None listed
Conditions
Interventions
Intervention1: Liquid Live Attenuated Human Seasonal Quadrivalent Influenza Vaccine (LAIV-LQ): A quadrivalent vaccine consisting of the four seasonal influenza vaccine strains for A/H1N1, A/H3N2 and t
Sponsors
Serum Institute of India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Normal healthy subjects of >= 2 years at the time of screening. 2.Parent of subject (2-17 years) willing to give written informed consent and willing to comply with study protocol 3.The subject (>=18 year) is willing to give informed consent and willing to comply with study protocol. 4.The subject (07-17 year) is willing to give informed assent and willing to comply with study protocol. 5.Free of obvious health problems as established by medical history, and physical examination. 6.The subject should be the resident of study area. 7.Female subject of child bearing potential must agree not to become pregnant and the male subject must agree not to conceive a child from the time of study enrolment until at least three months after the receiving the study vaccine
Exclusion criteria
Exclusion criteria: 1.Acute febrile illness 2.Acute infectious disease or had acute respiratory illness needing antibiotics or antivirals in the previous 7 days (temporary exclusion criteria) 3.Active allergic rhinitis (temporary exclusion criteria) 4.Active wheezing (temporary exclusion criteria) 5.Children or adolescents (2-17 years of age) receiving aspirin therapy or aspirin-containing therapy in the previous 7 days (temporary exclusion criteria) 6.History of influenza infection within one year prior to day of vaccination 7.History of vaccination against influenza within one year prior to day of vaccination 8.Have a known allergy to eggs or other components of the vaccine (including gelatin, sorbitol, lactalbumin and chicken protein). 9.Women with positive urine pregnancy test within 24 hours prior to vaccination, or women who are breastfeeding or are unwilling to undergo pregnancy testing. 10. Participating in other clinical trial or planned participation in another clinical trial during their entire trial period. 11. Altered immune status or chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying agents within six months prior to administration of study vaccine. 12. History of severe allergic reaction with generalized urticaria, angioedema or anaphylaxis. 13. History of Guillain-Barré Syndrome. 14. Major congenital defects or serious chronic illness 15. Receipt of licensed vaccine, immune sera and/or any blood products, or an investigational study agent within previous 30 days or planned during their participation in the study 16. Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, psychiatric, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and/or physical examination, which in the opinion of the investigator might interfere with the study objectives 17. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer participating in the study or make it unlikely that the subject could complete the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.The incidence of solicited local and systemic reactions within 7 days of vaccine administration. 2.The incidence of unsolicited adverse events and serious adverse events (SAEs) throughout the entire study periodTimepoint: 1.7 days 2.28 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| To estimate and compare between treatment arms the proportion of subjects with seroconversion in HI antibodies against each strain on Day 28 after vaccinationTimepoint: 28 Days;To estimate and compare between treatment arms the proportion of subjects with seroconversion in IgG antibodies against each strain on Day 28 after vaccinationTimepoint: 28 Days;To estimate and compare between treatment arms the proportion of subjects with seroconversion in nasal IgA antibodies against each strain on Day 14 after vaccinationTimepoint: 14 Days;To estimate and compare the proportion of subjects with total seroconversion against each strain on Day 28 after vaccination between the two treatment arms. Total seroconversion is defined as seroconversion in any one of three tests (HI, IgG and IgA)Timepoint: 28 Days;To estimate the Geometric Mean Titre of HI and serum IgG on Days 0 and 28 after vaccination; and of nasal IgA on Days 0 and 14 after vaccination and to compare the Geometric Mean Fold Increases in antibody levels between the treatment armsTimepoint: 14 & 28 Days | — |
Countries
India
Contacts
Public ContactPrasad Kulkarni
Serum Institute of India Pvt. Ltd.
Outcome results
None listed