Influenza
Conditions
Keywords
seasonal influenza, vaccine
Brief summary
A Phase 3, double-blind, randomized, placebo-controlled trial of a seasonal, trivalent, split, inactivated influenza vaccine produced by InstituteTorlak.
Detailed description
This is a phase 3, double-blind, randomized, placebo- controlled trial with two groups of participants to receive seasonal trivalent split, inactivated influenza vaccine (A/H1N1; A/H3N2 and B) or placebo (phosphate buffered saline). A total of about 480 healthy male and female adults 18 through 65 years of age; 320 participants will be randomized to receive vaccine and160 will receive placebo (a 2:1 ratio). At least 25% of the participants (N=120) will be \>/= 45 years of age (80 vaccine and 40 placebo recipients). Safety will be assessed in all participants through Day 91. Immunogenicity will be assessed in serum samples obtained at baseline and 21 days after vaccination in a subset of at least 100 individuals randomized to study vaccine and 50 placebo recipients.
Interventions
BIOLOGICALVaccine
Seasonal trivalent split, inactivated influenza vaccine 15 mcg hemagglutinin antigen (HA) of each of A/H1N1; A/H3N2 and B strains; 0.5 mL by IM injection
OTHERPlacebo
Phosphate buffered saline, 0.5 mL by IM injection
Sponsors
PATH
Comac Medical
World Health Organization
Institute of Virology, Vaccines and Sera, Torlak
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 18 to 65 years on the day of screening/enrollment. * Literate (by self-report) and willing to provide written informed consent. * Able to attend all scheduled visits and to comply with all trial procedures. * Healthy or medically stable, as established by medical history and physical examination. For individuals with medical conditions, symptoms/signs, if present must be stable under control or unchanged for the past three months. If medication is used to treat the condition, the medication dose must have been stable for at least one month preceding vaccination. For female participants: * Not breast feeding, non-pregnant (based on negative urine pregnancy test) and no plan to become pregnant up to Day 22. * Women who are not surgically sterile (hysterectomy or tubal ligation) or post-menopausal for more than one year must be willing to use effective contraceptive method to prevent pregnancy until three weeks (Day 22) after vaccination. Effective methods include intrauterine device, hormonal contraceptives (oral, injectable, patch, implant, ring) or double barrier contraceptives (condom or diaphragm with spermicide). Women with credible history of abstinence may be enrolled at the discretion of the investigator.
Exclusion criteria
* Participation in another clinical trial involving any therapy within the previous three months or planned enrollment in such a trial during the period of this study. * Receipt of influenza vaccine in the last 10 months. * Receipt of any non-study vaccine within four weeks prior to enrollment or refusal to postpone receipt of such vaccines until after the Day 22 visit. * Receipt of immune globulin or other blood products within three months prior to study enrollment or planned receipt of such products prior to the Day 22 visit. * Known or suspected congenital or acquired immunodeficiency. * Chronic administration (defined as more than 14 consecutively-prescribed days) of immunosuppressants or other immune-modulating therapy within six months prior to study enrollment. (For corticosteroids, this means prednisone or equivalent, ≥ 0.5 mg per kg per day; topical steroids are allowed.) * Unstable illness by history or physical examination that in the opinion of the investigator, might interfere with the conduct or results of the study or pose additional risk to the participant. * Hypersensitivity after previous administration of any vaccine. * Suspected or known hypersensitivity to any of the study vaccine components, including chicken or egg protein or antibiotics. * Bleeding disorder or receipt of anticoagulants in the three weeks preceding enrollment. * Known active tuberculosis or symptoms of active tuberculosis, regardless of cause (self-report). * Current alcohol or drug addiction that in the opinion of the Investigator, might interfere with the ability to comply with trial procedures. * History of Guillain-Barré Syndrome. * Neoplastic disease or any hematologic malignancy. Allowed: localized skin or prostate cancer that is no longer being treated and is stable at the time of vaccination and participants who have a history of neoplastic disease and who have been disease free for ≥ 5 years. * Any condition that, in the opinion of the investigator, would increase the health risk to the participant if he/she participates in the study, or would interfere with the evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Serum HAI Antibodies | Day 1 and Day 22 | Serum HAI Antibodies GMTs Pre- (Day 1) and Post-vaccination (Day 22); measured for each of the 3 antigens |
| Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity) | 30-minute post-vaccination period | Number of participants experiencing one or more solicited local AEs, including redness /erythema, swelling / induration and pain |
| Number of Participants With Solicited Local Adverse Events (Local Reactogenicity) | 5-day period (Days 1-5) post-vaccination | Number of subjects reporting one or more solicited local reactions (redness/erythema, swelling/induration, pain, and tenderness) at the injection site post-vaccination with study vaccine or placebo |
| Number of Participants With Solicited Systemic Adverse Events (Systemic Reactogenicity) | 5-day period (Days 1-5) post-vaccination | Number of subjects reporting one or more solicited systemic reactions (fever, fatigue/malaise, muscle aches, joint aches, chills, nausea, vomiting, and headache) post-vaccination with study vaccine or placebo. |
| Number of Participants With Unsolicited Adverse Events | Within 21 days post vaccination | Unsolicited AEs occurring in 1% or more of study participants; includes events irrespective of causality |
| Number of Participants With Serious Adverse Events (SAE) | Over the entire study period (Day 91) | Number of participants reporting one or more of all anticipated and unanticipated serious adverse events, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study. |
| Number and Percentage of Seroconverted Subjects | Day 22 | Seroconversion is defined as a serum HAI antibody titer meeting the following criteria: * Pre-vaccination titer \<1:10 and a post-vaccination titer measured on Day 22 of ≥1:40; or * Pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination measured on Day 22. Measured against each of the 3 antigens |
| Number and Percentage of Participants With a HAI Antibody Titer ≥1:40 (Seroprotection) | Day 1 and Day 22 | Seroprotective Titers is considered as HAI antibody Titre ≥1:40; measured for each of the 3 antigens |
| Geometric Mean Fold Rises (GMFRs) of Serum HAI Antibodies | Day 1 and Day 22 | GMFR calculated as GMT for of Serum HAI Antibodies Post-vaccination/Pre-vaccination; measured for each of the 3 antigens |
Countries
Serbia
Participant flow
Recruitment details
503 subjects were consented and screened from across 6 clinical trial sites located in Belgrade and Vrsac, Serbia. Of the 503 subjects screened, 23 subjects failed screening.
Pre-assignment details
Twenty-three (23) subjects failed screening and were not assigned to a treatment group. An additional 8 subjects withdrew consent prior to receiving any study product.
Participants by arm
| Arm | Count |
|---|---|
| Vaccine Seasonal trivalent split, inactivated influenza vaccine
Seasonal Influenza Vaccine: Seasonal trivalent split, inactivated influenza vaccine (A/H1N1; A/H3N2 and B); 0.5 mL by IM injection | 312 |
| Placebo Phosphate buffered saline
Phosphate Buffered Saline: Phosphate buffered saline, 0.5 mL by IM injection | 156 |
| Total | 468 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 8 | 4 |
Baseline characteristics
| Characteristic | Vaccine | Placebo | Total |
|---|---|---|---|
| Age, Continuous 18-44 years | 32.8 years | 32.0 years | 32.6 years |
| Age, Continuous 45-65 years | 54.7 years | 53.8 years | 54.4 years |
| Region of Enrollment Serbia | 312 participants | 156 participants | 468 participants |
| Sex: Female, Male Female | 145 Participants | 77 Participants | 222 Participants |
| Sex: Female, Male Male | 167 Participants | 79 Participants | 246 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 312 | 0 / 156 |
| other Total, other adverse events | 13 / 312 | 8 / 156 |
| serious Total, serious adverse events | 2 / 312 | 0 / 156 |
Outcome results
Primary
Geometric Mean Fold Rises (GMFRs) of Serum HAI Antibodies
GMFR calculated as GMT for of Serum HAI Antibodies Post-vaccination/Pre-vaccination; measured for each of the 3 antigens
Time frame: Day 1 and Day 22
Population: Per Protocol (PP) Population:~Immunogenicity was assessed in a subset of 151 participants (per-protocol population) with valid post-vaccination immunogenicity measures and no major protocol violations that were determined to potentially interfere with the immunogenicity assessment of the study vaccine. This was decided before unblinding.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Vaccine Arm | Geometric Mean Fold Rises (GMFRs) of Serum HAI Antibodies | GMFR for H1 | 22.5 Titer |
| Vaccine Arm | Geometric Mean Fold Rises (GMFRs) of Serum HAI Antibodies | GMFR for H3 | 12.9 Titer |
| Vaccine Arm | Geometric Mean Fold Rises (GMFRs) of Serum HAI Antibodies | GMFR for B | 3.8 Titer |
| Placebo Arm | Geometric Mean Fold Rises (GMFRs) of Serum HAI Antibodies | GMFR for H1 | 1.0 Titer |
| Placebo Arm | Geometric Mean Fold Rises (GMFRs) of Serum HAI Antibodies | GMFR for H3 | 1.0 Titer |
| Placebo Arm | Geometric Mean Fold Rises (GMFRs) of Serum HAI Antibodies | GMFR for B | 1.6 Titer |
Primary
Geometric Mean Titers (GMTs) of Serum HAI Antibodies
Serum HAI Antibodies GMTs Pre- (Day 1) and Post-vaccination (Day 22); measured for each of the 3 antigens
Time frame: Day 1 and Day 22
Population: Per Protocol (PP) Population:~Immunogenicity was assessed in a subset of 151 participants (per-protocol population) with valid post-vaccination immunogenicity measures and no major protocol violations that were determined to potentially interfere with the immunogenicity assessment of the study vaccine. This was decided before unblinding.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Vaccine Arm | Geometric Mean Titers (GMTs) of Serum HAI Antibodies | GMT to H1 : Day 1 | 15.0 Titer |
| Vaccine Arm | Geometric Mean Titers (GMTs) of Serum HAI Antibodies | GMT to H1 Day 22 | 336.3 Titer |
| Vaccine Arm | Geometric Mean Titers (GMTs) of Serum HAI Antibodies | GMT to H3 : Day 1 | 6.9 Titer |
| Vaccine Arm | Geometric Mean Titers (GMTs) of Serum HAI Antibodies | GMT to H3 : Day 22 | 88.4 Titer |
| Vaccine Arm | Geometric Mean Titers (GMTs) of Serum HAI Antibodies | GMT to B : Day 1 | 27.4 Titer |
| Vaccine Arm | Geometric Mean Titers (GMTs) of Serum HAI Antibodies | GMT to B : Day 22 | 103.5 Titer |
| Placebo Arm | Geometric Mean Titers (GMTs) of Serum HAI Antibodies | GMT to B : Day 1 | 21.9 Titer |
| Placebo Arm | Geometric Mean Titers (GMTs) of Serum HAI Antibodies | GMT to H1 : Day 1 | 24.1 Titer |
| Placebo Arm | Geometric Mean Titers (GMTs) of Serum HAI Antibodies | GMT to H3 : Day 22 | 8.4 Titer |
| Placebo Arm | Geometric Mean Titers (GMTs) of Serum HAI Antibodies | GMT to H1 Day 22 | 25.0 Titer |
| Placebo Arm | Geometric Mean Titers (GMTs) of Serum HAI Antibodies | GMT to B : Day 22 | 36.1 Titer |
| Placebo Arm | Geometric Mean Titers (GMTs) of Serum HAI Antibodies | GMT to H3 : Day 1 | 8.0 Titer |
Primary
Number and Percentage of Participants With a HAI Antibody Titer ≥1:40 (Seroprotection)
Seroprotective Titers is considered as HAI antibody Titre ≥1:40; measured for each of the 3 antigens
Time frame: Day 1 and Day 22
Population: Per Protocol (PP) Population:~Immunogenicity was assessed in a subset of 151 participants (per-protocol population) with valid post-vaccination immunogenicity measures and no major protocol violations that were determined to potentially interfere with the immunogenicity assessment of the study vaccine. This was decided before unblinding.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine Arm | Number and Percentage of Participants With a HAI Antibody Titer ≥1:40 (Seroprotection) | Seroprotection to H1N1 : Day 1 | 24 Participants |
| Vaccine Arm | Number and Percentage of Participants With a HAI Antibody Titer ≥1:40 (Seroprotection) | Seroprotection to H1N1 : Day 22 | 96 Participants |
| Vaccine Arm | Number and Percentage of Participants With a HAI Antibody Titer ≥1:40 (Seroprotection) | Seroconversion to H3N2 : Day 1 | 7 Participants |
| Vaccine Arm | Number and Percentage of Participants With a HAI Antibody Titer ≥1:40 (Seroprotection) | Seroconversion to H3N2 : Day 22 | 79 Participants |
| Vaccine Arm | Number and Percentage of Participants With a HAI Antibody Titer ≥1:40 (Seroprotection) | Seroprotection to B : Day 1 | 53 Participants |
| Vaccine Arm | Number and Percentage of Participants With a HAI Antibody Titer ≥1:40 (Seroprotection) | Seroprotection to B : Day 22 | 93 Participants |
| Placebo Arm | Number and Percentage of Participants With a HAI Antibody Titer ≥1:40 (Seroprotection) | Seroprotection to B : Day 1 | 18 Participants |
| Placebo Arm | Number and Percentage of Participants With a HAI Antibody Titer ≥1:40 (Seroprotection) | Seroprotection to H1N1 : Day 1 | 21 Participants |
| Placebo Arm | Number and Percentage of Participants With a HAI Antibody Titer ≥1:40 (Seroprotection) | Seroconversion to H3N2 : Day 22 | 3 Participants |
| Placebo Arm | Number and Percentage of Participants With a HAI Antibody Titer ≥1:40 (Seroprotection) | Seroprotection to H1N1 : Day 22 | 22 Participants |
| Placebo Arm | Number and Percentage of Participants With a HAI Antibody Titer ≥1:40 (Seroprotection) | Seroprotection to B : Day 22 | 26 Participants |
| Placebo Arm | Number and Percentage of Participants With a HAI Antibody Titer ≥1:40 (Seroprotection) | Seroconversion to H3N2 : Day 1 | 3 Participants |
Primary
Number and Percentage of Seroconverted Subjects
Seroconversion is defined as a serum HAI antibody titer meeting the following criteria: * Pre-vaccination titer \<1:10 and a post-vaccination titer measured on Day 22 of ≥1:40; or * Pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination measured on Day 22. Measured against each of the 3 antigens
Time frame: Day 22
Population: Per Protocol (PP) Population:~Immunogenicity was assessed in a subset of 151 participants (per-protocol population) with valid post-vaccination immunogenicity measures and no major protocol violations that were determined to potentially interfere with the immunogenicity assessment of the study vaccine. This was decided before unblinding.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine Arm | Number and Percentage of Seroconverted Subjects | Seroconversion to H1 | 91 Participants |
| Vaccine Arm | Number and Percentage of Seroconverted Subjects | Seroconversion to H3 | 77 Participants |
| Vaccine Arm | Number and Percentage of Seroconverted Subjects | Seroconversion to B | 52 Participants |
| Placebo Arm | Number and Percentage of Seroconverted Subjects | Seroconversion to H1 | 1 Participants |
| Placebo Arm | Number and Percentage of Seroconverted Subjects | Seroconversion to H3 | 0 Participants |
| Placebo Arm | Number and Percentage of Seroconverted Subjects | Seroconversion to B | 9 Participants |
Primary
Number of Participants With Serious Adverse Events (SAE)
Number of participants reporting one or more of all anticipated and unanticipated serious adverse events, grouped by organ system, with number and frequency of such events in each arm/group of the clinical study.
Time frame: Over the entire study period (Day 91)
Population: Full Analysis Population
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Vaccine Arm | Number of Participants With Serious Adverse Events (SAE) | Acute Lymphocytic Leukemia | Related | 0 Participants |
| Vaccine Arm | Number of Participants With Serious Adverse Events (SAE) | Acute Lymphocytic Leukemia | Not related | 1 Participants |
| Vaccine Arm | Number of Participants With Serious Adverse Events (SAE) | Acute Lymphocytic Leukemia | Not reporting this SAE | 311 Participants |
| Vaccine Arm | Number of Participants With Serious Adverse Events (SAE) | Varicocele | Related | 0 Participants |
| Vaccine Arm | Number of Participants With Serious Adverse Events (SAE) | Varicocele | Not related | 1 Participants |
| Vaccine Arm | Number of Participants With Serious Adverse Events (SAE) | Varicocele | Not reporting this SAE | 311 Participants |
| Placebo Arm | Number of Participants With Serious Adverse Events (SAE) | Varicocele | Not related | 0 Participants |
| Placebo Arm | Number of Participants With Serious Adverse Events (SAE) | Acute Lymphocytic Leukemia | Related | 0 Participants |
| Placebo Arm | Number of Participants With Serious Adverse Events (SAE) | Varicocele | Related | 0 Participants |
| Placebo Arm | Number of Participants With Serious Adverse Events (SAE) | Acute Lymphocytic Leukemia | Not related | 0 Participants |
| Placebo Arm | Number of Participants With Serious Adverse Events (SAE) | Varicocele | Not reporting this SAE | 156 Participants |
| Placebo Arm | Number of Participants With Serious Adverse Events (SAE) | Acute Lymphocytic Leukemia | Not reporting this SAE | 156 Participants |
Primary
Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity)
Number of participants experiencing one or more solicited local AEs, including redness /erythema, swelling / induration and pain
Time frame: 30-minute post-vaccination period
Population: The analysis was conducted for subjects who were randomized and received a study vaccination
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine Arm | Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity) | Hardness | 5 Participants |
| Vaccine Arm | Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity) | Pain | 5 Participants |
| Vaccine Arm | Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity) | Redness | 22 Participants |
| Vaccine Arm | Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity) | Swelling | 1 Participants |
| Vaccine Arm | Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity) | Tenderness | 2 Participants |
| Vaccine Arm | Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity) | Temperature above 37 C | 0 Participants |
| Vaccine Arm | Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity) | Chills | 0 Participants |
| Vaccine Arm | Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity) | Headache | 0 Participants |
| Vaccine Arm | Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity) | Joint aches | 0 Participants |
| Vaccine Arm | Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity) | Muscle aches | 0 Participants |
| Vaccine Arm | Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity) | Nausea | 0 Participants |
| Vaccine Arm | Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity) | Tiredness | 1 Participants |
| Placebo Arm | Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity) | Nausea | 0 Participants |
| Placebo Arm | Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity) | Hardness | 1 Participants |
| Placebo Arm | Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity) | Chills | 0 Participants |
| Placebo Arm | Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity) | Pain | 0 Participants |
| Placebo Arm | Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity) | Muscle aches | 0 Participants |
| Placebo Arm | Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity) | Redness | 3 Participants |
| Placebo Arm | Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity) | Headache | 0 Participants |
| Placebo Arm | Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity) | Swelling | 0 Participants |
| Placebo Arm | Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity) | Tiredness | 0 Participants |
| Placebo Arm | Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity) | Tenderness | 0 Participants |
| Placebo Arm | Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity) | Joint aches | 0 Participants |
| Placebo Arm | Number of Participants With Solicited Adverse Events (Local & Systemic Reactogenicity) | Temperature above 37 C | 0 Participants |
Primary
Number of Participants With Solicited Local Adverse Events (Local Reactogenicity)
Number of subjects reporting one or more solicited local reactions (redness/erythema, swelling/induration, pain, and tenderness) at the injection site post-vaccination with study vaccine or placebo
Time frame: 5-day period (Days 1-5) post-vaccination
Population: Full analysis population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine Arm | Number of Participants With Solicited Local Adverse Events (Local Reactogenicity) | Pain | 160 Participants |
| Vaccine Arm | Number of Participants With Solicited Local Adverse Events (Local Reactogenicity) | Swelling | 20 Participants |
| Vaccine Arm | Number of Participants With Solicited Local Adverse Events (Local Reactogenicity) | Redness | 40 Participants |
| Vaccine Arm | Number of Participants With Solicited Local Adverse Events (Local Reactogenicity) | Tenderness | 126 Participants |
| Vaccine Arm | Number of Participants With Solicited Local Adverse Events (Local Reactogenicity) | Hardness | 29 Participants |
| Placebo Arm | Number of Participants With Solicited Local Adverse Events (Local Reactogenicity) | Tenderness | 11 Participants |
| Placebo Arm | Number of Participants With Solicited Local Adverse Events (Local Reactogenicity) | Hardness | 0 Participants |
| Placebo Arm | Number of Participants With Solicited Local Adverse Events (Local Reactogenicity) | Pain | 17 Participants |
| Placebo Arm | Number of Participants With Solicited Local Adverse Events (Local Reactogenicity) | Redness | 3 Participants |
| Placebo Arm | Number of Participants With Solicited Local Adverse Events (Local Reactogenicity) | Swelling | 0 Participants |
Primary
Number of Participants With Solicited Systemic Adverse Events (Systemic Reactogenicity)
Number of subjects reporting one or more solicited systemic reactions (fever, fatigue/malaise, muscle aches, joint aches, chills, nausea, vomiting, and headache) post-vaccination with study vaccine or placebo.
Time frame: 5-day period (Days 1-5) post-vaccination
Population: Full analysis population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine Arm | Number of Participants With Solicited Systemic Adverse Events (Systemic Reactogenicity) | Joint Aches | 16 Participants |
| Vaccine Arm | Number of Participants With Solicited Systemic Adverse Events (Systemic Reactogenicity) | Nausea | 18 Participants |
| Vaccine Arm | Number of Participants With Solicited Systemic Adverse Events (Systemic Reactogenicity) | Headache | 47 Participants |
| Vaccine Arm | Number of Participants With Solicited Systemic Adverse Events (Systemic Reactogenicity) | Temperature | 6 Participants |
| Vaccine Arm | Number of Participants With Solicited Systemic Adverse Events (Systemic Reactogenicity) | Muscle Aches | 27 Participants |
| Vaccine Arm | Number of Participants With Solicited Systemic Adverse Events (Systemic Reactogenicity) | Tiredness | 53 Participants |
| Vaccine Arm | Number of Participants With Solicited Systemic Adverse Events (Systemic Reactogenicity) | Chills | 11 Participants |
| Placebo Arm | Number of Participants With Solicited Systemic Adverse Events (Systemic Reactogenicity) | Tiredness | 16 Participants |
| Placebo Arm | Number of Participants With Solicited Systemic Adverse Events (Systemic Reactogenicity) | Chills | 1 Participants |
| Placebo Arm | Number of Participants With Solicited Systemic Adverse Events (Systemic Reactogenicity) | Headache | 19 Participants |
| Placebo Arm | Number of Participants With Solicited Systemic Adverse Events (Systemic Reactogenicity) | Joint Aches | 5 Participants |
| Placebo Arm | Number of Participants With Solicited Systemic Adverse Events (Systemic Reactogenicity) | Muscle Aches | 6 Participants |
| Placebo Arm | Number of Participants With Solicited Systemic Adverse Events (Systemic Reactogenicity) | Nausea | 6 Participants |
| Placebo Arm | Number of Participants With Solicited Systemic Adverse Events (Systemic Reactogenicity) | Temperature | 1 Participants |
Primary
Number of Participants With Unsolicited Adverse Events
Unsolicited AEs occurring in 1% or more of study participants; includes events irrespective of causality
Time frame: Within 21 days post vaccination
Population: Full analysis population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Vaccine Arm | Number of Participants With Unsolicited Adverse Events | Nasopharyngitis | 3 Participants |
| Vaccine Arm | Number of Participants With Unsolicited Adverse Events | Respiratory tract infection | 7 Participants |
| Vaccine Arm | Number of Participants With Unsolicited Adverse Events | Rhinitis | 3 Participants |
| Placebo Arm | Number of Participants With Unsolicited Adverse Events | Nasopharyngitis | 4 Participants |
| Placebo Arm | Number of Participants With Unsolicited Adverse Events | Respiratory tract infection | 1 Participants |
| Placebo Arm | Number of Participants With Unsolicited Adverse Events | Rhinitis | 3 Participants |