An interventional study of Nasal swab sampling and Blood sampling in Respiratory Syncytial Virus, sponsored by GlaxoSmithKline. Completed at 23 sites in 8 countries. Open to participants aged Up to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-29.
Sponsored by GlaxoSmithKline · Not applicable, Interventional, and Other
The purpose of this study is to assess the incidence and associated healthcare utilization of RSV-associated, suspected LRTI in a general population of infants from birth up to 2 years of age, and also to assess the accuracy of a newly developed LRTI case definition and severity scale compared to two existing definitions. The study will also assess the population attributable risk percent of RSV LRTI on the development of wheeze and asthma from 0 to 6 years of age.
New born infants from various countries over the world will be followed up for up to two years for the occurrence of Lower Respiratory Tract Infections. Through active and passive surveillance, any suspected case will be identified, assessed during an examination visit and followed up until completion through a diary card. Full symptomology will be assessed during the examination visit. The disease course and all healthcare utilization will be subsequently collected through a two-week diary card and contact with ay healthcare providers involved in management of the disease. RSV detection will occur through quantitative PCR of collected nasal swabs. A baseline cord blood serum sample of all subjects and a follow-up blood serum sample from a sub-cohort will also be collected to assess antibody levels at various points in time and in relation to risk of RSV LRTI.
For extension period, pertaining to wheeze and asthma (Epoch 002): Subjects' parent(s)/LAR(s) will be asked to re-consent and subjects will be followed up through quarterly contacts up to the age of 6 years. Data collection will also occur from medical charts retrospectively for those who have a gap period between the end of the primary study and providing re-consent for the extension. The extension involves enrolment visit (at 2nd birthday [on completion of primary study or as soon as possible thereafter]) and quarterly surveillance contacts.
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Before birth:
After Birth:
For extension period:
Exclusion Criteria:
Before birth:
After Birth:
For extension period:
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.
Procedure: Nasal swab sampling · Procedure: Blood sampling · Other: Diary cards
Nasal swab samples will be collected from subjects at each examination visit, if they develop respiratory tract infection symptoms with difficulty in breathing and are called for an examination visit in the study.
A single blood sample will be collected from a sub-cohort consisting of the first 2000 enrolled subjects when they are either 2, 4, 6, 12, 18 or 24 months old.
Diary cards will be provided to parents or LARs of the subjects to record RTI/LRTI, wheeze and asthma symptoms.
Incidence Rates of First Episode of Respiratory Syncytial Virus (RSV) Respiratory Tract Infection (RTI) [Period 1]
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.
Time frame: From birth up to 2 years of age
Number of Subjects Hospitalized for RSV [Period 1]
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.
Time frame: From birth up to 2 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]
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.
Time frame: From birth up to 2 years of age
Number of RSV LRTI or Severe LRTI Episodes as Defined by the GlaxoSmithKline (GSK) LRTI Case Definition [Period 1]
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.
Time frame: From birth up to 2 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]
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.
Time frame: From birth up to 2 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]
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.
Time frame: From birth up to 2 years of age
Levels of RSV-A and B Neutralizing Antibodies in the Cord Blood [Period 1]
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.
Time frame: At birth (Month 0)
Levels of RSV-A and B Neutralizing Antibodies in the Blood Serum [Period 1]
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.
Time frame: At 2, 4, 6, 12, 18 and 24 months 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]
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.
Time frame: At Month 0
GMTs of RSV A and B Neutralizing Antibodies by Subjects Classified According to Non-overlapping Disease Severity Categories [Period 1]
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.
Time frame: During the first 6 months of life
Number of WHO LRTI Episodes by Age Categories [Period 1]
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.
Time frame: From birth up to 2 years of life
Number of WHO Severe LRTI Cases by Age Categories [Period 1]
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.
Time frame: From birth up to 2 years of life
Incidence Rates of First Episode of Medically Attended Wheeze [Period 2]
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.
Time frame: From 2 years of age up to 6 years of age
Incidence Rates of First Episode of Wheeze or Asthma Requiring Hospital Admission [Period 2]
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.
Time frame: From 2 years of age up to 6 years of age
Incidence Rates of First Episode of Reported Wheeze With Use of Any Medication [Period 2]
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.
Time frame: From 2 years of age up to 6 years of age
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).
| Milestone | Overall Group |
|---|---|
| Started | 2401 |
| Completed | 2148 |
| Not completed | 253 |
| Withdrew: Withdrawal by subject | 35 |
| Withdrew: Lost to follow-up | 102 |
| Withdrew: Other | 67 |
| Withdrew: Migrated / moved from the study area | 49 |
| Milestone | Overall Group |
|---|---|
| Started | 1395 |
| Completed | 1338 |
| Not completed | 57 |
| Withdrew: Other | 21 |
| Withdrew: Lost to follow-up | 22 |
| Withdrew: Migrated/moved from the study area | 6 |
| Withdrew: Consent withdrawal, not due to a serious adverse event | 7 |
| Withdrew: Protocol violation | 1 |
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.
| Cases per 100 person-years | Overall Group |
|---|---|
| Incidence Rates of First Episode of Respiratory Syncytial Virus (RSV) Respiratory Tract Infection (RTI) [Period 1] | 7.93 (7.10 to 8.84) |
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.
| Participants | Overall Group |
|---|---|
| Number of Subjects Hospitalized for RSV [Period 1] | 31 |
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.
| Cases per 100 person-years | Overall Group |
|---|---|
| WHO RSV LRTI | 4.75 (4.13 to 5.45) |
| WHO RSV severe LRTI | 1.53 (1.19 to 1.94) |
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.
| Episodes | Overall Group |
|---|---|
| GSK RSV LRTI episodes | 227 |
| GSK severe RSV LRTI episodes | 145 |
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.
| Episodes | Overall Group |
|---|---|
| WHO RSV LRTI episodes | 227 |
| WHO severe RSV LRTI episodes | 73 |
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.
| Episodes | Overall Group |
|---|---|
| Nokes et al. RSV LRTI episodes | 226 |
| Nokes et al. severe RSV LRTI episodes | 67 |
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.
| Titers | Overall Group |
|---|---|
| RSV-A at Month 0 (Overall) | 251.21 (241.31 to 261.51) |
| RSV-B at Month 0 (Overall) | 327.05 (315.17 to 339.38) |
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.
| Titers | Overall Group |
|---|---|
| RSV-A at Month 2 | 77.92 (67.70 to 89.68) |
| RSV-A at Month 4 | 31.25 (26.79 to 36.46) |
| RSV-A at Month 6 | 13.91 (11.96 to 16.17) |
| RSV-A at Month 12 | 14.30 (11.83 to 17.29) |
| RSV-A at Month 18 | 22.41 (18.30 to 27.44) |
| RSV-A at Month 24 | 46.32 (37.85 to 56.67) |
| RSV-B at Month 2 | 104.29 (91.17 to 119.31) |
| RSV-B at Month 4 | 50.59 (44.13 to 58.00) |
| RSV-B at Month 6 | 30.25 (25.82 to 35.45) |
| RSV-B at Month 12 | 20.45 (16.08 to 26.02) |
| RSV-B at Month 18 | 31.32 (24.33 to 40.33) |
| RSV-B at Month 24 | 59.89 (47.45 to 75.61) |
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.
| Titers | Overall Group |
|---|---|
| Non case- RSV A | 252.47 (242.41 to 262.94) |
| WHO RSV LRTI- RSV A | 213.24 (153.23 to 296.77) |
| WHO RSV Severe LRTI- RSV A | 165.80 (110.78 to 248.14) |
| Non Case- RSV B | 328.18 (316.12 to 340.71) |
| RSV LRTI- RSV A | 259.18 (182.97 to 367.12) |
| RSV severe LRTI- RSV A | 279.69 (205.47 to 380.73) |
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.
| Titers | Overall Group |
|---|---|
| Non case- RSV A | 254.08 (243.84 to 264.76) |
| WHO RSV LRTI- RSV A | 193.34 (154.08 to 242.60) |
| WHO RSV Severe LRTI- RSV A | 174.09 (132.41 to 228.89) |
| Non Case- RSV B | 327.83 (315.62 to 340.51) |
| RSV LRTI- RSV B | 276.52 (222.70 to 343.36) |
| RSV severe LRTI- RSV B | 349.53 (279.11 to 437.71) |
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.
| Episodes | Overall Group |
|---|---|
| 0-2 Months | 110 |
| 3-5 Months | 210 |
| 6-11 Months | 276 |
| 12-23 Months | 416 |
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.
| Episodes | Overall Group |
|---|---|
| 0-2 Months | 45 |
| 3-5 Months | 67 |
| 6-11 Months | 62 |
| 12-23 Months | 85 |
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.
| Cases per 100 person-years | Overall Group |
|---|---|
| All Subjects | 3.79 (3.27 to 4.37) |
| Non-case | 3.28 (2.78 to 3.85) |
| WHO RSV LRTI | 9.82 (6.95 to 13.47) |
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.
| Cases per 100 person-years | Overall Group |
|---|---|
| All subjects | 0.35 (0.21 to 0.55) |
| Non-case | 0.30 (0.17 to 0.50) |
| WHO RSV LRTI | 0.82 (0.22 to 2.09) |
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.
| Cases per 100 person-years | Overall Group |
|---|---|
| All subjects | 3.63 (3.12 to 4.20) |
| Non-case | 3.13 (2.64 to 3.69) |
| WHO RSV LRTI | 9.44 (6.65 to 13.01) |
Collected over No adverse events were collected during this prospective epidemiological study.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Overall Group | — | — | — |
| Age, Customized(Participants) | Overall Group |
|---|---|
| Gestational age at birth ≤28 weeks | 0 |
| Gestational age at birth 29-32 weeks | 26 |
| Gestational age at birth 33-36 weeks | 154 |
| Gestational age at birth ≥37 weeks | 2221 |
| Age, Customized(Participants) | Overall Group |
|---|---|
| 24 to 36 months of age | 1395 |
| Sex/Gender, Customized(Participants) | Overall Group |
|---|---|
| Male | 704 |
| Female | 729 |
| Missing | 968 |
| Sex/Gender, Customized(Participants) | Overall Group |
|---|---|
| Male | 687 |
| Female | 708 |
| Race/Ethnicity, Customized(Participants) | Overall Group |
|---|---|
| Geographic ancestry — African Heritage / African American | 632 |
| Geographic ancestry — American Indian or Alaskan Native | 7 |
| Geographic ancestry — Asian - Central/South Asian Heritage | 5 |
| Geographic ancestry — Asian - East Asian Heritage | 4 |
| Geographic ancestry — Asian - Japanese Heritage | 1 |
| Geographic ancestry — Asian - South East Asian Heritage | 435 |
| Geographic ancestry — Latino/Mestizo | 303 |
| Geographic ancestry — Native Hawaiian or Other Pacific Islander | 3 |
| Geographic ancestry — White - Arabic / North African Heritage | 6 |
| Geographic ancestry — White - Caucasian / European Heritage | 888 |
| Geographic ancestry — Not specified | 117 |
| Race/Ethnicity, Customized(Participants) | Overall Group |
|---|---|
| Geographic ancestry — African Heritage / African American | 386 |
| Geographic ancestry — American Indian or Alaskan Native | 4 |
| Geographic ancestry — Asian - Central/South Asian Heritage | 3 |
| Geographic ancestry — Asian - East Asian Heritage | 4 |
| Geographic ancestry — Asian - Japanese Heritage | 1 |
| Geographic ancestry — Asian - South East Asian Heritage | 271 |
| Geographic ancestry — Latino/Mestizo | 103 |
| Geographic ancestry — Native Hawaiian or Other Pacific Islander | 2 |
| Geographic ancestry — White - Arabic / North African Heritage | 2 |
| Geographic ancestry — White - Caucasian / European Heritage | 549 |
| Geographic ancestry — Not specified | 70 |
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