Efficacy Study of Two Influenza Vaccines and Placebo in H... | NCT00630331

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CCI	Experimental	Subjects received one dose of cell culture-derived influenza vaccine.	Biological: Cell culture-derived influenza vaccine
IVV	Experimental	Subjects received one dose of the trivalent egg-derived influenza vaccine.	Biological: Egg-derived influenza virus vaccine
Placebo	Placebo Comparator	Subjects received one dose of phosphate buffered solution (PBS).	Biological: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cell culture-derived influenza vaccine	Biological	One dose (0.5 mL) of cell culture-derived influenza vaccine, administered in the deltoid muscle.	CCI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects With Culture-Confirmed Influenza Illness Caused by Vaccine-like Strains	The vaccine efficacy of CCI and IVV vaccines was estimated relative to Placebo group as the number of subjects prevented against virus-confirmed symptomatic influenza illness caused by each of three vaccine-like virus strains.	6 Months

Secondary Outcomes

Measure	Description	Time Frame
Number of Subjects With Culture-confirmed Influenza Illness Caused by Non-Vaccine Like Strains	The vaccine efficacy of CCI and IVV vaccines was estimated relative to placebo group as the number of subjects prevented against virus-confirmed symptomatic influenza A or B illness caused by non-vaccine-like strains.	6 Months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

subjects 18 to 49 years of age;
in good health as determined by medical history and physical examination;
able and willing to provide written informed consent prior to any study procedure;
able to comply with all study procedures, including availability and willingness to be actively followed throughout the ensuing influenza season with weekly telephone calls and to comply with the need for prompt collection of nasal and throat specimens in the event of influenza symptoms.

Exclusion Criteria:

history of anaphylaxis or serious reaction after administration of any vaccine, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, neomycin, kanamycin, or any other vaccine component, chemically related substance, or component of the potential packaging materials;
any health condition for which the inactivated vaccine is recommended by the Advisory Committee on Immunization Practices (ACIP) including chronic diseases of the pulmonary or cardiovascular systems (including asthma), chronic metabolic diseases (including diabetes), renal dysfunction, hemoglobinopathies, immune deficiency disease (including HIV infection) or on-going immunosuppressive therapy;
employment in professions prone to influenza transmission to or from high-risk populations (this exclusion specifically includes nurses, physicians, all other healthcare workers with direct patient contact; and police, fire, and rescue personnel); or living in the same household as an immunocompromised person;
history of Guillain-Barré syndrome;
bleeding diathesis;
receipt of another investigational agent within 90 days prior to enrollment in the study or before completion of the safety follow-up period in another study, whichever is longer, and unwilling to refuse participation in another clinical study through the end of the study;
receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Visit 1;
laboratory-confirmed influenza disease within 6 months prior to Visit 1;
receipt of an influenza vaccine within 6 months prior to Visit 1 or plans to receive influenza vaccine outside of this study;
experienced a temperature (≥100.0°F / ≥37.8°C) and/or any acute illness within 3 days prior to study vaccination;
pregnant or breast-feeding female;
if female of childbearing potential and sexually active, has not used any of the birth control methods detailed in the section entitled "Females of Childbearing Potential" for at least 2 months prior to study entry;
if female of childbearing potential and sexually active, refusal to use a reliable contraceptive method as detailed in the section entitled "Females of Childbearing Potential" during the first 3 weeks after vaccination;
research staff directly involved with the clinical study or family members or household members of research staff. Research staff are individuals with direct or indirect contact with study subjects, or study site personnel who have access to any study documents containing subject information. This would include receptionists, persons scheduling appointments or making screening calls, regulatory specialists, laboratory technicians, etc.;
any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or with the safety of the study subject.

Name	Affiliation	Role
Novartis Vaccines	Novartis Vaccines	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Site 14		Denver	Colorado	80212	United States
Site 15

PubMed Identifier	Type	Citation	Retractions
20868284	Result	Frey S, Vesikari T, Szymczakiewicz-Multanowska A, Lattanzi M, Izu A, Groth N, Holmes S. Clinical efficacy of cell culture-derived and egg-derived inactivated subunit influenza vaccines in healthy adults. Clin Infect Dis. 2010 Nov 1;51(9):997-1004. doi: 10.1086/656578.

Results Section

Participant Flow Module

ID	Title	Description
FG000	CCI Vaccine	One dose of cell culture-derived influenza vaccine.
FG001	IVV Vaccine	One dose of the trivalent egg-derived influenza virus vaccine.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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

Number of Subjects With Culture-Confirmed Influenza Illness Caused by Vaccine-like Strains

The vaccine efficacy of CCI and IVV vaccines was estimated relative to Placebo group as the number of subjects prevented against virus-confirmed symptomatic influenza illness caused by each of three vaccine-like virus strains.

Analysis was performed on per protocol (PP) efficacy population i.e. the subjects in the exposed efficacy population who correctly received the vaccine and provided evaluable swab samples at the relevant time points.

Posted

Number

Subjects

6 Months

ID	Title	Description
OG000	CCI Vaccine	One dose of cell culture-derived influenza vaccine.
OG001	IVV Vaccine	One dose of the trivalent egg-derived influenza virus vaccine.
OG002	Placebo	One dose of phosphate buffered solution (PBS).

Units	Counts
Participants	OG0003776 OG0013638 OG0023843

Title

Denominators

Categories

Overall

Title	Measurements
	OG0007 OG0019 OG00244

A/Wisconsin/67/2005 (H3N2)-like

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002	Vaccine efficacy (VE) of CCI vaccine vs. Placebo (Overall) Simultaneous one-sided 97.5% confidence interval (CI) for the VE of CCI vaccine relative to Placebo was based on the Sidak-corrected score CIs for the two relative risks.	Sidak-corrected score CI		<0.001	Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is <= 40% (the relative risk, >= 0.60). If adjusted p-value is <0.025, then the comparison is statistically significant.	Vaccine Efficacy	83.8			1-Sided	97.5	61.0						Superiority or Other (legacy)

Secondary

Number of Subjects With Culture-confirmed Influenza Illness Caused by Non-Vaccine Like Strains

The vaccine efficacy of CCI and IVV vaccines was estimated relative to placebo group as the number of subjects prevented against virus-confirmed symptomatic influenza A or B illness caused by non-vaccine-like strains.

Analysis was done on PP efficacy population.

Posted

Number

Subjects

6 Months

ID	Title	Description
OG000	CCI Vaccine	One dose of cell culture-derived influenza vaccine.
OG001	IVV Vaccine	One dose of the trivalent egg-derived influenza virus vaccine.
OG002	Placebo	One dose of phosphate buffered solution (PBS).

Units	Counts
Participants	OG000

Secondary

Number of Subjects With Influenza Caused by Vaccine-like and Non-vaccine-like Strains

The vaccine efficacy of CCI and IVV vaccines was estimated relative to placebo as the number of subjected prevented against virus-confirmed symptomatic influenza A or B illness caused by vaccine-like and non-vaccine-like strains.

Analysis was done on PP efficacy population.

Posted

Number

Subjects

6 Months

ID	Title	Description
OG000	CCI Vaccine	One dose of cell culture-derived influenza vaccine.
OG001	IVV Vaccine	One dose of the trivalent egg-derived influenza virus vaccine.
OG002	Placebo	One dose of phosphate buffered solution (PBS).

Units	Counts
Participants

Secondary

Influenza-Associated Days in Bed, All Subjects

The number of subjects in this analysis included all subjects in the per protocol efficacy population.

Analysis was done on the PP efficacy population.

Posted

Mean

Standard Deviation

Number of Days

6 Months

ID	Title	Description
OG000	CCI Vaccine	One dose of cell culture-derived influenza vaccine.
OG001	IVV Vaccine	One dose of the trivalent egg-derived influenza virus vaccine.
OG002	Placebo	One dose of phosphate buffered solution (PBS).

Units	Counts
Participants	OG000

Secondary

Influenza-Associated Days in Bed, Subset of Subjects With Virus-Confirmed- Influenza

The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.

Analysis was done on PP efficacy population.

Posted

Mean

Standard Deviation

Number of Days

6 Months

ID	Title	Description
OG000	CCI Vaccine	One dose of cell culture-derived influenza vaccine.
OG001	IVV Vaccine	One dose of the trivalent egg-derived influenza virus vaccine.
OG002	Placebo	One dose of phosphate buffered solution (PBS).

Units	Counts
Participants	OG000

Secondary

Number Of Medical Visits (Inpatient and Outpatient) Due to Influenza Illness or Symptoms of Influenza, All Subjects

The number of subjects in this analysis included all subjects in the per protocol efficacy population.

Analysis was done of PP efficacy population.

Posted

Mean

Standard Deviation

Number of Medical Visits

6 Months

ID	Title	Description
OG000	CCI Vaccine	One dose of cell culture-derived influenza vaccine.
OG001	IVV Vaccine	One dose of the trivalent egg-derived influenza virus vaccine.
OG002	Placebo	One dose of phosphate buffered solution (PBS).

Units	Counts
Participants	OG000

Secondary

Number of Medical Visits (Inpatient and Outpatient), Subset of Subjects With Virus-Confirmed-Influenza

The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.

Analysis was done of PP efficacy population.

Posted

Mean

Standard Deviation

Number of Medical Visits

6 Months

ID	Title	Description
OG000	CCI Vaccine	One dose of cell culture-derived influenza vaccine.
OG001	IVV Vaccine	One dose of the trivalent egg-derived influenza virus vaccine.
OG002	Placebo	One dose of phosphate buffered solution (PBS).

Units	Counts
Participants	OG000

Secondary

Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost Due to Influenza Disease, All Subjects

The number of subjects in this analysis included all subjects in the per protocol efficacy population.

Analysis was done on PP efficacy population.

Posted

Mean

Standard Deviation

Numebr of Days of Usual Activity Lost

6 Months

ID	Title	Description
OG000	CCI Vaccine	One dose of cell culture-derived influenza vaccine.
OG001	IVV Vaccine	One dose of the trivalent egg-derived influenza virus vaccine.
OG002	Placebo	One dose of phosphate buffered solution (PBS).

Units	Counts
Participants	OG000

Secondary

Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost, Subset of Subjects With Virus-Confirmed-Influenza

The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.

Analysis was done on PP efficacy population.

Posted

Mean

Standard Deviation

Numebr of Days of Usual Activity Lost

6 Months

ID	Title	Description
OG000	CCI Vaccine	One dose of cell culture-derived influenza vaccine.
OG001	IVV Vaccine	One dose of the trivalent egg-derived influenza virus vaccine.
OG002	Placebo	One dose of phosphate buffered solution (PBS).

Units	Counts
Participants

Secondary

Percentages of Subjects Who Achieved HI Titers ≥40 After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo

Immunogenicity was measured as the percentage of subjects achieving HI titers ≥40 at baseline (day 1) and three weeks after (day 22) one vaccination of either cell-culture or egg-derived vaccine or placebo for each of the three influenza vaccine strains (A/H1N1, A/H3N2 and B), evaluated using hemagglutination inhibition (HI) egg-derived antigen assay. This criterion is met according to US (CBER) guideline if the lower limit of the two-sided 95% CI for the percentage of subjects achieving HI titers ≥40 is ≥70%.

Analysis was done on a subset of subjects who constituted the PP immunogenicity population.

Posted

Number

95% Confidence Interval

Percentages of subjects

Before vaccination (day 1) and three weeks after vaccination (day 22)

ID	Title	Description
OG000	CCI Vaccine	One dose of cell culture-derived influenza vaccine.
OG001	IVV Vaccine	One dose of the trivalent egg-derived influenza virus vaccine.
OG002	Placebo	One dose of phosphate buffered solution (PBS).

Secondary

Percentages of Subjects Achieving Seroconversion After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo

As per the CBER guideline, seroconversion is defined as the percentage of subjects with a prevaccination HI titer <10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. According to CBER criteria, the lower limit of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody titer at day 22 met exceeded 40%.

Analysis was done on a subset of subjects who constituted the PP immunogenicity population.

Posted

Number

95% Confidence Interval

Percentages of subjects

Three weeks after vaccination (day 22)

ID	Title	Description
OG000	CCI Vaccine	One dose of cell culture-derived influenza vaccine.
OG001	IVV Vaccine	One dose of the trivalent egg-derived influenza virus vaccine.
OG002	Placebo	One dose of phosphate buffered solution (PBS).

Secondary

Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination

The solicited local and systemic reactogenicity were collected up to 7 days after vaccination for all three vaccine groups.

Analysis was done on Safety population i.e. all subjects in the exposed population who provide post vaccination safety data.

Posted

Number

Subjects

Up to 7 days post vaccination

ID	Title	Description
OG000	CCI Vaccine	One dose of cell culture-derived influenza vaccine.
OG001	IVV Vaccine	One dose of the trivalent egg-derived influenza virus vaccine.
OG002	Placebo	One dose of phosphate buffered solution (PBS).

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac Failure Congestive	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Coronary Artery disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Vertigo Positional	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Hyperthyroidism	Endocrine disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Mydriasis	Eye disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0021 events1 affected3,894 at risk
Anal Fistula	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Colitis Ischaemic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Crohn's Disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0021 events1 affected3,894 at risk
Intestinal Obstructon	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Pancreatitis Acute	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Peritoneal Cyst	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Salivary Duct Inflammation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Salivary Gland Calculus	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Vomiting in Pregnancy	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Chest Pain	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Death	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Cholangitis Sclerosing	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Hepatitis Acute	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Jaundice	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Acute Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Acute Tonsillitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Appendicitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0023 events3 affected3,894 at risk
Breast Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Diverticulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Gastroenteritis Viral	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Lung Abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Mastitis Bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Perirectal Abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Peritonsillar Abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Pharyngitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0022 events2 affected3,894 at risk
Pneumonia	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0022 events2 affected3,894 at risk
Pyelonephritis Acute	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Urinary Tract Infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Wound Infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Abdominal Injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Alcohol Poisoning	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0002 events2 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Chest Injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Extradural Haematoma	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Foot Fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Joint Injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Road Traffic Accident	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Skull Fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Subdural Haematoma	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Tendon Rupture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Wound	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Obesity	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0022 events2 affected3,894 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0002 events2 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0022 events2 affected3,894 at risk
Adenocarcinoma of the Cervix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Bone Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Carcinoid Tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Leiomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Ovarian Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Cerebral Haemorrhage	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Epilepsy	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Headache	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Loss of Consciousness	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Migraine	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Syncope	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Tethered Cord Syndrome	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Abortion Spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Delivery	Pregnancy, puerperium and perinatal conditions	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Ectopic Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Acute Stress Disorder	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Anxiety	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Bipolar Disorder	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Borderline Personality Disorder	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Major Depression	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Psychotic Disorder	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Bladder Prolapse	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Dysuria	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Breast Hyperplasia	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Haemorrhagic Ovarian Cyst	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0012 events2 affected3,669 at risk EG0020 events0 affected3,894 at risk
Menometrorrhagia	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Pelvic Pain	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Polycystic Ovaries	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Uterine Haemorrhage	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Nasal Septum Deviation	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0012 events2 affected3,669 at risk EG0020 events0 affected3,894 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Tonsillar Hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Dermatitis Atopic	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Homicide	Social circumstances	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Aortic Valve Replacement	Surgical and medical procedures	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Appendicetomy	Surgical and medical procedures	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk
Knee Operation	Surgical and medical procedures	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Medical Device Removal	Surgical and medical procedures	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Nasal Septal Operation	Surgical and medical procedures	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Rhinoplasty	Surgical and medical procedures	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Tendon Operation	Surgical and medical procedures	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Hypertension	Vascular disorders	MedDRA	Non-systematic Assessment	EG0001 events1 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0020 events0 affected3,894 at risk
Thrombophlebitis	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0011 events1 affected3,669 at risk EG0020 events0 affected3,894 at risk
Varicose Vein	Vascular disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected3,813 at risk EG0010 events0 affected3,669 at risk EG0021 events1 affected3,894 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Chills	General disorders	MedDRA	Systematic Assessment	EG000212 affected3,813 at risk EG001212 affected3,669 at risk EG002225 affected3,894 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG000390 affected3,813 at risk EG001404 affected3,669 at risk EG002386 affected3,894 at risk
Injection Site Erythema	General disorders	MedDRA	Systematic Assessment	EG000510 affected3,813 at risk EG001492 affected3,669 at risk EG002391 affected3,894 at risk
Injection Site Induration	General disorders	MedDRA	Systematic Assessment	EG000239 affected3,813 at risk EG001207 affected3,669 at risk EG002101 affected3,894 at risk
Injection Site Pain	General disorders	MedDRA	Systematic Assessment	EG0001,158 affected3,813 at risk EG001893 affected3,669 at risk EG002375 affected3,894 at risk
Injection Site Swelling	General disorders	MedDRA	Systematic Assessment	EG000218 affected3,813 at risk EG001181 affected3,669 at risk EG002103 affected3,894 at risk
Malaise	General disorders	MedDRA	Systematic Assessment	EG000290 affected3,813 at risk EG001260 affected3,669 at risk EG002238 affected3,894 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG000451 affected3,813 at risk EG001369 affected3,669 at risk EG002278 affected3,894 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG000571 affected3,813 at risk EG001554 affected3,669 at risk EG002597 affected3,894 at risk

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

ID	Title	Description
BG000	CCI Vaccine	One dose of cell culture-derived influenza vaccine.
BG001	IVV Vaccine	One dose of the trivalent egg-derived influenza virus vaccine.
BG002	Placebo	One dose of phosphate buffered solution (PBS).
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	CCI Vaccine	One dose of cell culture-derived influenza vaccine.	42	3,813	1,949	3,813
EG001	IVV Vaccine	One dose of the trivalent egg-derived influenza virus vaccine.	35	3,669	1,703	3,669
EG002	Placebo	One dose of phosphate buffered solution (PBS).	38	3,894	1,387	3,894

ID	Type	Description	Link
2007-002871-15
11580