InfluenzaPhase 4NASIMMUNENCT02972957
A Study of Intranasal Live Attenuated Influenza Vaccine Immunogenicity and Associations With the Nasopharyngeal Microbiome Among Children in the Gambia
A Phase 4 study testing Nasovac-S and Azithromycin in people with Influenza, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
Trial summary
The live attenuated influenza vaccine (LAIV) is made up of weakened influenza viruses given into the nose and in early studies was shown to be better than the standard influenza vaccine at preventing infections in children. Read more about this study
- Who is it for?
- Ages 24 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Nasovac-S and Azithromycin
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 364 participants
- Where
- 1 siteThe Gambia
- Study dates
- 30 Jan 2017to 23 May 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 24 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- • Healthy male or female child at least 24 months of age and less than 60 months of age at the time of study entry.
- Resident in the study area and with no plans to travel outside the study area during the period of subject participation.
- Informed consent for the study participation obtained from a parent (or guardian only if neither parent is alive or if guardianship has been legally transferred (see section 11.2).
- Willingness and capacity to comply with the study protocol as judged by a member of the clinical trial team.
Who cannot join
- • Serious, active, medical condition, including but not limited to:
- chronic disease of any body system
- severe protein-energy malnutrition (weight-for-height Z-score of less than -3)
- known genetic disorders, such as Down's syndrome or other cytogenetic disorder
- Active wheezing
- History of documented hypersensitivity to eggs or other components of the vaccine (including gelatin, sorbitol, lactalbumin and chicken protein), or with life-threatening reactions to previous influenza vaccinations.
Show all 17Show fewer
- History of documented hypersensitivity to macrolide antibiotics
- History of Guillain-Barré syndrome.
- Receipt of aspirin therapy or aspirin-containing therapy within the two weeks before planned study vaccination.
- Any suspected or confirmed congenital or acquired state of immune deficiency including but not limited to primary immunodeficiencies including thymus disorders, HIV/AIDS, hematological or lymphoid malignancies (blood tests will not be routinely undertaken with this regard as part of the study).
- Any current immunosuppressive/immunomodulatory treatment or receipt of any such treatment within the six months preceding trial enrolment (for corticosteroids this is defined as a dose of prednisolone (or equivalent) of greater than 2mg/kg/day for one week or 1mg/kg/day for one month. The use of topical corticosteroids is not an exclusion criterion.
- The use of inhaled corticosteroids within the last one month.
- Receipt of an influenza vaccine within the past 12 months.
- Has any condition determined by investigator as likely to interfere with evaluation of the vaccine or be a significant potential health risk to the child or make it unlikely that the child would complete the study.
- Any significant signs or symptoms of an acute illness or infection including:
- an axillary temperature of 38.0°C or above or documented fever of 38°C or above in the preceding 14 days.
- Any acute respiratory infection within 14 days of enrollment visit. If the reason for ineligibility is likely to be temporary (e.g. a fever of 38°C or above or acute respiratory infection) and either will or may resolve before the infant reaches 60 months, they will not be recorded as a screening failure but instead will be re-screened within an appropriate future time-window (e.g. at least 14 days after the last documented fever of 38°C or above or resolution of respiratory illness) and a decision made regarding eligibility at that point.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of Intranasal Live Attenuated Influenza Vaccine Immunogenicity and Associations With the Nasopharyngeal Microbiome Among Children in the Gambia - The NASIMMUNE Study
The live attenuated influenza vaccine (LAIV) is made up of weakened influenza viruses given into the nose and in early studies was shown to be better than the standard influenza vaccine at preventing infections in children. However, more recently, it has performed less well and it may also work less well in Sub-Saharan Africa. Not only do the investigators not know why this is, but the investigators also do not fully understand why LAIV produces stronger nasal antibody responses in some individuals but not others. Usually harmless bacteria that are present in participants noses can influence how our immune system works and variations in these may explain differences in how LAIV works. The project will recruit children given LAIV in the Gambia to gain further understanding of these issues.
The investigators will measure a variety of responses to LAIV, including genes that can change their expression early after vaccination and use advanced computational techniques to identify new relationships between these genes and other LAIV responses. The investigators will also see whether nasal bacterial profiles in children who respond to LAIV are different from those who do not. In addition, the investigators will alter these bacteria in a subset of children with antibiotics and see whether this affects both nasal gene expression and later responses to LAIV.
Read the detailed description
Purpose The overall goal of this study is to conduct at detailed immunogenicity study of intranasal live attenuated influenza vaccine (LAIV; Nasovac-S, Serum Institute of India Pvt. Ltd.), including identification of early molecular signatures associated with a robust mucosal immune response. In addition, the study team will explore whether the nasopharyngeal microbiome influences this immune response and whether LAIV has an impact on the microbiome.
A total of 365 healthy children aged 24 - 59 months will be recruited in The Gambia for this study.
Background Both the burden of infection and use of influenza vaccines in children from sub-Saharan Africa (SSA) have been neglected. There are limited immunogenicity or efficacy data from SSA of the widely used Ann Arbor strain-derived LAIV. This LAIV was shown to have greater relative efficacy compared to inactivated influenza vaccine in children in early randomized-controlled trials. There has, however, been concern regarding lower vaccine effectiveness in the US in recent years.
The Serum Institute of India Pvt. Ltd. has recently developed a trivalent LAIV (Nasovac-S) via a WHO facilitated donation of a Russian-derived LAIV, with the intention of scaling up provision of LAIV to resource-limited settings. Based on initial safety and immunogenicity data, Nasovac-S was licensed in India and granted a WHO prequalification certificate in 2015. Two placebo-controlled efficacy studies using Nasovac-S were recently undertaken in Bangladesh and Senegal (in children aged 24 - 59 months and 24 - 71 months respectively), providing mixed and contrasting results. In Senegal, no efficacy was found against the circulating pandemic H1N1 influenza strain (-9.7%, 95% CI -62.6, 26.1). In Bangladesh the overall vaccine efficacy to vaccine-matched strains, in a study of identical design, was 57.5% (95% CI 43.6, 68.0), with efficacy against H1N1 and H3N2, 50.0% (95% CI 9.2, 72.5) and 60.4% (95% CI 44.8, 71.6) respectively. The reason for the discrepancy in these studies or the poorer performance of the H1N1 component is not clear and emphasizes the need to undertake detailed immunogenicity studies of this vaccine in SSA. On a wider note, the exact immunological mechanisms of action of LAIV are also under-explored.
Study type:
Interventional
Design:
All primary objectives will be addressed through the conduct of a phase 4, randomized, controlled clinical vaccine trial. A total of 330 healthy children aged 24 - 59 months will be enrolled into one of three groups of equal size (3 x 110 children):
(i) LAIV-vaccinated (Group A - blood sample at day 0, 2, 21) (ii) LAIV-vaccinated (Group B - blood sample at day 0, 7, 21) (iii) Control group (Group C)
The study is not blinded, but group allocation will be concealed from the investigator team and block randomization stratified by sex will be undertaken.
Two LAIV-vaccinated groups are included in order to achieve several exploratory objectives, which require blood sampling at different times following vaccination, whilst minimizing the number of times children are bled. The unvaccinated subjects will serve as a control group for the primary objective of assessing the impact of LAIV on the nasopharyngeal microbiome.
An additional 35 healthy children aged 24 - 59 months will be recruited in the 2nd phase of recruitment (approximately Jan - June 2018) to assess how modulation of the nasopharyngeal microbiome with antibiotics impacts the mucosal immunogenicity to LAIV. These subjects will be matched as closely as possible by pre-antibiotic nasopharyngeal microbiome profile, age and sex (in that order of preference), in an exploratory nested case-control study, to n = 35 children recruited in the main clinical trial.
Official title A Study of Intranasal Live Attenuated Influenza Vaccine Immunogenicity and Associations with the Nasopharyngeal Microbiome Among Children in the Gambia (The NASIMMUNE study)
Primary outcome measures
- To identify novel early systemic and mucosal molecular signatures following LAIV that are associated with subsequent robust nasal and oral influenza-specific immunoglobulin A (IgA) responses, in order to provide insight into the mechanisms of successful mucosal immunization
- To identify associations between nasopharyngeal microbiota and nasal and oral influenza-specific IgA responses post-LAIV in Gambian children, to explore whether microbiome variability can explain suboptimal immune responses in some individuals to live intranasal mucosal vaccines in Sub-Saharan Africa
- To establish whether LAIV impacts the nasopharyngeal microbiome, with a specific focus on the burden of S. pneumoniae
- Conditions
- Influenza
- Being tested
- Nasovac-S, Azithromycin
- Keywords
- intranasal, flu vaccine, Gambian children
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasovac-SBiological
one of 0.5ml intranasal dose of trivalent live attenuated vaccine (LAIV)
AzithromycinDrug
Also called Zithromax
a single dose of Azithromycin (liquid formulation - Zithromax) at 20mg/Kg (up to a maximum adult dose 1g) to be given to a subset of subjects
| Study group | Role | What they receive |
|---|---|---|
| LAIV-vaccinated group 1 | Experimental | Nasovac-S vaccination group A , blood samples days 0, 2, 21 Receives: Biological: Nasovac-S |
| LAIV-vaccinated group 2 | Experimental | Nasovac-S vaccination group B, blood samples at days 0, 7, 21 Receives: Biological: Nasovac-S |
| Unvaccinated | No intervention | control group C |
| Oral Azithromycin & vaccination | Experimental | group D - a single dose of oral Azithromycin will be given 28 days prior to Nasovac-S vaccination Receives: Biological: Nasovac-S; Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
nasal IgA response
Influenza specific nasal IgA responses
Measured: 21 days post LAIV
fold increase in oral fluid influenza-specific/total IgA ratio
Measured: day 0 - Day 21
fold increase in oral fluid influenza-specific/total IgG ratio
Measured: Day 0 - Day 21
Secondary outcomes (3)
density of S. Pneumoniae
density of S. Pneumoniae before and after LAIV as established by quantitative PCR
Measured: day 7 and day 21 after LAIV compared to day 0
Changes in the relative abundance of different operational taxanomic units (OTUs) of nasopharyngeal microbiota
Measured: day 7 and day 21 compared to day 0 in each participant
gene expression changes in nasal and systemic samples
Measured: 2 days after LAIV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study start30 Jan 2017
- Primary completion19 Dec 2018
- Study completion23 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Edinburgh, Public Health England, University of Oxford, National Institute for Public Health and the Environment (RIVM)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972957
- Sponsor's protocol ID
- SCC 1502
- Acronym
- NASIMMUNE
- Status last verified
- Feb 2020
- First submitted
- 17 Nov 2016
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peno C, Jagne YJ, Clerc M, Balcazar Lopez C, Armitage EP, Sallah H, Drammeh S, Senghore E, Goderski G, van Tol S, Meijer A, Ruiz-Rodriguez A, de Steenhuijsen Piters WAA, de Koff E, Jarju S, Lindsey BB, Camara J, Bah S, Mohammed NI, Kampmann B, Clarke E, Dockrell DH, de Silva TI, Bogaert D. Interactions between live attenuated influenza vaccine and nasopharyngeal microbiota among children aged 24-59 months in The Gambia: a phase 4, open-label, randomised controlled trial. Lancet Microbe. 2025 Mar;6(3):100971. doi: 10.1016/j.lanmic.2024.100971. Epub 2025 Jan 17.
PubMed 39832517Keeley AJ, Groves D, Armitage EP, Senghore E, Jagne YJ, Sallah HJ, Drammeh S, Angyal A, Hornsby H, de Crombrugghe G, Smeesters PR, Rossi O, Carducci M, Peno C, Bogaert D, Kampmann B, Marks M, Shaw HA, Turner CR, de Silva TI. Streptococcus pyogenes Colonization in Children Aged 24-59 Months in the Gambia: Impact of Live Attenuated Influenza Vaccine and Associated Serological Responses. J Infect Dis. 2023 Oct 3;228(7):957-965. doi: 10.1093/infdis/jiad153.
PubMed 37246259Peno C, Armitage EP, Clerc M, Balcazar Lopez C, Jagne YJ, Drammeh S, Jarju S, Sallah H, Senghore E, Lindsey BB, Camara J, Bah S, Mohammed NI, Dockrell DH, Kampmann B, Clarke E, Bogaert D, de Silva TI. The effect of live attenuated influenza vaccine on pneumococcal colonisation densities among children aged 24-59 months in The Gambia: a phase 4, open label, randomised, controlled trial. Lancet Microbe. 2021 Dec;2(12):e656-e665. doi: 10.1016/S2666-5247(21)00179-8.
PubMed 34881370Lindsey BB, Jagne YJ, Armitage EP, Singanayagam A, Sallah HJ, Drammeh S, Senghore E, Mohammed NI, Jeffries D, Hoschler K, Tregoning JS, Meijer A, Clarke E, Dong T, Barclay W, Kampmann B, de Silva TI. Effect of a Russian-backbone live-attenuated influenza vaccine with an updated pandemic H1N1 strain on shedding and immunogenicity among children in The Gambia: an open-label, observational, phase 4 study. Lancet Respir Med. 2019 Aug;7(8):665-676. doi: 10.1016/S2213-2600(19)30086-4. Epub 2019 Jun 21.
PubMed 31235405Armitage EP, Camara J, Bah S, Forster AS, Clarke E, Kampmann B, de Silva TI. Acceptability of intranasal live attenuated influenza vaccine, influenza knowledge and vaccine intent in The Gambia. Vaccine. 2018 Mar 20;36(13):1772-1780. doi: 10.1016/j.vaccine.2018.02.037. Epub 2018 Feb 23.
PubMed 29483030
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Intranasal Live Attenuated Influenza Vaccine Immunogenicity and Associations With the Nasopharyngeal Microbiome Among Children in the Gambia - The NASIMMUNE Study
- ClinicalTrials.gov ID
- NCT02972957
- Acronym / sponsor ID
- NASIMMUNE / SCC 1502
- Conditions
- Influenza
- Keywords
- intranasal, flu vaccine, Gambian children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- University of Edinburgh, Public Health England, University of Oxford, National Institute for Public Health and the Environment (RIVM)
- Study start
- 30 Jan 2017 (actual)
- Primary completion
- 19 Dec 2018 (actual)
- Study completion
- 23 May 2019 (actual)
- First posted
- 25 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The live attenuated influenza vaccine (LAIV) is made up of weakened influenza viruses given into the nose and in early studies was shown to be better than the standard influenza vaccine at preventing infections in children. However, more recently, it has performed less well and it may also work less well in Sub-Saharan Africa. Not only do the investigators not know why this is, but the investigators also do not fully understand why LAIV produces stronger nasal antibody responses in some individuals but not others. Usually harmless bacteria that are present in participants noses can influence how our immune system works and variations in these may explain differences in how LAIV works. The project will recruit children given LAIV in the Gambia to gain further understanding of these issues.
The investigators will measure a variety of responses to LAIV, including genes that can change their expression early after vaccination and use advanced computational techniques to identify new relationships between these genes and other LAIV responses. The investigators will also see whether nasal bacterial profiles in children who respond to LAIV are different from those who do not. In addition, the investigators will alter these bacteria in a subset of children with antibiotics and see whether this affects both nasal gene expression and later responses to LAIV.
Detailed description
Purpose The overall goal of this study is to conduct at detailed immunogenicity study of intranasal live attenuated influenza vaccine (LAIV; Nasovac-S, Serum Institute of India Pvt. Ltd.), including identification of early molecular signatures associated with a robust mucosal immune response. In addition, the study team will explore whether the nasopharyngeal microbiome influences this immune response and whether LAIV has an impact on the microbiome.
A total of 365 healthy children aged 24 - 59 months will be recruited in The Gambia for this study.
Background Both the burden of infection and use of influenza vaccines in children from sub-Saharan Africa (SSA) have been neglected. There are limited immunogenicity or efficacy data from SSA of the widely used Ann Arbor strain-derived LAIV. This LAIV was shown to have greater relative efficacy compared to inactivated influenza vaccine in children in early randomized-controlled trials. There has, however, been concern regarding lower vaccine effectiveness in the US in recent years.
The Serum Institute of India Pvt. Ltd. has recently developed a trivalent LAIV (Nasovac-S) via a WHO facilitated donation of a Russian-derived LAIV, with the intention of scaling up provision of LAIV to resource-limited settings. Based on initial safety and immunogenicity data, Nasovac-S was licensed in India and granted a WHO prequalification certificate in 2015. Two placebo-controlled efficacy studies using Nasovac-S were recently undertaken in Bangladesh and Senegal (in children aged 24 - 59 months and 24 - 71 months respectively), providing mixed and contrasting results. In Senegal, no efficacy was found against the circulating pandemic H1N1 influenza strain (-9.7%, 95% CI -62.6, 26.1). In Bangladesh the overall vaccine efficacy to vaccine-matched strains, in a study of identical design, was 57.5% (95% CI 43.6, 68.0), with efficacy against H1N1 and H3N2, 50.0% (95% CI 9.2, 72.5) and 60.4% (95% CI 44.8, 71.6) respectively. The reason for the discrepancy in these studies or the poorer performance of the H1N1 component is not clear and emphasizes the need to undertake detailed immunogenicity studies of this vaccine in SSA. On a wider note, the exact immunological mechanisms of action of LAIV are also under-explored.
Study type:
Interventional
Design:
All primary objectives will be addressed through the conduct of a phase 4, randomized, controlled clinical vaccine trial. A total of 330 healthy children aged 24 - 59 months will be enrolled into one of three groups of equal size (3 x 110 children):
(i) LAIV-vaccinated (Group A - blood sample at day 0, 2, 21) (ii) LAIV-vaccinated (Group B - blood sample at day 0, 7, 21) (iii) Control group (Group C)
The study is not blinded, but group allocation will be concealed from the investigator team and block randomization stratified by sex will be undertaken.
Two LAIV-vaccinated groups are included in order to achieve several exploratory objectives, which require blood sampling at different times following vaccination, whilst minimizing the number of times children are bled. The unvaccinated subjects will serve as a control group for the primary objective of assessing the impact of LAIV on the nasopharyngeal microbiome.
An additional 35 healthy children aged 24 - 59 months will be recruited in the 2nd phase of recruitment (approximately Jan - June 2018) to assess how modulation of the nasopharyngeal microbiome with antibiotics impacts the mucosal immunogenicity to LAIV. These subjects will be matched as closely as possible by pre-antibiotic nasopharyngeal microbiome profile, age and sex (in that order of preference), in an exploratory nested case-control study, to n = 35 children recruited in the main clinical trial.
Official title A Study of Intranasal Live Attenuated Influenza Vaccine Immunogenicity and Associations with the Nasopharyngeal Microbiome Among Children in the Gambia (The NASIMMUNE study)
Primary outcome measures
- To identify novel early systemic and mucosal molecular signatures following LAIV that are associated with subsequent robust nasal and oral influenza-specific immunoglobulin A (IgA) responses, in order to provide insight into the mechanisms of successful mucosal immunization
- To identify associations between nasopharyngeal microbiota and nasal and oral influenza-specific IgA responses post-LAIV in Gambian children, to explore whether microbiome variability can explain suboptimal immune responses in some individuals to live intranasal mucosal vaccines in Sub-Saharan Africa
- To establish whether LAIV impacts the nasopharyngeal microbiome, with a specific focus on the burden of S. pneumoniae
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LAIV-vaccinated group 1 | Experimental | Biological: Nasovac-SNasovac-S vaccination group A , blood samples days 0, 2, 21 |
| LAIV-vaccinated group 2 | Experimental | Biological: Nasovac-SNasovac-S vaccination group B, blood samples at days 0, 7, 21 |
| Unvaccinated | No intervention | –control group C |
| Oral Azithromycin & vaccination | Experimental | Biological: Nasovac-S, Drug: Azithromycingroup D - a single dose of oral Azithromycin will be given 28 days prior to Nasovac-S vaccination |
Who may qualify
- Ages
- 24 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- • Healthy male or female child at least 24 months of age and less than 60 months of age at the time of study entry.
Key exclusion criteria (17 listed)
- • Serious, active, medical condition, including but not limited to:
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 |
|---|---|---|
| Nasovac-Sone of 0.5ml intranasal dose of trivalent live attenuated vaccine (LAIV) | Biological | LAIV-vaccinated group 1, LAIV-vaccinated group 2, Oral Azithromycin & vaccination |
| AzithromycinAlso: Zithromaxa single dose of Azithromycin (liquid formulation - Zithromax) at 20mg/Kg (up to a maximum adult dose 1g) to be given to a subset of subjects | Drug | Oral Azithromycin & vaccination |
Primary outcome
nasal IgA response
Time frame: 21 days post LAIV
Influenza specific nasal IgA responses
fold increase in oral fluid influenza-specific/total IgA ratio
Time frame: day 0 - Day 21
fold increase in oral fluid influenza-specific/total IgG ratio
Time frame: Day 0 - Day 21
3 secondary outcomes
density of S. Pneumoniae
Time frame: day 7 and day 21 after LAIV compared to day 0
Changes in the relative abundance of different operational taxanomic units (OTUs) of nasopharyngeal microbiota
Time frame: day 7 and day 21 compared to day 0 in each participant
gene expression changes in nasal and systemic samples
Time frame: 2 days after LAIV
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Derived from this study: PubMed 39832517Peno C, Jagne YJ, Clerc M, Balcazar Lopez C, Armitage EP, Sallah H, Drammeh S, Senghore E, Goderski G, van Tol S, Meijer A, Ruiz-Rodriguez A, de Steenhuijsen Piters WAA, de Koff E, Jarju S, Lindsey BB, Camara J, Bah S, Mohammed NI, Kampmann B, Clarke E, Dockrell DH, de Silva TI, Bogaert D. Interactions between live attenuated influenza vaccine and nasopharyngeal microbiota among children aged 24-59 months in The Gambia: a phase 4, open-label, randomised controlled trial. Lancet Microbe. 2025 Mar;6(3):100971. doi: 10.1016/j.lanmic.2024.100971. Epub 2025 Jan 17.
- Derived from this study: PubMed 37246259Keeley AJ, Groves D, Armitage EP, Senghore E, Jagne YJ, Sallah HJ, Drammeh S, Angyal A, Hornsby H, de Crombrugghe G, Smeesters PR, Rossi O, Carducci M, Peno C, Bogaert D, Kampmann B, Marks M, Shaw HA, Turner CR, de Silva TI. Streptococcus pyogenes Colonization in Children Aged 24-59 Months in the Gambia: Impact of Live Attenuated Influenza Vaccine and Associated Serological Responses. J Infect Dis. 2023 Oct 3;228(7):957-965. doi: 10.1093/infdis/jiad153.
- Derived from this study: PubMed 34881370Peno C, Armitage EP, Clerc M, Balcazar Lopez C, Jagne YJ, Drammeh S, Jarju S, Sallah H, Senghore E, Lindsey BB, Camara J, Bah S, Mohammed NI, Dockrell DH, Kampmann B, Clarke E, Bogaert D, de Silva TI. The effect of live attenuated influenza vaccine on pneumococcal colonisation densities among children aged 24-59 months in The Gambia: a phase 4, open label, randomised, controlled trial. Lancet Microbe. 2021 Dec;2(12):e656-e665. doi: 10.1016/S2666-5247(21)00179-8.
- Derived from this study: PubMed 31235405Lindsey BB, Jagne YJ, Armitage EP, Singanayagam A, Sallah HJ, Drammeh S, Senghore E, Mohammed NI, Jeffries D, Hoschler K, Tregoning JS, Meijer A, Clarke E, Dong T, Barclay W, Kampmann B, de Silva TI. Effect of a Russian-backbone live-attenuated influenza vaccine with an updated pandemic H1N1 strain on shedding and immunogenicity among children in The Gambia: an open-label, observational, phase 4 study. Lancet Respir Med. 2019 Aug;7(8):665-676. doi: 10.1016/S2213-2600(19)30086-4. Epub 2019 Jun 21.
- Derived from this study: PubMed 29483030Armitage EP, Camara J, Bah S, Forster AS, Clarke E, Kampmann B, de Silva TI. Acceptability of intranasal live attenuated influenza vaccine, influenza knowledge and vaccine intent in The Gambia. Vaccine. 2018 Mar 20;36(13):1772-1780. doi: 10.1016/j.vaccine.2018.02.037. Epub 2018 Feb 23.
- Individual participant dataSharing planned: No
Related trials for Influenza
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nasovac-S and Azithromycin in people with Influenza, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
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 4 inclusion and 17 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 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in The Gambia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
nasal IgA response (time frame: 21 days post LAIV). The study lists 3 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 NCT02972957, which also lists 5 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 21 Feb 2020.