Trial Outcomes & Findings for A Prospective, Epidemiological Study to Assess the Disease Burden of Respiratory Syncytial Virus Associated, Suspected Lower Respiratory Tract Infections in Newborns, From 0 to 2 Years of Age and Risk of Development of Wheeze and Asthma From 0 to 6 Years of Age (NCT NCT01995175)
NCT ID: NCT01995175
Last Updated: 2022-11-29
Results Overview
The incidence rate was calculated by dividing the number of subjects reporting first episode over the follow-up period, to the total person-years. Detection of the RSV-infection was performed by reverse transcription quantitative real time polymerase chain reaction (RT-qPCR ) assay on ribonucleic acids (RNA) extracted from nasal swabs. Number of suspected RSV RTI cases were tabulated.
COMPLETED
NA
2409 participants
From birth up to 2 years of age
2022-11-29
Participant Flow
2409 subjects were enrolled in the primary study and followed-up from birth up to 2 years of age (Period 1 - from 0 up to 2 years of age). 1395 subjects from primary study were enrolled in the extension study and followed-up from 2 up to 6 years of age (Period 2 - from 2 up to 6 years of age).
Out of 2409 subjects enrolled in the primary study, 7 subjects did not sign the re-consent for study participation after delivery (birth), leaving 2402 subjects enrolled. 1 subject was excluded due to protocol violation, hence 2401 subjects formed the Per Protocol Set-Primary Study. Out of 2148 subjects who completed the primary study, 10 subjects were excluded due to invalid ICF/fraudulent data, 743 did not further participate, and therefore, 1395 subjects were enrolled in the extension study.
Participant milestones
| Measure |
Overall Group
Newborn subjects followed up for Lower Respiratory Tract Infections (LRTI) symptoms from birth until they are 2 years of age and for incidence of wheeze and asthma up to 6 years of age.
|
|---|---|
|
Period 1 - From 0 up to 2 Years of Age
STARTED
|
2401
|
|
Period 1 - From 0 up to 2 Years of Age
COMPLETED
|
2148
|
|
Period 1 - From 0 up to 2 Years of Age
NOT COMPLETED
|
253
|
|
Period 2 - From 2 up to 6 Years of Age
STARTED
|
1395
|
|
Period 2 - From 2 up to 6 Years of Age
COMPLETED
|
1338
|
|
Period 2 - From 2 up to 6 Years of Age
NOT COMPLETED
|
57
|
Reasons for withdrawal
| Measure |
Overall Group
Newborn subjects followed up for Lower Respiratory Tract Infections (LRTI) symptoms from birth until they are 2 years of age and for incidence of wheeze and asthma up to 6 years of age.
|
|---|---|
|
Period 1 - From 0 up to 2 Years of Age
Withdrawal by Subject
|
35
|
|
Period 1 - From 0 up to 2 Years of Age
Lost to Follow-up
|
102
|
|
Period 1 - From 0 up to 2 Years of Age
Other
|
67
|
|
Period 1 - From 0 up to 2 Years of Age
Migrated / moved from the study area
|
49
|
|
Period 2 - From 2 up to 6 Years of Age
Other
|
21
|
|
Period 2 - From 2 up to 6 Years of Age
Lost to Follow-up
|
22
|
|
Period 2 - From 2 up to 6 Years of Age
Migrated/moved from the study area
|
6
|
|
Period 2 - From 2 up to 6 Years of Age
Consent withdrawal, not due to a Serious Adverse Event
|
7
|
|
Period 2 - From 2 up to 6 Years of Age
Protocol Violation
|
1
|
Baseline Characteristics
Period 2 - From 2 up to 6 years of age
Baseline characteristics by cohort
| Measure |
Overall Group
n=2401 Participants
Newborn subjects followed up for Lower Respiratory Tract Infections (LRTI) symptoms from birth until they are 2 years of age and for incidence of wheeze and asthma up to 6 years of age.
|
|---|---|
|
Age, Customized
Gestational age at birth ≤28 weeks
|
0 Participants
n=2401 Participants
|
|
Age, Customized
Gestational age at birth 29-32 weeks
|
26 Participants
n=2401 Participants
|
|
Age, Customized
Gestational age at birth 33-36 weeks
|
154 Participants
n=2401 Participants
|
|
Age, Customized
Gestational age at birth ≥37 weeks
|
2221 Participants
n=2401 Participants
|
|
Age, Customized
24 to 36 months of age
|
1395 Participants
n=1395 Participants • Period 2 - From 2 up to 6 years of age
|
|
Sex/Gender, Customized
Male
|
687 Participants
n=1395 Participants • Period 2 - From 2 up to 6 years of age
|
|
Sex/Gender, Customized
Female
|
708 Participants
n=1395 Participants • Period 2 - From 2 up to 6 years of age
|
|
Sex/Gender, Customized
Missing
|
968 Participants
n=2401 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · African Heritage / African American
|
386 Participants
n=1395 Participants • Period 2 - From 2 up to 6 years of age
|
|
Race/Ethnicity, Customized
Geographic ancestry · American Indian or Alaskan Native
|
4 Participants
n=1395 Participants • Period 2 - From 2 up to 6 years of age
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian - Central/South Asian Heritage
|
3 Participants
n=1395 Participants • Period 2 - From 2 up to 6 years of age
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian - East Asian Heritage
|
4 Participants
n=1395 Participants • Period 2 - From 2 up to 6 years of age
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian - Japanese Heritage
|
1 Participants
n=1395 Participants • Period 2 - From 2 up to 6 years of age
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian - South East Asian Heritage
|
271 Participants
n=1395 Participants • Period 2 - From 2 up to 6 years of age
|
|
Race/Ethnicity, Customized
Geographic ancestry · Latino/Mestizo
|
103 Participants
n=1395 Participants • Period 2 - From 2 up to 6 years of age
|
|
Race/Ethnicity, Customized
Geographic ancestry · Native Hawaiian or Other Pacific Islander
|
2 Participants
n=1395 Participants • Period 2 - From 2 up to 6 years of age
|
|
Race/Ethnicity, Customized
Geographic ancestry · White - Arabic / North African Heritage
|
2 Participants
n=1395 Participants • Period 2 - From 2 up to 6 years of age
|
|
Race/Ethnicity, Customized
Geographic ancestry · White - Caucasian / European Heritage
|
549 Participants
n=1395 Participants • Period 2 - From 2 up to 6 years of age
|
|
Race/Ethnicity, Customized
Geographic ancestry · Not specified
|
70 Participants
n=1395 Participants • Period 2 - From 2 up to 6 years of age
|
PRIMARY outcome
Timeframe: From birth up to 2 years of agePopulation: The analysis was performed on the Per Protocol Set (PPS) which included all subjects enrolled in the primary study meeting all eligibility criteria up to the time of their censoring, either at completion of primary study or prematurely as drop-out (e.g., withdrawn consent, lost-to-follow-up).
The incidence rate was calculated by dividing the number of subjects reporting first episode over the follow-up period, to the total person-years. Detection of the RSV-infection was performed by reverse transcription quantitative real time polymerase chain reaction (RT-qPCR ) assay on ribonucleic acids (RNA) extracted from nasal swabs. Number of suspected RSV RTI cases were tabulated.
Outcome measures
| Measure |
Overall Group
n=2401 Participants
Newborn subjects followed up for Lower Respiratory Tract Infections (LRTI) symptoms from birth until they are 2 years of age and for incidence of wheeze and asthma up to 6 years of age.
|
|---|---|
|
Incidence Rates of First Episode of Respiratory Syncytial Virus (RSV) Respiratory Tract Infection (RTI) [Period 1]
|
7.93 Cases per 100 person-years
Interval 7.1 to 8.84
|
PRIMARY outcome
Timeframe: From birth up to 2 years of agePopulation: The analysis was performed on the Per Protocol Set (PPS) which included all subjects enrolled in the primary cohort study meeting all eligibility criteria up to the time of their censoring, either at completion of epoch 1 or prematurely as drop-out (e.g., withdrawn consent, lost-to-follow-up).
Healthcare utilization included primary, secondary and tertiary care settings such as self-care with Over-The-Counter \[OTC\] drugs, general practitioner \[GP\] visits, emergency room \[ER\] visits, hospital visits, etc. Note: This outcome measure presents results only for the more severe events of healthcare utilization - RSV hospitalization. Results for other causes (non-RSV) hospitalization and healthcare utilization for other settings were not calculated, as data were not available.
Outcome measures
| Measure |
Overall Group
n=2401 Participants
Newborn subjects followed up for Lower Respiratory Tract Infections (LRTI) symptoms from birth until they are 2 years of age and for incidence of wheeze and asthma up to 6 years of age.
|
|---|---|
|
Number of Subjects Hospitalized for RSV [Period 1]
|
31 Participants
|
PRIMARY outcome
Timeframe: From birth up to 2 years of agePopulation: The analysis was performed on the Per Protocol Set (PPS) which included all subjects enrolled in the primary study meeting all eligibility criteria up to the time of their censoring, either at completion of primary study or prematurely as drop-out (e.g., withdrawn consent, lost-to-follow-up).
The incidence rate was calculated by dividing the number of subjects reporting first episodes over the follow-up period, to the total person-years. LRTI Case definition by WHO (Modjarrad 2015): LRTI is diagnosed when a child \<5 years presents with cough and/or difficulty in breathing has the following symptoms: Fast breathing, (\>60 per minute in a child \<2 m, \>50 per minute in a child 2 to 11 m and \>40 per minute in a child 12 to 59 m) or Oxygen saturation \<95% by pulse oximetry. Severe LRTI is diagnosed when an infant with RSV LRTI has oxygen saturation\<93% or lower chest wall drawing.
Outcome measures
| Measure |
Overall Group
n=2401 Participants
Newborn subjects followed up for Lower Respiratory Tract Infections (LRTI) symptoms from birth until they are 2 years of age and for incidence of wheeze and asthma up to 6 years of age.
|
|---|---|
|
Incidence Rates of RSV Lower Respiratory Tract Infection (LRTI) or Severe LRTI as Defined by the LRTI Case Definition and Severity Scale [Period 1]
WHO RSV LRTI
|
4.75 Cases per 100 person-years
Interval 4.13 to 5.45
|
|
Incidence Rates of RSV Lower Respiratory Tract Infection (LRTI) or Severe LRTI as Defined by the LRTI Case Definition and Severity Scale [Period 1]
WHO RSV severe LRTI
|
1.53 Cases per 100 person-years
Interval 1.19 to 1.94
|
PRIMARY outcome
Timeframe: From birth up to 2 years of agePopulation: The analysis was performed on the RSV LRTI or severe LRTI episodes collected from subjects in the PPS.
LRTI Case definition by GSK: LRTI is diagnosed when a child \<5 years presents with cough or runny or blocked nose and oxygen saturation \<95% with a respiratory rate ≥ 60/minute (\< 2 months of age); ≥ 50/minute (2 to 11 months of age); ≥ 40/minute (12 to 24 months of age) and has RSV infection, confirmed on nasal swab positive for RSV A or B by quantitative polymerase chain reaction (qPCR). Severe LRTI case definition by GSK: Child with LRTI and oxygen saturation \< 92%, OR Difficulty breathing leading to: Irritability/agitation, or Lethargy/sleepiness, or Severe chest indrawing, or Reduced/no vocalization, or Apnoea \> 20 sec, or Cyanosis, or Stop feeding well/dehydration.
Outcome measures
| Measure |
Overall Group
n=1652 Episodes
Newborn subjects followed up for Lower Respiratory Tract Infections (LRTI) symptoms from birth until they are 2 years of age and for incidence of wheeze and asthma up to 6 years of age.
|
|---|---|
|
Number of RSV LRTI or Severe LRTI Episodes as Defined by the GlaxoSmithKline (GSK) LRTI Case Definition [Period 1]
GSK RSV LRTI episodes
|
227 Episodes
|
|
Number of RSV LRTI or Severe LRTI Episodes as Defined by the GlaxoSmithKline (GSK) LRTI Case Definition [Period 1]
GSK severe RSV LRTI episodes
|
145 Episodes
|
PRIMARY outcome
Timeframe: From birth up to 2 years of agePopulation: The analysis was performed on the suspected RSV LRTI or severe LRTI episodes reported by subjects in the PPS.
LRTI is diagnosed when a child \<5 years presents with cough and/or difficulty in breathing has the following symptoms: Fast breathing, (\>60 per minute in a child \<2 m, \>50 per minute in a child 2 to 11 m and \>40 per minute in a child 12 to 59 m) or Oxygen saturation \<95% by pulse oximetry. Severe LRTI is diagnosed when a child has LRTI and Oxygen saturation \<93% by pulse oximetry and/or lower chest wall in-drawing.
Outcome measures
| Measure |
Overall Group
n=1652 Episodes
Newborn subjects followed up for Lower Respiratory Tract Infections (LRTI) symptoms from birth until they are 2 years of age and for incidence of wheeze and asthma up to 6 years of age.
|
|---|---|
|
Number of RSV LRTI or Severe LRTI Episodes as Defined by the Existing Comparator LRTI Case Definition (WHO [Modjarrad 2015]) [Period 1]
WHO RSV LRTI episodes
|
227 Episodes
|
|
Number of RSV LRTI or Severe LRTI Episodes as Defined by the Existing Comparator LRTI Case Definition (WHO [Modjarrad 2015]) [Period 1]
WHO severe RSV LRTI episodes
|
73 Episodes
|
PRIMARY outcome
Timeframe: From birth up to 2 years of agePopulation: The analysis was performed on the suspected RSV LRTI or severe LRTI episodes collected from subjects in the PPS.
LRTI is diagnosed when a child has a history of acute cough or difficulty in breathing and greater than or equal to (≥) 1 of the following: Fast breathing for age (≥ 60 breaths/minimum if the child is \< 2 m ≥ 50 breaths/minimum if the child is 2-11 m). Indrawing, or Low oxygen saturation (\< 90%) by pulse oximetry or inability to feed (prostration or unconsciousness), when accompanied by a clinical diagnosis of LRTI or bronchiolitis. Severe LRTI is diagnosed when a child has Indrawing, or Low oxygen saturation (\< 90%) by pulse oximetry or inability to feed (prostration or unconsciousness), when accompanied by a clinical diagnosis of LRTI or bronchiolitis.
Outcome measures
| Measure |
Overall Group
n=1652 Episodes
Newborn subjects followed up for Lower Respiratory Tract Infections (LRTI) symptoms from birth until they are 2 years of age and for incidence of wheeze and asthma up to 6 years of age.
|
|---|---|
|
Number of RSV LRTI or Severe LRTI Episodes as Defined by the Existing Comparator LRTI Case Definition (Nokes et al.) [Period 1]
Nokes et al. RSV LRTI episodes
|
226 Episodes
|
|
Number of RSV LRTI or Severe LRTI Episodes as Defined by the Existing Comparator LRTI Case Definition (Nokes et al.) [Period 1]
Nokes et al. severe RSV LRTI episodes
|
67 Episodes
|
SECONDARY outcome
Timeframe: At birth (Month 0)Population: The analysis was performed on the Per Protocol Set (PPS) which included all subjects enrolled in the primary study meeting all eligibility criteria and for whom immunogenicity data were available at the time point considered and for the measured antibody.
Levels of RSV A and B neutralizing antibodies were expressed as Geometric Mean Titers (GMTs) and the cut off for the neutralization assay was 8 End Point Dilution 60 percent (ED60) for RSV-A antibodies and 6 ED60 for RSV-B antibodies. Infant baseline blood sample serum was tested for detection of RSV neutralizing antibodies level.
Outcome measures
| Measure |
Overall Group
n=2390 Participants
Newborn subjects followed up for Lower Respiratory Tract Infections (LRTI) symptoms from birth until they are 2 years of age and for incidence of wheeze and asthma up to 6 years of age.
|
|---|---|
|
Levels of RSV-A and B Neutralizing Antibodies in the Cord Blood [Period 1]
RSV-A at Month 0 (Overall)
|
251.21 Titers
Interval 241.31 to 261.51
|
|
Levels of RSV-A and B Neutralizing Antibodies in the Cord Blood [Period 1]
RSV-B at Month 0 (Overall)
|
327.05 Titers
Interval 315.17 to 339.38
|
SECONDARY outcome
Timeframe: At 2, 4, 6, 12, 18 and 24 months of agePopulation: The analysis was performed on the Per Protocol Set (PPS) which included all subjects enrolled in the primary study meeting all eligibility criteria and for whom immunogenicity data were available at the time point considered and for the measured antibody.
Levels of RSV A and B neutralizing antibodies were expressed as GMTs and the cut off for the neutralization assay was 8 End Point Dilution 60 percent (ED60) for RSV-A antibodies and 6 ED60 for RSV-B antibodies. Infant blood sample serum was tested for RSV neutralizing antibodies level detection.
Outcome measures
| Measure |
Overall Group
n=1384 Participants
Newborn subjects followed up for Lower Respiratory Tract Infections (LRTI) symptoms from birth until they are 2 years of age and for incidence of wheeze and asthma up to 6 years of age.
|
|---|---|
|
Levels of RSV-A and B Neutralizing Antibodies in the Blood Serum [Period 1]
RSV-B at Month 4
|
50.59 Titers
Interval 44.13 to 58.0
|
|
Levels of RSV-A and B Neutralizing Antibodies in the Blood Serum [Period 1]
RSV-A at Month 2
|
77.92 Titers
Interval 67.7 to 89.68
|
|
Levels of RSV-A and B Neutralizing Antibodies in the Blood Serum [Period 1]
RSV-A at Month 4
|
31.25 Titers
Interval 26.79 to 36.46
|
|
Levels of RSV-A and B Neutralizing Antibodies in the Blood Serum [Period 1]
RSV-A at Month 6
|
13.91 Titers
Interval 11.96 to 16.17
|
|
Levels of RSV-A and B Neutralizing Antibodies in the Blood Serum [Period 1]
RSV-A at Month 12
|
14.30 Titers
Interval 11.83 to 17.29
|
|
Levels of RSV-A and B Neutralizing Antibodies in the Blood Serum [Period 1]
RSV-A at Month 18
|
22.41 Titers
Interval 18.3 to 27.44
|
|
Levels of RSV-A and B Neutralizing Antibodies in the Blood Serum [Period 1]
RSV-A at Month 24
|
46.32 Titers
Interval 37.85 to 56.67
|
|
Levels of RSV-A and B Neutralizing Antibodies in the Blood Serum [Period 1]
RSV-B at Month 2
|
104.29 Titers
Interval 91.17 to 119.31
|
|
Levels of RSV-A and B Neutralizing Antibodies in the Blood Serum [Period 1]
RSV-B at Month 6
|
30.25 Titers
Interval 25.82 to 35.45
|
|
Levels of RSV-A and B Neutralizing Antibodies in the Blood Serum [Period 1]
RSV-B at Month 12
|
20.45 Titers
Interval 16.08 to 26.02
|
|
Levels of RSV-A and B Neutralizing Antibodies in the Blood Serum [Period 1]
RSV-B at Month 18
|
31.32 Titers
Interval 24.33 to 40.33
|
|
Levels of RSV-A and B Neutralizing Antibodies in the Blood Serum [Period 1]
RSV-B at Month 24
|
59.89 Titers
Interval 47.45 to 75.61
|
SECONDARY outcome
Timeframe: At Month 0Population: The analysis was performed on the Per Protocol Set (PPS) which included all subjects enrolled in the primary study meeting all eligibility criteria and for whom immunogenicity data were available at the time point considered and for the measured antibody.
The association between RSV LRTI, RSV severe LRTI and RSV A and B neutralizing antibodies were assessed by calculating the GMTs of RSV A and B neutralizing antibodies in the cord blood by subjects classified according to non-overlapping disease severity categories: Non case (defined as subject not reporting RSV LRTI or RSV severe LRTI), WHO RSV LRTI (excluding WHO RSV severe LRTI) and WHO RSV severe LRTI.
Outcome measures
| Measure |
Overall Group
n=2390 Participants
Newborn subjects followed up for Lower Respiratory Tract Infections (LRTI) symptoms from birth until they are 2 years of age and for incidence of wheeze and asthma up to 6 years of age.
|
|---|---|
|
GMTs of RSV A and B Neutralizing Antibodies in the Cord Blood by Subjects Classified According to Non-overlapping Disease Severity Categories [Period 1]
Non case- RSV A
|
252.47 Titers
Interval 242.41 to 262.94
|
|
GMTs of RSV A and B Neutralizing Antibodies in the Cord Blood by Subjects Classified According to Non-overlapping Disease Severity Categories [Period 1]
WHO RSV LRTI- RSV A
|
213.24 Titers
Interval 153.23 to 296.77
|
|
GMTs of RSV A and B Neutralizing Antibodies in the Cord Blood by Subjects Classified According to Non-overlapping Disease Severity Categories [Period 1]
RSV LRTI- RSV A
|
259.18 Titers
Interval 182.97 to 367.12
|
|
GMTs of RSV A and B Neutralizing Antibodies in the Cord Blood by Subjects Classified According to Non-overlapping Disease Severity Categories [Period 1]
RSV severe LRTI- RSV A
|
279.69 Titers
Interval 205.47 to 380.73
|
|
GMTs of RSV A and B Neutralizing Antibodies in the Cord Blood by Subjects Classified According to Non-overlapping Disease Severity Categories [Period 1]
WHO RSV Severe LRTI- RSV A
|
165.80 Titers
Interval 110.78 to 248.14
|
|
GMTs of RSV A and B Neutralizing Antibodies in the Cord Blood by Subjects Classified According to Non-overlapping Disease Severity Categories [Period 1]
Non Case- RSV B
|
328.18 Titers
Interval 316.12 to 340.71
|
SECONDARY outcome
Timeframe: During the first 6 months of lifePopulation: The analysis was performed on the Per Protocol Set (PPS) which included all subjects enrolled in the primary study meeting all eligibility criteria up to the time of their censoring, either at completion of primary study or prematurely as drop-out (e.g., withdrawn consent, lost-to-follow-up).
The association between RSV LRTI, RSV severe LRTI and RSV A and B neutralizing antibodies were assessed by calculating the GMTs of RSV A and B neutralizing antibodies by subjects classified according to non-overlapping disease severity categories: Non case (defined as subject not reporting RSV LRTI or RSV severe LRTI), RSV LTRI and RSV severe LRTI.
Outcome measures
| Measure |
Overall Group
n=2305 Participants
Newborn subjects followed up for Lower Respiratory Tract Infections (LRTI) symptoms from birth until they are 2 years of age and for incidence of wheeze and asthma up to 6 years of age.
|
|---|---|
|
GMTs of RSV A and B Neutralizing Antibodies by Subjects Classified According to Non-overlapping Disease Severity Categories [Period 1]
Non case- RSV A
|
254.08 Titers
Interval 243.84 to 264.76
|
|
GMTs of RSV A and B Neutralizing Antibodies by Subjects Classified According to Non-overlapping Disease Severity Categories [Period 1]
WHO RSV LRTI- RSV A
|
193.34 Titers
Interval 154.08 to 242.6
|
|
GMTs of RSV A and B Neutralizing Antibodies by Subjects Classified According to Non-overlapping Disease Severity Categories [Period 1]
WHO RSV Severe LRTI- RSV A
|
174.09 Titers
Interval 132.41 to 228.89
|
|
GMTs of RSV A and B Neutralizing Antibodies by Subjects Classified According to Non-overlapping Disease Severity Categories [Period 1]
Non Case- RSV B
|
327.83 Titers
Interval 315.62 to 340.51
|
|
GMTs of RSV A and B Neutralizing Antibodies by Subjects Classified According to Non-overlapping Disease Severity Categories [Period 1]
RSV LRTI- RSV B
|
276.52 Titers
Interval 222.7 to 343.36
|
|
GMTs of RSV A and B Neutralizing Antibodies by Subjects Classified According to Non-overlapping Disease Severity Categories [Period 1]
RSV severe LRTI- RSV B
|
349.53 Titers
Interval 279.11 to 437.71
|
SECONDARY outcome
Timeframe: From birth up to 2 years of lifePopulation: The analysis was performed on the WHO LRTI episodes collected from subjects in the PPS.
LRTI refers to Child with RTI AND Blood Oxygen Saturation (SaO2) lower than (\<) 95 percent (%), OR respiratory rate (RR) increase: higher than (\>) 60/min \< 2 months (m) of age; \> 50/min 2-11m of age, 40/min 12-24m of age. Severe LRTI refers to Child with LRTI AND SaO2 \< 92%, OR Difficulty breathing leading to: Irritability/agitation, OR Lethargy/sleepiness, OR Severe chest indrawing, OR Reduced/no vocalization, OR Apnoea \> 20 sec, OR Cyanosis, OR Stop feeding well/dehydration. The number of WHO LRTI cases were assessed for the following age groups: 0-2, 3-5, 6-11 and 12-23 months of age. Occurrence of LRTI/severe LRTI cases as classified by the LRTI case definitions and severity scale, was not limited to the subgroups of subjects recruited from Months 1-6 and 13-18 but was provided for subjects in all age intervals: 0-2 months, 3-5 months, 6-11 months and 12-23 months.
Outcome measures
| Measure |
Overall Group
n=1012 Episodes
Newborn subjects followed up for Lower Respiratory Tract Infections (LRTI) symptoms from birth until they are 2 years of age and for incidence of wheeze and asthma up to 6 years of age.
|
|---|---|
|
Number of WHO LRTI Episodes by Age Categories [Period 1]
0-2 Months
|
110 Episodes
|
|
Number of WHO LRTI Episodes by Age Categories [Period 1]
3-5 Months
|
210 Episodes
|
|
Number of WHO LRTI Episodes by Age Categories [Period 1]
6-11 Months
|
276 Episodes
|
|
Number of WHO LRTI Episodes by Age Categories [Period 1]
12-23 Months
|
416 Episodes
|
SECONDARY outcome
Timeframe: From birth up to 2 years of lifePopulation: The analysis was performed on WHO severe LRTI episodes collected from subjects in the PPS.
LRTI refers to Child with RTI AND Blood Oxygen Saturation (SaO2) lower than (\<) 95 percent (%), OR respiratory rate (RR) increase: higher than (\>) 60/min \< 2 months (m) of age; \> 50/min 2-11m of age, 40/min 12-24m of age. Severe LRTI refers to Child with LRTI AND SaO2 \< 92%, OR Difficulty breathing leading to: Irritability/agitation, OR Lethargy/sleepiness, OR Severe chest indrawing, OR Reduced/no vocalization, OR Apnoea \> 20 sec, OR Cyanosis, OR Stop feeding well/dehydration. The number of WHO severe LRTI cases were assessed for the following age groups: 0-2, 3-5, 6-11 and 12-23 months of age.
Outcome measures
| Measure |
Overall Group
n=259 Episodes
Newborn subjects followed up for Lower Respiratory Tract Infections (LRTI) symptoms from birth until they are 2 years of age and for incidence of wheeze and asthma up to 6 years of age.
|
|---|---|
|
Number of WHO Severe LRTI Cases by Age Categories [Period 1]
0-2 Months
|
45 Episodes
|
|
Number of WHO Severe LRTI Cases by Age Categories [Period 1]
3-5 Months
|
67 Episodes
|
|
Number of WHO Severe LRTI Cases by Age Categories [Period 1]
6-11 Months
|
62 Episodes
|
|
Number of WHO Severe LRTI Cases by Age Categories [Period 1]
12-23 Months
|
85 Episodes
|
SECONDARY outcome
Timeframe: From 2 years of age up to 6 years of agePopulation: The analysis was performed on the PPS extension study, which included all subjects who met the eligibility criteria for the extension study up to the time of their censoring, either at study completion or prematurely as drop-out.
The incidence rate was calculated by dividing the number of subjects reporting first episode of medically attended wheeze over the follow-up period, to the total person-years. Medically attended wheeze = an episode of health care provider confirmed wheeze. Medically attended wheeze, in the extension phase, was collected via a history from parents solicited by contact every 3 months, which was supplemented by the review of routine medical records or contact with health care provider. Incidence rate was assessed for the following categories: All subjects, Non-case (defined as subject not reporting RSV LRTI or RSV severe LRTI) and WHO RSV LRTI.
Outcome measures
| Measure |
Overall Group
n=1395 Participants
Newborn subjects followed up for Lower Respiratory Tract Infections (LRTI) symptoms from birth until they are 2 years of age and for incidence of wheeze and asthma up to 6 years of age.
|
|---|---|
|
Incidence Rates of First Episode of Medically Attended Wheeze [Period 2]
All Subjects
|
3.79 Cases per 100 person-years
Interval 3.27 to 4.37
|
|
Incidence Rates of First Episode of Medically Attended Wheeze [Period 2]
Non-case
|
3.28 Cases per 100 person-years
Interval 2.78 to 3.85
|
|
Incidence Rates of First Episode of Medically Attended Wheeze [Period 2]
WHO RSV LRTI
|
9.82 Cases per 100 person-years
Interval 6.95 to 13.47
|
SECONDARY outcome
Timeframe: From 2 years of age up to 6 years of agePopulation: The analysis was performed on the PPS extension study, which included all subjects who met the eligibility criteria for the extension study up to the time of their censoring, either at study completion or prematurely as drop-out.
The incidence rate was calculated by dividing the number of subjects reporting first episode of wheeze or asthma requiring hospital admission over the follow-up period, to the total person-years. Wheeze or asthma requiring hospital admission = an episode of health care provider confirmed wheeze or asthma requiring hospital admission. Wheeze or asthma requiring hospital admission, in the extension phase, was collected via a history from parents, which was supplemented by the review of routine medical records or contact with health care provider. Incidence rate was assessed for the following categories: All subjects, Non-case (defined as subject not reporting RSV LRTI or RSV severe LRTI) and WHO RSV LRTI.
Outcome measures
| Measure |
Overall Group
n=1395 Participants
Newborn subjects followed up for Lower Respiratory Tract Infections (LRTI) symptoms from birth until they are 2 years of age and for incidence of wheeze and asthma up to 6 years of age.
|
|---|---|
|
Incidence Rates of First Episode of Wheeze or Asthma Requiring Hospital Admission [Period 2]
All subjects
|
0.35 Cases per 100 person-years
Interval 0.21 to 0.55
|
|
Incidence Rates of First Episode of Wheeze or Asthma Requiring Hospital Admission [Period 2]
Non-case
|
0.30 Cases per 100 person-years
Interval 0.17 to 0.5
|
|
Incidence Rates of First Episode of Wheeze or Asthma Requiring Hospital Admission [Period 2]
WHO RSV LRTI
|
0.82 Cases per 100 person-years
Interval 0.22 to 2.09
|
SECONDARY outcome
Timeframe: From 2 years of age up to 6 years of agePopulation: The analysis was performed on the PPS extension study which included all subjects who met the eligibility criteria for the extension study up to the time of their censoring, either at study completion or prematurely as drop-out.
The incidence rate was calculated by dividing the number of subjects reporting first episode of reported wheeze with use of any medication over the follow-up period, to the total person-years. Reported wheeze = parents report a whistling sound associated with labored breathing. Prescription of medications for wheeze, in the extension phase, was collected via a specific request for relevant medication from parents, which was supplemented by the review of routine medical records or contact with health care provider. Incidence rate was assessed for the following categories: All subjects, Non-case (defined as subject not reporting RSV LRTI or RSV severe LRTI) and WHO RSV LRTI.
Outcome measures
| Measure |
Overall Group
n=1395 Participants
Newborn subjects followed up for Lower Respiratory Tract Infections (LRTI) symptoms from birth until they are 2 years of age and for incidence of wheeze and asthma up to 6 years of age.
|
|---|---|
|
Incidence Rates of First Episode of Reported Wheeze With Use of Any Medication [Period 2]
All subjects
|
3.63 Cases per 100 person-years
Interval 3.12 to 4.2
|
|
Incidence Rates of First Episode of Reported Wheeze With Use of Any Medication [Period 2]
Non-case
|
3.13 Cases per 100 person-years
Interval 2.64 to 3.69
|
|
Incidence Rates of First Episode of Reported Wheeze With Use of Any Medication [Period 2]
WHO RSV LRTI
|
9.44 Cases per 100 person-years
Interval 6.65 to 13.01
|
Adverse Events
Overall Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER