A clinical study to Evaluate The Safety, Tolerability And Immunogenicity Of Three Formulations (15µg Without Adjuvant, 7.5µg With Adjuvant And 3.75µg With Adjuvant) Of Monovalent H1N1 Influenza A (2009) Virus Vaccine In Healthy Adults

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2010
INTERVENTION: Intervention1: 15µg without adjuvant, 7.5µg with adjuvant and 3.75µg with adjuvant; Inactivated, split virion, monovalent influenza A H1N1 (2009) vaccine: Two doses(0.5 ml each)seperated by a 21 day gap Control Intervention1: Nil: Nil CONDITION: Pandemic influenza (H1N1) infection in adults PRIMARY OUTCOME: 1.Incidence of solicited adverse events 6 hours and during the 7 days after each vaccine dose in the three treatment groups ; 2.Incidence of unsolicited adverse events during the 42 days after each vaccination in all three treatment groups ; 3.Incidence of SAE during the entire study period in the three treatment groups ; ‐‐‐‐‐‐Timepoint: THROUGH OUT STUDY DURATION. SECONDARY OUTCOME: 1.Proportion/percentage of subjects achieving seroconversion and seroprotection after each dose of vaccine. ; 2.Seroconversion defined as: a prevaccination hemagglutination‐inhibition antibody titer 1:10 and a postvaccination titer 1:40 or a prevaccination titer 1:10 and an increase in the titer by a factor of four or more) and seroprotection as hemagglutinin‐inhibition antibody titer 1:40. ; ‐‐‐‐‐‐Timepoint: Serum Anti HA titres pre vaccination and 21 days after completion of two dose primary vaccination series. INCLUSION CRITERIA: 1.Healthy male or female volunteers aged 18 years and above. 2.Subjects with normal health as determined by personal medical history, clinical examination and past laboratory examinations (within the clinically acceptable normal range) done during screening. 3.Subject willing to give written informed consent and fulfill all study requirements. 4.If female subjects and; 1.Of child bearing potential but practicing acceptable method of contraception or surgically sterile. 2.Acceptable methods of contraception are: a.Intra‐uterine contraceptive device without hormone release system (placed at least 4weeks prior to study drug administration. b.Effective method of barrier contraception like condom or diaphragm with spermicidal gel/foam/film/cream/suppository
Epistemonikos ID: 7c7b3d9b4b40079773f32640ba562c847d72f98a
First added on: Aug 22, 2024