Trial Outcomes & Findings for V501 Immunogenicity Study in Females Age 9 to 17 Years (V501-028) (NCT NCT00411749)

Last Updated: 2017-04-21

Results Overview

Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers (GMT) by vaccine group. The limit of detection of the assay was 7 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "7.0".

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

107 participants

Primary outcome timeframe

At one month after completed vaccination series (Month 7)

Results posted on

2017-04-21

Participant Flow

Study was conducted at 8 sites in Japan from 2006 to 2009.

Participant milestones

Participant milestones
Measure	V501 V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)	Placebo Placebo vaccination 0.5 ml injection in 3 dosing regimen.
Overall Study STARTED	82	25
Overall Study Vaccinated	82	25
Overall Study COMPLETED	82	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

V501 Immunogenicity Study in Females Age 9 to 17 Years (V501-028)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	V501 n=82 Participants V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)	Placebo n=25 Participants Placebo vaccination 0.5 ml injection in 3 dosing regimen.	Total n=107 Participants Total of all reporting groups
Age, Continuous	12.8 years STANDARD_DEVIATION 2.4 • n=5 Participants	12.6 years STANDARD_DEVIATION 2.6 • n=7 Participants	12.7 years STANDARD_DEVIATION 2.4 • n=5 Participants
Sex: Female, Male Female	82 Participants n=5 Participants	25 Participants n=7 Participants	107 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Body Weight	45.5 Kilogram STANDARD_DEVIATION 10.8 • n=5 Participants	45.2 Kilogram STANDARD_DEVIATION 9.6 • n=7 Participants	45.4 Kilogram STANDARD_DEVIATION 10.5 • n=5 Participants

PRIMARY outcome

Timeframe: At one month after completed vaccination series (Month 7)

Population: The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 7 serum sample collected within an acceptable time range.

Outcome measures

Outcome measures
Measure	V501 n=80 Participants V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)	Placebo n=25 Participants Placebo vaccination 0.5 ml injection in 3 dosing regimen.	V501-HPV 16 HPV 16 serum antibody titer measured in V501 vaccination group	V501-HPV 18 HPV 18 serum antibody titer measured in V501 vaccination group
Human Papilloma Virus (HPV) 6 Serum Antibody Titer at One Month After Completed Vaccination Series	674.5 Geometric Mean Titers (mMU/mL) Interval 528.6 to 860.8	7.0 Geometric Mean Titers (mMU/mL) Interval 7.0 to 8.4	—	—

PRIMARY outcome

Timeframe: At one month after completed vaccination series (Month 7)

Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group. The limit of detection of the assay was 8 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "8.0".

Outcome measures

Outcome measures
Measure	V501 n=80 Participants V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)	Placebo n=25 Participants Placebo vaccination 0.5 ml injection in 3 dosing regimen.	V501-HPV 16 HPV 16 serum antibody titer measured in V501 vaccination group	V501-HPV 18 HPV 18 serum antibody titer measured in V501 vaccination group
Human Papilloma Virus (HPV) 11 Serum Antibody Titer at One Month After Completed Vaccination Series	944.5 Geometric Mean Titers (mMU/mL) Interval 755.3 to 1181.0	8.0 Geometric Mean Titers (mMU/mL) Interval 8.0 to 8.5	—	—

PRIMARY outcome

Timeframe: At one month after completed vaccination series (Month 7)

Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group. The limit of detection of the assay was 11 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "11.0".

Outcome measures

Outcome measures
Measure	V501 n=82 Participants V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)	Placebo n=25 Participants Placebo vaccination 0.5 ml injection in 3 dosing regimen.	V501-HPV 16 HPV 16 serum antibody titer measured in V501 vaccination group	V501-HPV 18 HPV 18 serum antibody titer measured in V501 vaccination group
Human Papilloma Virus (HPV) 16 Serum Antibody Titer at One Month After Completed Vaccination Series	4275.4 Geometric Mean Titers (mMU/mL) Interval 3375.4 to 5415.4	11.0 Geometric Mean Titers (mMU/mL) Interval 11.0 to 13.5	—	—

PRIMARY outcome

Timeframe: At one month after completed vaccination series (Month 7)

Month 7 HPV Competitive Luminex immunoassay (cLIA) Geometric Mean Titers by vaccine group. The limit of detection of the assay was 10 mMU/ml. GMTs and confidence limits below the limit of detection are shown as "10.0".

Outcome measures

Outcome measures
Measure	V501 n=82 Participants V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)	Placebo n=25 Participants Placebo vaccination 0.5 ml injection in 3 dosing regimen.	V501-HPV 16 HPV 16 serum antibody titer measured in V501 vaccination group	V501-HPV 18 HPV 18 serum antibody titer measured in V501 vaccination group
Human Papilloma Virus (HPV) 18 Serum Antibody Titer at One Month After Completed Vaccination Series	829.2 Geometric Mean Titers (mMU/mL) Interval 642.3 to 1070.5	10.0 Geometric Mean Titers (mMU/mL) Interval 10.0 to 10.1	—	—

SECONDARY outcome

Timeframe: 24 month after completed vaccination series (Month 30)

Population: The per protocol immunogenicity population includes all subjects who were not general protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 for the relevant HPV type, and a Month 30 serum sample collected within an acceptable time range.

Month 30 HPV cLIA Geometric Mean Titers by vaccine group.

Outcome measures

Outcome measures
Measure	V501 n=79 Participants V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)	Placebo n=80 Participants Placebo vaccination 0.5 ml injection in 3 dosing regimen.	V501-HPV 16 n=82 Participants HPV 16 serum antibody titer measured in V501 vaccination group	V501-HPV 18 n=82 Participants HPV 18 serum antibody titer measured in V501 vaccination group
HPV 6, 11, 16 and 18 Serum Antibody Titer at 24 Month After Completed Vaccination Series	155.2 Geometric Mean Titers (mMU/mL) Interval 126.2 to 190.9	198.2 Geometric Mean Titers (mMU/mL) Interval 160.9 to 244.2	617.1 Geometric Mean Titers (mMU/mL) Interval 491.7 to 774.5	90.0 Geometric Mean Titers (mMU/mL) Interval 68.8 to 117.8

Adverse Events

V501

Serious events: 2 serious events

Other events: 77 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	V501 n=82 participants at risk V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)	Placebo n=25 participants at risk Placebo vaccination 0.5 ml injection in 3 dosing regimen.
Congenital, familial and genetic disorders Strabismus congenital	1.2% 1/82 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.	0.00% 0/25 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.
Infections and infestations Bronchitis	1.2% 1/82 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.	0.00% 0/25 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck 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

Measure	V501 n=82 participants at risk V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)	Placebo n=25 participants at risk Placebo vaccination 0.5 ml injection in 3 dosing regimen.
Gastrointestinal disorders Abdominal pain	7.3% 6/82 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.	8.0% 2/25 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.
General disorders Injection site erythema	42.7% 35/82 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.	20.0% 5/25 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.
General disorders Injection site haemorrhage	0.00% 0/82 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.	4.0% 1/25 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.
General disorders Injection site pain	84.1% 69/82 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.	76.0% 19/25 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.
General disorders Injection site pruritus	14.6% 12/82 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.	4.0% 1/25 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.
General disorders Malais	2.4% 2/82 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.	0.00% 0/25 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.
General disorders Pyrexia	4.9% 4/82 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.	4.0% 1/25 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.
General disorders Injection site swelling	46.3% 38/82 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.	16.0% 4/25 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.
General disorders Injection site discomfort	1.2% 1/82 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.	4.0% 1/25 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.
Infections and infestations Nasopharyngitis	11.0% 9/82 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.	20.0% 5/25 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.
Investigations Platelet count increased	3.7% 3/82 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.	0.00% 0/25 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.
Investigations Protein urine present	4.9% 4/82 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.	8.0% 2/25 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.
Nervous system disorders Headache	11.0% 9/82 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.	4.0% 1/25 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	2.4% 2/82 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.	4.0% 1/25 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	4.9% 4/82 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.	8.0% 2/25 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.
Skin and subcutaneous tissue disorders Pruritus	2.4% 2/82 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.	0.00% 0/25 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/82 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.	4.0% 1/25 • Serious Adverse Event (SAE) data were collected from the entire period of the study. Other non serious AE data were collected from Day 1 to Day 15 following vaccination. All adverse events described in case report forms were tabulated by converting them to the preferred term (PT) and classifying them by primary system organ class (PSOC) using the International Conference on Harmonisation (ICH) medical dictionary for regulatory activities (MedDRA) Ver. 9.0.