Inactivated Split Virus Seasonal Influenza Vaccine (Vero... | NCT01773928

Label	Type	Description	Intervention Names
VCIV - Modified manufacturing process (18-49 Years Old) Lot 1	Experimental	Vero cell-derived trivalent influenza vaccine (VCIV)	Biological: Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
VCIV - Modified manufacturing process (18-49 Years Old) Lot 2	Experimental	Vero cell-derived trivalent influenza vaccine (VCIV)	Biological: Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
VCIV - Modified manufacturing process (18-49 Years Old) Lot 3	Experimental	Vero cell-derived trivalent influenza vaccine (VCIV)	Biological: Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
VCIV manufactured with current process (18-49 Years Old)	Active Comparator	Vero cell-derived trivalent influenza vaccine (VCIV)	Biological: VCIV manufactured with the current manufacturing process (VCIV current)
Fluzone® (18-49 Years Old)	Active Comparator	Fluzone®, licensed trivalent influenza vaccine (TIV)

Name	Type	Description	Arm Group Labels	Other Names
Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)	Biological		VCIV - Modified manufacturing process (18-49 Years Old) Lot 1 VCIV - Modified manufacturing process (18-49 Years Old) Lot 2

Measure	Description	Time Frame
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	21 days post vaccination
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	21 days post vaccination
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.	21 days post vaccination
Percentage of Participants With Fever	Percentage of participants with fever	onset within 7 days post vaccination

Measure	Description	Time Frame
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	21 days post vaccination
Percentage of Participants Demonstrating Seroconversion to Each of the Three Antigens Contained in the Vaccine

Eligibility Module

Eligibility Criteria

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.

Name	Affiliation	Role
Nirjhar Chatterjee, MD	Baxter Healthcare Corporation	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
East Valley Family Physicians, PLC		Chandler	Arizona	85224	United States
Anaheim Clinical Trials

PubMed Identifier	Type	Citation	Retractions
	Background	StatXact 7 PROCs for SAS Users, Cytel Inc, Cambridge, 2005.

ID	Title	Description
FG000	Fluzone® (18-49 Years Old)	Fluzone®, licensed trivalent influenza vaccine (TIV) Fluzone®, licensed trivalent influenza vaccine (TIV)
FG001	VCIV Current Process (18-49 Years Old)

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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

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.

Posted

Geometric Mean

95% Confidence Interval

Titers

21 days post vaccination

ID	Title	Description
OG000	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)
OG001	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)
OG002	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)
OG003	Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3	Vero cell-derived trivalent influenza vaccine (VCIV) Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
OG004	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)
OG005	Fluzone® (18-49 Years Old)	Fluzone®, licensed trivalent influenza vaccine (TIV) Fluzone®, licensed trivalent influenza vaccine (TIV)
OG006	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)
OG007	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)
OG008	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)
OG009	Total VCIV - Modified Process (≥50 Years Old) Lots 1-3	Vero cell-derived trivalent influenza vaccine (VCIV) Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
OG010	Fluzone® (≥50 Years Old)	Fluzone®, licensed trivalent influenza vaccine (TIV) Fluzone®, licensed trivalent influenza vaccine (TIV)

Units	Counts
Participants	OG000196 OG001193 OG002192 OG003

Title

Denominators

Categories

Strain A/H1N1

Title	Measurements
	OG000269.7(222.6 to 326.8) OG001337.3(286.9 to 396.6) OG002288.5(238.8 to 348.6)

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

Posted

Number

95% Confidence Interval

percentage of participants

21 days post vaccination

ID	Title	Description
OG000	VCIV - Modified Manufacturing Process (18-49 Years Old)	Vero cell-derived trivalent influenza vaccine (VCIV) Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
OG001	VCIV - Modified Manufacturing Process (≥50 Years Old)	Vero cell-derived trivalent influenza vaccine (VCIV) Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
OG002	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)

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

Posted

Number

95% Confidence Interval

percentage of participants

21 days post vaccination

ID	Title	Description
OG000	VCIV - Modified Manufacturing Process (18-49 Years Old)	Vero cell-derived trivalent influenza vaccine (VCIV) Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
OG001	VCIV - Modified Manufacturing Process (≥50 Years Old)	Vero cell-derived trivalent influenza vaccine (VCIV) Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
OG002	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)

Secondary

Fold Increase of HIA Titer for Each of the Three Antigens Contained in the Vaccine as Compared to Baseline

Posted

Geometric Mean

95% Confidence Interval

Titers

21 days post vaccination

ID	Title	Description
OG000	VCIV - Modified Process (18-49 Years Old) Lots 1-3	Vero cell-derived trivalent influenza vaccine (VCIV) Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
OG001	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)
OG002	Fluzone® (18-49 Years Old)	Fluzone®, licensed trivalent influenza vaccine (TIV) Fluzone®, licensed trivalent influenza vaccine (TIV)
OG003	VCIV - Modified Process (≥50 Years Old) Lots 1-3

Secondary

Percentage of Participants With Solicited Systemic Reactions

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.

Posted

Number

95% Confidence Interval

percentage of participants

within 7 days post vaccination

ID	Title	Description
OG000	Total VCIV - Modified Manufacturing Process (18-49 Years Old) Lots 1-3	Vero cell-derived trivalent influenza vaccine (VCIV) Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
OG001	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)
OG002	Fluzone® (18-49 Years Old)	Fluzone®, licensed trivalent influenza vaccine (TIV)
OG003	Total VCIV - Modified Manufacturing Process (≥50 Years Old) Lots 1-3

Secondary

Percentage of Participants With Injection Site Reactions

Posted

Number

95% Confidence Interval

percentage of participants

within 7 days post vaccination

ID	Title	Description
OG000	Total VCIV - Modified Manufacturing Process (18-49 Year Old) Lots 1-3	Vero cell-derived trivalent influenza vaccine (VCIV) Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
OG001	VCIV Manufactured With Current Process (18-49 Year Old)	Vero cell-derived trivalent influenza vaccine (VCIV) VCIV manufactured with the current manufacturing process (VCIV current)
OG002	Fluzone® (18-49 Year Old)	Fluzone®, licensed trivalent influenza vaccine (TIV) Fluzone®, licensed trivalent influenza vaccine (TIV)
OG003	Total VCIV - Modified Manufacturing Process (≥50 Year Old) Lots 1-3

Secondary

Number and Severity of Each Solicited Systemic Reaction and Injection Site Reaction

Posted

Number

number of adverse reactions

within 7 days post vaccination

ID	Title	Description
OG000	Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3	Vero cell-derived trivalent influenza vaccine (VCIV) Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
OG001	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)
OG002	Fluzone® (18-49 Years Old)	Fluzone®, licensed trivalent influenza vaccine (TIV) Fluzone®, licensed trivalent influenza vaccine (TIV)
OG003	Total VCIV - Modified Process (≥50 Years Old) Lots 1-3

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

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.

Posted

Geometric Mean

95% Confidence Interval

ratio of Geometric Mean- no units

21 days post vaccination

ID	Title	Description
OG000	Strain A/H1N1	Strain A/H1N1 from the Vero cell-derived trivalent influenza vaccine (VCIV)
OG001	Strain A/H3N2	Strain A/H3N2 from the Vero cell-derived trivalent influenza vaccine (VCIV)
OG002	Strain B	Strain B from the Vero cell-derived trivalent influenza vaccine (VCIV)

Secondary

Percentage of Participants With Adverse Events

Posted

Number

percentage of participants

within 21 days post vaccination

ID	Title	Description
OG000	Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3	Vero cell-derived trivalent influenza vaccine (VCIV) Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
OG001	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)
OG002	Fluzone® (18-49 Years Old)	Fluzone®, licensed trivalent influenza vaccine (TIV) Fluzone®, licensed trivalent influenza vaccine (TIV)
OG003	Total VCIV - Modified Process (≥50 Years Old) Lots 1-3

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.

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.

Posted

Geometric Mean

95% Confidence Interval

ratio of geometric mean- no units

21 days post vaccination

ID	Title	Description
OG000	Strain A/H1N1	Strain A/H1N1 from the Vero cell-derived trivalent influenza vaccine (VCIV)
OG001	Strain A/H3N2	Strain A/H3N2 from the Vero cell-derived trivalent influenza vaccine (VCIV)
OG002	Strain B	Strain B from the Vero cell-derived trivalent influenza vaccine (VCIV)

Primary

Percentage of Participants With Fever

Percentage of participants with fever

Posted

Number

95% Confidence Interval

percentage of participants with fever

onset within 7 days post vaccination

ID	Title	Description
OG000	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)
OG001	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)
OG002	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)

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

Posted

Number

percentage of related adverse events

within 21 days post vaccination

ID	Title	Description
OG000	Total VCIV - Modified Process (18 - 49 Years Old) Lots 1-3	Vero cell-derived trivalent influenza vaccine (VCIV) Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)
OG001	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)

Title

Denominators

Categories

LOC-GEN-Injection Site Anaesthesia-Mild

Title	Measurements
	OG0000 OG0010 OG0020.5 OG0030 OG0040

LOC-GEN-Injection Site Anaesthesia-Total

Title	Measurements
	OG0000 OG0010 OG0020.5 OG003

LOC-GEN-Injection Site Bruising-Mild

Title	Measurements
	OG0000 OG0010.5 OG0020 OG003

LOC-GEN-Injection Site Bruising-Total

Title	Measurements
	OG0000 OG0010.5 OG0020 OG003

LOC-GEN-Injection Site Discolouration-Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

LOC-GEN-Injection Site Discolouration-Total

Title	Measurements
	OG0000 OG0010 OG0020 OG003

LOC-GEN-Injection Site Erythema-Mild

Title	Measurements
	OG0000.8 OG0011.0 OG0020.5 OG003

LOC-GEN-Injection Site Erythema-Moderate

Title	Measurements
	OG0000.3 OG0010 OG0020.5 OG003

LOC-GEN-Injection Site Erythema-Severe

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

LOC-GEN-Injection Site Erythema-Unknown

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

LOC-GEN-Injection Site Erythema-Total

Title	Measurements
	OG0001.5 OG0010 OG0020 OG003

LOC-GEN-Injection Site Exfoliation-Mild

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

LOC-GEN-Injection Site Exfoliation-Total

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

LOC-GEN-Injection Site Haemorrhage-Mild

Title	Measurements
	OG0003.8 OG0013.0 OG0022.0 OG003

LOC-GEN-Injection Site Haemorrhage-Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

LOC-GEN-Injection Site Haemorrhage-Total

Title	Measurements
	OG0003.8 OG0010 OG0020 OG003

LOC-GEN-Injection Site Induration-Mild

Title	Measurements
	OG0000.8 OG0011.5 OG0020.5 OG003

LOC-GEN-Injection Site Induration-Moderate

Title	Measurements
	OG0001.0 OG0010.5 OG0020.5 OG003

LOC-GEN-Injection Site Induration-Unknown

Title	Measurements
	OG0000 OG0010 OG0020 OG003

LOC-GEN-Injection Site Induration-Total

Title	Measurements
	OG0000 OG0010 OG0020 OG003

LOC-GEN-Injection Site Pain-Mild

Title	Measurements
	OG00047.5 OG00150.2 OG00242.3 OG003

LOC-GEN-Injection Site Pain-Moderate

Title	Measurements
	OG0001.3 OG0010.5 OG0021.0 OG003

LOC-GEN-Injection Site Pain-Total

Title	Measurements
	OG00048.8 OG0010 OG0020 OG003

LOC-GEN-Injection Site Pruritus-Mild

Title	Measurements
	OG0001.0 OG0010 OG0020.5 OG003

LOC-GEN-Injection Site Pruritus-Moderate

Title	Measurements
	OG0000 OG0010 OG0020.5 OG003

LOC-GEN-Injection Site Pruritus-Total

Title	Measurements
	OG0001.0 OG0010 OG0020 OG003

LOC-GEN-Injection Site Rash-Mild

Title	Measurements
	OG0000 OG0010.5 OG0020 OG003

LOC-GEN-Injection Site Rash-Total

Title	Measurements
	OG0000 OG0010.5 OG0020 OG003

LOC-GEN-Injection Site Reaction-Mild

Title	Measurements
	OG0000.7 OG0010 OG0020 OG003

LOC-GEN-Injection Site Reaction-Total

Title	Measurements
	OG0000.7 OG0010 OG0020 OG003

LOC-GEN-Injection Site Scab-Mild

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

LOC-GEN-Injection Site Scab-Total

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

LOC-GEN-Injection Site Swelling-Mild

Title	Measurements
	OG0000.8 OG0010 OG0020.5 OG003

LOC-GEN-Injection Site Swelling-Moderate

Title	Measurements
	OG0000.3 OG0010.5 OG0020 OG003

LOC-GEN-Injection Site Swelling-Unknown

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

LOC-GEN-Injection Site Swelling-Total

Title	Measurements
	OG0001.3 OG0010 OG0020 OG003

LOC-GEN-Injection Site Warmth-Mild

Title	Measurements
	OG0000.2 OG0011.0 OG0020 OG003

LOC-GEN-Injection Site Warmth-Total

Title	Measurements
	OG0000.2 OG0011.0 OG0020 OG003

LOC-GEN-MILD-TOTAL

Title	Measurements
	OG00048.5 OG00150.7 OG00241.8 OG003

LOC-GEN-MODERATE-TOTAL

Title	Measurements
	OG0001.8 OG0011.0 OG0022.0 OG003

LOC-GEN-SEVERE-TOTAL

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

LOC-GEN-UNKNOWN-TOTAL

Title	Measurements
	OG0000.3 OG0010 OG0020.5 OG003

LOC-GEN-TOTAL

Title	Measurements
	OG00050.8 OG00151.7 OG00244.3 OG003

SYS-BLD-Lymph node pain-Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-BLD-Lymph node pain-Total

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-BLD-Lymphadenopathy-Mild

Title	Measurements
	OG0000.3 OG0010 OG0020 OG003

SYS-BLD-Lymphadenopathy-Moderate

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-BLD-Lymphadenopathy-Total

Title	Measurements
	OG0000.5 OG0010 OG0020 OG003

SYS-BLD-MILD-TOTAL

Title	Measurements
	OG0000.3 OG0010 OG0020 OG003

SYS-BLD-MODERATE-TOTAL

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-BLD-TOTAL

Title	Measurements
	OG0000.5 OG0010 OG0020 OG003

SYS-EAR-Ear pain-Mild

Title	Measurements
	OG0000.2 OG0010.5 OG0020 OG003

SYS-EAR-Ear pain-Total

Title	Measurements
	OG0000.2 OG0010.5 OG0020 OG003

SYS-EAR-MILD-TOTAL

Title	Measurements
	OG0000.2 OG0010.5 OG0020 OG003

SYS-EAR-TOTAL

Title	Measurements
	OG0000.2 OG0010.5 OG0020 OG003

SYS-EYE-Dark circles under eyes-Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-EYE-Dark circles under eyes-Total

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-EYE-Eye pruritus-Mild

Title	Measurements
	OG0000 OG0010.5 OG0020 OG003

SYS-EYE-Eye pruritus-Total

Title	Measurements
	OG0000 OG0010.5 OG0020 OG003

SYS-EYE-MILD-TOTAL

Title	Measurements
	OG0000 OG0010.5 OG0020 OG003

SYS-EYE-TOTAL

Title	Measurements
	OG0000 OG0010.5 OG0020 OG003

SYS-GID-Abdominal pain upper-Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-GID-Abdominal pain upper-Total

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-GID-Apthous stomatitis-Mild

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-GID-Apthous stomatitis-Total

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-GID-Diarrhoea-Mild

Title	Measurements
	OG0000.5 OG0010 OG0020 OG003

SYS-GID-Diarrhoea-Moderate

Title	Measurements
	OG0000.3 OG0010 OG0020 OG003

SYS-GID-Diarrhoea-Total

Title	Measurements
	OG0000.8 OG0010 OG0020 OG003

SYS-GID-Hypoaesthesia oral-Mild

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-GID-Hypoaesthesia oral-Total

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-GID-Nausea-Mild

Title	Measurements
	OG0003.8 OG0015.0 OG0023.0 OG003

SYS-GID-Nausea-Moderate

Title	Measurements
	OG0001.8 OG0012.0 OG0021.5 OG003

SYS-GID-Nausea-Severe

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-GID-Nausea-Total

Title	Measurements
	OG0005.9 OG0017.0 OG0024.5 OG003

SYS-GID-Oedema mouth-Mild

Title	Measurements
	OG0000 OG0010.5 OG0020 OG003

SYS-GID-Oedema mouth-Total

Title	Measurements
	OG0000 OG0010.5 OG0020 OG003

SYS-GID-Vomiting-Mild

Title	Measurements
	OG0000.3 OG0010 OG0021.0 OG003

SYS-GID-Vomiting-Moderate

Title	Measurements
	OG0001.0 OG0010.5 OG0021.0 OG003

SYS-GID-Vomiting-Severe

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-GID-Vomiting-Total

Title	Measurements
	OG0001.5 OG0010.5 OG0022.0 OG003

SYS-GID-MILD-TOTAL

Title	Measurements
	OG0004.0 OG0015.0 OG0023.0 OG003

SYS-GID-MODERATE-TOTAL

Title	Measurements
	OG0002.2 OG0012.0 OG0022.0 OG003

SYS-GID-SEVERE-TOTAL

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-GID-TOTAL

Title	Measurements
	OG0006.4 OG0017.0 OG0025.0 OG003

SYS-GEN-Chest discomfort-Mild

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-GEN-Chest discomfort-Total

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-GEN-Chest pain-Mild

Title	Measurements
	OG0000 OG0010.5 OG0020 OG003

SYS-GEN-Chest pain-Total

Title	Measurements
	OG0000 OG0010.5 OG0020 OG003

SYS-GEN-Chills-Mild

Title	Measurements
	OG0002.5 OG0013.5 OG0022.0 OG003

SYS-GEN-Chills-Moderate

Title	Measurements
	OG0001.0 OG0012.5 OG0022.0 OG003

SYS-GEN-Chills-Severe

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-GEN-Chills-Total

Title	Measurements
	OG0003.5 OG0016.0 OG0024.0 OG003

SYS-GEN-Discomfort-Mild

Title	Measurements
	OG0000.2 OG0011.0 OG0020 OG003

SYS-GEN-Discomfort-Total

Title	Measurements
	OG0000.2 OG0011.0 OG0020 OG003

SYS-GEN-Fatigue-Mild

Title	Measurements
	OG00012 OG00114.9 OG00210.9 OG003

SYS-GEN-Fatigue-Moderate

Title	Measurements
	OG0004.5 OG0014.5 OG0025.0 OG003

SYS-GEN-Fatigue-Severe

Title	Measurements
	OG0000 OG0010.5 OG0020.5 OG003

SYS-GEN-Fatigue-Total

Title	Measurements
	OG00016.6 OG00119.9 OG00216.4 OG003

SYS-GEN-Feeling abnormal-Mild

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-GEN-Feeling abnormal-Total

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-GEN-Feeling cold-Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-GEN-Feeling cold-Total

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-GEN-Injection site pain-Mild

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-GEN-Injection site pain-Total

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-GEN-Injection site reaction-Mild

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-GEN-Injection site reaction-Total

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-GEN-Malaise-Mild

Title	Measurements
	OG00014.4 OG00120.9 OG00215.9 OG003

SYS-GEN-Malaise-Moderate

Title	Measurements
	OG0003.5 OG0015.0 OG0024.0 OG003

SYS-GEN-Malaise-Severe

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-GEN-Malaise-Total

Title	Measurements
	OG00017.9 OG00125.9 OG00219.9 OG003

SYS-GEN-Nodule-Mild

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-GEN-Nodule-Total

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-GEN-Non-cardiac chest pain-Mild

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-GEN-Non-cardiac chest pain-Total

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-GEN-Oedema peripheral-Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-GEN-Oedema peripheral-Total

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-GEN-Pain-Mild

Title	Measurements
	OG0000.3 OG0011.0 OG0020.5 OG003

SYS-GEN-Pain-Moderate

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-GEN-Pain-Total

Title	Measurements
	OG0000.5 OG0011.0 OG0020.5 OG003

SYS-GEN-Pyrexia-Mild

Title	Measurements
	OG0001.3 OG0010.5 OG0020 OG003

SYS-GEN-Pyrexia-Moderate

Title	Measurements
	OG0000.3 OG0010 OG0020 OG003

SYS-GEN-Pyrexia-Severe

Title	Measurements
	OG0000.2 OG0010.5 OG0020 OG003

SYS-GEN-Pyrexia-Total

Title	Measurements
	OG0001.8 OG0011.0 OG0020 OG003

SYS-GEN-MILD-TOTAL

Title	Measurements
	OG00020.6 OG00126.4 OG00222.9 OG003

SYS-GEN-MODERATE-TOTAL

Title	Measurements
	OG0006.7 OG0018.5 OG0026.5 OG003

SYS-GEN-SEVERE-TOTAL

Title	Measurements
	OG0000.2 OG0011.0 OG0020.5 OG003

SYS-GEN-TOTAL

Title	Measurements
	OG00027.4 OG00135.8 OG00229.9 OG003

SYS-INF-Acute sinusitis-Moderate

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-INF-Acute sinusitis-Total

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-INF-Herpes simplex-Moderate

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-INF-Herpes simplex-Total

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-INF-Nasopharyngitis-Mild

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-INF-Nasopharyngitis-Total

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-INF-Oral herpes-Mild

Title	Measurements
	OG0000 OG0010.5 OG0020 OG003

SYS-INF-Oral herpes-Total

Title	Measurements
	OG0000 OG0010.5 OG0020 OG003

SYS-INF-Otitis media-Mild

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-INF-Otitis media-Total

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-INF-Sinusitis-Mild

Title	Measurements
	OG0000.3 OG0010 OG0020 OG003

SYS-INF-Sinusitis-Total

Title	Measurements
	OG0000.3 OG0010 OG0020 OG003

SYS-INF-Upper respiratory tract infection-Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-INF-Upper respiratory tract infection-Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-INF-Upper respiratory tract infection-Total

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-INF-MILD-TOTAL

Title	Measurements
	OG0000.7 OG0010.5 OG0020 OG003

SYS-INF-MODERATE-TOTAL

Title	Measurements
	OG0000.3 OG0010 OG0020 OG003

SYS-INF-TOTAL

Title	Measurements
	OG0001.0 OG0010.5 OG0020 OG003

SYS-MET-Decreased appetite-Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-MET-Decreased appetite-Total

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-MET-MILD-TOTAL

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-MET-TOTAL

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-MSK-Arthralgia-Mild

Title	Measurements
	OG0004.5 OG0012.5 OG0022.0 OG003

SYS-MSK-Arthralgia-Moderate

Title	Measurements
	OG0001.0 OG0012.0 OG0021.5 OG003

SYS-MSK-Arthralgia-Severe

Title	Measurements
	OG0000 OG0010 OG0020.5 OG003

SYS-MSK-Arthralgia-Total

Title	Measurements
	OG0005.5 OG0014.5 OG0024.0 OG003

SYS-MSK-Back pain-Mild

Title	Measurements
	OG0000.2 OG0010.5 OG0020 OG003

SYS-MSK-Back pain-Moderate

Title	Measurements
	OG0000 OG0010 OG0020.5 OG003

SYS-MSK-Back pain-Total

Title	Measurements
	OG0000.2 OG0010.5 OG0020.5 OG003

SYS-MSK-Joint swelling-Mild

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-MSK-Joint swelling-Total

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-MSK-Muscle spasms-Mild

Title	Measurements
	OG0000 OG0010.5 OG0020 OG003

SYS-MSK-Muscle spasms-Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-MSK-Muscle spasms-Total

Title	Measurements
	OG0000 OG0010.5 OG0020 OG003

SYS-MSK-Muscle tightness-Mild

Title	Measurements
	OG0000.3 OG0010 OG0020 OG003

SYS-MSK-Muscle tightness-Total

Title	Measurements
	OG0000.3 OG0010 OG0020 OG003

SYS-MSK-Musculoskeletal pain-Mild

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-MSK-Musculoskeletal pain-Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-MSK-Musculoskeletal pain-Total

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-MSK-Musculoskeletal stiffness-Mild

Title	Measurements
	OG0000.3 OG0010 OG0020 OG003

SYS-MSK-Musculoskeletal stiffness-Total

Title	Measurements
	OG0000.3 OG0010 OG0020 OG003

SYS-MSK-Myalgia-Mild

Title	Measurements
	OG00013.7 OG00115.9 OG00211.9 OG003

SYS-MSK-Myalgia-Moderate

Title	Measurements
	OG0002.5 OG0013.0 OG0026.0 OG003

SYS-MSK-Myalgia-Severe

Title	Measurements
	OG0000 OG0011.0 OG0020 OG003

SYS-MSK-Myalgia-Total

Title	Measurements
	OG00016.2 OG00119.9 OG00217.9 OG003

SYS-MSK-Neck pain-Mild

Title	Measurements
	OG0000.3 OG0010 OG0020 OG003

SYS-MSK-Neck pain-Total

Title	Measurements
	OG0000.3 OG0010 OG0020 OG003

SYS-MSK-Pain in extremity-Mild

Title	Measurements
	OG0000 OG0010 OG0020.5 OG003

SYS-MSK-Pain in extremity-Total

Title	Measurements
	OG0000 OG0010 OG0020.5 OG003

SYS-MSK-Pain in jaw-Mild

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-MSK-Pain in jaw-Total

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-MSK-MILD-TOTAL

Title	Measurements
	OG00014.7 OG00116.9 OG00212.4 OG003

SYS-MSK-MODERATE-TOTAL

Title	Measurements
	OG0002.7 OG0013.5 OG0025.5 OG003

SYS-MSK-SEVERE-TOTAL

Title	Measurements
	OG0000 OG0011.0 OG0020.5 OG003

SYS-MSK-TOTAL

Title	Measurements
	OG00017.4 OG00121.4 OG00218.4 OG003

SYS-NER-Burning sensation-Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-NER-Burning sensation-Total

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-NER-Dizziness-Mild

Title	Measurements
	OG0000.3 OG0010.5 OG0020 OG003

SYS-NER-Dizziness-Total

Title	Measurements
	OG0000.3 OG0010.5 OG0020 OG003

SYS-NER-Dysgeusia-Mild

Title	Measurements
	OG0000 OG0010.5 OG0020 OG003

SYS-NER-Dysgeusia-Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-NER-Dysgeusia-Total

Title	Measurements
	OG0000 OG0010.5 OG0020 OG003

SYS-NER-Headache-Mild

Title	Measurements
	OG00013.4 OG00113.4 OG00210.9 OG003

SYS-NER-Headache-Moderate

Title	Measurements
	OG0003.0 OG0013.5 OG0024.5 OG003

SSYS-NER-Headache-Severe

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-NER-Headache-Total

Title	Measurements
	OG00016.4 OG00116.9 OG00215.4 OG003

SYS-NER-Hypoaesthesia-Mild

Title	Measurements
	OG0000.3 OG0010 OG0020 OG003

SYS-NER-Hypoaesthesia-Total

Title	Measurements
	OG0000.3 OG0010 OG0020 OG003

SYS-NER-Lethargy-Mild

Title	Measurements
	OG0000 OG0010.5 OG0020 OG003

SYS-NER-Lethargy-Total

Title	Measurements
	OG0000 OG0010.5 OG0020 OG003

SYS-NER-Paraesthesia-Mild

Title	Measurements
	OG0000.3 OG0010 OG0020 OG003

SYS-NER-Paraesthesia-Total

Title	Measurements
	OG0000.3 OG0010 OG0020 OG003

SYS-NER-Sinus headache-Mild

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-NER-Sinus headache-Moderate

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-NER-Sinus headache-Total

Title	Measurements
	OG0000.3 OG0010 OG0020 OG003

SYS-NER-MILD-TOTAL

Title	Measurements
	OG00013.4 OG00113.9 OG00210.9 OG003

SYS-NER-MODERATE-TOTAL

Title	Measurements
	OG0003.2 OG0013.5 OG0024.5 OG003

SYS-NER-SEVERE-TOTAL

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-NER-TOTAL

Title	Measurements
	OG00016.6 OG00117.4 OG00215.4 OG003

SYS-RES-Cough-Mild

Title	Measurements
	OG0000.7 OG0010.5 OG0020.5 OG003

SYS-RES-Cough-Moderate

Title	Measurements
	OG0000.7 OG0010.5 OG0020 OG003

SYS-RES-Cough-Total

Title	Measurements
	OG0001.3 OG0011.0 OG0020.5 OG003

SYS-RES-Increased upper airway secretion-Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-RES-Increased upper airway secretion-Moderate

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-RES-Increased upper airway secretion-Total

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-RES-Nasal congestion-Mild

Title	Measurements
	OG0000.3 OG0010.5 OG0021.5 OG003

SYS-RES-Nasal congestion-Moderate

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-RES-Nasal congestion-Total

Title	Measurements
	OG0000.5 OG0010.5 OG0021.5 OG003

SYS-RES-Oropharyngeal pain-Mild

Title	Measurements
	OG0000.5 OG0012.0 OG0020 OG003

SYS-RES-Oropharyngeal pain-Moderate

Title	Measurements
	OG0000.8 OG0010 OG0020 OG003

SYS-RES-Oropharyngeal pain-Total

Title	Measurements
	OG0001.3 OG0012.0 OG0020 OG003

SYS-RES-Paranasal sinus hypersecretion-Moderate

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-RES-Paranasal sinus hypersecretion-Total

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-RES-Productive cough-Moderate

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-RES-Productive cough-Total

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-RES-Respiratory tract congestion-Mild

Title	Measurements
	OG0000.5 OG0010 OG0020 OG003

SYS-RES-Respiratory tract congestion-Moderate

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-RES-Respiratory tract congestion-Total

Title	Measurements
	OG0000.7 OG0010 OG0020 OG003

SYS-RES-Rhinorrhoea-Mild

Title	Measurements
	OG0001.0 OG0010.5 OG0020.5 OG003

SYS-RES-Rhinorrhoea-Moderate

Title	Measurements
	OG0000.3 OG0010 OG0020 OG003

SYS-RES-Rhinorrhoea-Total

Title	Measurements
	OG0001.3 OG0010.5 OG0020.5 OG003

SYS-RES-Sinus congestion-Mild

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-RES-Sinus congestion-Moderate

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-RES-Sinus congestion-Total

Title	Measurements
	OG0000.3 OG0010 OG0020 OG003

SYS-RES-Sneezing-Mild

Title	Measurements
	OG0000.7 OG0010 OG0020 OG003

SYS-RES-Sneezing-Total

Title	Measurements
	OG0000.7 OG0010 OG0020 OG003

SYS-RES-Throat irritation-Mild

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-RES-Throat irritation-Total

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-RES-MILD-TOTAL

Title	Measurements
	OG0001.8 OG0012.5 OG0022.0 OG003

SYS-RES-MODERATE-TOTAL

Title	Measurements
	OG0001.5 OG0010.5 OG0020 OG003

SYS-RES-TOTAL

Title	Measurements
	OG0003.3 OG0013.0 OG0022.0 OG003

SYS-SKN-Dermatitis allergic-Mild

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-SKN-Dermatitis allergic-Total

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-SKN-Dermatitis contact-Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-SKN-Dermatitis contact-Total

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-SKN-Erythema-Mild

Title	Measurements
	OG0000 OG0010.5 OG0020 OG003

SYS-SKN-Erythema-Total

Title	Measurements
	OG0000 OG0010.5 OG0020 OG003

SYS-SKN-Hyperhidrosis-Mild

Title	Measurements
	OG0002.5 OG0014.0 OG0022.0 OG003

SYS-SKN-Hyperhidrosis-Moderate

Title	Measurements
	OG0001.3 OG0011.5 OG0021.5 OG003

SYS-SKN-Hyperhidrosis-Severe

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-SKN-Hyperhidrosis-Total

Title	Measurements
	OG0003.8 OG0015.5 OG0023.5 OG003

SYS-SKN-Night sweats-Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-SKN-Night sweats-Total

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-SKN-Pruritus-Mild

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-SKN-Pruritus-Total

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-SKN-Rash-Mild

Title	Measurements
	OG0000.3 OG0010 OG0020 OG003

SYS-SKN-Rash-Total

Title	Measurements
	OG0000.3 OG0010 OG0020 OG003

SYS-SKN-Skin mass-Mild

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-SKN-Skin mass-Total

Title	Measurements
	OG0000.2 OG0010 OG0020 OG003

SYS-SKN-MILD-TOTAL

Title	Measurements
	OG0003.3 OG0014.5 OG0022.0 OG003

SYS-SKN-MODERATE-TOTAL

Title	Measurements
	OG0001.3 OG0011.5 OG0021.5 OG003

SYS-SKN-SEVERE-TOTAL

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-SKN-TOTAL

Title	Measurements
	OG0004.7 OG0016.0 OG0023.5 OG003

SYS-VAS-Pallor-Mild

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-VAS-Pallor-Total

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-VAS-MILD-TOTAL

Title	Measurements
	OG0000 OG0010 OG0020 OG003

SYS-VAS-TOTAL

Title	Measurements
	OG0000 OG0010 OG0020 OG003

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	1	200	133	200
EG001	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	0	199	124	199
EG002	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	0	199	120	199
EG003	VCIV Manufactured With Current Process	Vero cell-derived trivalent influenza vaccine (VCIV) VCIV manufactured with the current manufacturing process (VCIV current)	201	0	201	132	201
EG004	Fluzone® (18-49 Years Old)	Fluzone®, licensed trivalent influenza vaccine (TIV) Fluzone®, licensed trivalent influenza vaccine (TIV)	201	0	201	125	201
EG005	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	1	199	97	199
EG006	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	1	197	84	197
EG007	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	2	198	96	198
EG008	Fluzone® (≥50 Years Old)	Fluzone®, licensed trivalent influenza vaccine (TIV) Fluzone®, licensed trivalent influenza vaccine (TIV)	203	0	203	100	203

Term	Organ System	Source Vocabulary	Statistical Information
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	EG0000 affected200 at risk EG0010 affected199 at risk EG0020 affected199 at risk EG0030 affected201 at risk EG0040 affected201 at risk EG0050 affected199 at risk EG0061 affected197 at risk EG0070 affected198 at risk EG0080 affected203 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (Unspecified)	EG0000 affected200 at risk EG0010 affected199 at risk EG0020 affected199 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	EG0000 affected200 at risk EG0010 affected199 at risk EG0020 affected199 at risk EG003
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	EG0000 affected200 at risk EG0010 affected199 at risk EG0020 affected199 at risk EG003
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA (Unspecified)	EG0001 affected200 at risk EG0010 affected199 at risk EG0020 affected199 at risk EG003

Term	Organ System	Source Vocabulary	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA (Unspecified)	EG00023 affected200 at risk EG00114 affected199 at risk EG00212 affected199 at risk EG00317 affected201 at risk EG00413 affected201 at risk EG0055 affected199 at risk EG0068 affected197 at risk EG00710 affected198 at risk EG0087 affected203 at risk
Chills	General disorders	MedDRA (Unspecified)	EG00013 affected200 at risk EG0014 affected199 at risk EG0027 affected199 at risk EG003
Fatigue	General disorders	MedDRA (Unspecified)	EG00033 affected200 at risk EG00138 affected199 at risk EG00238 affected199 at risk EG003
Malaise	General disorders	MedDRA (Unspecified)	EG00040 affected200 at risk EG00142 affected199 at risk EG00238 affected199 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	EG00017 affected200 at risk EG00111 affected199 at risk EG00211 affected199 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	EG00037 affected200 at risk EG00129 affected199 at risk EG00236 affected199 at risk EG003
Headache	Nervous system disorders	MedDRA (Unspecified)	EG00050 affected200 at risk EG00143 affected199 at risk EG00239 affected199 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	EG0008 affected200 at risk EG0019 affected199 at risk EG0024 affected199 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	EG00011 affected200 at risk EG0018 affected199 at risk EG00211 affected199 at risk EG003
Injection site pain	General disorders	MedDRA (Unspecified)	EG000102 affected200 at risk EG001100 affected199 at risk EG00290 affected199 at risk EG003

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D012140	Respiratory Tract Diseases

ID	Term
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures

ID	Title	Description
BG000	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)
BG001	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)
BG002	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)
BG003	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)
BG004	Fluzone® (18-49 Years Old)	Fluzone®, licensed trivalent influenza vaccine (TIV) Fluzone®, licensed trivalent influenza vaccine (TIV)
BG005	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)
BG006	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)
BG007	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)
BG008	Fluzone® (≥50 Years Old)	Fluzone®, licensed trivalent influenza vaccine (TIV) Fluzone®, licensed trivalent influenza vaccine (TIV)
BG009	Total	Total of all reporting groups