Trial Outcomes & Findings for Respiratory Syncytial Virus (RSV) Follow-Up Study (MK-0476-374) (NCT NCT01140048)
NCT ID: NCT01140048
Last Updated: 2022-02-02
Results Overview
Asthma was defined as a positive response to the Epidemiology Questionnaire item "Has your child had wheezing or whistling in the chest in the past 6/12 months?" for the period of 12 months prior to age 6 years. Prognostic factors for asthma at age 6 years were derived from baseline characteristic, disease characteristic and family history data, and were identified by a forward stepwise regression model.
COMPLETED
343 participants
At 6 years of age
2022-02-02
Participant Flow
Participant milestones
| Measure |
All Enrolled Participants
|
|---|---|
|
Overall Study
STARTED
|
343
|
|
Overall Study
COMPLETED
|
298
|
|
Overall Study
NOT COMPLETED
|
45
|
Reasons for withdrawal
| Measure |
All Enrolled Participants
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
13
|
|
Overall Study
Lost to Follow-up
|
31
|
Baseline Characteristics
Respiratory Syncytial Virus (RSV) Follow-Up Study (MK-0476-374)
Baseline characteristics by cohort
| Measure |
All Enrolled Participants
n=343 Participants
|
|---|---|
|
Age, Continuous
|
45.7 months
STANDARD_DEVIATION 10.0 • n=99 Participants
|
|
Sex: Female, Male
Female
|
143 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
200 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At 6 years of agePopulation: All Enrolled Participants for whom data for the respective Epidemiology Questionnaire item at age 6 years and prognostic factors were available.
Asthma was defined as a positive response to the Epidemiology Questionnaire item "Has your child had wheezing or whistling in the chest in the past 6/12 months?" for the period of 12 months prior to age 6 years. Prognostic factors for asthma at age 6 years were derived from baseline characteristic, disease characteristic and family history data, and were identified by a forward stepwise regression model.
Outcome measures
| Measure |
All Enrolled Participants
n=309 Participants
|
|---|---|
|
Percentage of Participants With Asthma at 6 Years of Age: Overall and by Prognostic Factor
With Asthma at Age 6 Years
|
6.1 percentage of participants
|
|
Percentage of Participants With Asthma at 6 Years of Age: Overall and by Prognostic Factor
Relative with Asthma: Yes
|
11.2 percentage of participants
|
|
Percentage of Participants With Asthma at 6 Years of Age: Overall and by Prognostic Factor
Relative with Asthma: No
|
3.1 percentage of participants
|
|
Percentage of Participants With Asthma at 6 Years of Age: Overall and by Prognostic Factor
Gender: Male
|
9.6 percentage of participants
|
|
Percentage of Participants With Asthma at 6 Years of Age: Overall and by Prognostic Factor
Gender: Female
|
1.5 percentage of participants
|
SECONDARY outcome
Timeframe: At 6 years of agePopulation: All Enrolled Participants for whom data for the respective Epidemiology Questionnaire item at age 6 years and prognostic factors were available.
Atopic disorders include allergic rhinitis (AR) and/or atopic dermatitis (AD). Atopic disorders was defined as a positive response to the Epidemiology Questionnaire item "In the past 6/12 months, has your child had a problem with sneezing or runny or blocked nose when he/she did not have a cold or the flu?" for AR and/or a positive response to both of the following items for AD: "Has your child had an itchy rash which was coming and going at any time in the past 6/12 months?" and "Has this itchy rash at any time affected any of the following places: the folds of the elbows, behind the knees, in front of the ankles, under the buttocks, or around the neck, ears, or eyes?" for the period of 12 months prior to age 6 years. Prognostic factors for atopic disorders at age 6 years were derived from baseline characteristic, disease characteristic and family history data, and were identified by a forward stepwise regression model.
Outcome measures
| Measure |
All Enrolled Participants
n=309 Participants
|
|---|---|
|
Percentage of Participants With Atopic Disorders at 6 Years of Age: Overall and by Prognostic Factor
With Atopic Disorders at Age 6 Years
|
36.2 percentage of participants
|
|
Percentage of Participants With Atopic Disorders at 6 Years of Age: Overall and by Prognostic Factor
History of AR: Yes
|
65.1 percentage of participants
|
|
Percentage of Participants With Atopic Disorders at 6 Years of Age: Overall and by Prognostic Factor
History of AR: No
|
25.0 percentage of participants
|
|
Percentage of Participants With Atopic Disorders at 6 Years of Age: Overall and by Prognostic Factor
Relative with Asthma: Yes
|
47.4 percentage of participants
|
|
Percentage of Participants With Atopic Disorders at 6 Years of Age: Overall and by Prognostic Factor
Relative with Asthma: No
|
29.2 percentage of participants
|
SECONDARY outcome
Timeframe: At 6 years of agePopulation: All Enrolled Participants for whom data on concomitant asthma therapy at age 6 years and prognostic factors were available.
Use of Chronic Asthma Therapy for the period of 12 months prior to the age of 6 years was defined by clinical review of reported concomitant medications. Prognostic factors for use of chronic asthma therapy at age 6 years were derived from baseline characteristic, disease characteristic and family history data, and were identified by a forward stepwise regression model.
Outcome measures
| Measure |
All Enrolled Participants
n=310 Participants
|
|---|---|
|
Percentage of Participants With Use of Chronic Asthma Therapy at 6 Years of Age: Overall and by Prognostic Factor
Region: North & Central America
|
5.7 percentage of participants
|
|
Percentage of Participants With Use of Chronic Asthma Therapy at 6 Years of Age: Overall and by Prognostic Factor
With Use of Chronic Asthma Therapy at Age 6 Years
|
14.5 percentage of participants
|
|
Percentage of Participants With Use of Chronic Asthma Therapy at 6 Years of Age: Overall and by Prognostic Factor
History of Asthma: Yes
|
32.0 percentage of participants
|
|
Percentage of Participants With Use of Chronic Asthma Therapy at 6 Years of Age: Overall and by Prognostic Factor
History of Asthma: No
|
6.6 percentage of participants
|
|
Percentage of Participants With Use of Chronic Asthma Therapy at 6 Years of Age: Overall and by Prognostic Factor
Region: Africa
|
22.5 percentage of participants
|
|
Percentage of Participants With Use of Chronic Asthma Therapy at 6 Years of Age: Overall and by Prognostic Factor
Region: Europe
|
20.3 percentage of participants
|
|
Percentage of Participants With Use of Chronic Asthma Therapy at 6 Years of Age: Overall and by Prognostic Factor
Region: South America
|
15.9 percentage of participants
|
|
Percentage of Participants With Use of Chronic Asthma Therapy at 6 Years of Age: Overall and by Prognostic Factor
Region: Asia/Pacific
|
7.3 percentage of participants
|
Adverse Events
All Enrolled Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Results disclosure agreements
- Principal investigator is a sponsor employee The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER