Respiratory Syncytial VirusNCT01995175
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
A study testing Nasal swab sampling, Blood sampling and Diary cards in people with Respiratory Syncytial Virus, run by GlaxoSmithKline at 23 sites in 8 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus
- What is being tested?
- Nasal swab sampling, Blood sampling and Diary cards
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,409 participants
- Where
- 23 sitesin 8 countries
- Study dates
- 12 Dec 2013to 3 Nov 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Before birth:
- Subject whose parent(s)/Legally Acceptable Representative(s) (LARs), in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Written informed consent (including consent to obtain a cord blood sample at birth) obtained from the parent(s)/LAR(s) of the subject.
- After Birth:
- Subject for whom updated and re-signed informed consent and confirmation of eligibility is available not later than 5 working days after birth.
- Cord blood sample collection of at least 3 mL, at birth.
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- For extension period:
- Subject is enrolled at a study site that is participating in the extension period follow-up.
- Subject whose parent(s)/LAR(s), in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Written informed consent (or witnessed thumb printed consent in case of an illiterate subject) obtained from the parent(s)/LAR(s) of the subject.
- Previous participation in the primary study (from birth up to the age of 2 years).
Who cannot join
- Before birth:
- Subject expected to become Child in care
- Subjects whose parent(s)/LAR(s) are below the age of 18 or the legal consenting age of the respective country if this is higher.
- After Birth:
- Child in care
- Newborn with a gestational age of less than 28 weeks.
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- Subjects with any congenital condition that will require an expected postnatal stay in hospital of more than 12 consecutive weeks.
- Subjects with major congenital defects or serious chronic illness limiting life expectancy to less than 5 years.
- Subjects with any confirmed or suspected immunosuppressive or immunodeficient condition (including positive infection with human immunodeficiency virus [HIV]), based on medical history, physical examination or positive test result.
- For extension period:
- Child in care.
Trial locations and contacts
23 sites in 8 countries.
23 sites in 8 countries
United States9 sites
GSK Investigational Site
Oakland, California, 94611
GSK Investigational Site
Roy, Utah, 84067
GSK Investigational Site
Sacramento, California, 95815
GSK Investigational Site
Sacramento, California, 95823
GSK Investigational Site
Santa Clara, California, 95051
GSK Investigational Site
Seattle, Washington, 98105
GSK Investigational Site
Syracuse, New York, 13210
GSK Investigational Site
Syracuse, Utah, 84075
GSK Investigational Site
Walnut Creek, California, 94596
Finland4 sites
GSK Investigational Site
Kokkola, 67100
GSK Investigational Site
Oulu, 90220
GSK Investigational Site
Pori, 28100
GSK Investigational Site
Seinäjoki, 60100
Thailand3 sites
GSK Investigational Site
Bangkok, 10330
GSK Investigational Site
Khon Kaen, 40002
GSK Investigational Site
Pathum Thani, 12120
Argentina2 sites
GSK Investigational Site
Ciudad de Buenos Aires, Buenos Aires, C1431FWO
GSK Investigational Site
Río Cuarto, 5800
Honduras2 sites
GSK Investigational Site
San Pedro Sula, 21101
GSK Investigational Site
San Pedro Sula, 21102
About this study
Official title: A Prospective, Epidemiological Study to Assess the Disease Burden of RSV Associated, Suspected LRTIs From 0 to 2 Years and Population Attributable Risk Percent of RSV LRTI on the Development of Recurrent Wheeze and Asthma From 0 to 6 Years
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.
Read the detailed description
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.
- Conditions
- Respiratory Syncytial Virus
- Being tested
- Nasal swab sampling, Blood sampling, Diary cards
- Keywords
- Asthma, Respiratory Syncytial virus, Cohort study, Quarterly phone contacts, Wheeze, New born, Lower Respiratory Tract Infection
- Medical subject headings
- Asthma, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal swab samplingProcedure or surgery
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.
Blood samplingProcedure or surgery
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 cardsOther
Diary cards will be provided to parents or LARs of the subjects to record RTI/LRTI, wheeze and asthma symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Overall Group | Other | 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. Receives: Procedure: Nasal swab sampling; Procedure: Blood sampling; Other: Diary cards |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From birth up to 2 years of age
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From 2 years of age up to 6 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study start12 Dec 2013
- Primary completion3 Oct 2017
- Study completion3 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial VirusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,409 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995175
- Sponsor's protocol ID
- 200150
- Status last verified
- Nov 2022
- First submitted
- 7 Nov 2013
- Last updated
- 29 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Publications
Madhi SA, Ceballos A, Cousin L, Domachowske JB, Langley JM, Lu E, Puthanakit T, Ramet M, Tan A, Zaman K, Anspach B, Bueso A, Cinconze E, Colas JA, D'Andrea U, Dieussaert I, Englund JA, Gandhi S, Jose L, Kim JH, Klein NP, Laajalahti O, Mithani R, Ota MOC, Pinto M, Silas P, Stoszek SK, Tangsathapornpong A, Teeratakulpisarn J, Virta M, Cohen RA. Population Attributable Risk of Wheeze in 2-<6-Year-old Children, Following a Respiratory Syncytial Virus Lower Respiratory Tract Infection in The First 2 Years of Life. Pediatr Infect Dis J. 2025 May 1;44(5):379-386. doi: 10.1097/INF.0000000000004447. Epub 2024 Jul 1.
PubMed 38985986Englund JA, Cohen RA, Bianco V, Domachowske JB, Langley JM, Madhi SA, Zaman K, Bueso A, Ceballos A, Cousin L, Gandhi S, Gruselle O, Jose L, Klein NP, Koen A, Puthanakit T, Shi M, Silas P, Tangsathapornpong A, Teeratakulpisarn J, Vesikari T, Haars G, Leach A, Stoszek SK, Dieussaert I. Evaluation of Clinical Case Definitions for Respiratory Syncytial Virus Lower Respiratory Tract Infection in Young Children. J Pediatric Infect Dis Soc. 2023 May 31;12(5):273-281. doi: 10.1093/jpids/piad028.
PubMed 37142551Langley JM, Bianco V, Domachowske JB, Madhi SA, Stoszek SK, Zaman K, Bueso A, Ceballos A, Cousin L, D'Andrea U, Dieussaert I, Englund JA, Gandhi S, Gruselle O, Haars G, Jose L, Klein NP, Leach A, Maleux K, Nguyen TLA, Puthanakit T, Silas P, Tangsathapornpong A, Teeratakulpisarn J, Vesikari T, Cohen RA. Incidence of Respiratory Syncytial Virus Lower Respiratory Tract Infections During the First 2 Years of Life: A Prospective Study Across Diverse Global Settings. J Infect Dis. 2022 Aug 26;226(3):374-385. doi: 10.1093/infdis/jiac227.
PubMed 35668702
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Epidemiological Study to Assess the Disease Burden of RSV Associated, Suspected LRTIs From 0 to 2 Years and Population Attributable Risk Percent of RSV LRTI on the Development of Recurrent Wheeze and Asthma From 0 to 6 Years
- ClinicalTrials.gov ID
- NCT01995175
- Acronym / sponsor ID
- 200150
- Conditions
- Respiratory Syncytial Virus
- Keywords
- Asthma, Respiratory Syncytial virus, Cohort study, Quarterly phone contacts, Wheeze, New born, Lower Respiratory Tract Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,409 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2013 (actual)
- Primary completion
- 3 Oct 2017 (actual)
- Study completion
- 3 Nov 2021 (actual)
- First posted
- 26 Nov 2013 (estimated)
- Results
- Posted 15 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overall Group | Other | Procedure: Nasal swab sampling, Procedure: Blood sampling, Other: Diary cardsNewborn 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. |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Subject whose parent(s)/Legally Acceptable Representative(s) (LARs), in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Written informed consent (including consent to obtain a cord blood sample at birth) obtained from the parent(s)/LAR(s) of the subject.
- Subject for whom updated and re-signed informed consent and confirmation of eligibility is available not later than 5 working days after birth.
- Cord blood sample collection of at least 3 mL, at birth.
- Subject is enrolled at a study site that is participating in the extension period follow-up.
Key exclusion criteria (11 listed)
- Subject expected to become Child in care
- Subjects whose parent(s)/LAR(s) are below the age of 18 or the legal consenting age of the respective country if this is higher.
- Child in care
- Newborn with a gestational age of less than 28 weeks.
- Subjects with any congenital condition that will require an expected postnatal stay in hospital of more than 12 consecutive weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal swab samplingNasal 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. | Procedure or surgery | Overall Group |
| Blood samplingA 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. | Procedure or surgery | Overall Group |
| Diary cardsDiary cards will be provided to parents or LARs of the subjects to record RTI/LRTI, wheeze and asthma symptoms. | Other | Overall Group |
Primary outcome
Incidence Rates of First Episode of Respiratory Syncytial Virus (RSV) Respiratory Tract Infection (RTI) [Period 1]
Time frame: From birth up to 2 years of age
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.
Number of Subjects Hospitalized for RSV [Period 1]
Time frame: From birth up to 2 years of age
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.
Incidence Rates of RSV Lower Respiratory Tract Infection (LRTI) or Severe LRTI as Defined by the LRTI Case Definition and Severity Scale [Period 1]
Time frame: From birth up to 2 years of age
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.
Number of RSV LRTI or Severe LRTI Episodes as Defined by the GlaxoSmithKline (GSK) LRTI Case Definition [Period 1]
Time frame: From birth up to 2 years of age
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.
Number of RSV LRTI or Severe LRTI Episodes as Defined by the Existing Comparator LRTI Case Definition (WHO [Modjarrad 2015]) [Period 1]
Time frame: From birth up to 2 years of age
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.
Number of RSV LRTI or Severe LRTI Episodes as Defined by the Existing Comparator LRTI Case Definition (Nokes et al.) [Period 1]
Time frame: From birth up to 2 years of age
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.
9 secondary outcomes
Levels of RSV-A and B Neutralizing Antibodies in the Cord Blood [Period 1]
Time frame: At birth (Month 0)
Levels of RSV-A and B Neutralizing Antibodies in the Blood Serum [Period 1]
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]
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]
Time frame: During the first 6 months of life
Number of WHO LRTI Episodes by Age Categories [Period 1]
Time frame: From birth up to 2 years of life
Number of WHO Severe LRTI Cases by Age Categories [Period 1]
Time frame: From birth up to 2 years of life
Incidence Rates of First Episode of Medically Attended Wheeze [Period 2]
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]
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]
Time frame: From 2 years of age up to 6 years of age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38985986Madhi SA, Ceballos A, Cousin L, Domachowske JB, Langley JM, Lu E, Puthanakit T, Ramet M, Tan A, Zaman K, Anspach B, Bueso A, Cinconze E, Colas JA, D'Andrea U, Dieussaert I, Englund JA, Gandhi S, Jose L, Kim JH, Klein NP, Laajalahti O, Mithani R, Ota MOC, Pinto M, Silas P, Stoszek SK, Tangsathapornpong A, Teeratakulpisarn J, Virta M, Cohen RA. Population Attributable Risk of Wheeze in 2-<6-Year-old Children, Following a Respiratory Syncytial Virus Lower Respiratory Tract Infection in The First 2 Years of Life. Pediatr Infect Dis J. 2025 May 1;44(5):379-386. doi: 10.1097/INF.0000000000004447. Epub 2024 Jul 1.
- Derived from this study: PubMed 37142551Englund JA, Cohen RA, Bianco V, Domachowske JB, Langley JM, Madhi SA, Zaman K, Bueso A, Ceballos A, Cousin L, Gandhi S, Gruselle O, Jose L, Klein NP, Koen A, Puthanakit T, Shi M, Silas P, Tangsathapornpong A, Teeratakulpisarn J, Vesikari T, Haars G, Leach A, Stoszek SK, Dieussaert I. Evaluation of Clinical Case Definitions for Respiratory Syncytial Virus Lower Respiratory Tract Infection in Young Children. J Pediatric Infect Dis Soc. 2023 May 31;12(5):273-281. doi: 10.1093/jpids/piad028.
- Derived from this study: PubMed 35668702Langley JM, Bianco V, Domachowske JB, Madhi SA, Stoszek SK, Zaman K, Bueso A, Ceballos A, Cousin L, D'Andrea U, Dieussaert I, Englund JA, Gandhi S, Gruselle O, Haars G, Jose L, Klein NP, Leach A, Maleux K, Nguyen TLA, Puthanakit T, Silas P, Tangsathapornpong A, Teeratakulpisarn J, Vesikari T, Cohen RA. Incidence of Respiratory Syncytial Virus Lower Respiratory Tract Infections During the First 2 Years of Life: A Prospective Study Across Diverse Global Settings. J Infect Dis. 2022 Aug 26;226(3):374-385. doi: 10.1093/infdis/jiac227.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
23 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal swab sampling, Blood sampling and Diary cards in people with Respiratory Syncytial Virus, run by GlaxoSmithKline at 23 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Finland, Thailand, Argentina, Honduras and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence Rates of First Episode of Respiratory Syncytial Virus (RSV) Respiratory Tract Infection (RTI) [Period 1] (time frame: From birth up to 2 years of age). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01995175, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.