The study is a multi-center, multi-national, prospective surveillance study in which the study participants will not receive a study vaccine but will provide a baseline blood sample and be followed for acute respiratory disease during 6 months. The 6-month follow-up will occur for the most part during the Respiratory Syncytial Virus(RSV) season (based on enrollment timing and as per feasibility). A maximum of 1000 children from 6 to \< 22 months of age are planned to be enrolled in 5 to 10 countries, 1 to 2 sites per country, targeting approximately 100 participants per country. The purpose of the study is to assess the seroprevalence and incidence of RSV disease during the study period in the targeted countries and sites for a Phase III vaccine study.
The duration of the study will be 6 months for each participant.
Study Type
OBSERVATIONAL
Enrollment
344
Quality Clinical Research - 10040 Regency Cir - HyperCore - PPDS Site Number : 8400001
Omaha, Nebraska, United States
Senders Pediatrics Site Number : 8400002
Cleveland, Ohio, United States
Investigational Site Number : 2460002
Helsinki, Finland
Investigational Site Number : 2460001
Jarvenpaa, Finland
Investigational Site Number : 2460004
Kokkola, Finland
Investigational Site Number : 2460003
Tampere, Finland
Investigational Site Number : 2880002
Kintampo, Ghana
Investigational Site Number : 2880001
Navrongo, Ghana
Investigational Site Number : 3400002
San Pedro Sula, Honduras
Investigational Site Number : 3400001
Tegucigalpa, Honduras
...and 5 more locations
RSV A serum neutralizing antibody (Nab) titers
To assess RSV A serum Nab titers overall
Time frame: At Day 1
RSV A serum neutralizing antibody (Nab) titers
To assess RSV A serum Nab titers by country
Time frame: At Day 1
RSV B serum Nab titers
To assess RSV B serum Nab titers overall
Time frame: At Day 1
RSV B serum Nab titers
To assess RSV B serum Nab titers overall by country
Time frame: At Day 1
Anti-F immunoglobulin A (IgA) and G (IgG) enzyme linked immunosorbant assay (ELISA) titers
To assess Anti-F IgA and IgG ELISA titers overall
Time frame: At Day 1
Anti-F immunoglobulin A (IgA) and G (IgG) enzyme linked immunosorbant assay (ELISA) titers
To assess Anti-F IgA and IgG ELISA titers by country
Time frame: At Day 1
Baseline serostatus
To assess baseline serostatus overall
Time frame: At Day 1
Baseline serostatus
To assess baseline serostatus by country
Time frame: At Day 1
Occurrence of ARD associated with any RT PCR confirmed RSV strain during the study
To assess to incidence of ARD confirmed by RT PCR overall
Time frame: Throughout study, approximately 6 months
Occurrence of ARD associated with any RT PCR confirmed RSV strain during the study
To assess to incidence of ARD confirmed by RT PCR by country
Time frame: Throughout study, approximately 6 months
Occurrence of LRTD associated with any RT PCR confirmed RSV strain during the study
To assess to incidence of LRTD confirmed by RT PCR overall
Time frame: Throughout study, approximately 6 months
Occurrence of LRTD associated with any RT PCR confirmed RSV strain during the study
To assess to incidence of LRTD confirmed by RT PCR by country
Time frame: Throughout study, approximately 6 months
RSV A serum Nab titers
To assess RSV A serum Nab titers for each age group overall
Time frame: At Day 1
RSV A serum Nab titers
To assess RSV A serum Nab titers for each age group by country
Time frame: At Day 1
RSV B serum Nab antibody titers
To assess RSV B serum Nab titers for each age group overall
Time frame: At Day 1
RSV B serum Nab antibody titers
To assess RSV B serum Nab titers for each age group by country
Time frame: At Day 1
Anti-F IgA and IgG ELISA titers
To assess Anti-F IgA and IgG ELISA titers for each age group overall
Time frame: At Day 1
Anti-F IgA and IgG ELISA titers
To assess Anti-F IgA and IgG ELISA titers for each age group by country
Time frame: At Day 1
Baseline serostatus by age group
To assess baseline serostatus for each age group overall
Time frame: At Day 1
Baseline serostatus by age group
To assess baseline serostatus for each age group by country
Time frame: At Day 1
Occurrence of ARD associated with any RT PCR confirmed RSV strain during the study
To assess to incidence of ARD confirmed by RT PCR for each age group overall
Time frame: Throughout study, approximately 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Occurrence of ARD associated with any RT PCR confirmed RSV strain during the study
To assess to incidence of ARD confirmed by RT PCR for each age group by country
Time frame: Throughout study, approximately 6 months
Occurrence of LRTD associated with any RT PCR confirmed RSV strain during the study
To assess to incidence of LRTD confirmed by RT PCR for each age group overall
Time frame: Throughout study, approximately 6 months
Occurrence of LRTD associated with any RT PCR confirmed RSV strain during the study
To assess to incidence of LRTD confirmed by RT PCR for each age group by country
Time frame: Throughout study, approximately 6 months
Occurrence of ARD associated with each RT-PCR confirmed RSV strain (A/B) during the study
To assess to incidence of ARD confirmed by RT PCR for each strain overall
Time frame: Throughout study, approximately 6 months
Occurrence of ARD associated with each RT-PCR confirmed RSV strain (A/B) during the study
To assess to incidence of ARD confirmed by RT PCR for each strain by country
Time frame: Throughout study, approximately 6 months
Occurrence of severe LRTD associated with any RT PCR confirmed RSV strain during the study
To assess the severity of LRTD confirmed by any RT PCR for each strain
Time frame: Throughout study, approximately 6 months
Occurrence of LRTD associated with each RT-PCR confirmed RSV strain (A/B) during the study
To assess to incidence of LRTD confirmed by RT PCR for each strain overall
Time frame: Throughout study, approximately 6 months
Occurrence of LRTD associated with each RT-PCR confirmed RSV strain (A/B) during the study
To assess to incidence of LRTD confirmed by RT PCR for each strain by country
Time frame: Throughout study, approximately 6 months
Occurrence of clinically diagnosed RSV ARD according to routine practice (with or without RT-PCR RSV confirmation) during the study
Time frame: Throughout study, approximately 6 months
Occurrence of clinically diagnosed RSV LRTD according to routine practice (with or without RT-PCR RSV confirmation) during the study
Time frame: Throughout study, approximately 6 months
Occurrence of AOM episodes during the study
Time frame: Throughout study, approximately 6 months
Occurrence of ARD and LRTD associated with any RT PCR confirmed RSV strain during the study, RSV A and RSV B serum neutralizing antibody titers, anti-F IgA and IgG ELISA antibody titers
To assess the association between RT-PCR confirmed RSV ARD and LRTD and RSV A, B, anti-G IgA an IgG ELISA antibodies at baseline
Time frame: At Day 1