Trial Outcomes & Findings for Phase II Study to Evaluate Safety and Immunogenicity of a Chikungunya Vaccine (NCT NCT02861586)

NCT ID: NCT02861586

Last Updated: 2021-10-29

Results Overview

Immunogenicity on day 56 confirmed by the presence of functional anti-chikungunya antibodies as determined by the plaque reduction neutralization test (PRNT50). This means immunogenicity 28 days after primary immunization regime, comprising one or two vaccinations.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 263 participants
• Primary outcome timeframe: Study day 56 (28 days after one or two vaccinations depending on treatment group).
• Results posted on: 2021-10-29

Participant Flow

322 participants screened for eligibility, 263 participants randomized

59 screening failures (33 withdrawal of consent, 26 violation of in-/exclusion criteria)

Participant milestones

Measure	Treatment Group A; MV-CHIK Low Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group A/C; Priorix® Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B; MV-CHIK Low Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B/D; Priorix® Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group C; MV-CHIK High Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group D; MV-CHIK High Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 1 Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 2 Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
Overall Study STARTED	51	18	47	16	47	50	18	16
Overall Study COMPLETED	47	15	46	16	47	45	17	16
Overall Study NOT COMPLETED	4	3	1	0	0	5	1	0

Reasons for withdrawal

Measure	Treatment Group A; MV-CHIK Low Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group A/C; Priorix® Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B; MV-CHIK Low Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B/D; Priorix® Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group C; MV-CHIK High Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group D; MV-CHIK High Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 1 Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 2 Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
Overall Study Withdrawal by Subject	1	2	0	0	0	1	1	0
Overall Study Lost to Follow-up	3	1	1	0	0	3	0	0
Overall Study Adverse Event	0	0	0	0	0	1	0	0

Baseline Characteristics

Demography and baseline characteristics include 263 participants of the mITT population

Baseline characteristics by cohort

Measure	Treatment Group A; MV-CHIK Low n=51 Participants Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group A/C; Priorix® n=18 Participants Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B; MV-CHIK Low n=47 Participants Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B/D; Priorix® n=16 Participants Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group C; MV-CHIK High n=47 Participants Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group D; MV-CHIK High n=50 Participants Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 1 n=18 Participants Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 2 n=16 Participants Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Total n=263 Participants Total of all reporting groups
Age, Continuous	31.4 years STANDARD_DEVIATION 10.13 • n=5 Participants • Demography and baseline characteristics include 263 participants of the mITT population	32.2 years STANDARD_DEVIATION 10.01 • n=7 Participants • Demography and baseline characteristics include 263 participants of the mITT population	32.7 years STANDARD_DEVIATION 10.53 • n=5 Participants • Demography and baseline characteristics include 263 participants of the mITT population	33.6 years STANDARD_DEVIATION 11.56 • n=4 Participants • Demography and baseline characteristics include 263 participants of the mITT population	35.1 years STANDARD_DEVIATION 12.32 • n=21 Participants • Demography and baseline characteristics include 263 participants of the mITT population	31.2 years STANDARD_DEVIATION 9.93 • n=10 Participants • Demography and baseline characteristics include 263 participants of the mITT population	31.1 years STANDARD_DEVIATION 10.41 • n=115 Participants • Demography and baseline characteristics include 263 participants of the mITT population	32.6 years STANDARD_DEVIATION 10.28 • n=24 Participants • Demography and baseline characteristics include 263 participants of the mITT population	32.5 years STANDARD_DEVIATION 10.65 • n=42 Participants • Demography and baseline characteristics include 263 participants of the mITT population
Sex: Female, Male Female	27 Participants n=5 Participants • Demography and baseline characterisitcs of mITT Population including 263 subjects.	10 Participants n=7 Participants • Demography and baseline characterisitcs of mITT Population including 263 subjects.	29 Participants n=5 Participants • Demography and baseline characterisitcs of mITT Population including 263 subjects.	7 Participants n=4 Participants • Demography and baseline characterisitcs of mITT Population including 263 subjects.	24 Participants n=21 Participants • Demography and baseline characterisitcs of mITT Population including 263 subjects.	27 Participants n=10 Participants • Demography and baseline characterisitcs of mITT Population including 263 subjects.	11 Participants n=115 Participants • Demography and baseline characterisitcs of mITT Population including 263 subjects.	5 Participants n=24 Participants • Demography and baseline characterisitcs of mITT Population including 263 subjects.	140 Participants n=42 Participants • Demography and baseline characterisitcs of mITT Population including 263 subjects.
Sex: Female, Male Male	24 Participants n=5 Participants • Demography and baseline characterisitcs of mITT Population including 263 subjects.	8 Participants n=7 Participants • Demography and baseline characterisitcs of mITT Population including 263 subjects.	18 Participants n=5 Participants • Demography and baseline characterisitcs of mITT Population including 263 subjects.	9 Participants n=4 Participants • Demography and baseline characterisitcs of mITT Population including 263 subjects.	23 Participants n=21 Participants • Demography and baseline characterisitcs of mITT Population including 263 subjects.	23 Participants n=10 Participants • Demography and baseline characterisitcs of mITT Population including 263 subjects.	7 Participants n=115 Participants • Demography and baseline characterisitcs of mITT Population including 263 subjects.	11 Participants n=24 Participants • Demography and baseline characterisitcs of mITT Population including 263 subjects.	123 Participants n=42 Participants • Demography and baseline characterisitcs of mITT Population including 263 subjects.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=7 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=5 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=4 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=21 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=10 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=115 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=24 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=42 Participants • Demography and baseline characteristics including mITT Population of 263 participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants • Demography and baseline characteristics including mITT Population of 263 participants	1 Participants n=7 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=5 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=4 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=21 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=10 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=115 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=24 Participants • Demography and baseline characteristics including mITT Population of 263 participants	1 Participants n=42 Participants • Demography and baseline characteristics including mITT Population of 263 participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=7 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=5 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=4 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=21 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=10 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=115 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=24 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=42 Participants • Demography and baseline characteristics including mITT Population of 263 participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=7 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=5 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=4 Participants • Demography and baseline characteristics including mITT Population of 263 participants	1 Participants n=21 Participants • Demography and baseline characteristics including mITT Population of 263 participants	1 Participants n=10 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=115 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=24 Participants • Demography and baseline characteristics including mITT Population of 263 participants	2 Participants n=42 Participants • Demography and baseline characteristics including mITT Population of 263 participants
Race (NIH/OMB) White	50 Participants n=5 Participants • Demography and baseline characteristics including mITT Population of 263 participants	17 Participants n=7 Participants • Demography and baseline characteristics including mITT Population of 263 participants	47 Participants n=5 Participants • Demography and baseline characteristics including mITT Population of 263 participants	16 Participants n=4 Participants • Demography and baseline characteristics including mITT Population of 263 participants	45 Participants n=21 Participants • Demography and baseline characteristics including mITT Population of 263 participants	49 Participants n=10 Participants • Demography and baseline characteristics including mITT Population of 263 participants	17 Participants n=115 Participants • Demography and baseline characteristics including mITT Population of 263 participants	16 Participants n=24 Participants • Demography and baseline characteristics including mITT Population of 263 participants	257 Participants n=42 Participants • Demography and baseline characteristics including mITT Population of 263 participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=7 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=5 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=4 Participants • Demography and baseline characteristics including mITT Population of 263 participants	1 Participants n=21 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=10 Participants • Demography and baseline characteristics including mITT Population of 263 participants	1 Participants n=115 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=24 Participants • Demography and baseline characteristics including mITT Population of 263 participants	3 Participants n=42 Participants • Demography and baseline characteristics including mITT Population of 263 participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=7 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=5 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=4 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=21 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=10 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=115 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=24 Participants • Demography and baseline characteristics including mITT Population of 263 participants	0 Participants n=42 Participants • Demography and baseline characteristics including mITT Population of 263 participants

PRIMARY outcome

Timeframe: Study day 56 (28 days after one or two vaccinations depending on treatment group).

Population: The Per-Protocol (PP) population was defined as the mITT population minus subjects with at least one major protocol deviation

Immunogenicity on day 56 confirmed by the presence of functional anti-chikungunya antibodies as determined by the plaque reduction neutralization test (PRNT50). This means immunogenicity 28 days after primary immunization regime, comprising one or two vaccinations.

Outcome measures

Measure	Treatment Group A; MV-CHIK Low n=49 Participants Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group A/C; Priorix® n=16 Participants Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B; MV-CHIK Low n=44 Participants Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B/D; Priorix® n=2 Participants Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group C; MV-CHIK High n=47 Participants Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group D; MV-CHIK High n=44 Participants Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 1 n=16 Participants Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 2 n=15 Participants Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunisation) Confirmed by Plaque Reduction Neutralization Test (PRNT50)	50.2 Titer Standard Deviation 127.69	5.0 Titer Standard Deviation 0.00	12.9 Titer Standard Deviation 100.47	5.0 Titer Standard Deviation 0.00	174.8 Titer Standard Deviation 436.11	33.6 Titer Standard Deviation 59.38	80.0 Titer Standard Deviation 233.80	5.0 Titer Standard Deviation 0.00

SECONDARY outcome

Timeframe: Baseline until study day 224

Population: The Per-Protocol (PP) population was defined as the mITT population minus subjects with at least one major protocol deviation.

Evaluation of immunogenicity on day 0, 28, 196 and 224; additionally for group M1 and M2 on day 168 as confirmed by the presence of functional anti-chikungunya antibodies, determined by the plaque reduction neutralization test (PRNT50).

Outcome measures

Measure	Treatment Group A; MV-CHIK Low n=49 Participants Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group A/C; Priorix® n=16 Participants Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B; MV-CHIK Low n=44 Participants Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B/D; Priorix® n=16 Participants Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group C; MV-CHIK High n=47 Participants Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group D; MV-CHIK High n=44 Participants Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 1 n=16 Participants Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 2 n=15 Participants Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) Visit 1 /day 0	5.1 Titer Standard Deviation 0.71	5.0 Titer Standard Deviation 0.00	5.3 Titer Standard Deviation 3.16	5.0 Titer Standard Deviation 0.00	5.0 Titer Standard Deviation 0.00	5.0 Titer Standard Deviation 0.00	5.0 Titer Standard Deviation 0.00	5.0 Titer Standard Deviation 0.00
Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) Visit 2 /day 28	11.2 Titer Standard Deviation 63.40	5.0 Titer Standard Deviation 0.00	5.5 Titer Standard Deviation 3.82	5.0 Titer Standard Deviation 0.00	25.7 Titer Standard Deviation 52.22	5.1 Titer Standard Deviation 0.75	13.5 Titer Standard Deviation 40.52	5.0 Titer Standard Deviation 0.00
Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) Visit 4 /day 168	—	—	—	—	—	—	28.9 Titer Standard Deviation 52.25	5.0 Titer Standard Deviation 0.00
Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) Visit 5 /day 196	13.5 Titer Standard Deviation 33.46	5.0 Titer Standard Deviation 0.00	6.4 Titer Standard Deviation 8.29	5.00 Titer Standard Deviation 0.00	38.8 Titer Standard Deviation 70.59	16.5 Titer Standard Deviation 81.75	24.1 Titer Standard Deviation 106.25	11.5 Titer Standard Deviation 26.04
Functional Anti-Chikungunya Antibody Titers on Days 0, 28, 196 and 224 (M1/M2 Groups Day 168) Confirmed by Plaque Reduction Neutralization Test (PRNT50) Visit 6 /day 224	14.6 Titer Standard Deviation 37.87	5.0 Titer Standard Deviation 0.00	70.5 Titer Standard Deviation 174.57	5.0 Titer Standard Deviation 0.00	41.8 Titer Standard Deviation 105.55	609.8 Titer Standard Deviation 949.70	18.3 Titer Standard Deviation 87.50	66.5 Titer Standard Deviation 172.62

SECONDARY outcome

Timeframe: Baseline until study day 56

Population: The Per-Protocol (PP) population was defined as the mITT population minus subjects with at least one major protocol deviation

Determination of anti-measles antibodies on day 0, 28, and 56; additionally for group M1 and M2 on day -28 by enzyme linked immunosorbent assay (ELISA).

Outcome measures

Measure	Treatment Group A; MV-CHIK Low n=49 Participants Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group A/C; Priorix® n=16 Participants Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B; MV-CHIK Low n=44 Participants Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B/D; Priorix® n=16 Participants Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group C; MV-CHIK High n=47 Participants Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group D; MV-CHIK High n=44 Participants Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 1 n=16 Participants Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 2 n=15 Participants Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay Visit 3 / day 56	1651.8 Titer Standard Deviation 1384.39	1129.4 Titer Standard Deviation 1168.63	1255.0 Titer Standard Deviation 1279.28	673.8 Titer Standard Deviation 917.52	2750.5 Titer Standard Deviation 1284.23	2435.2 Titer Standard Deviation 1461.78	1825.2 Titer Standard Deviation 1459.93	521.4 Titer Standard Deviation 455.37
Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay Visit 0 / day -28	—	—	—	—	—	—	542.6 Titer Standard Deviation 1118.52	304.5 Titer Standard Deviation 343.53
Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay Visit 1 / day 0	456.2 Titer Standard Deviation 1398.54	693.9 Titer Standard Deviation 1307.42	398.1 Titer Standard Deviation 1267.55	390.4 Titer Standard Deviation 1106.86	495.0 Titer Standard Deviation 1181.36	401.8 Titer Standard Deviation 1073.54	785.6 Titer Standard Deviation 1149.47	645.9 Titer Standard Deviation 850.56
Measurement of Anti-measles Antibody Titer by Enzyme Linked Immunosorbent Assay Visit 2 / day 28	1509.4 Titer Standard Deviation 1360.83	1200.6 Titer Standard Deviation 1129.77	396.9 Titer Standard Deviation 1183.04	447.5 Titer Standard Deviation 1139.37	2343.9 Titer Standard Deviation 1357.29	492.1 Titer Standard Deviation 1227.24	1761.5 Titer Standard Deviation 1578.85	561.2 Titer Standard Deviation 385.36

SECONDARY outcome

Timeframe: Solicited adverse events were recorded for 7 days after each vaccination

Population: All safety analyses were based on the Safety Population, which included all subjects who received at least one vaccination.

Evaluation of solicited local and systemic adverse events as recorded in the subjects' diaries for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.

Outcome measures

Measure	Treatment Group A; MV-CHIK Low n=51 Participants Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group A/C; Priorix® n=18 Participants Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B; MV-CHIK Low n=47 Participants Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B/D; Priorix® n=16 Participants Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group C; MV-CHIK High n=47 Participants Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group D; MV-CHIK High n=50 Participants Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 1 n=18 Participants Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 2 n=16 Participants Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
Number of Participants With Solicited Local and Systemic Adverse Events	35 Participants	14 Participants	32 Participants	10 Participants	37 Participants	41 Participants	13 Participants	10 Participants

SECONDARY outcome

Timeframe: First vaccination until study day 224

Population: All safety analyses were based on the Safety Population, which included all subjects who received at least one vaccination.

Evaluation of all treatment emergent adverse events (TEAEs) occurred throughout the clinical study. Clinically relevant abnormal safety laboratory values were recorded as TEAEs. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.

Outcome measures

Measure	Treatment Group A; MV-CHIK Low n=51 Participants Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group A/C; Priorix® n=18 Participants Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B; MV-CHIK Low n=47 Participants Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B/D; Priorix® n=16 Participants Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group C; MV-CHIK High n=47 Participants Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group D; MV-CHIK High n=50 Participants Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 1 n=18 Participants Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 2 n=16 Participants Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
Number of Participants Who Experienced Treatment Emergent Adverse Events TEAEs	29 Participants	10 Participants	27 Participants	7 Participants	22 Participants	18 Participants	11 Participants	9 Participants
Number of Participants Who Experienced Treatment Emergent Adverse Events Serious TEAEs	1 Participants	1 Participants	2 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants Who Experienced Treatment Emergent Adverse Events Severe TEAEs	1 Participants	1 Participants	2 Participants	0 Participants	0 Participants	2 Participants	1 Participants	1 Participants
Number of Participants Who Experienced Treatment Emergent Adverse Events Related TEAEs	8 Participants	2 Participants	11 Participants	1 Participants	4 Participants	10 Participants	4 Participants	5 Participants
Number of Participants Who Experienced Treatment Emergent Adverse Events Medically attended TEAEs	12 Participants	3 Participants	15 Participants	1 Participants	9 Participants	8 Participants	4 Participants	3 Participants
Number of Participants Who Experienced Treatment Emergent Adverse Events TEAEs where an action was taken	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants Who Experienced Treatment Emergent Adverse Events TEAEs of special interest	2 Participants	0 Participants	2 Participants	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline until study day 196; assessed on days 0, 7, 10, 14, 28 and 196

Population: As subjects of the measles booster groups M1 and M2 received a measles vaccination prior to the modified MV-CHIK vaccine, these groups had to be excluded from measles shedding analysis.

Shedding was observed in a subset of subjects at one Austrian study site, by qualitative determination of live recombinant measles virus in urine by polymerase chain reaction (PCR).

Outcome measures

Measure	Treatment Group A; MV-CHIK Low n=8 Participants Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group A/C; Priorix® n=4 Participants Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B; MV-CHIK Low n=4 Participants Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B/D; Priorix® n=2 Participants Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group C; MV-CHIK High n=8 Participants Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group D; MV-CHIK High n=5 Participants Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 1 Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 2 Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 Visit 1 /day 0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 day 7	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 day 10	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 day 14	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 Visit 2 /day 28	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Shedding of Live Recombinant Virus in Urine Until Day 196 Visit 5 /day 196	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline until study day 196; assessed on days 0, 7, 10, 14, 28 and 196

Population: As subjects of the measles booster groups M1 and M2 received a measles vaccination prior to the modified MV-CHIK vaccine, these groups had to be excluded from measles shedding analysis.

Shedding was observed in a subset of subjects at one Austrian study site, by qualitative determination of live recombinant measles virus in saliva by polymerase chain reaction (PCR).

Outcome measures

Measure	Treatment Group A; MV-CHIK Low n=8 Participants Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group A/C; Priorix® n=4 Participants Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B; MV-CHIK Low n=4 Participants Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B/D; Priorix® n=2 Participants Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group C; MV-CHIK High n=8 Participants Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group D; MV-CHIK High n=5 Participants Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 1 Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 2 Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 Visit 2/Day 28	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 Visit 1/Day 0	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 Day 7	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 Day 10	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 Day 14	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Shedding of Live Recombinant Virus in Saliva Until Day 196 Visit 5/Day 196	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline until study day 224

Population: A subset of the mITT Population was analyzed for T-cell Response.

Peripheral blood mononuclear cells (PBMCs) were isolated from whole blood to determine functional IL-2-producing T cells on day 0, 28, 56 and 224 in a subset of subjects. ELISpots were performed using peptides covering the CHIK proteins E1, E2 and C for re-stimulation, thereby producing three values per sample representing the number of spots per 1 x 10^6 PBMCs. If one or more of the three values was greater than 50, the sample was considered positive and the highest of the three values was used in the analysis. If all three values were below 50, the sample was considered negative and a value of 0.0 was used for analysis.

Outcome measures

Measure	Treatment Group A; MV-CHIK Low n=51 Participants Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group A/C; Priorix® n=18 Participants Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B; MV-CHIK Low n=47 Participants Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B/D; Priorix® n=16 Participants Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group C; MV-CHIK High n=47 Participants Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group D; MV-CHIK High n=50 Participants Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 1 n=18 Participants Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 2 n=16 Participants Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
Chikungunya Virus Specific T Cell Responses Visit 1 /day 0	0.0 Titer Standard Deviation 0.00	0.0 Titer Standard Deviation 0.00	12.1 Titer Standard Deviation 40.10	0.0 Titer Standard Deviation 0.00	0.0 Titer Standard Deviation 0.00	0.0 Titer Standard Deviation 0.00	0.0 Titer Standard Deviation 0.00	—
Chikungunya Virus Specific T Cell Responses Visit 2 /day 28	41.5 Titer Standard Deviation 128.71	0.0 Titer Standard Deviation 0.00	—	—	10.5 Titer Standard Deviation 39.29	—	—	—
Chikungunya Virus Specific T Cell Responses Visit 3 /day 56	46.5 Titer Standard Deviation 63.54	0.0 Titer Standard Deviation 0.00	36.7 Titer Standard Deviation 68.41	25.2 Titer Standard Deviation 56.35	53.4 Titer Standard Deviation 74.38	6.5 Titer Standard Deviation 21.41	47.0 Titer Standard Deviation 51.55	0.0 Titer Standard Deviation 0.00
Chikungunya Virus Specific T Cell Responses Visit 6 /day 224	28.3 Titer Standard Deviation 48.92	0.0 Titer Standard Deviation 0.00	71.8 Titer Standard Deviation 133.03	13.2 Titer Standard Deviation 29.52	11.6 Titer Standard Deviation 23.06	30.1 Titer Standard Deviation 61.48	0.0 Titer Standard Deviation 0.00	0.0 Titer Standard Deviation 0.00

SECONDARY outcome

Timeframe: Baseline until study day 224; assessed on days 0, 28, 168, 196 and 224

Population: The Per-Protocol (PP) population was defined as the mITT population minus subjects with at least one major protocol Deviation.

Evaluation of immunogenicity mediated by serum IgG antibodies against Chikungunya on days 0, 28, 196 and 224; additionally for group M1 and M2 on day 168, determined by enzyme linked immunosorbent assay (ELISA).

Outcome measures

Measure	Treatment Group A; MV-CHIK Low n=49 Participants Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group A/C; Priorix® n=16 Participants Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B; MV-CHIK Low n=44 Participants Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B/D; Priorix® n=16 Participants Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group C; MV-CHIK High n=47 Participants Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group D; MV-CHIK High n=44 Participants Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 1 n=16 Participants Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 2 n=15 Participants Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) Visit 6 /day 224	4.6 Titer Standard Deviation 9.46	3.1 Titer Standard Deviation 4.66	25.4 Titer Standard Deviation 52.43	1.7 Titer Standard Deviation 1.82	13.1 Titer Standard Deviation 24.24	130.8 Titer Standard Deviation 43.94	7.3 Titer Standard Deviation 28.56	20.4 Titer Standard Deviation 43.19
Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) Visit 1 /day 0	2.1 Titer Standard Deviation 1.94	3.6 Titer Standard Deviation 3.64	2.3 Titer Standard Deviation 1.68	1.7 Titer Standard Deviation 1.05	2.3 Titer Standard Deviation 2.75	2.2 Titer Standard Deviation 1.53	2.4 Titer Standard Deviation 2.69	2.2 Titer Standard Deviation 2.25
Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) Visit 2 /day 28	3.2 Titer Standard Deviation 6.57	3.4 Titer Standard Deviation 3.13	2.2 Titer Standard Deviation 1.81	2.0 Titer Standard Deviation 2.75	6.2 Titer Standard Deviation 4.65	2.5 Titer Standard Deviation 1.74	4.3 Titer Standard Deviation 9.48	2.0 Titer Standard Deviation 2.37
Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) Visit 3 /day 56	13.6 Titer Standard Deviation 31.84	3.4 Titer Standard Deviation 4.06	3.4 Titer Standard Deviation 6.26	1.7 Titer Standard Deviation 1.63	74.4 Titer Standard Deviation 41.45	6.6 Titer Standard Deviation 18.68	28.0 Titer Standard Deviation 47.51	2.3 Titer Standard Deviation 2.10
Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) Visit 4 /day 168	—	—	—	—	—	—	9.5 Titer Standard Deviation 29.82	1.8 Titer Standard Deviation 2.28
Immunogenicity Confirmed by the Presence of Humoral Anti-chikungunya Antibodies, Determined by Enzyme Linked Immunosorbent Assay (ELISA) Visit 5 /day 196	5.6 Titer Standard Deviation 16.04	3.3 Titer Standard Deviation 4.02	3.0 Titer Standard Deviation 3.11	1.9 Titer Standard Deviation 2.06	15.2 Titer Standard Deviation 25.08	5.6 Titer Standard Deviation 21.33	8.9 Titer Standard Deviation 24.13	3.6 Titer Standard Deviation 5.48

SECONDARY outcome

Timeframe: Study day 56 (28 days after one or two vaccinations depending on treatment group)

Population: The Per-Protocol (PP) population was defined as the mITT population minus subjects with at least one major protocol Deviation.

To determine the potential impact of pre-existing antibodies against measles on MV-CHIK immunogenicity, participants from treatment Groups A to D were divided into quartiles according to serum IgG concentrations against measles virus on Day 0. Functional anti-chikungunya antibodies as determined by PRNT50 were compared between groups.

Outcome measures

Measure	Treatment Group A; MV-CHIK Low n=45 Participants Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group A/C; Priorix® n=48 Participants Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B; MV-CHIK Low n=45 Participants Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B/D; Priorix® n=46 Participants Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group C; MV-CHIK High Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group D; MV-CHIK High Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 1 Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 2 Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
Functional Anti-chikungunya Antibody Titers on Day 56 (28 Days Post Immunization) by Baseline Measles Titer	155.1 Titer Standard Deviation 532.68	177.0 Titer Standard Deviation 897.74	117.6 Titer Standard Deviation 346.86	100.8 Titer Standard Deviation 535.78	—	—	—	—

Adverse Events

Treatment Group A; MV-CHIK Low

Serious events: 1 serious events

Other events: 40 other events

Deaths: 0 deaths

Treatment Group A/C; Priorix®

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Treatment Group B; MV-CHIK Low

Serious events: 2 serious events

Other events: 36 other events

Deaths: 0 deaths

Treatment Group B/D; Priorix®

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Treatment Group C; MV-CHIK High

Serious events: 0 serious events

Other events: 38 other events

Deaths: 0 deaths

Treatment Group D; MV-CHIK High

Serious events: 1 serious events

Other events: 41 other events

Deaths: 0 deaths

Measles Booster Group 1

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Measles Booster Group 2

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment Group A; MV-CHIK Low n=51 participants at risk Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group A/C; Priorix® n=18 participants at risk Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B; MV-CHIK Low n=47 participants at risk Participants received i.m. vaccinations with placebo on study day 0. MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B/D; Priorix® n=16 participants at risk Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group C; MV-CHIK High n=47 participants at risk Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group D; MV-CHIK High n=50 participants at risk Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 1 n=18 participants at risk Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 2 n=16 participants at risk Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
Gastrointestinal disorders umbilical hernia	2.0% 1/51 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Injury, poisoning and procedural complications ligament rupture	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.1% 1/47 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Pregnancy, puerperium and perinatal conditions abortion	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.1% 1/47 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) papillary thyroid cancer	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.0% 1/50 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) laryngeal cancer	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Metabolism and nutrition disorders type 2 diabetes mellitus	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.

Other adverse events

Measure	Treatment Group A; MV-CHIK Low n=51 participants at risk Participants received i.m. vaccinations with MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group A/C; Priorix® n=18 participants at risk Participants received i.m. vaccinations with Priorix® on study day 0 and 28, placebo on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B; MV-CHIK Low n=47 participants at risk Participants received i.m. vaccinations with placebo on study day 0. MV-CHIK low dose (5xE4 (± 0.5 log) TCID50 per 0.3 mL) on day 28 and MV-CHIK boosting dose on day 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group B/D; Priorix® n=16 participants at risk Participants received i.m. vaccinations with placebo on study day 0, Priorix® on day 28 and one boosting dose with Priorix® on day 196. Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group C; MV-CHIK High n=47 participants at risk Participants received i.m. vaccinations with MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 0 and 28, placebo on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Treatment Group D; MV-CHIK High n=50 participants at risk Participants received i.m. vaccinations with placebo on study day 0, MV-CHIK high dose (5xE5 (± 0.5 log) TCID50 per 0.3 mL) on study day 28 and MV-CHIK boosting dose on day 196. MV-CHIK high dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection; 5xE5 (± 0.5 log) TCID50/dose physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 1 n=18 participants at risk Participants received i.m. vaccinations with Priorix® on study day -28, MV-CHIK on day 0 and 28 and placebo on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo	Measles Booster Group 2 n=16 participants at risk Participants received i.m. vaccinations with Priorix® on study day -28, placebo on day 0 and 28 and MV-CHIK on day 168 and 196. MV-CHIK low dose: recombinant measles virus vaccine expressing Chikungunya virus antigens, powder for suspension for injection, 5xE4 (± 0.5 log) TCID50/dose Priorix®: lyophilized mixed preparation containing the attenuated Schwarz measles virus strain, the RIT 4385 strain of mumps virus (derived from the Jeryl Lynn strain) and the Wistar RA 27/3 rubella virus strain. Powder and solvent for suspension for injection physiological saline solution: sterile physiological saline solution 0.9% used as placebo
Vascular disorders Haematoma	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.1% 1/47 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Immune system disorders Seasonal allergy	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.1% 1/47 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.0% 1/50 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
General disorders Influenza like illness	25.5% 13/51 • Number of events 17 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	22.2% 4/18 • Number of events 4 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	19.1% 9/47 • Number of events 12 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	19.1% 9/47 • Number of events 12 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	16.0% 8/50 • Number of events 16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	11.1% 2/18 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	25.0% 4/16 • Number of events 7 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
General disorders Fatigue	19.6% 10/51 • Number of events 15 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	27.8% 5/18 • Number of events 9 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	19.1% 9/47 • Number of events 20 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	18.8% 3/16 • Number of events 5 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	27.7% 13/47 • Number of events 19 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	28.0% 14/50 • Number of events 25 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	27.8% 5/18 • Number of events 10 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	25.0% 4/16 • Number of events 9 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
General disorders Axillary pain	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Reproductive system and breast disorders Dysmenorrhoea	2.0% 1/51 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.1% 1/47 • Number of events 3 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.1% 1/47 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	4.0% 2/50 • Number of events 8 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	11.1% 2/18 • Number of events 4 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Injury, poisoning and procedural complications Injury	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.1% 1/47 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.0% 1/50 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Injury, poisoning and procedural complications Contusion	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.0% 1/51 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.1% 1/47 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	8.5% 4/47 • Number of events 5 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.0% 1/50 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	11.1% 2/18 • Number of events 3 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Respiratory, thoracic and mediastinal disorders Cough	2.0% 1/51 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	4.3% 2/47 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.1% 1/47 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.1% 1/47 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Blood and lymphatic system disorders Lymphadenopathy	3.9% 2/51 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Nervous system disorders Headache	39.2% 20/51 • Number of events 36 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	55.6% 10/18 • Number of events 19 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	34.0% 16/47 • Number of events 32 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	37.5% 6/16 • Number of events 13 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	29.8% 14/47 • Number of events 30 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	34.0% 17/50 • Number of events 47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	50.0% 9/18 • Number of events 18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	50.0% 8/16 • Number of events 19 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Eye disorders Dry eye	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Eye disorders Eye pruritus	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Ear and labyrinth disorders Ear pain	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.1% 1/47 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 3 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Ear and labyrinth disorders Vertigo	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	12.5% 2/16 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Gastrointestinal disorders Abdominal pain upper	5.9% 3/51 • Number of events 3 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	4.3% 2/47 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Gastrointestinal disorders Diarrhoea	2.0% 1/51 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.1% 1/47 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.0% 1/50 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Gastrointestinal disorders Abdominal pain	2.0% 1/51 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.1% 1/47 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Gastrointestinal disorders Toothache	2.0% 1/51 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.0% 1/50 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Renal and urinary disorders Hypertonic bladder	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Skin and subcutaneous tissue disorders Dermatitis contact	2.0% 1/51 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.0% 1/50 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Skin and subcutaneous tissue disorders Rash	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	11.1% 2/18 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.4% 3/47 • Number of events 3 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.0% 1/50 • Number of events 8 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Musculoskeletal and connective tissue disorders Back pain	3.9% 2/51 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	4.3% 2/47 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	4.3% 2/47 • Number of events 3 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Musculoskeletal and connective tissue disorders Myalgia	17.6% 9/51 • Number of events 12 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	27.8% 5/18 • Number of events 8 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	12.8% 6/47 • Number of events 9 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	12.5% 2/16 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	10.6% 5/47 • Number of events 7 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	26.0% 13/50 • Number of events 22 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	22.2% 4/18 • Number of events 8 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.1% 1/47 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Metabolism and nutrition disorders Appetite disorder	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Infections and infestations Nasopharyngitis	13.7% 7/51 • Number of events 7 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	11.1% 2/18 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	8.5% 4/47 • Number of events 4 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	12.5% 2/16 • Number of events 3 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	8.5% 4/47 • Number of events 5 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	8.0% 4/50 • Number of events 5 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	11.1% 2/18 • Number of events 5 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Infections and infestations Rhinitis	3.9% 2/51 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.4% 3/47 • Number of events 3 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	4.0% 2/50 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	11.1% 2/18 • Number of events 3 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	12.5% 2/16 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Infections and infestations Upper respiratory tract infection	5.9% 3/51 • Number of events 3 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.4% 3/47 • Number of events 4 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.1% 1/47 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Infections and infestations Urinary tract infection	2.0% 1/51 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.1% 1/47 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.1% 1/47 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Infections and infestations Gingivitis	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Infections and infestations Hordeolum	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Infections and infestations Respiratory tract infection	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Infections and infestations Vaginal infection	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Infections and infestations Vulvovaginal candidiasis	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
General disorders Injection site erythema	11.8% 6/51 • Number of events 8 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	11.1% 2/18 • Number of events 3 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	10.6% 5/47 • Number of events 6 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	12.5% 2/16 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	21.3% 10/47 • Number of events 18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	18.0% 9/50 • Number of events 11 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	11.1% 2/18 • Number of events 4 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	12.5% 2/16 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
General disorders Injection site induration	9.8% 5/51 • Number of events 7 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	12.8% 6/47 • Number of events 6 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	17.0% 8/47 • Number of events 12 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	30.0% 15/50 • Number of events 24 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	11.1% 2/18 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
General disorders Injection site oedema	7.8% 4/51 • Number of events 8 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	4.3% 2/47 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.4% 3/47 • Number of events 4 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	8.0% 4/50 • Number of events 6 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
General disorders Injection site pain	47.1% 24/51 • Number of events 51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	33.3% 6/18 • Number of events 12 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	44.7% 21/47 • Number of events 37 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	31.2% 5/16 • Number of events 7 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	63.8% 30/47 • Number of events 71 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	78.0% 39/50 • Number of events 119 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	44.4% 8/18 • Number of events 29 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	43.8% 7/16 • Number of events 18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
General disorders Injection site pruritus	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.1% 1/47 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	4.3% 2/47 • Number of events 4 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.0% 3/50 • Number of events 4 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	12.5% 2/16 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
General disorders Pyrexia	5.9% 3/51 • Number of events 3 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.1% 1/47 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Gastrointestinal disorders Nausea	15.7% 8/51 • Number of events 10 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	22.2% 4/18 • Number of events 7 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	4.3% 2/47 • Number of events 3 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	12.5% 2/16 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	4.3% 2/47 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	12.0% 6/50 • Number of events 7 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	11.1% 2/18 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 3 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Gastrointestinal disorders Vomiting	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.1% 1/47 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.0% 1/50 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Musculoskeletal and connective tissue disorders Arthralgia	15.7% 8/51 • Number of events 9 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	16.7% 3/18 • Number of events 3 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	10.6% 5/47 • Number of events 7 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	12.5% 2/16 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	4.3% 2/47 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	14.0% 7/50 • Number of events 11 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	11.1% 2/18 • Number of events 3 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	18.8% 3/16 • Number of events 3 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Musculoskeletal and connective tissue disorders Arthritis reactive	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Musculoskeletal and connective tissue disorders Intervertabral disc protrusion	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.1% 1/47 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Musculoskeletal and connective tissue disorders Limb Discomfort	13.7% 7/51 • Number of events 7 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	16.7% 3/18 • Number of events 3 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	10.6% 5/47 • Number of events 7 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	12.5% 2/16 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	8.5% 4/47 • Number of events 4 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	22.0% 11/50 • Number of events 19 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Infections and infestations Cystitis	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.0% 1/50 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Infections and infestations Gastroenteritis	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	4.3% 2/47 • Number of events 2 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Infections and infestations Otitis externa	2.0% 1/51 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/47 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	5.6% 1/18 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.
Infections and infestations Tonsillitis	0.00% 0/51 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.1% 1/47 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/16 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	2.1% 1/47 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/50 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	0.00% 0/18 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.	6.2% 1/16 • Number of events 1 • 32 - 36 weeks Adverse events were collected in the period after the first vaccination until the last on site study visit. Local and systemic solicited adverse events were collected via subject diary, for 7 days after each vaccination. As per the protocol, adverse events were analyzed per treatment group but were not assessed with respect to individual vaccinations.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60