The overall aim of this study is to evaluate the safety, immunogenicity and dose sparing effects of H7N9 influenza antigen formulated with 2 different adjuvants .
Following the emergence of avian influenza A/H7N9 influenza virus in humans in China in March 2013, the WHO Essential Regulatory Laboratories prepared candidate vaccine viruses and reagents for further development and several manufacturers have developed various inactivated influenza vaccines with and without adjuvant against A/H7N9 and tested these candidates in trials in healthy adults. The overall aim of this study is to evaluate the safety, immunogenicity and dose sparing effects of H7N9 influenza antigen produced by Butantan Institute in combination with 2 different adjuvants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
432
H7N9 monovalent (fragmented and inactivated)
H7N9 monovalent (fragmented and inactivated)
H7N9 monovalent (fragmented and inactivated)
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, São Paulo, Brazil
Centro de Pesquisas Clínicas do Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
Centro de Pesquisa Clínica do Instituto da Criança do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - ICr/HCFMUSP
São Paulo, São Paulo, Brazil
Number of participants with solicited local Adverse Events over the 7-day period post each study injection.
Solicited local Adverse Events (AE) include erythema, swelling/induration, pain/tenderness, ecchymosis, pruritis. The participant will be given a Participant Diary, a digital thermometer and ruler in which the participant will be asked to record any local and/or systemic reactions. The participant will have been instructed that if he/she experiences an AE requiring medical care, the participant should inform the study staff as soon as possible and seek medical care as appropriate. A visit will be schedule to occur 7 days after each study injection. Study staff will review the Participant Diary and interim history with the participant and inquire about new medical events, which will be recorded in the appropriate Clinical Research Forms.
Time frame: 7-day period post each study injection (Days 0-6)
Number of participants with solicited systemic Adverse Effects over the 7-day period post each study injection.
Solicited systemic Adverse Events (AE) include fever, fatigue/malaise, myalgia, arthralgia, chills, nausea/vomiting, and headache. The participant will be given a Participant Diary, a digital thermometer and ruler in which the participant will be asked to record any local and/or systemic reactions. The participant will have been instructed that if he/she experiences an AE requiring medical care, the participant should inform the study staff as soon as possible and seek medical care as appropriate. A visit will be schedule to occur 7 days after each study injection. Study staff will review the Participant Diary and interim history with the participant and inquire about new medical events, which will be recorded in the appropriate Clinical Research Forms.
Time frame: 7-day period post each study injection (Days 0-6)
Number of participants with unsolicited local and/or systemic Adverse Events over the 7-day period post each study injection.
Unsolicited local and/or systemic Adverse Events include any AE not include in the description of solicited AE, as described in Outcome 1 and 2. The participant will be given a Participant Diary, a digital thermometer and ruler in which the participant will be asked to record any local and/or systemic reactions. The participant will have been instructed that if he/she experiences an AE requiring medical care, the participant should inform the study staff as soon as possible and seek medical care as appropriate. A visit will be schedule to occur 7 days after each study injection. Study staff will review the Participant Diary and interim history with the participant and inquire about new medical events, which will be recorded in the appropriate Clinical Research Forms.
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Placebo (Phosphate Buffered Saline -PBS)
Time frame: 7-day period post each study injection (Days 0-6)
Number of participants with unsolicited local and/or systemic Adverse Events over the 28-day period post each study injection.
Unsolicited local and/or systemic Adverse Events include any AE not include in the description of solicited AE, as described in Outcome 1 and 2. A visit will be schedule to occur 28 days after each study injection. Study staff will review the Participant Diary and interim history with the participant and inquire about new medical events, which will be recorded in the appropriate Clinical Research Forms.
Time frame: 28-day period post each study injection (Days 0-27)
Number of participants with Serious Adverse Events over the 222-day period post second study injection.
Serious Adverse Event (SAE) is defined as an adverse event that meets one of the following conditions: * Death. * Life-threatening. * Requires inpatient hospitalization or prolongation of existing hospitalization. * Results in congenital anomaly/birth defect. * Results in a persistent or significant disability or incapacity. * Important medical events that might not result in death, be life-threatening, or require hospitalization might be considered SAEs when, based upon appropriate medical judgment, the event might jeopardize the well-being of the participant and require medical or surgical intervention to prevent one of the outcomes listed above. Participants will be contacted by phone on Day 222 after administration of second dose of study product for (a) closure of any ongoing AEs and concomitant medications; and (b) collection of any SAEs and new concomitant medications, if associated with the SAE reported.
Time frame: 222-day period post the second study injection (Days 0-221)
Number of participants that presented seroconversion at day 28, 45 and 56 post first study injection
Seroconvertion is defined as: prevaccination Hemagglutination-inhibition test (HI) antibody titer ≤1:10 and postvaccination HI antibody titer ≥1:40, or prevaccination HI antibody titer ≥1:10 and a postvaccination increase by a factor of four or more). Participants will be invited to return on days 28, 45 and 56 post first study injection, when blood samples will be taken for HI testing.
Time frame: 56-day period post the first study injection
Number of participants that presented seroprotection at day 28, 45 and 56 post first study injection
Seroprotection is defined as postvaccination Hemagglutination-inhibition test (HI) antibody titer ≥ 1:40. Participants will be invited to return on days 28, 45 and 56 post first study injection, when blood samples will be taken for HI testing.
Time frame: 56-day period post the first study injection
Geometric mean of Hemagglutination-inhibition titre at day 28, 45 and 56 post first study injection
Geometric mean of Hemagglutination-inhibition test titre will be calculated for the different groups of participants at day 28, 45 and 56 post first study injection. Participants will be invited to return on days 28, 45 and 56 post first study injection, when blood samples will be taken for HI testing.
Time frame: 56-day period post the first study injection