Trial Outcomes & Findings for Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/CALIFORNIA/66/395 (H2N2) Influenza Vaccine (NCT NCT01982331)
NCT ID: NCT01982331
Last Updated: 2019-02-26
Results Overview
Measured as observed by study staff or reported by the subject to study staff whether related or not related.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
38 participants
Primary outcome timeframe
2 hours
Results posted on
2019-02-26
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Received Vaccination 1
STARTED
|
28
|
10
|
|
Received Vaccination 1
COMPLETED
|
28
|
10
|
|
Received Vaccination 1
NOT COMPLETED
|
0
|
0
|
|
Received Vaccination 2
STARTED
|
28
|
10
|
|
Received Vaccination 2
COMPLETED
|
27
|
7
|
|
Received Vaccination 2
NOT COMPLETED
|
1
|
3
|
|
Completed Study (Day 112)
STARTED
|
27
|
7
|
|
Completed Study (Day 112)
COMPLETED
|
25
|
7
|
|
Completed Study (Day 112)
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Received Vaccination 2
Adverse Event
|
1
|
2
|
|
Received Vaccination 2
Withdrawal by Subject
|
0
|
1
|
|
Completed Study (Day 112)
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/CALIFORNIA/66/395 (H2N2) Influenza Vaccine
Baseline characteristics by cohort
| Measure |
LAIV H2N2 Vaccine
n=28 Participants
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
|
Placebo
n=10 Participants
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
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.0 years
n=5 Participants
|
26.2 years
n=7 Participants
|
27.6 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
28 participants
n=5 Participants
|
10 participants
n=7 Participants
|
38 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 hoursMeasured as observed by study staff or reported by the subject to study staff whether related or not related.
Outcome measures
| Measure |
LAIV H2N2 Vaccine
n=28 Participants
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
|
Placebo
n=10 Participants
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
|
|---|---|---|
|
Percentage of Participants With Immediate Reactions
Vaccination 1 · Yes
|
0 Participants
|
0 Participants
|
|
Percentage of Participants With Immediate Reactions
Vaccination 1 · No
|
28 Participants
|
10 Participants
|
|
Percentage of Participants With Immediate Reactions
Vaccination 2 · Yes
|
0 Participants
|
0 Participants
|
|
Percentage of Participants With Immediate Reactions
Vaccination 2 · No
|
28 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 7 daysAdverse 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.
Outcome measures
| Measure |
LAIV H2N2 Vaccine
n=28 Participants
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
|
Placebo
n=10 Participants
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
|
|---|---|---|
|
Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 1
Any solicited local or systemic reaction · Yes
|
13 Participants
|
5 Participants
|
|
Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 1
Any solicited local or systemic reaction · No
|
15 Participants
|
5 Participants
|
|
Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 1
Any solicited local reaction · Yes
|
4 Participants
|
2 Participants
|
|
Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 1
Any solicited local reaction · No
|
24 Participants
|
8 Participants
|
|
Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 1
Any solicited systemic reaction · Yes
|
13 Participants
|
4 Participants
|
|
Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 1
Any solicited systemic reaction · No
|
15 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 7 daysAdverse 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.
Outcome measures
| Measure |
LAIV H2N2 Vaccine
n=28 Participants
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
|
Placebo
n=10 Participants
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
|
|---|---|---|
|
Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 2
Any solicited local or systemic reaction · Yes
|
9 Participants
|
2 Participants
|
|
Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 2
Any solicited local or systemic reaction · No
|
19 Participants
|
8 Participants
|
|
Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 2
Any solicited local reaction · Yes
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 2
Any solicited local reaction · No
|
28 Participants
|
10 Participants
|
|
Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 2
Any solicited systemic reaction · Yes
|
9 Participants
|
2 Participants
|
|
Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 2
Any solicited systemic reaction · No
|
19 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 7 days following each vaccinationAll 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.
Outcome measures
| Measure |
LAIV H2N2 Vaccine
n=28 Participants
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
|
Placebo
n=10 Participants
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
|
|---|---|---|
|
Percentage of Subjects With Unsolicited Adverse Events After Vaccination 1
Unrelated to vaccination · Yes
|
15 Participants
|
7 Participants
|
|
Percentage of Subjects With Unsolicited Adverse Events After Vaccination 1
Unrelated to vaccination · No
|
13 Participants
|
3 Participants
|
|
Percentage of Subjects With Unsolicited Adverse Events After Vaccination 1
Related to vaccination · Yes
|
16 Participants
|
5 Participants
|
|
Percentage of Subjects With Unsolicited Adverse Events After Vaccination 1
Related to vaccination · No
|
12 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 7 days following each vaccinationAll 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.
Outcome measures
| Measure |
LAIV H2N2 Vaccine
n=28 Participants
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
|
Placebo
n=10 Participants
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
|
|---|---|---|
|
Percentage of Subjects With Unsolicited Adverse Events After Vaccination 2
Unrelated to vaccination · Yes
|
19 Participants
|
6 Participants
|
|
Percentage of Subjects With Unsolicited Adverse Events After Vaccination 2
Unrelated to vaccination · No
|
9 Participants
|
4 Participants
|
|
Percentage of Subjects With Unsolicited Adverse Events After Vaccination 2
Related to vaccination · Yes
|
19 Participants
|
4 Participants
|
|
Percentage of Subjects With Unsolicited Adverse Events After Vaccination 2
Related to vaccination · No
|
9 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 28, Day 56 and Day 112Population: 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.
Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination and after 112 days.
Outcome measures
| Measure |
LAIV H2N2 Vaccine
n=25 Participants
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
|
Placebo
n=7 Participants
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
|
|---|---|---|
|
Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibodies
Day 28 · Yes
|
4 Participants
|
0 Participants
|
|
Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibodies
Day 28 · No
|
21 Participants
|
7 Participants
|
|
Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibodies
Day 56 · Yes
|
8 Participants
|
0 Participants
|
|
Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibodies
Day 56 · No
|
17 Participants
|
7 Participants
|
|
Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibodies
Day 112 · Yes
|
15 Participants
|
0 Participants
|
|
Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI) Antibodies
Day 112 · No
|
10 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 28, Day 56 and Day 112Population: 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.
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.
Outcome measures
| Measure |
LAIV H2N2 Vaccine
n=25 Participants
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
|
Placebo
n=7 Participants
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
|
|---|---|---|
|
Percentage of Subjects With Seroconversion for Serum Neutralizing Antibodies
Day 28 · Yes
|
8 Participants
|
1 Participants
|
|
Percentage of Subjects With Seroconversion for Serum Neutralizing Antibodies
Day 28 · No
|
17 Participants
|
6 Participants
|
|
Percentage of Subjects With Seroconversion for Serum Neutralizing Antibodies
Day 56 · Yes
|
10 Participants
|
1 Participants
|
|
Percentage of Subjects With Seroconversion for Serum Neutralizing Antibodies
Day 56 · No
|
15 Participants
|
6 Participants
|
|
Percentage of Subjects With Seroconversion for Serum Neutralizing Antibodies
Day 112 · Yes
|
11 Participants
|
1 Participants
|
|
Percentage of Subjects With Seroconversion for Serum Neutralizing Antibodies
Day 112 · No
|
14 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Day 28, Day 56 and Day 112Population: 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.
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).
Outcome measures
| Measure |
LAIV H2N2 Vaccine
n=25 Participants
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
|
Placebo
n=7 Participants
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
|
|---|---|---|
|
Percentage of Subjects With Seroconversion for Serum Immunoglobulin A Antibodies
Day 28 · Yes
|
2 Participants
|
0 Participants
|
|
Percentage of Subjects With Seroconversion for Serum Immunoglobulin A Antibodies
Day 28 · No
|
23 Participants
|
7 Participants
|
|
Percentage of Subjects With Seroconversion for Serum Immunoglobulin A Antibodies
Day 56 · Yes
|
13 Participants
|
0 Participants
|
|
Percentage of Subjects With Seroconversion for Serum Immunoglobulin A Antibodies
Day 56 · No
|
12 Participants
|
7 Participants
|
|
Percentage of Subjects With Seroconversion for Serum Immunoglobulin A Antibodies
Day 112 · Yes
|
12 Participants
|
0 Participants
|
|
Percentage of Subjects With Seroconversion for Serum Immunoglobulin A Antibodies
Day 112 · No
|
13 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 28, Day 56 and Day 112Population: 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.
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).
Outcome measures
| Measure |
LAIV H2N2 Vaccine
n=25 Participants
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
|
Placebo
n=7 Participants
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
|
|---|---|---|
|
Percentage of Subjects With Seroconversion for Serum Immunoglobulin G Antibodies
Day 28 · Yes
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects With Seroconversion for Serum Immunoglobulin G Antibodies
Day 28 · No
|
25 Participants
|
7 Participants
|
|
Percentage of Subjects With Seroconversion for Serum Immunoglobulin G Antibodies
Day 56 · Yes
|
1 Participants
|
0 Participants
|
|
Percentage of Subjects With Seroconversion for Serum Immunoglobulin G Antibodies
Day 56 · No
|
24 Participants
|
7 Participants
|
|
Percentage of Subjects With Seroconversion for Serum Immunoglobulin G Antibodies
Day 112 · Yes
|
2 Participants
|
0 Participants
|
|
Percentage of Subjects With Seroconversion for Serum Immunoglobulin G Antibodies
Day 112 · No
|
23 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 28 and Day 56Population: 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.
Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination.
Outcome measures
| Measure |
LAIV H2N2 Vaccine
n=25 Participants
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
|
Placebo
n=7 Participants
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
|
|---|---|---|
|
Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies From Nasal Mucosa
Day 28 · Yes
|
6 Participants
|
0 Participants
|
|
Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies From Nasal Mucosa
Day 28 · No
|
19 Participants
|
7 Participants
|
|
Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies From Nasal Mucosa
Day 56 · Yes
|
10 Participants
|
0 Participants
|
|
Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies From Nasal Mucosa
Day 56 · No
|
15 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 28 and Day 56Population: 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.
Defined as a 4-fold or higher response from baseline (day 0), 28 days after each vaccination.
Outcome measures
| Measure |
LAIV H2N2 Vaccine
n=25 Participants
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
|
Placebo
n=7 Participants
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
|
|---|---|---|
|
Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies Detected in Saliva Specimens
Day 28 · Yes
|
3 Participants
|
0 Participants
|
|
Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies Detected in Saliva Specimens
Day 28 · No
|
22 Participants
|
7 Participants
|
|
Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies Detected in Saliva Specimens
Day 56 · Yes
|
9 Participants
|
0 Participants
|
|
Percentage of Subjects With Seroconversion for Secretory Immunoglobulin A Antibodies Detected in Saliva Specimens
Day 56 · No
|
16 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Days 0-6 and Days 28-34Detected by real-time reverse transcriptase polymerase chain reaction. Specimens were collected prior to each vaccination and 7 days post-vaccination.
Outcome measures
| Measure |
LAIV H2N2 Vaccine
n=27 Participants
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
|
Placebo
n=7 Participants
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
|
|---|---|---|
|
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Day 30 · Positive
|
2 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Day 31 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Day 31 · Positive
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Day 32 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Day 32 · Positive
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Day 33 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Day 33 · Positive
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Day 34 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Day 34 · Positive
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Day 0 pre-dose · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Day 0 pre-dose · Positive
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Day 1 · Negative
|
6 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Day 1 · Positive
|
21 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Day 2 · Negative
|
17 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Day 2 · Positive
|
10 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Day 3 · Negative
|
23 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Day 3 · Positive
|
4 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Day 4 · Negative
|
25 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Day 4 · Positive
|
2 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Day 5 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Day 5 · Positive
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Day 6 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Day 6 · Positive
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Day 28 pre-dose · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Day 28 pre-dose · Positive
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Day 29 · Negative
|
7 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Day 29 · Positive
|
20 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Nasal Swab
Day 30 · Negative
|
25 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Days 0-6 and Days 28-34Detected by real-time reverse transcriptase polymerase chain reaction. Specimens were collected prior to each vaccination and 7 days post-vaccination.
Outcome measures
| Measure |
LAIV H2N2 Vaccine
n=27 Participants
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
|
Placebo
n=7 Participants
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
|
|---|---|---|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Day 0 pre-dose · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Day 0 pre-dose · H2
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Day 1 · Negative
|
7 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Day 1 · H2
|
20 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Day 2 · Negative
|
18 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Day 2 · H2
|
9 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Day 3 · Negative
|
23 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Day 3 · H2
|
4 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Day 4 · Negative
|
26 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Day 4 · H2
|
1 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Day 5 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Day 5 · H2
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Day 6 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Day 6 · H2
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Day 28 pre-dose · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Day 28 pre-dose · H2
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Day 29 · Negative
|
7 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Day 29 · H2
|
20 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Day 30 · Negative
|
25 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Day 30 · H2
|
2 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Day 31 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Day 31 · H2
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Day 32 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Day 32 · H2
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Day 33 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Day 33 · H2
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Day 34 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Nasal Swab
Day 34 · H2
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 0-6 and Days 28-34Detected by real-time reverse transcriptase polymerase chain reaction. Specimens were collected prior to each vaccination and 7 days post-vaccination.
Outcome measures
| Measure |
LAIV H2N2 Vaccine
n=27 Participants
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
|
Placebo
n=7 Participants
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
|
|---|---|---|
|
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Day 0 pre-dose · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Day 0 pre-dose · Positive
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Day 1 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Day 1 · Positive
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Day 2 · Negative
|
25 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Day 2 · Positive
|
2 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Day 3 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Day 3 · Positive
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Day 4 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Day 4 · Positive
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Day 5 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Day 5 · Positive
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Day 6 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Day 6 · Positive
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Day 28 pre-dose · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Day 28 pre-dose · Positive
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Day 29 · Negative
|
25 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Day 29 · Positive
|
2 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Day 30 · Negative
|
26 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Day 30 · Positive
|
1 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Day 31 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Day 31 · Positive
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Day 32 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Day 32 · Positive
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Day 33 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Day 33 · Positive
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Day 34 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza A Virus Using Throat Swab
Day 34 · Positive
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 1-6 and Days 29-34Detected by real-time reverse transcriptase polymerase chain reaction. Specimens were collected prior to each vaccination and 7 days post-vaccination.
Outcome measures
| Measure |
LAIV H2N2 Vaccine
n=27 Participants
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
|
Placebo
n=7 Participants
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
|
|---|---|---|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab
Day 1 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab
Day 1 · H2
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab
Day 2 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab
Day 2 · H2
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab
Day 3 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab
Day 3 · H2
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab
Day 4 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab
Day 4 · H2
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab
Day 5 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab
Day 5 · H2
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab
Day 6 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab
Day 6 · H2
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab
Day 29 · Negative
|
25 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab
Day 29 · H2
|
2 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab
Day 30 · Negative
|
26 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab
Day 30 · H2
|
1 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab
Day 31 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab
Day 31 · H2
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab
Day 32 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab
Day 32 · H2
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab
Day 33 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab
Day 33 · H2
|
0 Participants
|
0 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab
Day 34 · Negative
|
27 Participants
|
7 Participants
|
|
Percentage of Subjects Shedding Influenza Virus Subtype Using Throat Swab
Day 34 · H2
|
0 Participants
|
0 Participants
|
Adverse Events
LAIV H2N2 Vaccine
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LAIV H2N2 Vaccine
n=28 participants at risk
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
|
Placebo
n=10 participants at risk
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
|
|---|---|---|
|
Ear and labyrinth disorders
Ear congestion
|
3.6%
1/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
0.00%
0/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
|
General disorders
Fatigue
|
3.6%
1/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
10.0%
1/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
|
General disorders
Pyrexia
|
7.1%
2/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
20.0%
2/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
10.0%
1/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
3.6%
1/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
20.0%
2/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
|
Infections and infestations
Periodontitis
|
3.6%
1/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
0.00%
0/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
|
Investigations
Alanine aminotransferase increased
|
10.7%
3/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
10.0%
1/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
2/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
0.00%
0/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
|
Investigations
Blood bicarbonate increased
|
7.1%
2/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
30.0%
3/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
|
Investigations
Blood bilirubin increased
|
21.4%
6/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
20.0%
2/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
|
Investigations
Blood calcium increased
|
14.3%
4/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
10.0%
1/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
|
Investigations
Blood creatinine increased
|
7.1%
2/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
10.0%
1/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
|
Investigations
Blood glucose increased
|
25.0%
7/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
20.0%
2/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
|
Investigations
Blood urea increased
|
7.1%
2/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
0.00%
0/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
|
Investigations
Eosinophil count increased
|
14.3%
4/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
0.00%
0/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
|
Investigations
Haemoglobin increased
|
10.7%
3/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
0.00%
0/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
|
Investigations
Lymphocyte count decreased
|
17.9%
5/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
20.0%
2/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
|
Investigations
Lymphocyte count increased
|
75.0%
21/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
60.0%
6/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
|
Investigations
Mean cell haemoglobin concentration increased
|
10.7%
3/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
20.0%
2/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
|
Investigations
Monocyte count increased
|
35.7%
10/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
20.0%
2/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
|
Investigations
Neutrophil count decreased
|
46.4%
13/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
60.0%
6/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
|
Investigations
Neutrophil count increased
|
3.6%
1/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
10.0%
1/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
|
Investigations
Protein total decreased
|
10.7%
3/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
20.0%
2/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
10.0%
1/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
|
Investigations
Red blood cell count increased
|
3.6%
1/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
0.00%
0/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
|
Investigations
Red blood cell sedimentation rate increased
|
14.3%
4/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
20.0%
2/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
|
Investigations
White blood cell count increased
|
0.00%
0/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
10.0%
1/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
|
Investigations
Headache
|
3.6%
1/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
10.0%
1/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
|
Investigations
Nasal congestion
|
3.6%
1/28 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
0.00%
0/10 • 6 days following either dose for non-serious adverse events, and 4 weeks after either dose for serious adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place