88%)  1
Injury, poisoning and procedural complications     
Head, Eye and Right Arm Injury--Suspected trauma to lacrimal sac.  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Minor Injury--Bruise Right Eye and Cheek and Left Forehead  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Musculoskeletal and connective tissue disorders     
Buckle Fracture of Right Tibia and Fibula  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Osteopenia  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Psychiatric disorders     
Agitation  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Crying since first dose  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Fussiness  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Hallucination-Nightmare  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Intermittent Hyperactivity  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Lethargic and Sleeping more than usual  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Screaming--Unsettled  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Renal and urinary disorders     
Blood in Urine  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Protein in Urine  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Urinary Incontinence  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Blocked Nose  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Bronchiolitis  1  0/18 (0.00%)  0 2/17 (11.76%)  2
Coryzal Symptoms  1  1/18 (5.56%)  2 2/17 (11.76%)  2
Cough  1  2/18 (11.11%)  5 1/17 (5.88%)  1
Cough and Runny Nose  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Cough and Cold  1  1/18 (5.56%)  1 0/17 (0.00%)  0
Exacerbation  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Upper Respiratory Tract Infection  1  2/18 (11.11%)  2 1/17 (5.88%)  1
Rhinos Virus Infection  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Runny Nose  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Skin and subcutaneous tissue disorders     
Fine Erythematous, raised rash on Chest and Abdomen  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Glass in Foot  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Impetigo  1  0/18 (0.00%)  0 1/17 (5.88%)  1
Rash  1  0/18 (0.00%)  0 2/17 (11.76%)  4
White Discolouration of Lips and Throat  1  1/18 (5.56%)  1 0/17 (0.00%)  0
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Kimberlin, MD
Organization: University of Alabama at Birmingham
Phone: (205) 638-2530
EMail: DKimberlin@peds.uab.edu
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01649869    
Other Study ID Numbers: 11-0069
HHSN272201100035C
First Submitted: July 20, 2012
First Posted: July 25, 2012
Results First Submitted: December 23, 2020
Results First Posted: June 2, 2021
Last Update Posted: June 2, 2021