Trial Outcomes & Findings for Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity (NCT NCT00772954)

NCT ID: NCT00772954

Last Updated: 2012-05-21

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

36 participants

Primary outcome timeframe

Day 0 up to 70 days post first vaccination

Results posted on

2012-05-21

Participant Flow

Participants were enrolled on 28 March 2006 in 2 clinical centers in the US.

A total of 36 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated.

Participant milestones

Participant milestones
Measure	Placebo Vaccine Group Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28.	Clostridium Difficile Toxoid Vaccine Group 1 Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.	Clostridium Difficile Toxoid Vaccine Group 2 Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
Overall Study STARTED	12	12	12
Overall Study COMPLETED	12	12	11
Overall Study NOT COMPLETED	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Vaccine Group Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28.	Clostridium Difficile Toxoid Vaccine Group 1 Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.	Clostridium Difficile Toxoid Vaccine Group 2 Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
Overall Study Adverse Event	0	0	1

Baseline Characteristics

Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Vaccine Group n=12 Participants Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28.	Clostridium Difficile Toxoid Vaccine Group 1 n=12 Participants Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.	Clostridium Difficile Toxoid Vaccine Group 2 n=12 Participants Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=93 Participants	12 Participants n=4 Participants	12 Participants n=27 Participants	36 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age Continuous	38.3 Years STANDARD_DEVIATION 12.98 • n=93 Participants	36.9 Years STANDARD_DEVIATION 12.67 • n=4 Participants	30.0 Years STANDARD_DEVIATION 8.57 • n=27 Participants	35.1 Years STANDARD_DEVIATION 11.84 • n=483 Participants
Sex: Female, Male Female	7 Participants n=93 Participants	11 Participants n=4 Participants	5 Participants n=27 Participants	23 Participants n=483 Participants
Sex: Female, Male Male	5 Participants n=93 Participants	1 Participants n=4 Participants	7 Participants n=27 Participants	13 Participants n=483 Participants
Region of Enrollment United States	12 participants n=93 Participants	12 participants n=4 Participants	12 participants n=27 Participants	36 participants n=483 Participants

PRIMARY outcome

Timeframe: Day 0 up to 70 days post first vaccination

Population: Safety assessments were on the safety population.

Outcome measures

Outcome measures
Measure	Placebo Vaccine Group n=12 Participants Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28.	Clostridium Difficile Toxoid Vaccine Group 1 n=12 Participants Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.	Clostridium Difficile Toxoid Vaccine Group 2 n=12 Participants Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. Injection site pain	7 Participants	12 Participants	9 Participants
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. Headache	5 Participants	4 Participants	5 Participants
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. Blood potassium decreased	1 Participants	4 Participants	3 Participants
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. Protein urine present	1 Participants	4 Participants	3 Participants
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. White blood cell count increased	1 Participants	4 Participants	3 Participants
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. Diarrhoea	3 Participants	3 Participants	2 Participants
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. Fatigue	3 Participants	3 Participants	2 Participants
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. Myalgia	1 Participants	5 Participants	1 Participants
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. White blood cells urine positive	2 Participants	2 Participants	3 Participants
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. Eosinophil count increased	3 Participants	1 Participants	3 Participants
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. Abdominal pain	2 Participants	1 Participants	3 Participants
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. Injection site erythema	2 Participants	3 Participants	1 Participants
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. Red blood cells urine positive	2 Participants	2 Participants	2 Participants
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. Injection site swelling	0 Participants	4 Participants	1 Participants
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. Injection site warmth	0 Participants	2 Participants	2 Participants
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. Malaise	0 Participants	3 Participants	0 Participants
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. Blood urea increased	2 Participants	1 Participants	0 Participants
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. Sinus congestion	2 Participants	0 Participants	1 Participants
Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine. Urine ketone body present	0 Participants	0 Participants	2 Participants

Adverse Events

Placebo Vaccine Group

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Clostridium Difficile Toxoid Vaccine Group 1

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Clostridium Difficile Toxoid Vaccine Group 2

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Medical Director

Sanofi Pasteur Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
Publication restrictions are in place

Restriction type: OTHER

Other adverse events
Measure	Placebo Vaccine Group n=12 participants at risk Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28.	Clostridium Difficile Toxoid Vaccine Group 1 n=12 participants at risk Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.	Clostridium Difficile Toxoid Vaccine Group 2 n=12 participants at risk Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
Gastrointestinal disorders Diarrhoea	25.0% 3/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	25.0% 3/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	16.7% 2/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Gastrointestinal disorders Abdominal pain	16.7% 2/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	25.0% 3/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
General disorders Injection site pain	58.3% 7/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	100.0% 12/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	75.0% 9/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
General disorders Fatigue	25.0% 3/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	25.0% 3/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	16.7% 2/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
General disorders Injection site erythema	16.7% 2/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	25.0% 3/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
General disorders Injection site swelling	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	33.3% 4/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
General disorders Injection site warmth	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	16.7% 2/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	16.7% 2/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
General disorders Malaise	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	25.0% 3/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Investigations Blood potassium decreased	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	33.3% 4/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	25.0% 3/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Investigations Protein urine present	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	33.3% 4/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	25.0% 3/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Investigations White blood cell count increased	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	33.3% 4/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	25.0% 3/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Investigations White blood cells urine positive	16.7% 2/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	16.7% 2/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	25.0% 3/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Investigations Eosinophil count increased	25.0% 3/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	25.0% 3/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Investigations Red blood cells urine positive	16.7% 2/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	16.7% 2/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	16.7% 2/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Investigations Blood urea increased	16.7% 2/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Investigations Urine ketone body present	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	16.7% 2/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Musculoskeletal and connective tissue disorders Myalgia	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	41.7% 5/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Nervous system disorders Headache	41.7% 5/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	33.3% 4/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	41.7% 5/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Respiratory, thoracic and mediastinal disorders Sinus congestion	16.7% 2/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Gastrointestinal disorders Abdominal pain lower	16.7% 2/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	25.0% 3/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Gastrointestinal disorders Nausea	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Gastrointestinal disorders Toothache	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
General disorders Injection site hemorrhage	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
General disorders Injection site induration	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
General disorders Injection site pruritus	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
General disorders Pyrexia	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Infections and infestations Nasopharyngitis	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Infections and infestations Sinusitis	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Investigations Blood bilirubin increased	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Investigations Blood calcium decreased	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Investigations Haematocrit decreased	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Investigations Monocyte count increased	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Investigations White blood cell count decreased	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Metabolism and nutrition disorders Anorexia	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Musculoskeletal and connective tissue disorders Pain in extremity	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Musculoskeletal and connective tissue disorders Shoulder pain	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	8.3% 1/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.	0.00% 0/12 • Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.