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.

Recruitment status

COMPLETED

Target enrollment

343 participants

Primary outcome timeframe

At 6 years of age

Results posted on

2022-02-02

Participant Flow

Participant milestones

Participant milestones
Measure
All Enrolled Participants
Overall Study
STARTED
343
Overall Study
COMPLETED
298
Overall Study
NOT COMPLETED
45

Reasons for withdrawal

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

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 age

Population: 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

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 age

Population: 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

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 age

Population: 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

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 events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 1-800-672-6372

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