Trial Outcomes & Findings for Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok (NCT NCT00539981)

Last Updated: 2022-04-06

Results Overview

Solicited reaction (reactogenicity event) was an adverse event (AE) that was pre-listed in electronic case report form(eCRF), considered to be related to vaccination and recorded by participant by means of memory aid. Injection sites reaction included pain,bruising,redness,swelling. Pain and bruising:Grade0: didn't have it at all; Grade1: noticed it, but it didn't interfere with usual activities at all; Grade2: had it, and it was bad enough to prevent a significant part of usual activities; Grade3: had it, and it prevented most or all of normal activities, or had to see a doctor for prescription medicine, Redness and swelling: participants measured largest diameter of any injection site reaction and grade them from 0 to 3, where Grade0: measured less than(\<)10 milliliters(mm); Grade1: larger than or equal to(\>=) 10mm and \<20mm; Grade 2: \>=20mm and \<50mm; Grade3: \>=50mm. Participants with multiple symptoms in same category were counted once per category using symptom with maximum grade

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

4648 participants

Primary outcome timeframe

Within 7 days post vaccination

Results posted on

2022-04-06

Participant Flow

The study was conducted at 24 active centers in the United States from 15-September-2007 to 28-May-2008.

A total of 4648 participants were randomized in the study. Participants were randomized in 1:1 ratio to receive FluBlok or Placebo. The FluBlok assignment was further stratified into three lots, A, B and C to assess lot consistency.

Participant milestones

Participant milestones
Measure	FluBlok (Lots A, B, C) Participants received a single 0.5 milliliters (mL) dose of FluBlok vaccine from any of the Lots A, B, or C, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.	Placebo Participants received a single dose of placebo matched to FluBlok, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.
Overall Study STARTED	2344	2304
Overall Study COMPLETED	2049	2022
Overall Study NOT COMPLETED	295	282

Reasons for withdrawal

Reasons for withdrawal
Measure	FluBlok (Lots A, B, C) Participants received a single 0.5 milliliters (mL) dose of FluBlok vaccine from any of the Lots A, B, or C, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.	Placebo Participants received a single dose of placebo matched to FluBlok, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.
Overall Study Adverse events (AE)	3	3
Overall Study Lost to Follow-up	260	251
Overall Study Withdrew consent	22	14
Overall Study Death	1	1
Overall Study Other reason-unspecified	9	13

Baseline Characteristics

Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FluBlok (Lots A, B, C) n=2344 Participants Participants received a single 0.5 mL dose of FluBlok vaccine from any of the Lots A, B, or C, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.	Placebo n=2304 Participants Participants received a single dose of placebo matched to FluBlok, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.	Total n=4648 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2344 Participants n=5 Participants	2304 Participants n=7 Participants	4648 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1391 Participants n=5 Participants	1349 Participants n=7 Participants	2740 Participants n=5 Participants
Sex: Female, Male Male	953 Participants n=5 Participants	955 Participants n=7 Participants	1908 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · White/Caucasian	1570 Participants n=5 Participants	1530 Participants n=7 Participants	3100 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Black/African-American	430 Participants n=5 Participants	447 Participants n=7 Participants	877 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Latino/Hispanic	250 Participants n=5 Participants	239 Participants n=7 Participants	489 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Asian	62 Participants n=5 Participants	52 Participants n=7 Participants	114 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · American Indian/Alaska Native	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Native Hawaiian/Pacific Islander	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Other-unspecified	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 7 days post vaccination

Population: Analysis was performed on safety population.

Outcome measures

Outcome measures
Measure	FluBlok (Lots A, B, C) n=2344 Participants Participants received a single 0.5 mL dose of FluBlok vaccine from any of the Lots A, B, or C, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.	Placebo n=2304 Participants Participants received a single dose of placebo matched to FluBlok, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.	FluBlok: Lot C Participants received a single 0.5 mL dose of FluBlok vaccine from Lot C, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.
Number of Participants Reporting Solicited Injection Site (Local) Reactions Injection site pain- Grade 0	1421 Participants	2050 Participants	—
Number of Participants Reporting Solicited Injection Site (Local) Reactions Injection site pain- Grade 1	797 Participants	177 Participants	—
Number of Participants Reporting Solicited Injection Site (Local) Reactions Injection site pain- Grade 2	52 Participants	3 Participants	—
Number of Participants Reporting Solicited Injection Site (Local) Reactions Injection site pain- Grade 3	2 Participants	1 Participants	—
Number of Participants Reporting Solicited Injection Site (Local) Reactions Injection site bruising- Grade 0	2197 Participants	2172 Participants	—
Number of Participants Reporting Solicited Injection Site (Local) Reactions Injection site bruising- Grade 1	68 Participants	57 Participants	—
Number of Participants Reporting Solicited Injection Site (Local) Reactions Injection site bruising- Grade 2	6 Participants	1 Participants	—
Number of Participants Reporting Solicited Injection Site (Local) Reactions Injection site bruising- Grade 3	1 Participants	1 Participants	—
Number of Participants Reporting Solicited Injection Site (Local) Reactions Injection site redness- Grade 0	2181 Participants	2184 Participants	—
Number of Participants Reporting Solicited Injection Site (Local) Reactions Injection site redness- Grade 1	72 Participants	40 Participants	—
Number of Participants Reporting Solicited Injection Site (Local) Reactions Injection site redness- Grade 2	15 Participants	6 Participants	—
Number of Participants Reporting Solicited Injection Site (Local) Reactions Injection site redness- Grade 3	4 Participants	1 Participants	—
Number of Participants Reporting Solicited Injection Site (Local) Reactions Injection site swelling- Grade 0	2195 Participants	2189 Participants	—
Number of Participants Reporting Solicited Injection Site (Local) Reactions Injection site swelling- Grade 1	55 Participants	34 Participants	—
Number of Participants Reporting Solicited Injection Site (Local) Reactions Injection site swelling- Grade 2	16 Participants	6 Participants	—
Number of Participants Reporting Solicited Injection Site (Local) Reactions Injection site swelling- Grade 3	6 Participants	2 Participants	—

PRIMARY outcome

Timeframe: Within 7 days post vaccination

Population: Analysis was performed on safety population.

Solicited reaction (reactogenicity event) was an AE that was pre-listed in eCRF, considered to be related to vaccination recorded by the participant by means of a memory aid between the day of vaccination (Day 0) and Day 7 post vaccination. Systemic events included fever, fatigue, shivering, joint pain, muscle pain, headache, and nausea. Fever: \>=100.4 degree Fahrenheit (ºF) to \<101.1ºF; \>=101.2ºF to \<102.2ºF; \>=102.2ºF; Fatigue, shivering, joint pain, muscle pain, headache and nausea: Grade 0: didn't have it at all; Grade 1: noticed it, but it didn't interfere with usual activities at all; Grade 2: had it, and it was bad enough to prevent a significant part of usual activities; and Grade 3: had it, and it prevented most or all of normal activities, or had to see a doctor for prescription medicine. Participants with multiple symptoms in the same category were counted once per category using the symptom with the maximum grade.

Outcome measures

Outcome measures
Measure	FluBlok (Lots A, B, C) n=2344 Participants Participants received a single 0.5 mL dose of FluBlok vaccine from any of the Lots A, B, or C, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.	Placebo n=2304 Participants Participants received a single dose of placebo matched to FluBlok, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.	FluBlok: Lot C Participants received a single 0.5 mL dose of FluBlok vaccine from Lot C, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.
Number of Participants Reporting Solicited Systemic Reactions Fever (>=100.4ºF)	2238 Participants	2188 Participants	—
Number of Participants Reporting Solicited Systemic Reactions Fever (>=100.4 to <101.1ºF)	8 Participants	5 Participants	—
Number of Participants Reporting Solicited Systemic Reactions Fever (>=101.2 to <102.2ºF)	5 Participants	6 Participants	—
Number of Participants Reporting Solicited Systemic Reactions Fever (>=102.2ºF)	4 Participants	1 Participants	—
Number of Participants Reporting Solicited Systemic Reactions Fatigue- Grade 0	1932 Participants	1898 Participants	—
Number of Participants Reporting Solicited Systemic Reactions Fatigue- Grade 1	250 Participants	256 Participants	—
Number of Participants Reporting Solicited Systemic Reactions Fatigue- Grade 2	78 Participants	66 Participants	—
Number of Participants Reporting Solicited Systemic Reactions Shivering- Grade 0	2202 Participants	2160 Participants	—
Number of Participants Reporting Solicited Systemic Reactions Shivering- Grade 1	52 Participants	54 Participants	—
Number of Participants Reporting Solicited Systemic Reactions Shivering- Grade 2	12 Participants	13 Participants	—
Number of Participants Reporting Solicited Systemic Reactions Shivering- Grade 3	6 Participants	4 Participants	—
Number of Participants Reporting Solicited Systemic Reactions Joint pain- Grade 0	2183 Participants	2148 Participants	—
Number of Participants Reporting Solicited Systemic Reactions Joint pain- Grade 1	69 Participants	67 Participants	—
Number of Participants Reporting Solicited Systemic Reactions Joint pain- Grade 2	14 Participants	12 Participants	—
Number of Participants Reporting Solicited Systemic Reactions Joint pain- Grade 3	6 Participants	4 Participants	—
Number of Participants Reporting Solicited Systemic Reactions Muscle pain- Grade 0	2033 Participants	2077 Participants	—
Number of Participants Reporting Solicited Systemic Reactions Muscle pain- Grade 1	197 Participants	124 Participants	—
Number of Participants Reporting Solicited Systemic Reactions Muscle pain- Grade 2	36 Participants	22 Participants	—
Number of Participants Reporting Solicited Systemic Reactions Headache- Grade 0	1923 Participants	1877 Participants	—
Number of Participants Reporting Solicited Systemic Reactions Headache- Grade 1	264 Participants	273 Participants	—
Number of Participants Reporting Solicited Systemic Reactions Headache- Grade 2	70 Participants	68 Participants	—
Number of Participants Reporting Solicited Systemic Reactions Headache- Grade 3	15 Participants	13 Participants	—
Number of Participants Reporting Solicited Systemic Reactions Nausea- Grade 1	94 Participants	74 Participants	—
Number of Participants Reporting Solicited Systemic Reactions Nausea- Grade 2	29 Participants	25 Participants	—
Number of Participants Reporting Solicited Systemic Reactions Nausea- Grade 3	6 Participants	10 Participants	—
Number of Participants Reporting Solicited Systemic Reactions Fatigue- Grade 3	12 Participants	11 Participants	—
Number of Participants Reporting Solicited Systemic Reactions Muscle pain- Grade 3	6 Participants	8 Participants	—
Number of Participants Reporting Solicited Systemic Reactions Nausea- Grade 0	2143 Participants	2122 Participants	—

PRIMARY outcome

Timeframe: From Day 0 (post-vaccination) through Day 28 post vaccination

Population: Analysis was performed on safety population.

An AE was defined as any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a study vaccine, whether or not considered to be related to the study vaccine. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination, ascertained during follow-up visit or telephone contact up to (and including) the Day 28 contact, whether reported spontaneously by the participant or in response to general questions about current or interim health status.

Outcome measures

Outcome measures
Measure	FluBlok (Lots A, B, C) n=2344 Participants Participants received a single 0.5 mL dose of FluBlok vaccine from any of the Lots A, B, or C, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.	Placebo n=2304 Participants Participants received a single dose of placebo matched to FluBlok, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.	FluBlok: Lot C Participants received a single 0.5 mL dose of FluBlok vaccine from Lot C, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.
Number of Participants Reporting Unsolicited Adverse Events	61 Participants	67 Participants	—

PRIMARY outcome

Timeframe: Day 28 post vaccination

Population: Analysis was done on evaluable population that included all participants who had met the study entry criteria and had titers taken at Baseline (Day 0) and after vaccination (Day 28). Data for this outcome measure was planned to be collected and analyzed for each FluBlok lot separately and not planned to be collected for placebo, as pre-specified in protocol.

GMTs of anti-influenza antibodies were measured using a single radial immunodiffusion (SRID) assay for 3 strains: A/Solomon Islands \[H1N1\], A/Wisconsin \[H3N2\], and B/Malaysia. Titers were expressed in terms of 1/dilution.

Outcome measures

Outcome measures
Measure	FluBlok (Lots A, B, C) n=150 Participants Participants received a single 0.5 mL dose of FluBlok vaccine from any of the Lots A, B, or C, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.	Placebo n=151 Participants Participants received a single dose of placebo matched to FluBlok, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.	FluBlok: Lot C n=147 Participants Participants received a single 0.5 mL dose of FluBlok vaccine from Lot C, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.
Lot Consistency: Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies Following FluBlok Vaccination A/Solomon Islands (H1N1)	346.15 Titer (1/dilution) Interval 291.96 to 410.41	322.95 Titer (1/dilution) Interval 274.8 to 379.55	381.00 Titer (1/dilution) Interval 321.79 to 451.1
Lot Consistency: Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies Following FluBlok Vaccination A/Wisconsin (H3N2)	390.34 Titer (1/dilution) Interval 324.83 to 469.06	192.25 Titer (1/dilution) Interval 159.59 to 231.59	240.01 Titer (1/dilution) Interval 200.14 to 287.82
Lot Consistency: Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies Following FluBlok Vaccination B/Malaysia	182.10 Titer (1/dilution) Interval 151.95 to 218.24	205.95 Titer (1/dilution) Interval 174.16 to 243.55	215.34 Titer (1/dilution) Interval 179.31 to 258.62

PRIMARY outcome

Timeframe: 14 days post vaccination through and up to 6 months

Population: Analysis was performed on safety population.

CDC-defined ILI was defined as fever (body temperature \>=100ºF oral accompanied by cough and/or sore throat, on the same day or on consecutive days) due to strains represented in the vaccine.

Outcome measures

Outcome measures
Measure	FluBlok (Lots A, B, C) n=2344 Participants Participants received a single 0.5 mL dose of FluBlok vaccine from any of the Lots A, B, or C, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.	Placebo n=2304 Participants Participants received a single dose of placebo matched to FluBlok, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.	FluBlok: Lot C Participants received a single 0.5 mL dose of FluBlok vaccine from Lot C, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.
Percentage of Participants With Positive Cell Culture/Culture-Confirmed Influenza Like Illness as Defined by Centers for Disease Control and Prevention (CDC-ILI)	0.04 percentage of participants	0.2 percentage of participants	—

SECONDARY outcome

Timeframe: 28 days post vaccination

Population: Analysis was performed on evaluable population. Data for this outcome measure was not planned to be collected and analyzed for placebo group, as pre-specified in protocol.

Anti-influenza antibodies were measured using an HAI assay for 3 strains: A/Solomon Islands \[H1N1\], A/Wisconsin \[H3N2\] and B/Malaysia. Seroprotection was defined as a post-vaccination HAI antibody titer of \>=1:40.

Outcome measures

Outcome measures
Measure	FluBlok (Lots A, B, C) n=448 Participants Participants received a single 0.5 mL dose of FluBlok vaccine from any of the Lots A, B, or C, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.	Placebo Participants received a single dose of placebo matched to FluBlok, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.	FluBlok: Lot C Participants received a single 0.5 mL dose of FluBlok vaccine from Lot C, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.
Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With FluBlok A/Solomon Islands (H1N1)	99 percentage of participants Interval 97.1 to 99.5	—	—
Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With FluBlok A/Wisconsin (H3N2)	97 percentage of participants Interval 94.8 to 98.3	—	—
Percentage of Participants With Seroprotection to Influenza Vaccine Antigens After Vaccination With FluBlok B/Malaysia	96 percentage of participants Interval 94.0 to 97.8	—	—

SECONDARY outcome

Timeframe: 28 days post vaccination

Population: Analysis was performed on evaluable population. Data for this outcome measure was not planned to be collected and analyzed for placebo group, as pre-specified in protocol.

Anti-influenza antibodies were measured using an HAI assay for 3 strains: A/Solomon Islands \[H1N1\], A/Wisconsin \[H3N2\] and B/Malaysia. Seroconversion was defined as a post-vaccination titer of \>=1:40 in participants with undetectable baseline antibody (HI titer = \<1:10) or a \>=4-fold rise in antibody in participants with a baseline titer of \>=1:10, with the achievement of post-vaccination titer of at least 1:40.

Outcome measures

Outcome measures
Measure	FluBlok (Lots A, B, C) n=448 Participants Participants received a single 0.5 mL dose of FluBlok vaccine from any of the Lots A, B, or C, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.	Placebo Participants received a single dose of placebo matched to FluBlok, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.	FluBlok: Lot C Participants received a single 0.5 mL dose of FluBlok vaccine from Lot C, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.
Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With FluBlok A/Solomon Islands (H1N1)	78 percentage of participants Interval 73.5 to 81.5	—	—
Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With FluBlok A/Wisconsin (H3N2)	81 percentage of participants Interval 77.1 to 84.6	—	—
Percentage of Participants With Seroconversion to Influenza Vaccine Antigens After Vaccination With FluBlok B/Malaysia	52 percentage of participants Interval 47.0 to 56.5	—	—

Adverse Events

FluBlok (Lots A, B, C)

Serious events: 30 serious events

Other events: 152 other events

Deaths: 1 deaths

Placebo

Serious events: 34 serious events

Other events: 120 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	FluBlok (Lots A, B, C) n=2344 participants at risk Participants received a single 0.5 mL dose of FluBlok vaccine from any of the Lots A, B, or C, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.	Placebo n=2304 participants at risk Participants received a single dose of placebo matched to FluBlok, intramuscularly on Day 0 (Visit 1). Participants were followed up to 6 months after vaccination.
Nervous system disorders Headache	1.5% 35/2344 • Unsolicited non-serious AEs: Day 0 to Day 28 post vaccination, Solicited reactions: within 7 days post vaccination, SAE: through the end of influenza season (up to 6 months) Solicited reaction was AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety population.	1.8% 42/2304 • Unsolicited non-serious AEs: Day 0 to Day 28 post vaccination, Solicited reactions: within 7 days post vaccination, SAE: through the end of influenza season (up to 6 months) Solicited reaction was AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety population.
Respiratory, thoracic and mediastinal disorders Cough	2.0% 48/2344 • Unsolicited non-serious AEs: Day 0 to Day 28 post vaccination, Solicited reactions: within 7 days post vaccination, SAE: through the end of influenza season (up to 6 months) Solicited reaction was AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety population.	1.6% 37/2304 • Unsolicited non-serious AEs: Day 0 to Day 28 post vaccination, Solicited reactions: within 7 days post vaccination, SAE: through the end of influenza season (up to 6 months) Solicited reaction was AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety population.
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.6% 37/2344 • Unsolicited non-serious AEs: Day 0 to Day 28 post vaccination, Solicited reactions: within 7 days post vaccination, SAE: through the end of influenza season (up to 6 months) Solicited reaction was AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety population.	1.3% 31/2304 • Unsolicited non-serious AEs: Day 0 to Day 28 post vaccination, Solicited reactions: within 7 days post vaccination, SAE: through the end of influenza season (up to 6 months) Solicited reaction was AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety population.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	1.8% 42/2344 • Unsolicited non-serious AEs: Day 0 to Day 28 post vaccination, Solicited reactions: within 7 days post vaccination, SAE: through the end of influenza season (up to 6 months) Solicited reaction was AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety population.	2.1% 49/2304 • Unsolicited non-serious AEs: Day 0 to Day 28 post vaccination, Solicited reactions: within 7 days post vaccination, SAE: through the end of influenza season (up to 6 months) Solicited reaction was AE that was prelisted (i.e., solicited) in the eCRF and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination. Analysis was performed on Safety population.

Additional Information

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Email: [email protected]

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