Influenza
Conditions
Keywords
H2N2, vaccine
Brief summary
This is a phase I study to evaluate the safety of a vaccine to protect against influenza viruses of the H2N2 subtype. A total of 40 adults will be enrolled and receive two doses of vaccine or placebo one month apart.
Detailed description
The aim of this study is to evaluate the safety profile of two intranasal doses of LAIV A/17/California/66/395 (H2N2) in healthy adults in Russia. A(H2N2) viruses which are antigenically similar to the pandemic strain A/Singapore/1/57, continue to circulate in domestic and wild bird populations, as confirmed by routine moni¬toring of avian influenza viruses. 40 adults aged 18-40 will be enrolled. They will be randomized to receive vaccine or placebo. Blood and urine will be collected during the week following each vaccination and before the next vaccination to monitor safety. Blood samples will also be collected at several timepoints to assess the volunteer's immune response to the vaccine. The total duration of the study is 16 weeks for each volunteer.
Interventions
BIOLOGICALLAIV H2N2
vaccine is delivered intranasally, .25 cc to each nostril at day 0 and day 28
OTHERPlacebo
placebo delivered intranasally. .25cc to each nostril at day 0 and day 28
Sponsors
Ministry of Health, Russian Federation
Institute of Experimental Medicine, Russia
PATH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Legal male or female adult aged 18 through 40 years * Literate and willing to provide written informed consent. * A signed informed consent. * Free of obvious health problems, as established by medical history and screening evaluations, including physical examination. * Capable and willing to complete diary cards and willing to return for all follow-up visits * Willing to comply with the rules of isolation unit (including willing and able to take oseltamivir influenza antiviral medication, should that be recommended by study physician). * For females, willing to take reliable birth control measures through day 56.
Exclusion criteria
* Participation in another clinical trial involving any therapy within the previous three months or planned enrollment in such a trial during trial period. * Receipt of any non-study vaccine within four weeks prior to enrollment or refusal to postpone receipt of such vaccines until four weeks after study completion. * Practice of nasal irrigation on a regular basis within the past six months or has engaged in nasal irrigation within two weeks prior to enrollment. * Recent history of frequent nose bleeds (\>5 within the past year). * Clinically relevant abnormal paranasal anatomy. * Recent history (within the past month) of rhino or sinus surgery, or surgery for any traumatic injury of the nose. * Current or recent (within two weeks of enrollment) acute respiratory illness with or without fever. * Other acute illness at the time of study enrollment. * Receipt of immune globulin or other blood products within three months prior to study enrollment or planned receipt during period of subject participation in the study. * Chronic administration (defined as more than 14 consecutively-prescribed days) of immunosuppressants and/or other immune-modulating therapy within six months prior to study enrollment. * Participation in any previous trial of any H2N2 containing influenza vaccine. * History of asthma. * Hypersensitivity after previous administration of any influenza vaccine. * History of wheezing after past receipt of any live influenza vaccine. * Other adverse event (AE) following immunization (body temperature more than 40°C, collapse, non-febrile seizures, anaphylaxis), at least possibly related to previous receipt of any vaccine (not only influenza). * Suspected or known hypersensitivity to any study vaccine components, including chicken or egg protein. * Seasonal (autumnal) hypersensitivity to the natural environment * Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, metabolic, neurologic, psychiatric or renal functional abnormality, as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives. Subjects with physical examination findings or clinical laboratory screening results which would be graded 2 or higher on the AE severity grading scale (see Attachments) will be excluded from entry into the study and will be excluded from receipt of dose two of study vaccine or placebo. * History of leukemia or any other blood or solid organ cancer. * History of thrombocytopenic purpura or known bleeding disorder. * History of seizures. * Known or suspected immunosuppressive or immunodeficient condition of any kind, including HIV infection. * Known chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. * Known tuberculosis infection or evidence of previous tuberculosis exposure. * History of chronic alcohol abuse and/or illegal drug use. * Claustrophobia or sociophobia. * Pregnancy or lactation. * Any condition that, in the opinion of the investigator, would increase the health risk to the subject if participates in the study or would interfere with the evaluation of the study objectives. * Allergic, including anaphylactic, reactions to the introduction of any vaccines (not only influenza) in the subject's medical history
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Immediate Reactions | 2 hours | Measured as observed by study staff or reported by the subject to study staff whether related or not related. |
| Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 1 | 7 days | Adverse events commonly associated with intranasal vaccination occurring greater than two hours after administration of any dose of study vaccine or placebo through 6 days following any dose, measured as observed by study staff or reported by the subject to study staff. Solicited local reactions included: dryness of the nose, nose bleeds, ticklish nose, nasal congestion, runny nose, ticklish throat, catarrhal nasopharynx. Solicited systemic reactions included: body temperature, feverishness/subjective fever, chills, cough, difficulty breathing, sore throat, headache, confusion, convulsions/seizures, fatigue/malaise, joint aches, muscle aches, pink or red eyes, draining eyes, swollen eyelids, ear pain or discharge, rash, abdominal pain, diarrhea, vomiting. |
| Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 2 | 7 days | Adverse events commonly associated with intranasal vaccination occurring greater than two hours after administration of any dose of study vaccine or placebo through 6 days following any dose, measured as observed by study staff or reported by the subject to study staff. Solicited local reactions included: dryness of the nose, nose bleeds, ticklish nose, nasal congestion, runny nose, ticklish throat, catarrhal nasopharynx. Solicited systemic reactions included: body temperature, feverishness/subjective fever, chills, cough, difficulty breathing, sore throat, headache, confusion, convulsions/seizures, fatigue/malaise, joint aches, muscle aches, pink or red eyes, draining eyes, swollen eyelids, ear pain or discharge, rash, abdominal pain, diarrhea, vomiting. |
| Percentage of Subjects With Unsolicited Adverse Events After Vaccination 1 | 7 days following each vaccination | All other adverse events (including unsolicited events and abnormal laboratory parameters) occurring during the 6 days following any dose, measured as observed by study staff or reported by the subject to study staff. |
| Percentage of Subjects With Unsolicited Adverse Events After Vaccination 2 | 7 days following each vaccination | All other adverse events (including unsolicited events and abnormal laboratory parameters) occurring during the 6 days following any dose, measured as observed by study staff or reported by the subject to study staff. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies Detected in Saliva Specimens | Day 28 and Day 56 | Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination. |
| Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Days 0-6 and Days 28-34 | Detected by real-time reverse transcriptase polymerase chain reaction. Specimens were collected prior to each vaccination and 7 days post-vaccination. |
| Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibodies | Day 28, Day 56 and Day 112 | Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination and after 112 days. |
| Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Days 0-6 and Days 28-34 | Detected by real-time reverse transcriptase polymerase chain reaction. Specimens were collected prior to each vaccination and 7 days post-vaccination. |
| Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Days 1-6 and Days 29-34 | Detected by real-time reverse transcriptase polymerase chain reaction. Specimens were collected prior to each vaccination and 7 days post-vaccination. |
| Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Days 0-6 and Days 28-34 | Detected by real-time reverse transcriptase polymerase chain reaction. Specimens were collected prior to each vaccination and 7 days post-vaccination. |
| Percentage of Subjects With Seroconversion for Serum Neutralizing Antibodies | Day 28, Day 56 and Day 112 | Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination and after 112 days. Measured by microneutralization assay. |
| Percentage of Subjects With Seroconversion for Serum Immunoglobulin A Antibodies | Day 28, Day 56 and Day 112 | Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination and after 112 days. Measured by enzyme-linked immunosorbent assay (ELISA). |
| Percentage of Subjects With Seroconversion for Serum Immunoglobulin G Antibodies | Day 28, Day 56 and Day 112 | Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination and after 112 days. Measured by enzyme-linked immunosorbent assay (ELISA). |
| Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies From Nasal Mucosa | Day 28 and Day 56 | Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LAIV H2N2 Vaccine LAIV H2N2 vaccine A/17/California/66/395 (H2N2) live monovalent influenza vaccine delivered intranasally 2 doses 1 month apart
LAIV H2N2: vaccine is delivered intranasally, .25 cc to each nostril at day 0 and day 28 | 28 |
| Placebo Placebo is composed of a lyophilizate containing the same concentrations of stabilizers as LAIV vaccine. It is prepared onsite in an identical fashion to the vaccine and delivered intranasally.
Placebo: placebo delivered intranasally. .25cc to each nostril at day 0 and day 28 | 10 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Completed Study (Day 112) | Withdrawal by Subject | 2 | 0 |
| Received Vaccination 2 | Adverse Event | 1 | 2 |
| Received Vaccination 2 | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | LAIV H2N2 Vaccine | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 28.0 years | 27.6 years | 26.2 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 38 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 38 Participants | 10 Participants |
| Region of Enrollment Russia | 28 participants | 38 participants | 10 participants |
| Sex: Female, Male Female | 12 Participants | 15 Participants | 3 Participants |
| Sex: Female, Male Male | 16 Participants | 23 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 10 |
| other Total, other adverse events | 26 / 28 | 9 / 10 |
| serious Total, serious adverse events | 0 / 28 | 0 / 10 |
Outcome results
Primary
Percentage of Participants With Immediate Reactions
Measured as observed by study staff or reported by the subject to study staff whether related or not related.
Time frame: 2 hours
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAIV H2N2 Vaccine | Percentage of Participants With Immediate Reactions | Vaccination 1 | Yes | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Participants With Immediate Reactions | Vaccination 2 | Yes | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Participants With Immediate Reactions | Vaccination 1 | No | 28 Participants |
| LAIV H2N2 Vaccine | Percentage of Participants With Immediate Reactions | Vaccination 2 | No | 28 Participants |
| Placebo | Percentage of Participants With Immediate Reactions | Vaccination 1 | No | 10 Participants |
| Placebo | Percentage of Participants With Immediate Reactions | Vaccination 1 | Yes | 0 Participants |
| Placebo | Percentage of Participants With Immediate Reactions | Vaccination 2 | No | 10 Participants |
| Placebo | Percentage of Participants With Immediate Reactions | Vaccination 2 | Yes | 0 Participants |
Primary
Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 1
Adverse events commonly associated with intranasal vaccination occurring greater than two hours after administration of any dose of study vaccine or placebo through 6 days following any dose, measured as observed by study staff or reported by the subject to study staff. Solicited local reactions included: dryness of the nose, nose bleeds, ticklish nose, nasal congestion, runny nose, ticklish throat, catarrhal nasopharynx. Solicited systemic reactions included: body temperature, feverishness/subjective fever, chills, cough, difficulty breathing, sore throat, headache, confusion, convulsions/seizures, fatigue/malaise, joint aches, muscle aches, pink or red eyes, draining eyes, swollen eyelids, ear pain or discharge, rash, abdominal pain, diarrhea, vomiting.
Time frame: 7 days
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAIV H2N2 Vaccine | Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 1 | Any solicited local or systemic reaction | Yes | 13 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 1 | Any solicited local or systemic reaction | No | 15 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 1 | Any solicited local reaction | Yes | 4 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 1 | Any solicited local reaction | No | 24 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 1 | Any solicited systemic reaction | Yes | 13 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 1 | Any solicited systemic reaction | No | 15 Participants |
| Placebo | Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 1 | Any solicited systemic reaction | Yes | 4 Participants |
| Placebo | Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 1 | Any solicited local or systemic reaction | Yes | 5 Participants |
| Placebo | Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 1 | Any solicited local reaction | No | 8 Participants |
| Placebo | Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 1 | Any solicited local or systemic reaction | No | 5 Participants |
| Placebo | Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 1 | Any solicited systemic reaction | No | 6 Participants |
| Placebo | Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 1 | Any solicited local reaction | Yes | 2 Participants |
Primary
Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 2
Adverse events commonly associated with intranasal vaccination occurring greater than two hours after administration of any dose of study vaccine or placebo through 6 days following any dose, measured as observed by study staff or reported by the subject to study staff. Solicited local reactions included: dryness of the nose, nose bleeds, ticklish nose, nasal congestion, runny nose, ticklish throat, catarrhal nasopharynx. Solicited systemic reactions included: body temperature, feverishness/subjective fever, chills, cough, difficulty breathing, sore throat, headache, confusion, convulsions/seizures, fatigue/malaise, joint aches, muscle aches, pink or red eyes, draining eyes, swollen eyelids, ear pain or discharge, rash, abdominal pain, diarrhea, vomiting.
Time frame: 7 days
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAIV H2N2 Vaccine | Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 2 | Any solicited local or systemic reaction | Yes | 9 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 2 | Any solicited local or systemic reaction | No | 19 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 2 | Any solicited local reaction | Yes | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 2 | Any solicited local reaction | No | 28 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 2 | Any solicited systemic reaction | Yes | 9 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 2 | Any solicited systemic reaction | No | 19 Participants |
| Placebo | Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 2 | Any solicited systemic reaction | Yes | 2 Participants |
| Placebo | Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 2 | Any solicited local or systemic reaction | Yes | 2 Participants |
| Placebo | Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 2 | Any solicited local reaction | No | 10 Participants |
| Placebo | Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 2 | Any solicited local or systemic reaction | No | 8 Participants |
| Placebo | Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 2 | Any solicited systemic reaction | No | 8 Participants |
| Placebo | Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 2 | Any solicited local reaction | Yes | 0 Participants |
Primary
Percentage of Subjects With Unsolicited Adverse Events After Vaccination 1
All other adverse events (including unsolicited events and abnormal laboratory parameters) occurring during the 6 days following any dose, measured as observed by study staff or reported by the subject to study staff.
Time frame: 7 days following each vaccination
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAIV H2N2 Vaccine | Percentage of Subjects With Unsolicited Adverse Events After Vaccination 1 | Unrelated to vaccination | Yes | 15 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Unsolicited Adverse Events After Vaccination 1 | Unrelated to vaccination | No | 13 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Unsolicited Adverse Events After Vaccination 1 | Related to vaccination | Yes | 16 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Unsolicited Adverse Events After Vaccination 1 | Related to vaccination | No | 12 Participants |
| Placebo | Percentage of Subjects With Unsolicited Adverse Events After Vaccination 1 | Related to vaccination | No | 5 Participants |
| Placebo | Percentage of Subjects With Unsolicited Adverse Events After Vaccination 1 | Unrelated to vaccination | Yes | 7 Participants |
| Placebo | Percentage of Subjects With Unsolicited Adverse Events After Vaccination 1 | Related to vaccination | Yes | 5 Participants |
| Placebo | Percentage of Subjects With Unsolicited Adverse Events After Vaccination 1 | Unrelated to vaccination | No | 3 Participants |
Primary
Percentage of Subjects With Unsolicited Adverse Events After Vaccination 2
All other adverse events (including unsolicited events and abnormal laboratory parameters) occurring during the 6 days following any dose, measured as observed by study staff or reported by the subject to study staff.
Time frame: 7 days following each vaccination
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAIV H2N2 Vaccine | Percentage of Subjects With Unsolicited Adverse Events After Vaccination 2 | Unrelated to vaccination | Yes | 19 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Unsolicited Adverse Events After Vaccination 2 | Unrelated to vaccination | No | 9 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Unsolicited Adverse Events After Vaccination 2 | Related to vaccination | Yes | 19 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Unsolicited Adverse Events After Vaccination 2 | Related to vaccination | No | 9 Participants |
| Placebo | Percentage of Subjects With Unsolicited Adverse Events After Vaccination 2 | Related to vaccination | No | 6 Participants |
| Placebo | Percentage of Subjects With Unsolicited Adverse Events After Vaccination 2 | Unrelated to vaccination | Yes | 6 Participants |
| Placebo | Percentage of Subjects With Unsolicited Adverse Events After Vaccination 2 | Related to vaccination | Yes | 4 Participants |
| Placebo | Percentage of Subjects With Unsolicited Adverse Events After Vaccination 2 | Unrelated to vaccination | No | 4 Participants |
Secondary
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Detected by real-time reverse transcriptase polymerase chain reaction. Specimens were collected prior to each vaccination and 7 days post-vaccination.
Time frame: Days 0-6 and Days 28-34
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 28 pre-dose | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 2 | Negative | 17 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 28 pre-dose | Positive | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 4 | Negative | 25 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 29 | Negative | 7 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 0 pre-dose | Positive | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 29 | Positive | 20 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 4 | Positive | 2 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 30 | Negative | 25 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 2 | Positive | 10 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 30 | Positive | 2 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 5 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 31 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 1 | Positive | 21 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 31 | Positive | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 5 | Positive | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 32 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 3 | Negative | 23 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 32 | Positive | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 6 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 33 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 1 | Negative | 6 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 33 | Positive | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 6 | Positive | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 34 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 3 | Positive | 4 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 34 | Positive | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 0 pre-dose | Negative | 27 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 34 | Positive | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 0 pre-dose | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 0 pre-dose | Positive | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 1 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 1 | Positive | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 2 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 2 | Positive | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 3 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 3 | Positive | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 4 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 4 | Positive | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 5 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 5 | Positive | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 6 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 6 | Positive | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 28 pre-dose | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 28 pre-dose | Positive | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 29 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 29 | Positive | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 30 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 30 | Positive | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 31 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 31 | Positive | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 32 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 32 | Positive | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 33 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 33 | Positive | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab | Day 34 | Negative | 7 Participants |
Secondary
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Detected by real-time reverse transcriptase polymerase chain reaction. Specimens were collected prior to each vaccination and 7 days post-vaccination.
Time frame: Days 0-6 and Days 28-34
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 28 pre-dose | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 3 | Positive | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 28 pre-dose | Positive | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 0 pre-dose | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 29 | Negative | 25 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 2 | Negative | 25 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 29 | Positive | 2 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 4 | Positive | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 30 | Negative | 26 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 1 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 30 | Positive | 1 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 5 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 31 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 2 | Positive | 2 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 31 | Positive | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 5 | Positive | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 32 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 0 pre-dose | Positive | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 32 | Positive | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 6 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 33 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 3 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 33 | Positive | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 6 | Positive | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 34 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 1 | Positive | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 34 | Positive | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 4 | Negative | 27 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 34 | Positive | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 0 pre-dose | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 0 pre-dose | Positive | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 1 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 1 | Positive | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 2 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 2 | Positive | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 3 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 3 | Positive | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 4 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 4 | Positive | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 5 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 5 | Positive | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 6 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 6 | Positive | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 28 pre-dose | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 28 pre-dose | Positive | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 29 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 29 | Positive | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 30 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 30 | Positive | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 31 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 31 | Positive | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 32 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 32 | Positive | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 33 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 33 | Positive | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza A Virus Using Throat Swab | Day 34 | Negative | 7 Participants |
Secondary
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Detected by real-time reverse transcriptase polymerase chain reaction. Specimens were collected prior to each vaccination and 7 days post-vaccination.
Time frame: Days 0-6 and Days 28-34
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 28 pre-dose | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 2 | Negative | 18 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 28 pre-dose | H2 | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 4 | Negative | 26 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 29 | Negative | 7 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 0 pre-dose | H2 | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 29 | H2 | 20 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 4 | H2 | 1 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 30 | Negative | 25 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 2 | H2 | 9 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 30 | H2 | 2 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 5 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 31 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 1 | H2 | 20 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 31 | H2 | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 5 | H2 | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 32 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 3 | Negative | 23 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 32 | H2 | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 6 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 33 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 1 | Negative | 7 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 33 | H2 | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 6 | H2 | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 34 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 3 | H2 | 4 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 34 | H2 | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 0 pre-dose | Negative | 27 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 34 | H2 | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 0 pre-dose | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 0 pre-dose | H2 | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 1 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 1 | H2 | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 2 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 2 | H2 | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 3 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 3 | H2 | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 4 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 4 | H2 | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 5 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 5 | H2 | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 6 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 6 | H2 | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 28 pre-dose | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 28 pre-dose | H2 | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 29 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 29 | H2 | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 30 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 30 | H2 | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 31 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 31 | H2 | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 32 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 32 | H2 | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 33 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 33 | H2 | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab | Day 34 | Negative | 7 Participants |
Secondary
Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab
Detected by real-time reverse transcriptase polymerase chain reaction. Specimens were collected prior to each vaccination and 7 days post-vaccination.
Time frame: Days 1-6 and Days 29-34
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 5 | H2 | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 33 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 30 | Negative | 26 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 33 | H2 | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 6 | H2 | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 30 | H2 | 1 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 34 | H2 | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 5 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 1 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 31 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 1 | H2 | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 29 | Negative | 25 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 2 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 31 | H2 | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 2 | H2 | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 6 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 3 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 32 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 3 | H2 | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 29 | H2 | 2 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 4 | Negative | 27 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 32 | H2 | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 4 | H2 | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 34 | Negative | 27 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 4 | H2 | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 5 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 5 | H2 | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 6 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 6 | H2 | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 29 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 29 | H2 | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 30 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 30 | H2 | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 31 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 31 | H2 | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 32 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 32 | H2 | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 33 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 33 | H2 | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 34 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 34 | H2 | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 1 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 1 | H2 | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 2 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 2 | H2 | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 3 | Negative | 7 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 3 | H2 | 0 Participants |
| Placebo | Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab | Day 4 | Negative | 7 Participants |
Secondary
Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies Detected in Saliva Specimens
Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination.
Time frame: Day 28 and Day 56
Population: Subjects that received each vaccination (vaccination 1 for day 28, vaccination 2 for days 56 and 112), did not withdraw from the study, and that had viable immunologic data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies Detected in Saliva Specimens | Day 28 | Yes | 3 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies Detected in Saliva Specimens | Day 28 | No | 22 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies Detected in Saliva Specimens | Day 56 | Yes | 9 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies Detected in Saliva Specimens | Day 56 | No | 16 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies Detected in Saliva Specimens | Day 56 | No | 7 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies Detected in Saliva Specimens | Day 28 | Yes | 0 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies Detected in Saliva Specimens | Day 56 | Yes | 0 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies Detected in Saliva Specimens | Day 28 | No | 7 Participants |
Secondary
Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies From Nasal Mucosa
Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination.
Time frame: Day 28 and Day 56
Population: Subjects that received each vaccination (vaccination 1 for day 28, vaccination 2 for days 56 and 112), did not withdraw from the study, and that had viable immunologic data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies From Nasal Mucosa | Day 28 | Yes | 6 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies From Nasal Mucosa | Day 28 | No | 19 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies From Nasal Mucosa | Day 56 | Yes | 10 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies From Nasal Mucosa | Day 56 | No | 15 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies From Nasal Mucosa | Day 56 | No | 7 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies From Nasal Mucosa | Day 28 | Yes | 0 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies From Nasal Mucosa | Day 56 | Yes | 0 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies From Nasal Mucosa | Day 28 | No | 7 Participants |
Secondary
Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibodies
Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination and after 112 days.
Time frame: Day 28, Day 56 and Day 112
Population: Subjects that received each vaccination (vaccination 1 for day 28, vaccination 2 for days 56 and 112), did not withdraw from the study, and that had viable immunologic data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibodies | Day 28 | Yes | 4 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibodies | Day 28 | No | 21 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibodies | Day 56 | Yes | 8 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibodies | Day 56 | No | 17 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibodies | Day 112 | Yes | 15 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibodies | Day 112 | No | 10 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibodies | Day 112 | Yes | 0 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibodies | Day 28 | Yes | 0 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibodies | Day 56 | No | 7 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibodies | Day 28 | No | 7 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibodies | Day 112 | No | 7 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibodies | Day 56 | Yes | 0 Participants |
Secondary
Percentage of Subjects With Seroconversion for Serum Immunoglobulin A Antibodies
Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination and after 112 days. Measured by enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 28, Day 56 and Day 112
Population: Subjects that received each vaccination (vaccination 1 for day 28, vaccination 2 for days 56 and 112), did not withdraw from the study, and that had viable immunologic data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Serum Immunoglobulin A Antibodies | Day 28 | Yes | 2 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Serum Immunoglobulin A Antibodies | Day 28 | No | 23 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Serum Immunoglobulin A Antibodies | Day 56 | Yes | 13 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Serum Immunoglobulin A Antibodies | Day 56 | No | 12 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Serum Immunoglobulin A Antibodies | Day 112 | Yes | 12 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Serum Immunoglobulin A Antibodies | Day 112 | No | 13 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Serum Immunoglobulin A Antibodies | Day 112 | Yes | 0 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Serum Immunoglobulin A Antibodies | Day 28 | Yes | 0 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Serum Immunoglobulin A Antibodies | Day 56 | No | 7 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Serum Immunoglobulin A Antibodies | Day 28 | No | 7 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Serum Immunoglobulin A Antibodies | Day 112 | No | 7 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Serum Immunoglobulin A Antibodies | Day 56 | Yes | 0 Participants |
Secondary
Percentage of Subjects With Seroconversion for Serum Immunoglobulin G Antibodies
Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination and after 112 days. Measured by enzyme-linked immunosorbent assay (ELISA).
Time frame: Day 28, Day 56 and Day 112
Population: Subjects that received each vaccination (vaccination 1 for day 28, vaccination 2 for days 56 and 112), did not withdraw from the study, and that had viable immunologic data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Serum Immunoglobulin G Antibodies | Day 28 | Yes | 0 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Serum Immunoglobulin G Antibodies | Day 28 | No | 25 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Serum Immunoglobulin G Antibodies | Day 56 | Yes | 1 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Serum Immunoglobulin G Antibodies | Day 56 | No | 24 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Serum Immunoglobulin G Antibodies | Day 112 | Yes | 2 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Serum Immunoglobulin G Antibodies | Day 112 | No | 23 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Serum Immunoglobulin G Antibodies | Day 112 | Yes | 0 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Serum Immunoglobulin G Antibodies | Day 28 | Yes | 0 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Serum Immunoglobulin G Antibodies | Day 56 | No | 7 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Serum Immunoglobulin G Antibodies | Day 28 | No | 7 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Serum Immunoglobulin G Antibodies | Day 112 | No | 7 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Serum Immunoglobulin G Antibodies | Day 56 | Yes | 0 Participants |
Secondary
Percentage of Subjects With Seroconversion for Serum Neutralizing Antibodies
Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination and after 112 days. Measured by microneutralization assay.
Time frame: Day 28, Day 56 and Day 112
Population: Subjects that received each vaccination (vaccination 1 for day 28, vaccination 2 for days 56 and 112), did not withdraw from the study, and that had viable immunologic data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Serum Neutralizing Antibodies | Day 28 | Yes | 8 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Serum Neutralizing Antibodies | Day 28 | No | 17 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Serum Neutralizing Antibodies | Day 56 | Yes | 10 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Serum Neutralizing Antibodies | Day 56 | No | 15 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Serum Neutralizing Antibodies | Day 112 | Yes | 11 Participants |
| LAIV H2N2 Vaccine | Percentage of Subjects With Seroconversion for Serum Neutralizing Antibodies | Day 112 | No | 14 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Serum Neutralizing Antibodies | Day 112 | Yes | 1 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Serum Neutralizing Antibodies | Day 28 | Yes | 1 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Serum Neutralizing Antibodies | Day 56 | No | 6 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Serum Neutralizing Antibodies | Day 28 | No | 6 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Serum Neutralizing Antibodies | Day 112 | No | 6 Participants |
| Placebo | Percentage of Subjects With Seroconversion for Serum Neutralizing Antibodies | Day 56 | Yes | 1 Participants |