Influenza
Conditions
Keywords
Active immunization against influenza disease
Brief summary
The purpose of this study is to determine if a Vero cell-derived trivalent seasonal influenza vaccine produced by the modified manufacturing process: 1. induces immune responses comparable to that produced by the current manufacturing process 2. has an acceptable safety profile compared to a licensed trivalent seasonal influenza vaccine 3. demonstrates consistency of immune response among three different lots.
Interventions
BIOLOGICALVero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
BIOLOGICALVCIV manufactured with the current manufacturing process (VCIV current)
BIOLOGICALFluzone®, licensed trivalent influenza vaccine (TIV)
Sponsors
Alachua Government Services, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participant is 18 to 49 years of age, inclusive, at the time of screening (for Cohort 18 to 49 years of age); * Participant is 50 years of age, inclusive, or older at the time of screening (for Cohort 50 years of age or older); * Participant gave written informed consent prior to study entry * Participant is generally healthy without any significant medical risk conditions, as determined by the Investigator's clinical judgment through collection of medical history and performance of a physical examination; * Participant is willing and able to comply with the requirements of the protocol; * Participant agrees to keep a record of symptoms for the duration of the study; * If female and capable of bearing children - participant has a negative urine pregnancy test at the study site, within 36 hours prior to vaccination, and agrees to employ adequate birth control measures for the duration of the study. For the purposes of this study adequate birth control measures incorporate one of the following FDA approved birth control measures for the duration of the study: * Hormonal types of birth control (such as implants, birth control pills, patches or other methods) or an intrauterine device, OR * A barrier type of birth control measure (i.e., condoms, diaphragms, cervical caps, etc.).
Exclusion criteria
* Participant has been vaccinated with seasonal trivalent influenza vaccine in the current season; * Participant has an oral temperature of ≥100.4°F (≥38.0°C) on the day of vaccination in this study; * Participant has received a live vaccine within 4 weeks, or an inactivated or subunit vaccine within 2 weeks of study entry; * Participant with a known history of infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBsAgs) or Hepatitis C Virus (HCV); * Participant has any medically diagnosed or suspected immune deficient condition based on medical history and physical examination as determined by the Investigator; * Participant has an immune compromising condition or disease, or is currently undergoing a form of treatment or was undergoing a form of treatment within 30 days prior to study entry that can be expected to influence immune response. Such treatment includes, but is not limited to, systemic or high dose inhaled corticosteroids (\> 800 μg/day of beclomethasone dipropionate or equivalent), radiation treatment or other immunosuppressive or cytotoxic drugs (use of inhaled and nasal steroids will be permitted); * Participant has a known history of Guillain Barré Syndrome, demyelinating disorders (including acute demyelinating encephalomyelitis (ADEM), Multiple Sclerosis) or convulsions; * Participant has a history of severe allergic reactions or anaphylaxis as determined by the Investigator; * Participant has a rash, dermatologic condition or tattoos which may interfere with injection site reaction rating as determined by the Investigator; * Participant has received any blood products (e.g. blood transfusion or immunoglobulins) within 90 days prior to study entry; * Participant has donated one or more units of blood (approximately 450 mL) or plasma within 30 days prior to study entry; * Participant has a functional or surgical asplenia; * Participant has a known or suspected problem with alcohol or drug abuse as determined by the Investigator; * Participant is a member of the team conducting this study or is in a dependent relationship with one of the study team members. Dependent relationships include close relatives (ie., children, partner/spouse, siblings, parents) as well as employees of the Investigator or study site personnel conducting the study; * If female, participant is pregnant or lactating at the time of study enrollment; * Participant is currently enrolled or has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to study enrolment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study; * Participant has any condition that in the opinion of the Investigator would interfere with evaluation of the vaccine or interpretation of study results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | 21 days post vaccination | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine Two co-primary analyses relating to this primary immunogenicity outcome measure were also performed: Outcome Measure 2 - Noninferiority Outcome Measure 3 - Lot Consistency |
| Non-inferiority of Modified Manufacturing Process Compared to the Current Process | 21 days post vaccination | Non-inferiority of modified manufacturing process compared to the current process. Co-primary analysis of HIA Titer for each of the three antigens (Outcome Measure 1) was performed on a subset of the Per Protocol analysis dataset for participants 18-49 Years Old treated with Vero cell-derived trivalent influenza vaccine (VCIV) from the modified manufacturing process and VCIV manufactured with the current process |
| Lot Consistency of the Three Modified Manufacturing Process Lots | 21 days post vaccination | Lot consistency of the three modified manufacturing process lots Co-primary analysis of HIA Titer for each of the three antigens (Outcome Measure 1) was performed on a subset of the Per Protocol Analysis Dataset for participants of all ages treated with three Vero cell-derived trivalent influenza vaccine (VCIV) lots manufactured from the modified process. |
| Percentage of Participants With Fever | onset within 7 days post vaccination | Percentage of participants with fever |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Injection Site Reactions | within 7 days post vaccination | — |
| Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | within 7 days post vaccination | — |
| Percentage of Participants With Seroprotective Antibody Titer for Each of the Three Antigens | 21 days post vaccination | Percentage of participants with seroprotective antibody titer \[reciprocal HIA titer ≥40\] for each of the three antigens contained in the vaccine |
| Frequency and Severity of Related Adverse Events | within 21 days post vaccination | Frequency and severity of adverse events considered related to the vaccination (possibly related, probably related, unknown) according to System Organ Class (SOC) and Preferred Term (PT) SOCs are abbreviated as follows:- BLD- Blood and lymphatic system disorders EAR- Ear and labyrinth disorders EYE- Eye disorders GID- Gastrointestinal disorders GEN- General disorders and administration site conditions IMM- Immune system disorders INF- Infections and infestations MET- Metabolism and nutrition disorders MSK- Musculoskeletal and connective tissue disorders NER- Nervous system disorders RES- Respiratory, thoracic and mediastinal disorders SKN- Skin and subcutaneous tissue disorders VAS- Vascular disorders SYS-Systemic LOC-Local |
| Percentage of Participants With Adverse Events | within 21 days post vaccination | — |
| Percentage of Participants Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine | 21 days post vaccination | Seroconversion is defined as a ≥ 4-fold increase in HIA titer from baseline OR a reciprocal HIA titer ≥ 40 when there is no detectable HIA titer (reciprocal HIA titer \< 10) at baseline |
| Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine as Compared to Baseline | 21 days post vaccination | — |
| Percentage of Participants With Solicited Systemic Reactions | within 7 days post vaccination | — |
Countries
United States
Participant flow
Recruitment details
Recruitment was conducted in the U.S. at 20 study sites. The first participant was enrolled in January 2013.
Pre-assignment details
1,928 potential participants were enrolled at clinical study sites in the United States. 75 were screen failures; and 52 were not assigned to a treatment group once the randomization goals were reached. Therefore, 1,801 participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified) | 200 |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified) | 199 |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified) | 199 |
| VCIV Manufactured With Current Process (18-49 Years Old) Vero cell-derived trivalent influenza vaccine (VCIV)
VCIV manufactured with the current manufacturing process (VCIV current) | 201 |
| Fluzone® (18-49 Years Old) Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV) | 201 |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified) | 199 |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified) | 197 |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 3 Vero cell-derived trivalent influenza vaccine (VCIV)
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified) | 198 |
| Fluzone® (≥50 Years Old) Fluzone®, licensed trivalent influenza vaccine (TIV)
Fluzone®, licensed trivalent influenza vaccine (TIV) | 203 |
| Total | 1,797 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Randomized, had to leave, never returned | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Refused vaccine, withdrew consent | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Subject met exclusion criteria | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Subject misrepresented age | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 5 | 4 | 4 | 4 | 7 | 1 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Fluzone® (≥50 Years Old) | Total | VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | VCIV Manufactured With Current Process (18-49 Years Old) | Fluzone® (18-49 Years Old) | VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 3 |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 62.4 years STANDARD_DEVIATION 8.71 | 46.1 years STANDARD_DEVIATION 16.63 | 32.6 years STANDARD_DEVIATION 9.09 | 34.2 years STANDARD_DEVIATION 9.26 | 32.6 years STANDARD_DEVIATION 9.05 | 34.4 years STANDARD_DEVIATION 9.28 | 34.0 years STANDARD_DEVIATION 9.28 | 61.5 years STANDARD_DEVIATION 8.44 | 62.2 years STANDARD_DEVIATION 8.55 | 61.5 years STANDARD_DEVIATION 7.91 |
| Region of Enrollment United States | 203 participants | 1797 participants | 200 participants | 199 participants | 199 participants | 201 participants | 201 participants | 199 participants | 197 participants | 198 participants |
| Sex: Female, Male Female | 115 Participants | 998 Participants | 121 Participants | 121 Participants | 102 Participants | 111 Participants | 117 Participants | 116 Participants | 92 Participants | 103 Participants |
| Sex: Female, Male Male | 88 Participants | 799 Participants | 79 Participants | 78 Participants | 97 Participants | 90 Participants | 84 Participants | 83 Participants | 105 Participants | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 200 | 0 / 199 | 0 / 199 | 0 / 201 | 0 / 201 | 0 / 199 | 0 / 197 | 0 / 198 | 0 / 203 |
| other Total, other adverse events | 133 / 200 | 124 / 199 | 120 / 199 | 132 / 201 | 125 / 201 | 97 / 199 | 84 / 197 | 96 / 198 | 100 / 203 |
| serious Total, serious adverse events | 1 / 200 | 0 / 199 | 0 / 199 | 0 / 201 | 0 / 201 | 1 / 199 | 1 / 197 | 2 / 198 | 0 / 203 |
Outcome results
Primary
Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine
Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine Two co-primary analyses relating to this primary immunogenicity outcome measure were also performed: Outcome Measure 2 - Noninferiority Outcome Measure 3 - Lot Consistency
Time frame: 21 days post vaccination
Population: Immunogenicity Analysis Set. The primary immunogenicity and safety analyses groups included the VCIV Modified lots separately. The secondary immunogenicity and safety analyses groups included all three of the VCIV Modified lots pooled.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain A/H3N2 | 153.5 Titers |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain A/H1N1 | 269.7 Titers |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain B | 86.8 Titers |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain A/H3N2 | 245.3 Titers |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain B | 83.5 Titers |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain A/H1N1 | 337.3 Titers |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain B | 83.6 Titers |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain A/H3N2 | 205.5 Titers |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain A/H1N1 | 288.5 Titers |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain A/H3N2 | 197.5 Titers |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain A/H1N1 | 297.1 Titers |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain B | 84.6 Titers |
| VCIV Manufactured With Current Process (18-49 Years Old) | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain B | 60.7 Titers |
| VCIV Manufactured With Current Process (18-49 Years Old) | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain A/H1N1 | 264.4 Titers |
| VCIV Manufactured With Current Process (18-49 Years Old) | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain A/H3N2 | 172.2 Titers |
| Fluzone® (18-49 Years Old) | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain A/H3N2 | 314.4 Titers |
| Fluzone® (18-49 Years Old) | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain A/H1N1 | 595.6 Titers |
| Fluzone® (18-49 Years Old) | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain B | 97.3 Titers |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain A/H1N1 | 141.3 Titers |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain A/H3N2 | 174.4 Titers |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain B | 40.5 Titers |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain A/H1N1 | 118.3 Titers |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain A/H3N2 | 165.8 Titers |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain B | 35.9 Titers |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 3 | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain B | 30.4 Titers |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 3 | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain A/H1N1 | 112.8 Titers |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 3 | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain A/H3N2 | 168.4 Titers |
| Total VCIV - Modified Process (≥50 Years Old) Lots 1-3 | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain A/H1N1 | 123.7 Titers |
| Total VCIV - Modified Process (≥50 Years Old) Lots 1-3 | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain B | 35.4 Titers |
| Total VCIV - Modified Process (≥50 Years Old) Lots 1-3 | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain A/H3N2 | 169.5 Titers |
| Fluzone® (≥50 Years Old) | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain B | 37.1 Titers |
| Fluzone® (≥50 Years Old) | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain A/H1N1 | 306.3 Titers |
| Fluzone® (≥50 Years Old) | Hemagglutination Inhibition Antibody (HIA) Titer for Each of the Three Antigens Contained in the Vaccine | Strain A/H3N2 | 294.8 Titers |
Primary
Lot Consistency of the Three Modified Manufacturing Process Lots
Lot consistency of the three modified manufacturing process lots Co-primary analysis of HIA Titer for each of the three antigens (Outcome Measure 1) was performed on a subset of the Per Protocol Analysis Dataset for participants of all ages treated with three Vero cell-derived trivalent influenza vaccine (VCIV) lots manufactured from the modified process.
Time frame: 21 days post vaccination
Population: Subset of the PP analysis dataset comprising the 3 VCIV modified lots (as the aim of the analysis was to show similarity between three different lots of the VCIV manufactured with the modified process), both cohort pooled, for all three strains separately.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Lot Consistency of the Three Modified Manufacturing Process Lots | Lot 3 vs. Lot 1 | 0.90 ratio of geometric mean- no units |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Lot Consistency of the Three Modified Manufacturing Process Lots | Lot 2 vs. Lot 1 | 1.00 ratio of geometric mean- no units |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Lot Consistency of the Three Modified Manufacturing Process Lots | Lot 3 vs. Lot 2 | 0.89 ratio of geometric mean- no units |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Lot Consistency of the Three Modified Manufacturing Process Lots | Lot 3 vs. Lot 1 | 1.17 ratio of geometric mean- no units |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Lot Consistency of the Three Modified Manufacturing Process Lots | Lot 2 vs. Lot 1 | 1.15 ratio of geometric mean- no units |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Lot Consistency of the Three Modified Manufacturing Process Lots | Lot 3 vs. Lot 2 | 1.02 ratio of geometric mean- no units |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Lot Consistency of the Three Modified Manufacturing Process Lots | Lot 2 vs. Lot 1 | 0.87 ratio of geometric mean- no units |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Lot Consistency of the Three Modified Manufacturing Process Lots | Lot 3 vs. Lot 2 | 0.96 ratio of geometric mean- no units |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Lot Consistency of the Three Modified Manufacturing Process Lots | Lot 3 vs. Lot 1 | 0.84 ratio of geometric mean- no units |
Comparison: The overall power to prove the similarity between the three lots for all three strains is approximately 99%.~For the two primary co-analyses (Noninferiority and Lot Consistency), the overall power of the immunogenicity analyses is approximately 96% (calculated as 0.97 x 0.99=0.96).95% CI: [0.67, 1.5]
Primary
Non-inferiority of Modified Manufacturing Process Compared to the Current Process
Non-inferiority of modified manufacturing process compared to the current process. Co-primary analysis of HIA Titer for each of the three antigens (Outcome Measure 1) was performed on a subset of the Per Protocol analysis dataset for participants 18-49 Years Old treated with Vero cell-derived trivalent influenza vaccine (VCIV) from the modified manufacturing process and VCIV manufactured with the current process
Time frame: 21 days post vaccination
Population: Subset of the per-protocol (PP) analysis dataset of Cohort 1 (18-49 years) comprising subjects from the VCIV modified and VCIV current treatment groups (because the aim of the analysis was to show non-inferiority between the two VCIV manufacturing processes), for all three strains separately.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Non-inferiority of Modified Manufacturing Process Compared to the Current Process | 1.12 ratio of Geometric Mean- no units |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Non-inferiority of Modified Manufacturing Process Compared to the Current Process | 1.16 ratio of Geometric Mean- no units |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Non-inferiority of Modified Manufacturing Process Compared to the Current Process | 1.33 ratio of Geometric Mean- no units |
Primary
Percentage of Participants With Fever
Percentage of participants with fever
Time frame: onset within 7 days post vaccination
Population: Safety Analysis Set. The primary immunogenicity and safety analyses groups included the VCIV Modified lots separately. The secondary immunogenicity and safety analyses groups included all three of the VCIV Modified lots pooled.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Percentage of Participants With Fever | 2.5 percentage of participants with fever |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Percentage of Participants With Fever | 1.0 percentage of participants with fever |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Percentage of Participants With Fever | 2.0 percentage of participants with fever |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Percentage of Participants With Fever | 1.8 percentage of participants with fever |
| VCIV Manufactured With Current Process (18-49 Years Old) | Percentage of Participants With Fever | 1.0 percentage of participants with fever |
| Fluzone® (18-49 Years Old) | Percentage of Participants With Fever | 0.0 percentage of participants with fever |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Percentage of Participants With Fever | 2.5 percentage of participants with fever |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Percentage of Participants With Fever | 1.0 percentage of participants with fever |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 3 | Percentage of Participants With Fever | 2.0 percentage of participants with fever |
| Total VCIV - Modified Process (≥50 Years Old) Lots 1-3 | Percentage of Participants With Fever | 1.9 percentage of participants with fever |
| Fluzone® (≥50 Years Old) | Percentage of Participants With Fever | 0.0 percentage of participants with fever |
95% CI: [0.1, 3.3]
Secondary
Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine as Compared to Baseline
Time frame: 21 days post vaccination
Population: Immunogenicity Analysis Set. The primary immunogenicity and safety analyses groups included the VCIV Modified lots separately. The secondary immunogenicity and safety analyses groups included all three of the VCIV Modified lots pooled.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine as Compared to Baseline | Strain A/H3N2 | 5.6 Titers |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine as Compared to Baseline | Strain A/H1N1 | 9.6 Titers |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine as Compared to Baseline | Strain B | 6.7 Titers |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine as Compared to Baseline | Strain A/H3N2 | 4.8 Titers |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine as Compared to Baseline | Strain A/H1N1 | 8.5 Titers |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine as Compared to Baseline | Strain B | 5.6 Titers |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine as Compared to Baseline | Strain A/H3N2 | 9.5 Titers |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine as Compared to Baseline | Strain A/H1N1 | 19.9 Titers |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine as Compared to Baseline | Strain B | 9.1 Titers |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine as Compared to Baseline | Strain A/H1N1 | 5.5 Titers |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine as Compared to Baseline | Strain A/H3N2 | 5.1 Titers |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine as Compared to Baseline | Strain B | 3.9 Titers |
| VCIV Manufactured With Current Process (18-49 Years Old) | Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine as Compared to Baseline | Strain A/H3N2 | 8.5 Titers |
| VCIV Manufactured With Current Process (18-49 Years Old) | Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine as Compared to Baseline | Strain B | 4.8 Titers |
| VCIV Manufactured With Current Process (18-49 Years Old) | Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine as Compared to Baseline | Strain A/H1N1 | 12.7 Titers |
Secondary
Frequency and Severity of Related Adverse Events
Frequency and severity of adverse events considered related to the vaccination (possibly related, probably related, unknown) according to System Organ Class (SOC) and Preferred Term (PT) SOCs are abbreviated as follows:- BLD- Blood and lymphatic system disorders EAR- Ear and labyrinth disorders EYE- Eye disorders GID- Gastrointestinal disorders GEN- General disorders and administration site conditions IMM- Immune system disorders INF- Infections and infestations MET- Metabolism and nutrition disorders MSK- Musculoskeletal and connective tissue disorders NER- Nervous system disorders RES- Respiratory, thoracic and mediastinal disorders SKN- Skin and subcutaneous tissue disorders VAS- Vascular disorders SYS-Systemic LOC-Local
Time frame: within 21 days post vaccination
Population: Safety Analysis Set. The primary immunogenicity and safety analyses groups included the VCIV Modified lots separately. The secondary immunogenicity and safety analyses groups included all three of the VCIV Modified lots pooled.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Oropharyngeal pain-Total | 1.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-EAR-Ear pain-Mild | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pain-Moderate | 1.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-BLD-TOTAL | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pain-Total | 48.8 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-BLD-MODERATE-TOTAL | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pruritus-Mild | 1.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pruritus-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Pyrexia-Total | 1.8 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Rash-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-EAR-MILD-TOTAL | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Rash-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-BLD-Lymph node pain-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Reaction-Mild | 0.7 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Reaction-Total | 0.7 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MET-Decreased appetite-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-TOTAL | 50.8 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Scab-Mild | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Pyrexia-Severe | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-UNKNOWN-TOTAL | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Scab-Total | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Rhinorrhoea-Mild | 1.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-SEVERE-TOTAL | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Swelling-Mild | 0.8 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-NER-Headache-Total | 16.4 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-MODERATE-TOTAL | 1.8 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Swelling-Moderate | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-MILD-TOTAL | 48.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Swelling-Unknown | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Pain-Total | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Warmth-Total | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Swelling-Total | 1.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Rhinorrhoea-Total | 1.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Warmth-Mild | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Pain-Moderate | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Oedema peripheral-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Sinus congestion-Total | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Non-cardiac chest pain-Total | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Sneezing-Mild | 0.7 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MET-Decreased appetite-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Non-cardiac chest pain-Mild | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Sneezing-Total | 0.7 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Arthralgia-Mild | 4.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Throat irritation-Mild | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-MODERATE-TOTAL | 2.7 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Throat irritation-Total | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-MILD-TOTAL | 14.7 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-MILD-TOTAL | 1.8 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Sinus congestion-Mild | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Pain in jaw-Total | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-SKN-Night sweats-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-INF-Upper respiratory tract infection-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Pain in jaw-Mild | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-SKN-Pruritus-Mild | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Pain in extremity-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-SKN-Pruritus-Total | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-NER-Lethargy-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Injection site pain-Mild | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-SKN-Skin mass-Mild | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Feeling cold-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-SKN-Skin mass-Total | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-INF-Upper respiratory tract infection-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Feeling cold-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-SKN-SEVERE-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-NER-Paraesthesia-Mild | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Feeling abnormal-Total | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-VAS-Pallor-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-NER-Paraesthesia-Total | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Fatigue-Mild | 12 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-VAS-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Discomfort-Total | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Discomfort-Mild | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-INF-Sinusitis-Mild | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chills-Total | 3.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chest pain-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Bruising-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-NER-Sinus headache-Mild | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chest pain-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chest discomfort-Total | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GID-SEVERE-TOTAL | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Discolouration-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GID-MODERATE-TOTAL | 2.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GID-MILD-TOTAL | 4.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Joint swelling-Mild | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-INF-Oral herpes-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GID-Vomiting-Total | 1.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Discolouration-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Joint swelling-Total | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GID-Vomiting-Severe | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GID-Vomiting-Moderate | 1.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Muscle spasms-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GID-Nausea-Severe | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Muscle spasms-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Arthralgia-Moderate | 1.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GID-Nausea-Moderate | 1.8 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-INF-Oral herpes-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GID-Nausea-Mild | 3.8 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GID-Hypoaesthesia oral-Mild | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Muscle tightness-Mild | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Muscle tightness-Total | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GID-Diarrhoea-Total | 0.8 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GID-Diarrhoea-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GID-Apthous stomatitis-Total | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Exfoliation-Total | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Paranasal sinus hypersecretion-Total | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GID-Apthous stomatitis-Mild | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Musculoskeletal pain-Total | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-EYE-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-INF-Herpes simplex-Moderate | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-EYE-MILD-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-TOTAL | 17.4 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Neck pain-Mild | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Neck pain-Total | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Productive cough-Total | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-EYE-Eye pruritus-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Induration-Unknown | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-SEVERE-TOTAL | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-MODERATE-TOTAL | 6.7 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-EAR-Ear pain-Total | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pain-Mild | 47.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Myalgia-Moderate | 2.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Musculoskeletal pain-Mild | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-SKN-Dermatitis contact-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Nasal congestion-Total | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Pyrexia-Moderate | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chills-Mild | 2.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GID-TOTAL | 6.4 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-SKN-Dermatitis contact-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pruritus-Total | 1.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Respiratory tract congestion-Moderate | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-INF-Herpes simplex-Total | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-NER-Burning sensation-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-SKN-Erythema-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Oropharyngeal pain-Moderate | 0.8 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Malaise-Severe | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-NER-Headache-Moderate | 3.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-NER-Dizziness-Mild | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-SKN-Erythema-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-NER-Sinus headache-Total | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Pain-Mild | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-NER-MODERATE-TOTAL | 3.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-BLD-Lymph node pain-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-SKN-Hyperhidrosis-Mild | 2.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Increased upper airway secretion-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-INF-Acute sinusitis-Total | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Musculoskeletal stiffness-Mild | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chills-Moderate | 1.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-SKN-Hyperhidrosis-Moderate | 1.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Respiratory tract congestion-Total | 0.7 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-BLD-Lymphadenopathy-Mild | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GID-Oedema mouth-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Exfoliation-Mild | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-SKN-Hyperhidrosis-Severe | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-BLD-Lymphadenopathy-Moderate | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Paranasal sinus hypersecretion-Moderate | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Nodule-Mild | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MET-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-SKN-Hyperhidrosis-Total | 3.8 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Nodule-Total | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chills-Severe | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Haemorrhage-Mild | 3.8 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-BLD-Lymphadenopathy-Total | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-SKN-Night sweats-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Haemorrhage-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chest discomfort-Mild | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-NER-SEVERE-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GID-Hypoaesthesia oral-Total | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-NER-Hypoaesthesia-Mild | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-INF-Acute sinusitis-Moderate | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-SKN-Rash-Mild | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-BLD-MILD-TOTAL | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Myalgia-Severe | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-NER-Lethargy-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MET-MILD-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-NER-Dysgeusia-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-SKN-MILD-TOTAL | 3.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Injection site reaction-Mild | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Fatigue-Moderate | 4.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-NER-TOTAL | 16.6 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Rhinorrhoea-Moderate | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-SKN-MODERATE-TOTAL | 1.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Malaise-Moderate | 3.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Nasal congestion-Mild | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-INF-TOTAL | 1.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-SKN-TOTAL | 4.7 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Increased upper airway secretion-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GID-Oedema mouth-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-VAS-Pallor-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-EAR-TOTAL | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-INF-Nasopharyngitis-Total | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Haemorrhage-Total | 3.8 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Musculoskeletal stiffness-Total | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-VAS-MILD-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-TOTAL | 27.4 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Malaise-Total | 17.9 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Anaesthesia-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-EYE-Dark circles under eyes-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Anaesthesia-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-INF-Otitis media-Total | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Bruising-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-NER-Dysgeusia-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Fatigue-Severe | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Sinus congestion-Moderate | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Cough-Mild | 0.7 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-INF-MODERATE-TOTAL | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Arthralgia-Severe | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Malaise-Mild | 14.4 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Arthralgia-Total | 5.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-EYE-Dark circles under eyes-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Back pain-Mild | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Induration-Mild | 0.8 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Back pain-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Myalgia-Total | 16.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SSYS-NER-Headache-Severe | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-SEVERE-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Cough-Total | 1.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Fatigue-Total | 16.6 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-EYE-Eye pruritus-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Back pain-Total | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Nasal congestion-Moderate | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-MILD-TOTAL | 20.6 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GID-Abdominal pain upper-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-INF-Otitis media-Mild | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Oropharyngeal pain-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-INF-MILD-TOTAL | 0.7 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-MODERATE-TOTAL | 1.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Erythema-Mild | 0.8 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Respiratory tract congestion-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GID-Vomiting-Mild | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Erythema-Moderate | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Feeling abnormal-Mild | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Myalgia-Mild | 13.7 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GID-Abdominal pain upper-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-NER-Dysgeusia-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Pyrexia-Mild | 1.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Erythema-Severe | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-NER-Hypoaesthesia-Total | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-NER-Headache-Mild | 13.4 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-INF-Upper respiratory tract infection-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Erythema-Unknown | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Muscle spasms-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Musculoskeletal pain-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-NER-Sinus headache-Moderate | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Injection site pain-Total | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-INF-Nasopharyngitis-Mild | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Erythema-Total | 1.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Cough-Moderate | 0.7 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GID-Diarrhoea-Moderate | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Induration-Moderate | 1.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Productive cough-Moderate | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-TOTAL | 3.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-RES-Increased upper airway secretion-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Injection site reaction-Total | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-MSK-Pain in extremity-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-NER-Dizziness-Total | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-SKN-Dermatitis allergic-Mild | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GEN-Oedema peripheral-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-INF-Sinusitis-Total | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-NER-MILD-TOTAL | 13.4 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-NER-Burning sensation-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-SKN-Rash-Total | 0.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-SKN-Dermatitis allergic-Total | 0.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Induration-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Frequency and Severity of Related Adverse Events | SYS-GID-Nausea-Total | 5.9 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Discolouration-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-MODERATE-TOTAL | 3.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Injection site reaction-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-INF-Sinusitis-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Haemorrhage-Mild | 3.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Musculoskeletal pain-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Injection site reaction-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Oropharyngeal pain-Mild | 2.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Musculoskeletal stiffness-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Productive cough-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-INF-Otitis media-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Musculoskeletal stiffness-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Myalgia-Mild | 15.9 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Malaise-Mild | 20.9 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Myalgia-Moderate | 3.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SSYS-NER-Headache-Severe | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Malaise-Moderate | 5.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-NER-Dysgeusia-Total | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-INF-Nasopharyngitis-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Myalgia-Severe | 1.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Haemorrhage-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Haemorrhage-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-TOTAL | 21.4 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Increased upper airway secretion-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Induration-Mild | 1.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GID-TOTAL | 7.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-NER-Sinus headache-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-INF-Nasopharyngitis-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Respiratory tract congestion-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Pain in extremity-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Increased upper airway secretion-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Induration-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Rhinorrhoea-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-INF-Herpes simplex-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Rash-Total | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Increased upper airway secretion-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-NER-Sinus headache-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-INF-Acute sinusitis-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-BLD-Lymphadenopathy-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-BLD-MILD-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-NER-Dysgeusia-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-NER-Dysgeusia-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Rhinorrhoea-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-TOTAL | 35.8 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-EAR-TOTAL | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Rhinorrhoea-Total | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Nasal congestion-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-EYE-Dark circles under eyes-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Sinus congestion-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-EYE-Dark circles under eyes-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chest discomfort-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-MODERATE-TOTAL | 8.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GID-Abdominal pain upper-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Nasal congestion-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-MODERATE-TOTAL | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GID-Abdominal pain upper-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-NER-Dizziness-Total | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Pyrexia-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GID-Diarrhoea-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-TOTAL | 3.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Oropharyngeal pain-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-NER-Headache-Moderate | 3.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-SKN-Dermatitis allergic-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chest pain-Total | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-SKN-Dermatitis allergic-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-NER-MILD-TOTAL | 13.9 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GID-Nausea-Total | 7.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-SKN-Dermatitis contact-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-NER-Burning sensation-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-SKN-Dermatitis contact-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chills-Mild | 3.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-NER-Hypoaesthesia-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-SKN-Erythema-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-NER-Sinus headache-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-SKN-Erythema-Total | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-NER-Burning sensation-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-SKN-Hyperhidrosis-Mild | 4.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Nodule-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-NER-MODERATE-TOTAL | 3.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-SKN-Hyperhidrosis-Moderate | 1.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chills-Moderate | 2.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MET-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-SKN-Hyperhidrosis-Severe | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-SKN-Hyperhidrosis-Total | 5.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chills-Severe | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GID-Oedema mouth-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-SKN-Night sweats-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Paranasal sinus hypersecretion-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GID-Hypoaesthesia oral-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MET-MILD-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-SKN-Rash-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GID-Hypoaesthesia oral-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Malaise-Total | 25.9 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-SKN-MILD-TOTAL | 4.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-INF-TOTAL | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-SKN-MODERATE-TOTAL | 1.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-NER-TOTAL | 17.4 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Fatigue-Moderate | 4.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-VAS-Pallor-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-NER-Headache-Total | 16.9 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-NER-Paraesthesia-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-INF-MODERATE-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-VAS-MILD-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Anaesthesia-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Anaesthesia-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Bruising-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-NER-Headache-Mild | 13.4 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Arthralgia-Severe | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Fatigue-Severe | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GID-Oedema mouth-Total | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Bruising-Total | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Nasal congestion-Total | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Cough-Moderate | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-INF-MILD-TOTAL | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Back pain-Total | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Fatigue-Total | 19.9 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Joint swelling-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Cough-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Oedema peripheral-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Joint swelling-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Feeling abnormal-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GID-Vomiting-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Muscle spasms-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-INF-Upper respiratory tract infection-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Erythema-Severe | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Muscle spasms-Total | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Erythema-Unknown | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Injection site pain-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Pyrexia-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Muscle tightness-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-SKN-Rash-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Erythema-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-NER-Dizziness-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GID-Nausea-Severe | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-SKN-Skin mass-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-NER-Lethargy-Total | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Feeling cold-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pain-Mild | 50.2 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-EYE-Eye pruritus-Total | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-SKN-Skin mass-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Sinus congestion-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Muscle spasms-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Feeling cold-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Oropharyngeal pain-Total | 2.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-EAR-Ear pain-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-SKN-SEVERE-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-BLD-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-INF-Sinusitis-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pain-Moderate | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-MILD-TOTAL | 26.4 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-SKN-TOTAL | 6.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-BLD-MODERATE-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GID-Nausea-Moderate | 2.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pain-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Pyrexia-Total | 1.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Feeling abnormal-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-BLD-Lymphadenopathy-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-EYE-MILD-TOTAL | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pruritus-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Respiratory tract congestion-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-EAR-MILD-TOTAL | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-BLD-Lymphadenopathy-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-EAR-Ear pain-Total | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pruritus-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pruritus-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-VAS-Pallor-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GID-Nausea-Mild | 5.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Rash-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Pyrexia-Severe | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Fatigue-Mild | 14.9 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-INF-Acute sinusitis-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-BLD-Lymph node pain-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Myalgia-Total | 19.9 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-VAS-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Reaction-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Respiratory tract congestion-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-BLD-Lymph node pain-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-TOTAL | 51.7 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-NER-Paraesthesia-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Reaction-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Discomfort-Total | 1.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Induration-Unknown | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-UNKNOWN-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MET-Decreased appetite-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Scab-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Discomfort-Mild | 1.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Muscle tightness-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-SEVERE-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-INF-Herpes simplex-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Scab-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chills-Total | 6.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Erythema-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-MODERATE-TOTAL | 1.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GID-Diarrhoea-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Swelling-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Productive cough-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-INF-Otitis media-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-MILD-TOTAL | 50.7 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Neck pain-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Swelling-Moderate | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Pain-Total | 1.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chest pain-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Warmth-Total | 1.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GID-Diarrhoea-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Swelling-Unknown | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Arthralgia-Total | 4.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-INF-Oral herpes-Total | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Warmth-Mild | 1.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chest discomfort-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Swelling-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Back pain-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Exfoliation-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Arthralgia-Mild | 2.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-NER-SEVERE-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Pain-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MET-Decreased appetite-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GID-SEVERE-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Pain-Mild | 1.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-NER-Hypoaesthesia-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Oedema peripheral-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Musculoskeletal pain-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GID-MODERATE-TOTAL | 2.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Sinus congestion-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Cough-Total | 1.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Non-cardiac chest pain-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Back pain-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Arthralgia-Moderate | 2.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Sneezing-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GID-Apthous stomatitis-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Non-cardiac chest pain-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GID-MILD-TOTAL | 5.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Musculoskeletal pain-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Sneezing-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GID-Vomiting-Total | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Nodule-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Malaise-Severe | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Induration-Moderate | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Throat irritation-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-INF-Upper respiratory tract infection-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-SEVERE-TOTAL | 1.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GID-Apthous stomatitis-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-SEVERE-TOTAL | 1.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Throat irritation-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-NER-Lethargy-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-MILD-TOTAL | 16.9 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Exfoliation-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Discolouration-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-MILD-TOTAL | 2.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-EYE-Eye pruritus-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Pain in jaw-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GID-Vomiting-Severe | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Erythema-Mild | 1.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-SKN-Night sweats-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-INF-Oral herpes-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Pain in jaw-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Neck pain-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GID-Vomiting-Moderate | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-SKN-Pruritus-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-INF-Upper respiratory tract infection-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-MSK-Pain in extremity-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-RES-Paranasal sinus hypersecretion-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-EYE-TOTAL | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-SKN-Pruritus-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Frequency and Severity of Related Adverse Events | SYS-GEN-Injection site pain-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Pain-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-NER-Dizziness-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-NER-Hypoaesthesia-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-NER-Hypoaesthesia-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-NER-Lethargy-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-NER-Lethargy-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-NER-Paraesthesia-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Oropharyngeal pain-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Productive cough-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Respiratory tract congestion-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Respiratory tract congestion-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Rhinorrhoea-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Rhinorrhoea-Total | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Sinus congestion-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Sinus congestion-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Sinus congestion-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Sneezing-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Sneezing-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Throat irritation-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Throat irritation-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-MILD-TOTAL | 2.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Night sweats-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Pruritus-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Rash-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Skin mass-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Skin mass-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-SKN-MODERATE-TOTAL | 1.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-SKN-SEVERE-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-SKN-TOTAL | 3.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-VAS-Pallor-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-VAS-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Anaesthesia-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Anaesthesia-Total | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Arthralgia-Moderate | 1.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Arthralgia-Severe | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Arthralgia-Total | 4.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Joint swelling-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Joint swelling-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Muscle spasms-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Muscle spasms-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Erythema-Severe | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Muscle spasms-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Muscle tightness-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Exfoliation-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Haemorrhage-Mild | 2.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Haemorrhage-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Induration-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Myalgia-Total | 17.9 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Neck pain-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Induration-Moderate | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Neck pain-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Induration-Unknown | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Pain in extremity-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Induration-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pain-Mild | 42.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pain-Moderate | 1.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pain-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pruritus-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pruritus-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Rash-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Reaction-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Reaction-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Scab-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Scab-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Swelling-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Swelling-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Swelling-Unknown | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Swelling-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Warmth-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Warmth-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-MILD-TOTAL | 41.8 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-MODERATE-TOTAL | 2.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-SEVERE-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-UNKNOWN-TOTAL | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-TOTAL | 44.3 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-BLD-Lymph node pain-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-BLD-Lymph node pain-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-BLD-Lymphadenopathy-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-BLD-MODERATE-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-BLD-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-EAR-Ear pain-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-EAR-Ear pain-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-EYE-Eye pruritus-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-EYE-Eye pruritus-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-EYE-MILD-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-EYE-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GID-Apthous stomatitis-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GID-Apthous stomatitis-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GID-Diarrhoea-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GID-Diarrhoea-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GID-Nausea-Mild | 3.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GID-Nausea-Moderate | 1.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GID-Vomiting-Moderate | 1.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GID-Vomiting-Severe | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GID-Vomiting-Total | 2.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GID-MILD-TOTAL | 3.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GID-MODERATE-TOTAL | 2.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GID-SEVERE-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chest discomfort-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chest pain-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chills-Total | 4.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Discomfort-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Discomfort-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Feeling abnormal-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Feeling cold-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Feeling cold-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Injection site pain-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Pain in extremity-Total | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Pain in jaw-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Pain in jaw-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-MILD-TOTAL | 12.4 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-SEVERE-TOTAL | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Malaise-Severe | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Nodule-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Non-cardiac chest pain-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Non-cardiac chest pain-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Oedema peripheral-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Pain-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Pain-Total | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Pyrexia-Severe | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-MILD-TOTAL | 22.9 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-SEVERE-TOTAL | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-INF-Acute sinusitis-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-INF-Herpes simplex-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-INF-Oral herpes-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-INF-Oral herpes-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-INF-Otitis media-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-INF-Sinusitis-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-INF-Upper respiratory tract infection-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-INF-Upper respiratory tract infection-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MET-Decreased appetite-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MET-Decreased appetite-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Arthralgia-Mild | 2.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Injection site reaction-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-INF-Acute sinusitis-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GID-Hypoaesthesia oral-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Pyrexia-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GID-Hypoaesthesia oral-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GID-Nausea-Severe | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Nasal congestion-Total | 1.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GID-Nausea-Total | 4.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GID-Oedema mouth-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-NER-Dysgeusia-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Oedema peripheral-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GID-Oedema mouth-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GID-Vomiting-Mild | 1.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Oropharyngeal pain-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GID-TOTAL | 5.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chest discomfort-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chest pain-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Oropharyngeal pain-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Nodule-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chills-Mild | 2.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-NER-Sinus headache-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chills-Moderate | 2.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chills-Severe | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Malaise-Total | 19.9 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Fatigue-Mild | 10.9 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Paranasal sinus hypersecretion-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Fatigue-Moderate | 5.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Fatigue-Severe | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-NER-Burning sensation-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Fatigue-Total | 16.4 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Paranasal sinus hypersecretion-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-MODERATE-TOTAL | 5.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Feeling abnormal-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Injection site pain-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Injection site reaction-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Malaise-Moderate | 4.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Malaise-Mild | 15.9 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-NER-Headache-Moderate | 4.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Productive cough-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-TOTAL | 18.4 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Respiratory tract congestion-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Rhinorrhoea-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-NER-Sinus headache-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-NER-Dizziness-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-MODERATE-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-TOTAL | 2.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Dermatitis allergic-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Dermatitis allergic-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-NER-Burning sensation-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Dermatitis contact-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-NER-MILD-TOTAL | 10.9 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Dermatitis contact-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Erythema-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Erythema-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Hyperhidrosis-Mild | 2.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MET-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Hyperhidrosis-Moderate | 1.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-NER-MODERATE-TOTAL | 4.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Hyperhidrosis-Severe | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SSYS-NER-Headache-Severe | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Hyperhidrosis-Total | 3.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-NER-Headache-Mild | 10.9 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MET-MILD-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Night sweats-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Pruritus-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-NER-SEVERE-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Rash-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-INF-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-SKN-MILD-TOTAL | 2.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-NER-TOTAL | 15.4 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-INF-MODERATE-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-VAS-Pallor-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-VAS-MILD-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Bruising-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-INF-MILD-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Back pain-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Bruising-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Back pain-Moderate | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Discolouration-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Back pain-Total | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Discolouration-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Cough-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Erythema-Mild | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-INF-Upper respiratory tract infection-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Erythema-Moderate | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-NER-Paraesthesia-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Erythema-Unknown | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-INF-Sinusitis-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Erythema-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Muscle tightness-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Cough-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Musculoskeletal pain-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Musculoskeletal pain-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Exfoliation-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Musculoskeletal pain-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-NER-Headache-Total | 15.4 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-INF-Otitis media-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Musculoskeletal stiffness-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-NER-Dysgeusia-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Musculoskeletal stiffness-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Myalgia-Mild | 11.9 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Cough-Total | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Myalgia-Moderate | 6.0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-INF-Nasopharyngitis-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Haemorrhage-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Myalgia-Severe | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Increased upper airway secretion-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-INF-Nasopharyngitis-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-INF-Herpes simplex-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pruritus-Moderate | 0.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Increased upper airway secretion-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-NER-Sinus headache-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-NER-Dysgeusia-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Rash-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GID-Diarrhoea-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-BLD-Lymphadenopathy-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Increased upper airway secretion-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-BLD-Lymphadenopathy-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-BLD-MILD-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-TOTAL | 29.9 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-EAR-MILD-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-EAR-TOTAL | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-EYE-Dark circles under eyes-Mild | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Nasal congestion-Mild | 1.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-MODERATE-TOTAL | 6.5 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-EYE-Dark circles under eyes-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GID-Abdominal pain upper-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Pyrexia-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GID-Abdominal pain upper-Total | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-RES-Nasal congestion-Moderate | 0 percentage of related adverse events |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Pyrexia-Moderate | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SSYS-NER-Headache-Severe | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-NER-Headache-Total | 7.4 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-NER-Paraesthesia-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-NER-Sinus headache-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-NER-Sinus headache-Moderate | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-NER-Sinus headache-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-NER-MILD-TOTAL | 6.4 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-NER-MODERATE-TOTAL | 1.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-NER-SEVERE-TOTAL | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-NER-TOTAL | 7.7 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Cough-Mild | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Cough-Moderate | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Cough-Total | 0.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Increased upper airway secretion-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Increased upper airway secretion-Moderate | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Increased upper airway secretion-Total | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Nasal congestion-Mild | 0.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Nasal congestion-Moderate | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Nasal congestion-Total | 0.5 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Oropharyngeal pain-Moderate | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Paranasal sinus hypersecretion-Moderate | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Productive cough-Moderate | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-TOTAL | 10.8 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Respiratory tract congestion-Total | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Rhinorrhoea-Mild | 0.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-MODERATE-TOTAL | 0.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-TOTAL | 1.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Dermatitis allergic-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Dermatitis allergic-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Dermatitis contact-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Dermatitis contact-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Erythema-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Erythema-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Hyperhidrosis-Mild | 1.9 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Hyperhidrosis-Moderate | 0.5 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Hyperhidrosis-Severe | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Hyperhidrosis-Total | 2.5 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Night sweats-Mild | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Pruritus-Total | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Rash-Mild | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-SKN-MILD-TOTAL | 2.4 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-SKN-SEVERE-TOTAL | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-VAS-Pallor-Mild | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-VAS-Pallor-Total | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Bruising-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Arthralgia-Moderate | 1.0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Joint swelling-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Discolouration-Total | 0.5 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Erythema-Moderate | 0.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Muscle spasms-Moderate | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Muscle tightness-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Muscle tightness-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Erythema-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Musculoskeletal pain-Total | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Musculoskeletal stiffness-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Musculoskeletal stiffness-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Myalgia-Mild | 8.6 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Myalgia-Moderate | 1.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Haemorrhage-Mild | 1.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Haemorrhage-Moderate | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Myalgia-Severe | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Myalgia-Total | 10.1 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Neck pain-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Induration-Mild | 1.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Neck pain-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Induration-Unknown | 0.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pruritus-Moderate | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pruritus-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Rash-Mild | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-BLD-Lymph node pain-Mild | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-BLD-Lymph node pain-Total | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-BLD-Lymphadenopathy-Moderate | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-BLD-Lymphadenopathy-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-BLD-MILD-TOTAL | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-EAR-MILD-TOTAL | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-EAR-TOTAL | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-EYE-Dark circles under eyes-Mild | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-EYE-Dark circles under eyes-Total | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-EYE-TOTAL | 0.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GID-Abdominal pain upper-Moderate | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GID-Abdominal pain upper-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GID-Diarrhoea-Mild | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GID-Diarrhoea-Moderate | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GID-Hypoaesthesia oral-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GID-Hypoaesthesia oral-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GID-Nausea-Severe | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GID-Nausea-Total | 2.5 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GID-Oedema mouth-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GID-Oedema mouth-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GID-Vomiting-Mild | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GID-SEVERE-TOTAL | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GID-TOTAL | 2.7 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chest discomfort-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chest pain-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chills-Mild | 0.5 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chills-Moderate | 0.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chills-Severe | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Fatigue-Mild | 5.6 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Fatigue-Moderate | 2.9 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Fatigue-Severe | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Fatigue-Total | 8.6 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Injection site pain-Total | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Injection site reaction-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Malaise-Mild | 7.7 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Malaise-Moderate | 1.7 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-MODERATE-TOTAL | 1.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Malaise-Total | 9.6 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Nodule-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Pain-Total | 0.7 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Oedema peripheral-Moderate | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Oedema peripheral-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Pyrexia-Mild | 1.0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Pyrexia-Moderate | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Pyrexia-Total | 1.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-TOTAL | 14.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-INF-Acute sinusitis-Moderate | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-INF-Herpes simplex-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-INF-Nasopharyngitis-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-INF-Nasopharyngitis-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-INF-Oral herpes-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-INF-Otitis media-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-INF-Sinusitis-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-INF-Upper respiratory tract infection-Total | 0.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-INF-MILD-TOTAL | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-INF-MODERATE-TOTAL | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-INF-TOTAL | 0.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MET-Decreased appetite-Total | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MET-MILD-TOTAL | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-NER-Dizziness-Mild | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-NER-Dizziness-Total | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-NER-Dysgeusia-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-NER-Burning sensation-Total | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-NER-Dysgeusia-Moderate | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-NER-Dysgeusia-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-NER-Headache-Mild | 6.1 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-NER-Headache-Moderate | 1.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-MILD-TOTAL | 10.4 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-EYE-Eye pruritus-Mild | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Induration-Moderate | 0.5 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MET-TOTAL | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-EYE-Eye pruritus-Total | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Haemorrhage-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-INF-Herpes simplex-Moderate | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-EYE-MILD-TOTAL | 0.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Musculoskeletal pain-Moderate | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Exfoliation-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GID-Apthous stomatitis-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Exfoliation-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Oropharyngeal pain-Total | 0.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GID-Apthous stomatitis-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Musculoskeletal pain-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GID-Diarrhoea-Total | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Erythema-Unknown | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Muscle spasms-Total | 0.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-INF-Oral herpes-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GID-Nausea-Mild | 2.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Erythema-Severe | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GID-Nausea-Moderate | 0.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Muscle spasms-Mild | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Erythema-Mild | 1.9 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GID-Vomiting-Moderate | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Joint swelling-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Oropharyngeal pain-Mild | 0.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GID-Vomiting-Severe | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GID-Vomiting-Total | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Back pain-Total | 0.5 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Back pain-Moderate | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GID-MILD-TOTAL | 2.4 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Discolouration-Mild | 0.5 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GID-MODERATE-TOTAL | 0.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Bruising-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-INF-Otitis media-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Back pain-Mild | 0.5 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Arthralgia-Total | 2.7 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chest discomfort-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Arthralgia-Severe | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-NER-Paraesthesia-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chest pain-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Anaesthesia-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Chills-Total | 1.0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Anaesthesia-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-NER-Burning sensation-Mild | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Discomfort-Mild | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-VAS-TOTAL | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-INF-Sinusitis-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Discomfort-Total | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-VAS-MILD-TOTAL | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Feeling abnormal-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-SKN-TOTAL | 3.0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Feeling abnormal-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-SKN-MODERATE-TOTAL | 0.5 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-INF-Upper respiratory tract infection-Mild | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Feeling cold-Mild | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Skin mass-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Feeling cold-Total | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Rash-Total | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Skin mass-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-NER-Lethargy-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Injection site pain-Mild | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Pruritus-Mild | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Pain in extremity-Total | 0.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-SKN-Night sweats-Total | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Arthralgia-Mild | 1.5 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Pain in jaw-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-MILD-TOTAL | 0.8 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-INF-Upper respiratory tract infection-Moderate | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Pain in jaw-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Throat irritation-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-MILD-TOTAL | 9.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Throat irritation-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-NER-Lethargy-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-SEVERE-TOTAL | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-NER-Hypoaesthesia-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Malaise-Severe | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Sneezing-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Nodule-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Sneezing-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Non-cardiac chest pain-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Sinus congestion-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-NER-Hypoaesthesia-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Non-cardiac chest pain-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Sinus congestion-Moderate | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Pain-Mild | 0.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Sinus congestion-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Rhinorrhoea-Total | 0.5 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Pain-Moderate | 0.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Rhinorrhoea-Moderate | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MET-Decreased appetite-Mild | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Pyrexia-Severe | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Respiratory tract congestion-Moderate | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Respiratory tract congestion-Mild | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-EAR-Ear pain-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Swelling-Total | 2.0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Warmth-Mild | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Swelling-Unknown | 0.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Warmth-Total | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Swelling-Moderate | 0.5 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-MODERATE-TOTAL | 3.5 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-MILD-TOTAL | 25.9 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Swelling-Mild | 1.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-MODERATE-TOTAL | 2.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Scab-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Productive cough-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-SEVERE-TOTAL | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Scab-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-UNKNOWN-TOTAL | 0.7 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Reaction-Total | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-TOTAL | 28.8 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Reaction-Mild | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-SEVERE-TOTAL | 0.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Rash-Total | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pruritus-Mild | 0.7 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-BLD-Lymphadenopathy-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pain-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-GEN-Injection site reaction-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-BLD-MODERATE-TOTAL | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pain-Moderate | 1.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-INF-Acute sinusitis-Total | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-BLD-TOTAL | 0.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pain-Mild | 25.1 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-EAR-Ear pain-Mild | 0 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Induration-Total | 2.2 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-MSK-Pain in extremity-Mild | 0.3 percentage of related adverse events |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Frequency and Severity of Related Adverse Events | SYS-RES-Paranasal sinus hypersecretion-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Swelling-Total | 2.0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Injection site pain-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Pain in extremity-Mild | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-SKN-Pruritus-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pain-Moderate | 1.0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-NER-Lethargy-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Swelling-Unknown | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Pain in extremity-Total | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-SKN-Night sweats-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-EAR-Ear pain-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Induration-Unknown | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Oropharyngeal pain-Total | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-MILD-TOTAL | 13.8 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-EYE-Eye pruritus-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Induration-Moderate | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-TOTAL | 31.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Warmth-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Pain in jaw-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-EYE-Eye pruritus-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Haemorrhage-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-SKN-Night sweats-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-INF-Acute sinusitis-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Swelling-Moderate | 1.0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-EYE-MILD-TOTAL | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Myalgia-Severe | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Productive cough-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-INF-Herpes simplex-Moderate | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Pain in jaw-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Exfoliation-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-INF-Nasopharyngitis-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Throat irritation-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GID-Apthous stomatitis-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-BLD-TOTAL | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Musculoskeletal pain-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-INF-Upper respiratory tract infection-Moderate | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Warmth-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GID-Apthous stomatitis-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-MILD-TOTAL | 10.8 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Muscle tightness-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Oropharyngeal pain-Moderate | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Erythema-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Muscle tightness-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MET-TOTAL | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Throat irritation-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GID-Diarrhoea-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Rash-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Muscle spasms-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Swelling-Mild | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-BLD-MODERATE-TOTAL | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-SEVERE-TOTAL | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GID-Nausea-Mild | 2.0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Muscle spasms-Moderate | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Sneezing-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-INF-Oral herpes-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-SEVERE-TOTAL | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GID-Nausea-Moderate | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Erythema-Moderate | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-MILD-TOTAL | 29.1 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GID-Vomiting-Mild | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Erythema-Mild | 1.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Rash-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Oropharyngeal pain-Mild | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Arthralgia-Mild | 3.0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GID-Vomiting-Moderate | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Scab-Total | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Discolouration-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Nodule-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Sneezing-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GID-Vomiting-Severe | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Discolouration-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Back pain-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Nasal congestion-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-MODERATE-TOTAL | 3.9 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GID-Vomiting-Total | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-INF-TOTAL | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pruritus-Mild | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-NER-Paraesthesia-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Non-cardiac chest pain-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GID-MILD-TOTAL | 2.0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Sinus congestion-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Bruising-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-NER-SEVERE-TOTAL | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-MODERATE-TOTAL | 2.0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GID-MODERATE-TOTAL | 1.0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-EAR-Ear pain-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Back pain-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Scab-Mild | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Chest discomfort-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Non-cardiac chest pain-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Sinus congestion-Moderate | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-INF-Otitis media-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pain-Mild | 26.6 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Chest discomfort-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Arthralgia-Severe | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-NER-Headache-Total | 10.8 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Sinus congestion-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-NER-Burning sensation-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Chest pain-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Bruising-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Anaesthesia-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-BLD-Lymphadenopathy-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-NER-Lethargy-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Pain-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Chills-Total | 3.0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Anaesthesia-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-SEVERE-TOTAL | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Rhinorrhoea-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pain-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Discomfort-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-VAS-TOTAL | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Reaction-Total | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Pain-Moderate | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Rhinorrhoea-Moderate | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Discomfort-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-VAS-MILD-TOTAL | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Productive cough-Moderate | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Paranasal sinus hypersecretion-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Feeling abnormal-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-SKN-TOTAL | 3.4 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Respiratory tract congestion-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-INF-Sinusitis-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Respiratory tract congestion-Moderate | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Feeling abnormal-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-SKN-MODERATE-TOTAL | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MET-Decreased appetite-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-UNKNOWN-TOTAL | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Pyrexia-Severe | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Feeling cold-Mild | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-SKN-Skin mass-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Induration-Total | 1.0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-INF-Upper respiratory tract infection-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Respiratory tract congestion-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Feeling cold-Total | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Reaction-Mild | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SSYS-NER-Headache-Severe | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-SKN-Rash-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GID-Nausea-Severe | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GID-Hypoaesthesia oral-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GID-Hypoaesthesia oral-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Increased upper airway secretion-Total | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Pyrexia-Mild | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GID-Diarrhoea-Moderate | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GID-Diarrhoea-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GID-Abdominal pain upper-Total | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Increased upper airway secretion-Moderate | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Pyrexia-Moderate | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GID-Abdominal pain upper-Moderate | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-NER-Headache-Moderate | 3.0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Pyrexia-Total | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-EYE-TOTAL | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-EYE-Dark circles under eyes-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-EYE-Dark circles under eyes-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-EAR-TOTAL | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-EAR-MILD-TOTAL | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-BLD-MILD-TOTAL | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-NER-Sinus headache-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-TOTAL | 17.7 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-BLD-Lymphadenopathy-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-BLD-Lymphadenopathy-Moderate | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-BLD-Lymph node pain-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-NER-Dysgeusia-Moderate | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-INF-Acute sinusitis-Moderate | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-BLD-Lymph node pain-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pruritus-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Pruritus-Moderate | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Neck pain-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Increased upper airway secretion-Mild | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-INF-Herpes simplex-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Neck pain-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Induration-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Myalgia-Total | 9.9 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-NER-Burning sensation-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-INF-Nasopharyngitis-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Haemorrhage-Moderate | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Haemorrhage-Mild | 2.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Myalgia-Moderate | 1.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Cough-Total | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Myalgia-Mild | 8.4 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Cough-Moderate | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-INF-Oral herpes-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Musculoskeletal stiffness-Total | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Musculoskeletal stiffness-Mild | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Musculoskeletal pain-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-NER-Paraesthesia-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-INF-Otitis media-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Musculoskeletal pain-Moderate | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Exfoliation-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Erythema-Unknown | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-NER-Dysgeusia-Total | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-INF-Sinusitis-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | LOC-GEN-Injection Site Erythema-Severe | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Muscle spasms-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Joint swelling-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Cough-Mild | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-INF-Upper respiratory tract infection-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Joint swelling-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Back pain-Moderate | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Arthralgia-Total | 3.4 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-NER-TOTAL | 10.8 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-INF-MILD-TOTAL | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-Arthralgia-Moderate | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-VAS-Pallor-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-VAS-Pallor-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-NER-MODERATE-TOTAL | 3.0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-INF-MODERATE-TOTAL | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-SKN-SEVERE-TOTAL | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-SKN-MILD-TOTAL | 3.0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-SKN-Skin mass-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-NER-Hypoaesthesia-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-NER-Headache-Mild | 7.9 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MET-Decreased appetite-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-SKN-Rash-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-SKN-Pruritus-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-SKN-Hyperhidrosis-Total | 3.4 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-NER-MILD-TOTAL | 7.9 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MET-MILD-TOTAL | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-SKN-Hyperhidrosis-Severe | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-SKN-Hyperhidrosis-Moderate | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-SKN-Hyperhidrosis-Mild | 3.0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-SKN-Erythema-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-SKN-Erythema-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-SKN-Dermatitis contact-Total | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-SKN-Dermatitis contact-Mild | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-SKN-Dermatitis allergic-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-SKN-Dermatitis allergic-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-NER-Sinus headache-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-NER-Dizziness-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-TOTAL | 1.0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-MODERATE-TOTAL | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-MILD-TOTAL | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-NER-Sinus headache-Moderate | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-NER-Dizziness-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Malaise-Mild | 7.4 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Injection site reaction-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-TOTAL | 12.3 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Malaise-Moderate | 1.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Injection site reaction-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Injection site pain-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Fatigue-Total | 11.8 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Rhinorrhoea-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-MSK-MODERATE-TOTAL | 1.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Fatigue-Severe | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Malaise-Severe | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Fatigue-Moderate | 2.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Fatigue-Mild | 9.4 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Chills-Severe | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Paranasal sinus hypersecretion-Moderate | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Malaise-Total | 8.9 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Chills-Moderate | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Chills-Mild | 2.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Chest pain-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Nasal congestion-Total | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Nodule-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GID-TOTAL | 3.0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-NER-Hypoaesthesia-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-NER-Dysgeusia-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Oedema peripheral-Moderate | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GID-SEVERE-TOTAL | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GID-Oedema mouth-Total | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GID-Oedema mouth-Mild | 0 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-RES-Nasal congestion-Moderate | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Oedema peripheral-Total | 0.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GID-Nausea-Total | 2.5 percentage of related adverse events |
| VCIV Manufactured With Current Process (18-49 Years Old) | Frequency and Severity of Related Adverse Events | SYS-GEN-Pain-Total | 0 percentage of related adverse events |
Secondary
Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction
Time frame: within 7 days post vaccination
Population: Safety Analysis Set. The primary immunogenicity and safety analyses groups included the VCIV Modified lots separately. The secondary immunogenicity and safety analyses groups included all three of the VCIV Modified lots pooled.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Mild | 86 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site ecchymosis-Total | 23 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site ecchymosis-Moderate | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site pain-Total | 180 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site ecchymosis-Mild | 23 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site tenderness-Total | 234 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site tenderness-Mild | 230 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Total | 36 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site tenderness-Moderate | 4 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Unknown | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Severe | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Moderate | 11 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Severe | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Mild | 24 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Total | 36 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Total | 9 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Total | 9 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Moderate | 6 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Mild | 30 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site swelling-Mild | 5 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Total | 101 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Moderate | 16 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site swelling-Moderate | 2 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Severe | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Mild | 85 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Total | 23 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site sweling-Unknown | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness- Mild | 5 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Moderate | 8 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Mild | 15 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site swelling-Total | 8 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Total | 109 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Mild | 5 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Moderate | 2 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Moderate | 17 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Mild | 92 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Total | 105 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Moderate | 6 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Moderate | 28 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Mild | 77 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Unknown | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Total | 20 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Total | 11 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Moderate | 6 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Moderate | 6 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Mild | 14 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Total | 108 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site pain-Mild | 174 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Moderate | 22 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site pain-Moderate | 6 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Mild | 2 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Mild | 33 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site ecchymosis-Total | 6 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Mild | 42 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site ecchymosis-Moderate | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Moderate | 3 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Total | 52 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site pain-Total | 68 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Total | 14 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site ecchymosis-Mild | 6 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Mild | 8 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site tenderness-Total | 81 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Unknown | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site tenderness-Moderate | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness- Mild | 2 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site tenderness-Mild | 81 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site swelling-Total | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Moderate | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Total | 39 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Unknown | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Total | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Total | 12 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Moderate | 4 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Mild | 10 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Moderate | 10 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site swelling-Mild | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Moderate | 7 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Total | 9 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Mild | 3 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site pain-Moderate | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Total | 2 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Moderate | 5 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Moderate | 4 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Mild | 32 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Mild | 5 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site pain-Mild | 67 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Total | 42 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Total | 43 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Total | 4 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Severe | 2 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Severe | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Moderate | 6 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Mild | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Moderate | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site swelling-Moderate | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Moderate | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Mild | 34 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Total | 11 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Moderate | 9 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Mild | 7 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site sweling-Unknown | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site sweling-Unknown | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness- Mild | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Moderate | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Unknown | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Total | 2 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site swelling-Mild | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site swelling-Moderate | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site swelling-Total | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Mild | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Moderate | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Unknown | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Total | 3 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site pain-Mild | 50 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site pain-Moderate | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site pain-Total | 50 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site tenderness-Mild | 68 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site tenderness-Moderate | 2 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site tenderness-Total | 70 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site ecchymosis-Mild | 4 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site ecchymosis-Moderate | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site ecchymosis-Total | 4 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Mild | 32 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Moderate | 8 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Total | 40 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Mild | 5 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Moderate | 4 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Total | 9 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Mild | 25 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Moderate | 10 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Severe | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Total | 36 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Mild | 24 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Moderate | 9 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Total | 33 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Mild | 4 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Moderate | 3 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Total | 7 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Mild | 26 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Moderate | 12 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Total | 38 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Mild | 4 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Moderate | 3 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Severe | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Total | 8 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Mild | 2 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Mild | 8 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Moderate | 3 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Total | 11 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Moderate | 2 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Total | 4 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Severe | 0 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Unknown | 2 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Mild | 1 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Total | 6 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site ecchymosis-Moderate | 1 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Mild | 8 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Mild | 41 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Moderate | 2 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Total | 56 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Severe | 1 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Moderate | 10 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Mild | 37 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site pain-Moderate | 6 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Mild | 3 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Moderate | 3 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Moderate | 18 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Total | 1 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Unknown | 1 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Moderate | 2 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site ecchymosis-Mild | 8 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site pain-Mild | 67 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Mild | 14 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Severe | 1 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Total | 16 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness- Mild | 11 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Severe | 0 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Total | 17 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Severe | 1 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Moderate | 6 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Total | 14 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Total | 60 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Mild | 49 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Mild | 10 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Total | 62 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Severe | 0 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site swelling-Mild | 7 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site ecchymosis-Total | 9 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Severe | 1 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site pain-Total | 73 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Moderate | 8 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Mild | 53 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site swelling-Moderate | 3 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Total | 13 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Total | 18 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Severe | 1 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Moderate | 2 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site tenderness-Total | 134 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site sweling-Unknown | 2 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Moderate | 3 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Mild | 14 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Total | 50 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Moderate | 0 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site tenderness-Moderate | 5 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Severe | 1 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site tenderness-Mild | 129 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site swelling-Total | 12 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Severe | 1 number of adverse reactions |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Moderate | 8 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site ecchymosis-Total | 6 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Mild | 16 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Total | 5 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Moderate | 3 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site pain-Mild | 20 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Severe | 0 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Total | 19 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Total | 2 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Mild | 4 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Moderate | 1 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Moderate | 0 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Severe | 0 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Unknown | 2 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Total | 5 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Mild | 1 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Mild | 20 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Moderate | 1 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Moderate | 5 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Severe | 0 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Total | 25 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Mild | 1 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Mild | 19 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Moderate | 6 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Severe | 0 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site swelling-Total | 4 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Total | 25 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Moderate | 0 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Mild | 7 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site sweling-Unknown | 1 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Moderate | 1 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Severe | 0 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Total | 8 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site swelling-Moderate | 2 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Mild | 17 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Moderate | 3 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site swelling-Mild | 1 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Severe | 0 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Total | 20 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Severe | 0 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Mild | 6 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Total | 4 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Moderate | 1 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Severe | 0 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Severe | 0 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Total | 7 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness- Mild | 3 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Mild | 4 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Total | 1 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Moderate | 1 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Unknown | 1 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Severe | 0 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site tenderness-Mild | 47 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site tenderness-Moderate | 2 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site tenderness-Total | 49 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site pain-Total | 21 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site ecchymosis-Mild | 5 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site ecchymosis-Moderate | 1 number of adverse reactions |
| VCIV Manufactured With Current Process (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site pain-Moderate | 1 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site tenderness-Total | 368 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Moderate | 24 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Severe | 1 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Mild | 38 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site swelling-Mild | 12 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site sweling-Unknown | 3 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Total | 52 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Severe | 1 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Total | 53 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Severe | 1 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site tenderness-Mild | 359 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Severe | 1 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Total | 24 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Severe | 1 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site ecchymosis-Mild | 31 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Moderate | 6 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site ecchymosis-Total | 32 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Total | 163 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Severe | 1 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Moderate | 12 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Total | 26 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Total | 23 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Mild | 135 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Total | 168 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Total | 10 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Mild | 40 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Moderate | 11 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Severe | 1 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Total | 159 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Mild | 114 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Moderate | 8 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Moderate | 46 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site swelling-Total | 20 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Moderate | 4 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site pain-Total | 253 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Severe | 1 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Mild | 133 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Mild | 3 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Mild | 13 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site swelling-Moderate | 5 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Severe | 1 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Moderate | 9 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site ecchymosis-Moderate | 1 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Total | 41 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Moderate | 25 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site pain-Mild | 241 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site tenderness-Moderate | 9 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Moderate | 32 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Total | 161 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Severe | 1 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site pain-Moderate | 12 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Mild | 138 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Mild | 29 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Moderate | 13 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Unknown | 2 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Unknown | 2 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness- Mild | 16 number of adverse reactions |
| Fluzone® (18-49 Years Old) | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Mild | 17 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Total | 14 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Unknown | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Total | 39 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site sweling-Unknown | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site tenderness-Moderate | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Mild | 8 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Moderate | 5 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site pain-Total | 68 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Moderate | 3 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Moderate | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site swelling-Moderate | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Total | 11 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Mild | 42 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness- Mild | 2 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Mild | 7 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Mild | 34 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site swelling-Mild | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Moderate | 6 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site tenderness-Total | 81 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Severe | 2 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Total | 52 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Total | 42 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Total | 2 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Mild | 5 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Total | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Total | 4 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Moderate | 4 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site ecchymosis-Mild | 6 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Total | 9 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site pain-Moderate | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Mild | 10 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Unknown | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Moderate | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Moderate | 4 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site ecchymosis-Total | 6 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Moderate | 10 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site ecchymosis-Moderate | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Moderate | 9 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Mild | 33 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Mild | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Moderate | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Severe | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Mild | 3 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site tenderness-Mild | 81 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Total | 43 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Total | 12 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site pain-Mild | 67 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Mild | 32 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Moderate | 7 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site swelling-Total | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Moderate | 15 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site pain-Total | 71 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Mild | 12 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Total | 61 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site swelling-Mild | 2 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site sweling-Unknown | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Moderate | 11 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site ecchymosis-Total | 10 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Mild | 43 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site tenderness-Mild | 115 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Moderate | 4 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Total | 14 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Mild | 48 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Mild | 9 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Total | 15 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Unknown | 2 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Moderate | 2 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Mild | 45 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site swelling-Moderate | 2 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Total | 58 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Moderate | 15 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Moderate | 15 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Moderate | 4 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Headache-Mild | 43 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site ecchymosis-Moderate | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site pain-Mild | 70 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site tenderness-Moderate | 4 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Mild | 10 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Sweating-Mild | 11 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Moderate | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Total | 58 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site swelling-Total | 5 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Moderate | 4 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Fatigue-Severe | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Mild | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Total | 5 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Total | 59 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Total | 6 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness- Mild | 4 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Severe | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Muscle pain-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Mild | 3 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Malaise-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site ecchymosis-Mild | 9 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site pain-Moderate | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site tenderness-Total | 119 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site induration-Moderate | 2 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Arthralgia (joint pain)-Total | 15 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Severe | 0 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Injection site redness-Unknown | 1 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Nausea-Total | 16 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Vomiting-Total | 5 number of adverse reactions |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 2 | Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction | Shivering-Moderate | 5 number of adverse reactions |
Secondary
Percentage of Participants Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine
Seroconversion is defined as a ≥ 4-fold increase in HIA titer from baseline OR a reciprocal HIA titer ≥ 40 when there is no detectable HIA titer (reciprocal HIA titer \< 10) at baseline
Time frame: 21 days post vaccination
Population: Immunogenicity Analysis Set. The primary immunogenicity and safety analyses groups included the VCIV Modified lots separately. The secondary immunogenicity and safety analyses groups included all three of the VCIV Modified lots pooled.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Percentage of Participants Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine | Strain A/H1N1 | 70.9 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Percentage of Participants Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine | Strain B | 61.4 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Percentage of Participants Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine | Strain A/H3N2 | 57.5 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Percentage of Participants Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine | Strain A/H3N2 | 50.3 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Percentage of Participants Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine | Strain A/H1N1 | 52.7 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Percentage of Participants Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine | Strain B | 40.3 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Percentage of Participants Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine | Strain A/H3N2 | 51.3 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Percentage of Participants Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine | Strain A/H1N1 | 64.6 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Percentage of Participants Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine | Strain B | 54.9 percentage of participants |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Percentage of Participants Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine | Strain A/H1N1 | 79.1 percentage of participants |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Percentage of Participants Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine | Strain B | 70.9 percentage of participants |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Percentage of Participants Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine | Strain A/H3N2 | 67.9 percentage of participants |
| VCIV Manufactured With Current Process (18-49 Years Old) | Percentage of Participants Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine | Strain A/H3N2 | 63.5 percentage of participants |
| VCIV Manufactured With Current Process (18-49 Years Old) | Percentage of Participants Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine | Strain A/H1N1 | 70.5 percentage of participants |
| VCIV Manufactured With Current Process (18-49 Years Old) | Percentage of Participants Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine | Strain B | 49.0 percentage of participants |
Secondary
Percentage of Participants With Adverse Events
Time frame: within 21 days post vaccination
Population: Safety Analysis Set. The primary immunogenicity and safety analyses groups included the VCIV Modified lots separately. The secondary immunogenicity and safety analyses groups included all three of the VCIV Modified lots pooled.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Percentage of Participants With Adverse Events | Serious AEs | 0.2 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Percentage of Participants With Adverse Events | Any non-serious systemic AEs | 47.7 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Percentage of Participants With Adverse Events | Treatment-related non-serious systemic AEs | 38.5 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Percentage of Participants With Adverse Events | Any non-serious local AEs | 50.8 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Percentage of Participants With Adverse Events | Serious AEs | 0 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Percentage of Participants With Adverse Events | Any non-serious local AEs | 51.7 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Percentage of Participants With Adverse Events | Any non-serious systemic AEs | 53.2 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Percentage of Participants With Adverse Events | Treatment-related non-serious systemic AEs | 44.8 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Percentage of Participants With Adverse Events | Any non-serious local AEs | 44.3 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Percentage of Participants With Adverse Events | Any non-serious systemic AEs | 48.3 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Percentage of Participants With Adverse Events | Treatment-related non-serious systemic AEs | 40.3 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Percentage of Participants With Adverse Events | Serious AEs | 0 percentage of participants |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Percentage of Participants With Adverse Events | Serious AEs | 0.7 percentage of participants |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Percentage of Participants With Adverse Events | Any non-serious systemic AEs | 35.4 percentage of participants |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Percentage of Participants With Adverse Events | Any non-serious local AEs | 28.8 percentage of participants |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Percentage of Participants With Adverse Events | Treatment-related non-serious systemic AEs | 21.4 percentage of participants |
| VCIV Manufactured With Current Process (18-49 Years Old) | Percentage of Participants With Adverse Events | Any non-serious local AEs | 31.5 percentage of participants |
| VCIV Manufactured With Current Process (18-49 Years Old) | Percentage of Participants With Adverse Events | Treatment-related non-serious systemic AEs | 27.6 percentage of participants |
| VCIV Manufactured With Current Process (18-49 Years Old) | Percentage of Participants With Adverse Events | Any non-serious systemic AEs | 38.4 percentage of participants |
| VCIV Manufactured With Current Process (18-49 Years Old) | Percentage of Participants With Adverse Events | Serious AEs | 0 percentage of participants |
Secondary
Percentage of Participants With Injection Site Reactions
Time frame: within 7 days post vaccination
Population: Safety Analysis Set. The primary immunogenicity and safety analyses groups included the VCIV Modified lots separately. The secondary immunogenicity and safety analyses groups included all three of the VCIV Modified lots pooled.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Percentage of Participants With Injection Site Reactions | 50.7 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Percentage of Participants With Injection Site Reactions | 51.7 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Percentage of Participants With Injection Site Reactions | 44.3 percentage of participants |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Percentage of Participants With Injection Site Reactions | 28.6 percentage of participants |
| VCIV Manufactured With Current Process (18-49 Years Old) | Percentage of Participants With Injection Site Reactions | 30.5 percentage of participants |
| Fluzone® (18-49 Years Old) | Percentage of Participants With Injection Site Reactions | 39.7 percentage of participants |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Percentage of Participants With Injection Site Reactions | 37.4 percentage of participants |
Secondary
Percentage of Participants With Seroprotective Antibody Titer for Each of the Three Antigens
Percentage of participants with seroprotective antibody titer \[reciprocal HIA titer ≥40\] for each of the three antigens contained in the vaccine
Time frame: 21 days post vaccination
Population: Immunogenicity Analysis Set. The primary immunogenicity and safety analyses groups included the VCIV Modified lots separately. The secondary immunogenicity and safety analyses groups included all three of the VCIV Modified lots pooled.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Percentage of Participants With Seroprotective Antibody Titer for Each of the Three Antigens | Strain A/H1N1 | 94.7 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Percentage of Participants With Seroprotective Antibody Titer for Each of the Three Antigens | Strain B | 82.8 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Percentage of Participants With Seroprotective Antibody Titer for Each of the Three Antigens | Strain A/H3N2 | 91.6 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Percentage of Participants With Seroprotective Antibody Titer for Each of the Three Antigens | Strain A/H3N2 | 86.4 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Percentage of Participants With Seroprotective Antibody Titer for Each of the Three Antigens | Strain A/H1N1 | 79.0 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Percentage of Participants With Seroprotective Antibody Titer for Each of the Three Antigens | Strain B | 53.6 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Percentage of Participants With Seroprotective Antibody Titer for Each of the Three Antigens | Strain A/H3N2 | 90.8 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Percentage of Participants With Seroprotective Antibody Titer for Each of the Three Antigens | Strain A/H1N1 | 90.8 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Percentage of Participants With Seroprotective Antibody Titer for Each of the Three Antigens | Strain B | 72.3 percentage of participants |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Percentage of Participants With Seroprotective Antibody Titer for Each of the Three Antigens | Strain A/H1N1 | 100.0 percentage of participants |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Percentage of Participants With Seroprotective Antibody Titer for Each of the Three Antigens | Strain B | 88.8 percentage of participants |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Percentage of Participants With Seroprotective Antibody Titer for Each of the Three Antigens | Strain A/H3N2 | 98.5 percentage of participants |
| VCIV Manufactured With Current Process (18-49 Years Old) | Percentage of Participants With Seroprotective Antibody Titer for Each of the Three Antigens | Strain A/H3N2 | 94.0 percentage of participants |
| VCIV Manufactured With Current Process (18-49 Years Old) | Percentage of Participants With Seroprotective Antibody Titer for Each of the Three Antigens | Strain A/H1N1 | 95.5 percentage of participants |
| VCIV Manufactured With Current Process (18-49 Years Old) | Percentage of Participants With Seroprotective Antibody Titer for Each of the Three Antigens | Strain B | 59.5 percentage of participants |
Secondary
Percentage of Participants With Solicited Systemic Reactions
Time frame: within 7 days post vaccination
Population: Safety Analysis Set. The primary immunogenicity and safety analyses groups included the VCIV Modified lots separately. The secondary immunogenicity and safety analyses groups included all three of the VCIV Modified lots pooled.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 1 | Percentage of Participants With Solicited Systemic Reactions | 37.0 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 2 | Percentage of Participants With Solicited Systemic Reactions | 44.3 percentage of participants |
| VCIV - Modified Manufacturing Process (18-49 Years Old) Lot 3 | Percentage of Participants With Solicited Systemic Reactions | 39.8 percentage of participants |
| Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3 | Percentage of Participants With Solicited Systemic Reactions | 19.5 percentage of participants |
| VCIV Manufactured With Current Process (18-49 Years Old) | Percentage of Participants With Solicited Systemic Reactions | 27.1 percentage of participants |
| Fluzone® (18-49 Years Old) | Percentage of Participants With Solicited Systemic Reactions | 28.3 percentage of participants |
| VCIV - Modified Manufacturing Process (≥50 Years Old) Lot 1 | Percentage of Participants With Solicited Systemic Reactions | 33.4 percentage of participants |