Phase 3
N=1,761
Clinical Efficacy of Trivalent Live-Attenuated Influenza Vaccine (LAIV) Among Children in Senegal
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT01854632 ↗Enrolled (actual)
1,761
Serious AEs
0.8%
Results posted
Jun 2015
Primary outcome: Primary: Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Regardless of Vaccine Match) — 17.9; 18.0 percentage of participants — p=0.996
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SIIL Live Attenuated Influenza Vaccine (Biological); Matched placebo (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- PATH
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Regardless of Vaccine Match) |
17.9; 18.0 | 0.996 |
| SECONDARY Safety Profile of LAIV: Immediate Reactions Occurring Within 30 Minutes of Administration of Study Vaccine. |
— | — |
| SECONDARY Safety Profile of LAIV: Solicited and Unsolicited Local and Systemic Reactions |
— | — |
| SECONDARY Safety Profile of LAIV: Serious Adverse Events |
— | — |
| SECONDARY Safety Profile of LAIV: Other Non-serious Adverse Events |
— | — |
| SECONDARY Safety Profile of LAIV: Protocol Defined Wheezing Illness |
— | — |
| SECONDARY Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection (Vaccine-matched Strains) |
— | — |
| SECONDARY Percentage of Participants With Symptomatic, Laboratory-confirmed Influenza Virus Infection by Influenza Type/Subtype (Influenza A/H1N1, Influenza A/H3N2, and Influenza B) |
— | — |
| SECONDARY Clinical Characteristics of Influenza in the Study Population |
— | — |
| SECONDARY Etiologies of Influenza-like Illness in the Study Population |
— | — |
| SECONDARY Evaluation of Vaccine-take as Shedding of Vaccine Virus Post-vaccination, Including Viral Load and Duration of Virus Detection |
— | — |
Summary
This study will provide the Senegal Ministry of Health with data on the clinical efficacy of the Live-Attenuated Influenza Vaccine (LAIV). This data will inform future policy considerations for influenza vaccine.
Eligibility Criteria
Inclusion Criteria
- Healthy male or female child at least 24 months of age and no older than 71 months of age at the time of study vaccination.
- A child whose parent or guardian's primary residence, at the time of study vaccinations, is within the Niakhar DSS and who intends to be present in the area for the duration of the trial.
- A child whose parent or legal guardian is willing to provide written informed consent prior to the participant's study vaccination
Exclusion Criteria
- Serious, active, medical condition, including: chronic disease of any body system,chronic infections such as tuberculosis, genetic disorders, such as Down's syndrome or other cytogenetic disorder, known or suspected disease of the immune system of any kind.
- 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.
- History of Guillain-Barré syndrome.
- Receipt of immunosuppressive agents, including systemic corticosteroids, during the month before planned study vaccination.
- Receipt of aspirin therapy or aspirin-containing therapy within the two weeks before planned study vaccination.
- History of any severe allergic reaction with generalized urticarial, angioedema, or anaphylaxis.
- 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.
Temporary Contraindications:
- Acute illness accompanied by a body temperature of 37.5°C or above (axillary measurement) within 14 days of enrollment visit.
- Any acute respiratory infection within 14 days of enrollment visit.
- Any illness accompanied by active wheezing within 14 days of enrollment visit.
Data sourced from ClinicalTrials.gov (NCT01854632). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.