Trial Outcomes & Findings for Evaluation of Safety of GlaxoSmithKline (GSK) Vaccines' Quadrivalent Seasonal Influenza Vaccine, Fluarix Tetra When Administered According to the Approved Prescribing Information (PI) in Korea. (NCT NCT02663102)

NCT ID: NCT02663102

Last Updated: 2024-04-05

Results Overview

An adverse event that is expected from the subject during the post-vaccination follow-up period as described in the locally approved Prescribing Information.

• Recruitment status: COMPLETED
• Target enrollment: 1388 participants
• Primary outcome timeframe: During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)
• Results posted on: 2024-04-05

Participant Flow

Participant milestones

Measure	Fluarix Tetra Group 1 Subjects aged between 6-35 months old who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).	Fluarix Tetra Group 2 Subjects aged 3 years and above who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).
Overall Study STARTED	687	701
Overall Study COMPLETED	687	701
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Safety of GlaxoSmithKline (GSK) Vaccines' Quadrivalent Seasonal Influenza Vaccine, Fluarix Tetra When Administered According to the Approved Prescribing Information (PI) in Korea.

Baseline characteristics by cohort

Measure	Fluarix Tetra Group 1 n=687 Participants Subjects aged between 6-35 months old who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).	Fluarix Tetra Group 2 n=701 Participants Subjects aged 3 years and above who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).	Total n=1388 Participants Total of all reporting groups
Age, Customized 6 months - 11 months	275 Participants n=5 Participants	0 Participants n=7 Participants	275 Participants n=5 Participants
Age, Customized >1 year - <2 years	233 Participants n=5 Participants	0 Participants n=7 Participants	233 Participants n=5 Participants
Age, Customized >2 years - < 3 years	179 Participants n=5 Participants	0 Participants n=7 Participants	179 Participants n=5 Participants
Age, Customized 3 years - 9 years	0 Participants n=5 Participants	167 Participants n=7 Participants	167 Participants n=5 Participants
Age, Customized 10 years - 19 years	0 Participants n=5 Participants	89 Participants n=7 Participants	89 Participants n=5 Participants
Age, Customized 20 years - 29 years	0 Participants n=5 Participants	56 Participants n=7 Participants	56 Participants n=5 Participants
Age, Customized 30 years - 39 years	0 Participants n=5 Participants	108 Participants n=7 Participants	108 Participants n=5 Participants
Age, Customized 40 years - 49 years	0 Participants n=5 Participants	104 Participants n=7 Participants	104 Participants n=5 Participants
Age, Customized 50 years or more	0 Participants n=5 Participants	177 Participants n=7 Participants	177 Participants n=5 Participants
Sex: Female, Male Female	323 Participants n=5 Participants	376 Participants n=7 Participants	699 Participants n=5 Participants
Sex: Female, Male Male	364 Participants n=5 Participants	325 Participants n=7 Participants	689 Participants n=5 Participants
Race/Ethnicity, Customized Korean	686 Participants n=5 Participants	701 Participants n=7 Participants	1387 Participants n=5 Participants
Race/Ethnicity, Customized Non-Korean	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)

Population: The analysis was performed on the Safety analysis set which included all subjects who received Fluarix Tetra, participated in the drug use investigation and provided post vaccination safety data.

An adverse event that is expected from the subject during the post-vaccination follow-up period as described in the locally approved Prescribing Information.

Outcome measures

Measure	Fluarix Tetra Group 1 n=687 Participants Subjects aged between 6-35 months old who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).	Fluarix Tetra Group 2 n=701 Participants Subjects aged 3 years and above who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).
Number of Participants With Expected Adverse Events (AEs)	54 Participants	44 Participants

PRIMARY outcome

Timeframe: During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)

Population: The analysis was performed on the Safety analysis set which included all subjects who received Fluarix Tetra, participated in the drug use investigation and provided post vaccination safety data.

Any adverse event reported in addition to those expected during the drug use investigation. Adverse events that are not reflected in the approved Prescribing Information.

Outcome measures

Measure	Fluarix Tetra Group 1 n=687 Participants Subjects aged between 6-35 months old who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).	Fluarix Tetra Group 2 n=701 Participants Subjects aged 3 years and above who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).
Number of Participants With Unexpected Adverse Events (AEs)	116 Participants	62 Participants

PRIMARY outcome

Timeframe: During the 21 days follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)

Population: The analysis was performed on the Safety analysis set which included all subjects who received Fluarix Tetra, participated in the drug use investigation and provided post vaccination safety data.

SAEs assessed included any adverse event that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject.

Outcome measures

Measure	Fluarix Tetra Group 1 n=687 Participants Subjects aged between 6-35 months old who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).	Fluarix Tetra Group 2 n=701 Participants Subjects aged 3 years and above who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).
Number of Participants With Serious Adverse Events (SAEs)	3 Participants	1 Participants

Adverse Events

Fluarix Tetra Group 1

Serious events: 3 serious events

Other events: 167 other events

Deaths: 0 deaths

Fluarix Tetra Group 2

Serious events: 1 serious events

Other events: 105 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fluarix Tetra Group 1 n=687 participants at risk Subjects aged between 6-35 months old who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).	Fluarix Tetra Group 2 n=701 participants at risk Subjects aged 3 years and above who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).
Gastrointestinal disorders Gastroenteritis	0.00% 0/687 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.14% 1/701 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Infections and infestations Exanthema subitum	0.15% 1/687 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.00% 0/701 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Infections and infestations Pneumonia	0.15% 1/687 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.00% 0/701 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Nervous system disorders Febrile convulsion	0.15% 1/687 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.00% 0/701 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Vascular disorders Kawasaki's disease	0.15% 1/687 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.00% 0/701 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.

Other adverse events

Measure	Fluarix Tetra Group 1 n=687 participants at risk Subjects aged between 6-35 months old who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).	Fluarix Tetra Group 2 n=701 participants at risk Subjects aged 3 years and above who received Fluarix Tetra as per locally approved PI (which is not part of the drug use investigation).
Infections and infestations Nasopharyngitis	7.1% 49/687 • Number of events 53 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	2.4% 17/701 • Number of events 17 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Infections and infestations Rhinitis	3.3% 23/687 • Number of events 23 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.57% 4/701 • Number of events 4 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Infections and infestations Bronchitis	2.8% 19/687 • Number of events 19 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	1.3% 9/701 • Number of events 9 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Infections and infestations Acute sinusitis	0.73% 5/687 • Number of events 5 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.00% 0/701 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Infections and infestations Otitis media acute	0.58% 4/687 • Number of events 4 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.00% 0/701 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Infections and infestations Upper respiratory tract infection	0.58% 4/687 • Number of events 4 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.43% 3/701 • Number of events 3 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Infections and infestations Bronchiolitis	0.44% 3/687 • Number of events 3 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.00% 0/701 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Infections and infestations Tonsillitis	0.44% 3/687 • Number of events 3 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.14% 1/701 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Infections and infestations Exanthema subitum	0.15% 1/687 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.00% 0/701 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Infections and infestations Laryngopharyngitis	0.29% 2/687 • Number of events 2 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.00% 0/701 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Infections and infestations Pharyngitis	0.29% 2/687 • Number of events 2 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.71% 5/701 • Number of events 5 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Infections and infestations Dacryocystitis	0.15% 1/687 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.00% 0/701 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Infections and infestations Herpangina	0.15% 1/687 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.00% 0/701 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Infections and infestations Influenza	0.15% 1/687 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.71% 5/701 • Number of events 5 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Infections and infestations Myringitis	0.15% 1/687 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.00% 0/701 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Infections and infestations Otitis externa	0.15% 1/687 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.00% 0/701 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Infections and infestations Pharyngotonsillitis	0.00% 0/687 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.43% 3/701 • Number of events 3 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Infections and infestations Conjunctivitis	0.00% 0/687 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.29% 2/701 • Number of events 3 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Infections and infestations Sinusitis	0.00% 0/687 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.29% 2/701 • Number of events 2 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Infections and infestations Furuncle	0.00% 0/687 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.14% 1/701 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Infections and infestations Herpes simplex	0.00% 0/687 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.14% 1/701 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Infections and infestations Impetigo	0.00% 0/687 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.14% 1/701 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
General disorders Injection site swelling	1.0% 7/687 • Number of events 7 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	1.3% 9/701 • Number of events 9 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
General disorders Pyrexia	4.8% 33/687 • Number of events 35 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	1.1% 8/701 • Number of events 8 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
General disorders Administration site pruritus	0.29% 2/687 • Number of events 2 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.43% 3/701 • Number of events 3 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
General disorders Injection site erythema	0.29% 2/687 • Number of events 2 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.43% 3/701 • Number of events 3 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
General disorders Administration site induration	0.15% 1/687 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.00% 0/701 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
General disorders Asthenia	0.15% 1/687 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.00% 0/701 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
General disorders Injection site pain	0.15% 1/687 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	1.3% 9/701 • Number of events 9 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
General disorders Injection site warmth	0.15% 1/687 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.00% 0/701 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
General disorders Fatigue	0.00% 0/687 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.14% 1/701 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.9% 13/687 • Number of events 13 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.00% 0/701 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Respiratory, thoracic and mediastinal disorders Cough	0.87% 6/687 • Number of events 6 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.57% 4/701 • Number of events 4 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.73% 5/687 • Number of events 5 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.29% 2/701 • Number of events 2 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.73% 5/687 • Number of events 5 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.43% 3/701 • Number of events 3 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Respiratory, thoracic and mediastinal disorders Sneezing	0.29% 2/687 • Number of events 2 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.14% 1/701 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.15% 1/687 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.43% 3/701 • Number of events 3 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/687 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.29% 2/701 • Number of events 2 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/687 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.14% 1/701 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Gastrointestinal disorders Diarrhoea	0.73% 5/687 • Number of events 5 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.00% 0/701 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Gastrointestinal disorders Vomiting	0.73% 5/687 • Number of events 5 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.14% 1/701 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Gastrointestinal disorders Enteritis	0.44% 3/687 • Number of events 3 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.14% 1/701 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Gastrointestinal disorders Constipation	0.29% 2/687 • Number of events 2 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.14% 1/701 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Gastrointestinal disorders Gastritis	0.29% 2/687 • Number of events 2 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.29% 2/701 • Number of events 2 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Gastrointestinal disorders Gastroenteritis	0.29% 2/687 • Number of events 2 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.14% 1/701 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Gastrointestinal disorders Abdominal pain	0.00% 0/687 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.57% 4/701 • Number of events 4 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Gastrointestinal disorders Gastritis erosive	0.00% 0/687 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.14% 1/701 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/687 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.29% 2/701 • Number of events 2 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/687 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.14% 1/701 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/687 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.14% 1/701 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Musculoskeletal and connective tissue disorders Muscle spams	0.00% 0/687 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.14% 1/701 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Nervous system disorders Headache	0.00% 0/687 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.57% 4/701 • Number of events 4 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Nervous system disorders Dizziness	0.00% 0/687 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.29% 2/701 • Number of events 2 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Skin and subcutaneous tissue disorders Dermatitis contact	0.44% 3/687 • Number of events 3 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.00% 0/701 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Skin and subcutaneous tissue disorders Rash	0.44% 3/687 • Number of events 3 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.00% 0/701 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Skin and subcutaneous tissue disorders Urticaria	0.44% 3/687 • Number of events 3 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.29% 2/701 • Number of events 2 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.15% 1/687 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.00% 0/701 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.15% 1/687 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.00% 0/701 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Skin and subcutaneous tissue disorders Dermatitis diaper	0.15% 1/687 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.00% 0/701 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Skin and subcutaneous tissue disorders Eczema	0.15% 1/687 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.00% 0/701 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Skin and subcutaneous tissue disorders Erythema	0.15% 1/687 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.14% 1/701 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Skin and subcutaneous tissue disorders Miliaria	0.15% 1/687 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.00% 0/701 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/687 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.14% 1/701 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Psychiatric disorders Irritability	0.44% 3/687 • Number of events 3 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.00% 0/701 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Psychiatric disorders Affective disorder	0.00% 0/687 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.14% 1/701 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Psychiatric disorders Anxiety disorder	0.00% 0/687 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.14% 1/701 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Psychiatric disorders Insomnia	0.00% 0/687 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.14% 1/701 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/687 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.14% 1/701 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Injury, poisoning and procedural complications Traumatic arthrosis	0.00% 0/687 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.14% 1/701 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Injury, poisoning and procedural complications Limb injury	0.15% 1/687 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.00% 0/701 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Ear and labyrinth disorders Vertigo positional	0.00% 0/687 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.14% 1/701 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Eye disorders Xerophthalmia	0.00% 0/687 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.14% 1/701 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/687 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.14% 1/701 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.00% 0/687 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.	0.14% 1/701 • Number of events 1 • Solicited and Unsolicited AEs were collected during the 21-day follow-up period after each vaccination. SAEs were collected from the date of vaccination in the drug use investigation up to 21 days (Day 0 to Day 20) after vaccination of the subject in the drug use investigation.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: GSKClinicalSupportHD@gsk.com

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER