Trial Outcomes & Findings for A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV) (NCT NCT01376778)
NCT ID: NCT01376778
Last Updated: 2023-02-02
Results Overview
The primary outcome is a binary outcome defined by the occurrence or non-occurrence of any of the following vs. none of the following: fetal loss (spontaneous or termination), confirmed fetal CMV infection from amniocentesis, neonatal death before assessment of CMV infection can be made, or neonatal congenital CMV infection. Neonatal congenital CMV infection is diagnosed by urine or saliva collected by 3 weeks of age that is positive for CMV by culture (the intent will be to obtain in the first two days of life). In the event that Polymerase Chain Reaction (PCR) is positive but culture is negative, a repeat culture must be positive by 3 weeks of age.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
399 participants
Primary outcome timeframe
From randomization through 3 weeks of life
Results posted on
2023-02-02
Participant Flow
206,082 Pregnant women were assessed for eligibility (screened for primary CMV infection). 205,683 Were excluded.
Participant milestones
| Measure |
CMV Hyperimmune Globulin - Cytogam®
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Overall Study
STARTED
|
206
|
193
|
|
Overall Study
COMPLETED
|
203
|
191
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
CMV Hyperimmune Globulin - Cytogam®
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
Baseline Characteristics
Includes only participants who completed the self-report.
Baseline characteristics by cohort
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=206 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=193 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
Total
n=399 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.2 years
STANDARD_DEVIATION 6.3 • n=206 Participants
|
28.5 years
STANDARD_DEVIATION 6.0 • n=193 Participants
|
27.8 years
STANDARD_DEVIATION 6.2 • n=399 Participants
|
|
Sex: Female, Male
Female
|
206 Participants
n=206 Participants
|
193 Participants
n=193 Participants
|
399 Participants
n=399 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=206 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=399 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
135 Participants
n=206 Participants
|
124 Participants
n=193 Participants
|
259 Participants
n=399 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
35 Participants
n=206 Participants
|
30 Participants
n=193 Participants
|
65 Participants
n=399 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
30 Participants
n=206 Participants
|
33 Participants
n=193 Participants
|
63 Participants
n=399 Participants
|
|
Race/Ethnicity, Customized
Other, unknown, or more than one race or ethnic group
|
6 Participants
n=206 Participants
|
6 Participants
n=193 Participants
|
12 Participants
n=399 Participants
|
|
Married or living with partner
|
145 Participants
n=206 Participants
|
142 Participants
n=193 Participants
|
287 Participants
n=399 Participants
|
|
Education
|
14.1 years
STANDARD_DEVIATION 2.1 • n=206 Participants
|
14.2 years
STANDARD_DEVIATION 2.3 • n=193 Participants
|
14.2 years
STANDARD_DEVIATION 2.2 • n=399 Participants
|
|
Occupational exposure
|
78 Participants
n=195 Participants • Includes only participants who completed the self-report.
|
63 Participants
n=174 Participants • Includes only participants who completed the self-report.
|
141 Participants
n=369 Participants • Includes only participants who completed the self-report.
|
|
1 or more children living at home
|
150 Participants
n=206 Participants
|
140 Participants
n=193 Participants
|
290 Participants
n=399 Participants
|
|
1 or more children in day care
|
83 Participants
n=206 Participants
|
78 Participants
n=193 Participants
|
161 Participants
n=399 Participants
|
|
Nulliparous
|
75 Participants
n=206 Participants
|
62 Participants
n=193 Participants
|
137 Participants
n=399 Participants
|
|
Tobacco use
|
22 Participants
n=206 Participants
|
23 Participants
n=193 Participants
|
45 Participants
n=399 Participants
|
|
Alcohol use
|
21 Participants
n=206 Participants
|
24 Participants
n=193 Participants
|
45 Participants
n=399 Participants
|
|
CMV infection at screening
IgM+, IgG+, low avidity (low avidity defined as less than 50 percent)
|
200 Participants
n=206 Participants
|
183 Participants
n=193 Participants
|
383 Participants
n=399 Participants
|
|
CMV infection at screening
IgM+, IgG seroconversion
|
5 Participants
n=206 Participants
|
10 Participants
n=193 Participants
|
15 Participants
n=399 Participants
|
|
CMV infection at screening
No primary CMV infection - randomization error
|
1 Participants
n=206 Participants
|
0 Participants
n=193 Participants
|
1 Participants
n=399 Participants
|
|
Mean weeks gestation at randomization
|
16.2 weeks
STANDARD_DEVIATION 3.9 • n=206 Participants
|
15.6 weeks
STANDARD_DEVIATION 4.1 • n=193 Participants
|
15.9 weeks
STANDARD_DEVIATION 4.0 • n=399 Participants
|
|
Distribution of weeks gestation at randomization
≤11 weeks, 6 days
|
26 Participants
n=206 Participants
|
36 Participants
n=193 Participants
|
62 Participants
n=399 Participants
|
|
Distribution of weeks gestation at randomization
12 weeks, 0 days to 19 weeks, 6 days
|
142 Participants
n=206 Participants
|
126 Participants
n=193 Participants
|
268 Participants
n=399 Participants
|
|
Distribution of weeks gestation at randomization
≥20 weeks, 0 days
|
38 Participants
n=206 Participants
|
31 Participants
n=193 Participants
|
69 Participants
n=399 Participants
|
|
Body-mass index at randomization
|
27.2 kg/m^2
STANDARD_DEVIATION 7.0 • n=206 Participants
|
26.9 kg/m^2
STANDARD_DEVIATION 7.0 • n=193 Participants
|
27.1 kg/m^2
STANDARD_DEVIATION 7.0 • n=399 Participants
|
|
Avidity index at randomization
|
29.7 avidity index
STANDARD_DEVIATION 14.6 • n=205 Participants • Data are not included for 4 participants (1 in the hyperimmune globulin group and 3 in the placebo group) who underwent seroconversion.
|
29.9 avidity index
STANDARD_DEVIATION 13.6 • n=190 Participants • Data are not included for 4 participants (1 in the hyperimmune globulin group and 3 in the placebo group) who underwent seroconversion.
|
29.8 avidity index
STANDARD_DEVIATION 14.1 • n=395 Participants • Data are not included for 4 participants (1 in the hyperimmune globulin group and 3 in the placebo group) who underwent seroconversion.
|
|
Days from screening to randomization
|
25.5 days
STANDARD_DEVIATION 9.1 • n=206 Participants
|
25.2 days
STANDARD_DEVIATION 8.2 • n=193 Participants
|
25.3 days
STANDARD_DEVIATION 8.7 • n=399 Participants
|
PRIMARY outcome
Timeframe: From randomization through 3 weeks of lifeThe primary outcome is a binary outcome defined by the occurrence or non-occurrence of any of the following vs. none of the following: fetal loss (spontaneous or termination), confirmed fetal CMV infection from amniocentesis, neonatal death before assessment of CMV infection can be made, or neonatal congenital CMV infection. Neonatal congenital CMV infection is diagnosed by urine or saliva collected by 3 weeks of age that is positive for CMV by culture (the intent will be to obtain in the first two days of life). In the event that Polymerase Chain Reaction (PCR) is positive but culture is negative, a repeat culture must be positive by 3 weeks of age.
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=203 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=191 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Number of Participants With the Composite Primary Outcome
|
46 Participants
|
37 Participants
|
PRIMARY outcome
Timeframe: From randomization through 3 weeks of lifeComponent of composite primary outcome
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=203 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=191 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Number of Participants Who Had a Fetus or Neonate With CMV Infection
|
36 Participants
|
32 Participants
|
PRIMARY outcome
Timeframe: From randomization through 3 weeks of lifecomponent of composite primary outcome
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=203 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=191 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Number of Participants Who Had a Neonatal Death Without CMV Infection
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From randomization through 3 weeks of lifecomponent of primary composite outcome
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=203 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=191 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Number of Participants With a Fetal or Neonatal Death With Proven CMV Infection
|
7 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From randomization through deliverycomponent of primary composite outcome
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=203 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=191 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Number of Participants With Fetal Death Without Proven CMV Infection
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: from randomization through discharge from the hospitalGestational hypertension or preeclampsia is a binary outcome defined by occurrence or non-occurrence of gestational hypertension or preeclampsia. Gestational hypertension or preeclampsia are new onset hypertension during pregnancy
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=205 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=193 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Number of Participants With Gestational Hypertension or Preeclampsia
|
24 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: From randomization through delivery (maximum 42 weeks gestation)Placental abruption is a binary outcome defined by occurrence or non-occurrence of placental abruption, defined as bleeding and contraction pain
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=205 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=193 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Number of Participants With Placental Abruption
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: DeliveryGestational age at delivery in weeks
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=203 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=191 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Median Gestational Age at Delivery
|
38.2 weeks
Standard Deviation 4.1
|
38.6 weeks
Standard Deviation 3.6
|
SECONDARY outcome
Timeframe: Delivery before 37 weeks gestationGestational age before 37 weeks gestation is a binary outcome meaning occurrence or non-occurrence of delivery before 37 weeks gestation
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=203 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=191 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Number of Participants Whose Gestational Age at Delivery Was Before 37 Weeks
|
25 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Delivery before 34 weeks gestationGestational age before 34 weeks, 0 days gestation is a binary outcome meaning occurrence or non-occurrence of delivery before 34 weeks gestation
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=203 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=191 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Number of Participants Whose Gestational Age at Delivery Was Before 34 Weeks, 0 Days
|
12 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: From randomization (10-27 weeks gestation) through delivery (maximum 42 weeks gestation)Occurrence or non-occurrence of a designated side effect of medication
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=206 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=193 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Number of Participants Reporting Yes or no to Medication Side Effects
Participants reported no side effects
|
125 Participants
|
131 Participants
|
|
Number of Participants Reporting Yes or no to Medication Side Effects
Participants reported any side effects
|
81 Participants
|
62 Participants
|
SECONDARY outcome
Timeframe: From randomization (10-27 weeks gestation) through delivery (maximum 42 weeks gestation) up to 120 days of lifeFetal death or death of a neonate born alive
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=203 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=191 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Number of Participants Who Had a Fetal or Neonatal Death
|
10 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 72 hours postpartumNeonatal head circumference measured within 72 hours of birth
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=203 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=191 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Median Neonatal Head Circumference
|
33.9 centimeters
Standard Deviation 2.1
|
34.1 centimeters
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: DeliveryBirth weight as recorded in the medical record
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=203 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=191 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Median Birth Weight
|
3268 grams
Standard Deviation 657
|
3303 grams
Standard Deviation 548
|
SECONDARY outcome
Timeframe: DeliveryFetal growth restriction is a binary outcome defined as the occurrence or non-occurrence of growth restriction (defined as \<5th percentile weight for gestational age, assessed specifically by sex and race of the infant based on United States birth certificate data)
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=194 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=186 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Number of Participants With Fetal Growth Restriction
|
20 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: During pregnancy up to 3 weeks postpartumFetal or neonatal symptomatic CMV infection is a binary outcome defined as the occurrence or non-occurrence of symptomatic CMV infection defined as CMV isolated from an amniocentesis, or urine or saliva during the first three weeks of life and at least one of the following: jaundice (with direct bilirubin exceeding 20% of total bilirubin), thrombocytopenia , anemia , hepatitis, hepatomegaly, splenomegaly, growth restriction, failure to thrive, intracerebral calcifications, microcephaly, hypotonia, seizures, petechial rash, hearing loss, interstitial pneumonitis, thrombocytopenia, anemia, hepatitis, chorioretinitis, or CMV in cerebrospinal fluid
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=203 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=191 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Number of Participants With Symptomatic CMV Infection
|
23 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 0 days to approximately 120 days of life or hospital discharge, whichever is soonerIntraventricular hemorrhage (IVH) as determined by cranial ultrasounds performed as part of routine clinical care and classified based on the Papile classification system. IVH is a binary outcome defined by occurrence or non-occurrence of IVH
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=193 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=186 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Number of Neonates With Grade 3 or 4 Intraventricular Hemorrhage
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0 days to approximately 120 days of life or hospital discharge, whichever is soonerVentriculomegaly is a binary outcome defined by the occurrence or non-occurrence of ventriculomegaly
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=194 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=186 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Number of Neonates With Ventriculomegaly
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0 days to approximately 120 days of life or hospital discharge, whichever is soonerRetinopathy of prematurity is a binary outcome defined by the occurrence or non-occurrence of retinopathy of prematurity, diagnosed by ophthalmologic examination of the retina and a diagnosis of Stage I (demarcation line in the retina) or greater.
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=193 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=186 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Number of Neonates With Retinopathy of Prematurity (ROP)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 0 days to approximately 120 days of life or hospital discharge, whichever is soonerRespiratory distress syndrome is a binary outcome defined by the occurrence or non-occurrence of Respiratory distress syndrome (defined as the presence of clinical signs of respiratory distress (tachypnea, retractions, flaring, grunting, or cyanosis), with an oxygen requirement and a chest x-ray that shows hypoventilation and reticulogranular infiltrates).
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=193 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=186 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Number of Neonates With Respiratory Distress Syndrome
|
5 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 28 days of lifeNeonatal chronic lung disease is a binary outcome defined by the occurrence or non-occurrence of chronic lung disease or bronchopulmonary dysplasia (BPD) defined as oxygen requirement at 28 days of life
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=193 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=186 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Number of Neonates With Chronic Lung Disease
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0 days to approximately 120 days of life or hospital discharge, whichever is soonerNecrotizing enterocolitis (NEC) is a binary outcome defined by the occurrence or non-occurrence of NEC, defined as modified Bell Stage 2 or 3. Stage 2: Clinical signs and symptoms with pneumatosis intestinalis on radiographs. Stage 3: Advanced clinical signs and symptoms, pneumatosis, impending or proven intestinal perforation.
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=193 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=186 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Number of Neonates With Necrotizing Enterocolitis (NEC)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From birth to 1 week of lifeHyperbilirubinemia is a binary outcome defined by the occurrence or non-occurrence of hyperbilirubinemia. Peak total bilirubin of at least 15 mg% or the use of phototherapy
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=150 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=138 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Number of Neonates With Hyperbilirubinemia
|
13 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 0 days to approximately 120 days of life or hospital discharge, whichever is soonerSuspected neonatal sepsis is a binary outcome defined as the occurrence or non-occurrence of suspected neonatal sepsis
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=193 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=186 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Number of Neonates With Suspected Neonatal Sepsis
|
14 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 0 days to approximately 120 days of life or hospital discharge, whichever is soonerNeonatal pneumonia is a binary outcome defined as the occurrence or non-occurrence of neonatal pneumonia
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=193 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=186 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Number of Neonates With Neonatal Pneumonia
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 0 days to approximately 120 days of life or hospital discharge, whichever is soonerNeonatal seizures/encephalopathy is a binary outcome defined as the occurrence or non-occurrence of seizures/encephalopathy
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=193 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=186 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Number of Neonates Experiencing Seizures / Encephalopathy
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: birth to neonatal hospital discharge (usually a maximum of 120 days)Length of hospital stay, need for Neonatal Intensive Care Unit (NICU) or intermediate care admission and length of stay if admitted
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=193 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=186 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Median Length of Neonatal Hospital Stay
|
2 days
Interval 2.0 to 2.0
|
2 days
Interval 2.0 to 2.0
|
SECONDARY outcome
Timeframe: Birth to 24 month study examDeath of infant or child before the 24 month study exam
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=184 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=176 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Number of Participants Experiencing Infant or Child Death
|
10 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 12 and 24 months corrected agePopulation: Hearing data was not available for approximately 25% of children due to loss to followup or consent refusal.
Sensorineural hearing loss is defined as the occurrence or non-occurrence of sensorineural hearing loss defined as unilateral and bilateral sensorineural hearing loss
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=138 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=146 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Number of Children With Sensorineural Hearing Loss
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 2 years of ageChorioretinitis is defined as the occurrence or non-occurrence of chorioretinitis defined by ophthalmologic exam
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=173 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=171 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Number of Children Diagnosed With Chorioretinitis
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 and 24 months corrected ageThe Bayley Scales of Infant and Toddler Development® \| Third Edition (Bayley®-III), is a comprehensive tool to identify development issues during early childhood. The Bayley-III Cognitive Scale subtests assess cognitive function through the use of memory, problem solving and manipulation subtests. Scores on individual Cognitive subtests range from 1 (worst outcome) to 19 (better outcome) (Mean 10, SD 3). Individual subtest scores between 8 and 12 are considered average. The raw scores on the subtests are converted to scaled scores based on American norms by age. Cognitive Scale composite scores range from 55 (low, worse outcome) to 155 (high, better outcome) (mean 100; SD 15). Severe disability was defined as a composite score \<70.
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=155 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=160 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Mean Cognitive Composite Scores From the Bayley Scales of Infant and Toddler Development Third Edition (Bayley-III)
|
96.2 score on a scale
Standard Deviation 15.1
|
97.1 score on a scale
Standard Deviation 13.5
|
SECONDARY outcome
Timeframe: 12 and 24 months corrected ageThe Bayley Scales of Infant and Toddler Development® \| Third Edition (Bayley®-III), is a comprehensive tool to identify development issues during early childhood. The Bayley-III Motor Scale subtests assess motor function through fine motor and gross motor subtests. Scores on individual Motor subtests range from 1 (worst outcome) to 19 (better outcome) (Mean 10, SD 3). Individual subtest scores between 8 and 12 are considered average. The raw scores on the subtests are converted to scaled scores based on American norms by age. Motor Scale composite scores range from 55 (low, worse outcome) to 155 (high, better outcome) (mean 100; SD 15). Severe disability was defined as a composite score \<70.
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=155 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=158 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Mean Motor Composite Scores From the Bayley Scales of Infant and Toddler Development Third Edition (Bayley-III)
|
98.7 score on a scale
Standard Deviation 16.4
|
101.9 score on a scale
Standard Deviation 14.9
|
SECONDARY outcome
Timeframe: 24 month study examComposite outcome at 24 months including any of the following attributable to congenital CMV infection: • Sensorineural hearing loss (unilateral and bilateral) • Developmental delay defined as Cognitive score \< 70 or Motor score \< 70 on the Bayley III • Chorioretinitis • Fetal loss or death of neonate, infant or child
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=149 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=149 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Number of Infants or Children With the Composite Outcome
|
20 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 24 month study examChild status at age 24 months, classified as: • Fetal loss or death of neonate, infant or child • Congenital CMV infection with severe disability • Congenital CMV infection without severe disability • Infant not infected with CMV
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=148 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=149 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Overall Child Status at 24 Months of Age
Death or fetal loss
|
10 Participants
|
5 Participants
|
|
Overall Child Status at 24 Months of Age
Congenital CMV with severe disability
|
6 Participants
|
7 Participants
|
|
Overall Child Status at 24 Months of Age
Congenital CMV without severe disability
|
21 Participants
|
19 Participants
|
|
Overall Child Status at 24 Months of Age
Not infected with CMV with severe disability
|
4 Participants
|
3 Participants
|
|
Overall Child Status at 24 Months of Age
Not infected with CMV and no disabilities
|
107 Participants
|
115 Participants
|
SECONDARY outcome
Timeframe: 24 months of ageFailure to thrive defined as \<10th percentile for weight at 24 months
Outcome measures
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=169 Participants
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=167 Participants
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Failure to Thrive at 24 Months
|
20 Participants
|
21 Participants
|
Adverse Events
CMV Hyperimmune Globulin - Cytogam®
Serious events: 32 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo
Serious events: 25 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=206 participants at risk
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=193 participants at risk
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Blood and lymphatic system disorders
hyperbilirubinemia
|
0.49%
1/206 • Number of events 1 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
0.00%
0/193 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/206 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
0.52%
1/193 • Number of events 1 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
|
Congenital, familial and genetic disorders
Congenital Anomaly
|
4.4%
9/206 • Number of events 9 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
1.0%
2/193 • Number of events 2 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
|
General disorders
Serious allergic reaction
|
0.97%
2/206 • Number of events 2 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
0.00%
0/193 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
|
Infections and infestations
Meningitis
|
0.00%
0/206 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
0.52%
1/193 • Number of events 1 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
|
Renal and urinary disorders
Renal mass
|
0.00%
0/206 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
0.52%
1/193 • Number of events 1 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
|
Nervous system disorders
Corpus callosum lesion
|
0.00%
0/206 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
0.52%
1/193 • Number of events 1 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
|
Pregnancy, puerperium and perinatal conditions
Elective termination
|
2.4%
5/206 • Number of events 5 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
1.0%
2/193 • Number of events 2 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
|
Pregnancy, puerperium and perinatal conditions
Fetal death
|
1.9%
4/206 • Number of events 4 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
1.6%
3/193 • Number of events 3 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
|
Pregnancy, puerperium and perinatal conditions
Preterm birth
|
5.8%
12/206 • Number of events 12 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
5.2%
10/193 • Number of events 10 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory syncytial virus
|
0.97%
2/206 • Number of events 2 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
0.00%
0/193 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/206 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
0.52%
1/193 • Number of events 1 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiolitis
|
0.97%
2/206 • Number of events 2 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
0.00%
0/193 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Meconium aspiration
|
0.00%
0/206 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
0.52%
1/193 • Number of events 1 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
|
Vascular disorders
Hypotension
|
0.00%
0/206 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
1.0%
2/193 • Number of events 2 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
Other adverse events
| Measure |
CMV Hyperimmune Globulin - Cytogam®
n=206 participants at risk
Infusion of Cytogam®, Cytomegalovirus Immune Globulin Intravenous (Human) (CMV-IGIV)
CMV hyperimmune globulin: The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
|
Placebo
n=193 participants at risk
IV 5% albumin diluted 1 to 9 with 5% Dextrose in water (D5W)
Placebo: The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
|
|---|---|---|
|
Congenital, familial and genetic disorders
congenital anomaly (non-serious)
|
2.4%
5/206 • Number of events 5 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
2.6%
5/193 • Number of events 5 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
|
Skin and subcutaneous tissue disorders
allergic reaction
|
1.5%
3/206 • Number of events 3 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
1.0%
2/193 • Number of events 2 • Adverse events were collected from randomization through delivery (a time period of up to 36 weeks)
Adverse events are described in general terms and grouped where possible to protect the confidentiality of participants, given that some events rarely occurred.
|
Additional Information
Dr. Rebecca Clifton, MFMU Principal Investigator
The George Washington University Biostatistics Center
Phone: 301-881-9260
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place