Trial Outcomes & Findings for Safety and Immunogenicity Study of V710 Lyophilized Formulation (V710-004) (NCT NCT00822757)

Last Updated: 2015-10-02

Results Overview

Participants whose geometric mean fold-rise (GMFR) in anti-0657n IgG was measured 14 days after a single dose of the lyophilized formulation of V710 (60 mcg) by a LUMINEX™ assay for IgG antibodies directly binding to the 0651nI S. aureus antigen. The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) prevaccination (pre)/14 days postvaccination (postvac).

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

51 participants

Primary outcome timeframe

Prevaccination to 14 days postvaccination

Results posted on

2015-10-02

Participant Flow

Participant milestones

Participant milestones
Measure	V710 (60 mcg) Lyophilized V710 (60 mcg) single dose at baseline.	Placebo Saline placebo single dose at baseline.
Overall Study STARTED	41	10
Overall Study COMPLETED	41	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Immunogenicity Study of V710 Lyophilized Formulation (V710-004)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	V710 (60 mcg) Lyophilized n=41 Participants V710 (60 mcg) single dose at baseline.	Placebo n=10 Participants Saline placebo single dose at baseline.	Total n=51 Participants Total of all reporting groups
Age, Customized 17 years of age and under	0 participants n=93 Participants	0 participants n=4 Participants	0 participants n=27 Participants
Age, Customized 18 to 29 years of age	6 participants n=93 Participants	1 participants n=4 Participants	7 participants n=27 Participants
Age, Customized 30 to 39 years of age	5 participants n=93 Participants	0 participants n=4 Participants	5 participants n=27 Participants
Age, Customized 40 to 49 years of age	8 participants n=93 Participants	4 participants n=4 Participants	12 participants n=27 Participants
Age, Customized 50 to 59 years of age	1 participants n=93 Participants	0 participants n=4 Participants	1 participants n=27 Participants
Age, Customized 60 to 69 years of age	10 participants n=93 Participants	5 participants n=4 Participants	15 participants n=27 Participants
Age, Customized 70 to 80 years of age	11 participants n=93 Participants	0 participants n=4 Participants	11 participants n=27 Participants
Sex: Female, Male Female	22 Participants n=93 Participants	4 Participants n=4 Participants	26 Participants n=27 Participants
Sex: Female, Male Male	19 Participants n=93 Participants	6 Participants n=4 Participants	25 Participants n=27 Participants

PRIMARY outcome

Timeframe: Prevaccination to 14 days postvaccination

Outcome measures

Outcome measures
Measure	V710 (60 mcg) Lyophilized n=41 Participants V710 (60 mcg) single dose at baseline.	Placebo n=10 Participants Saline placebo single dose at baseline.
Geometric Mean Fold-rise (GMFR) After the Administration of the Lyophilized Formulation of V710 (60 mcg).	5.3 Ratio Interval 3.8 to 7.2	1.0 Ratio Interval 0.9 to 1.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Prevaccination to 14 days postvaccination

Participants whose geometric mean fold-rise (GMFR) in anti-0657n IgG was measured among two age groups (18 to 59 years of age and 60 to 70 years of age)14 days after a single dose of the lyophilized formulation of V710 (60 Mcg) by a LUMINEX™ assay for IgG antibodies directly binding to the 0657nI S.aureus antigen. The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) pre/14 days postvac.

Outcome measures

Outcome measures
Measure	V710 (60 mcg) Lyophilized n=41 Participants V710 (60 mcg) single dose at baseline.	Placebo n=10 Participants Saline placebo single dose at baseline.
GMFR by Age Age <60 years	4.0 Ratio Interval 2.6 to 6.2	0.9 Ratio Interval 0.8 to 1.0
GMFR by Age Age ≥60 years	6.8 Ratio Interval 4.3 to 10.8	1.0 Ratio Interval 0.9 to 1.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Prevaccination to Days 10, 14, 28, and 84 postvaccination

An assessment of the kinetics of the immune response in the V710 group over time from baseline measurement and all postvaccination time points (Days 10, 14, 28, and 84). The calculation of GMFR is based on the ratio of IgG Titers (geometric mean concentrations in which the units of measure are µg/mL) pre/all (10, 14, 28, and 84) days postvac.

Outcome measures

Outcome measures
Measure	V710 (60 mcg) Lyophilized n=41 Participants V710 (60 mcg) single dose at baseline.	Placebo n=10 Participants Saline placebo single dose at baseline.
GMFR in Antibody Concentration From Baseline Day 10	3.6 Ratio Interval 2.6 to 5.0	1.2 Ratio Interval 0.7 to 2.2
GMFR in Antibody Concentration From Baseline Day 14	5.3 Ratio Interval 3.8 to 7.2	1.0 Ratio Interval 0.9 to 1.0
GMFR in Antibody Concentration From Baseline Day 28	6.9 Ratio Interval 4.8 to 9.9	0.9 Ratio Interval 0.8 to 1.0
GMFR in Antibody Concentration From Baseline Day 84	7.8 Ratio Interval 5.5 to 11.2	0.9 Ratio Interval 0.8 to 1.1

Adverse Events

V710 (60 mcg) Lyophilized

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	V710 (60 mcg) Lyophilized n=41 participants at risk V710 (60 mcg)single dose at baseline.	Placebo n=10 participants at risk Saline placebo single dose at baseline.
Eye disorders Eye haemorrhage	2.4% 1/41 • Number of events 1 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)	0.00% 0/10 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)
Gastrointestinal disorders Diarrhoea	2.4% 1/41 • Number of events 1 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)	0.00% 0/10 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)
Gastrointestinal disorders Nausea	2.4% 1/41 • Number of events 1 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)	10.0% 1/10 • Number of events 1 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)
Gastrointestinal disorders Vomiting	0.00% 0/41 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)	10.0% 1/10 • Number of events 1 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)
General disorders Fatigue	4.9% 2/41 • Number of events 2 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)	0.00% 0/10 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)
General disorders Injection site bruising	2.4% 1/41 • Number of events 1 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)	0.00% 0/10 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)
General disorders Injection site pain	12.2% 5/41 • Number of events 5 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)	10.0% 1/10 • Number of events 1 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)
General disorders Vessel puncture site haematoma	0.00% 0/41 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)	10.0% 1/10 • Number of events 1 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)
General disorders Vessel puncture site pain	2.4% 1/41 • Number of events 1 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)	0.00% 0/10 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)
Infections and infestations Upper respiratory tract infection	2.4% 1/41 • Number of events 1 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)	10.0% 1/10 • Number of events 1 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)
Musculoskeletal and connective tissue disorders Bursitis	2.4% 1/41 • Number of events 1 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)	0.00% 0/10 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)
Musculoskeletal and connective tissue disorders Myalgia	2.4% 1/41 • Number of events 1 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)	0.00% 0/10 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)
Nervous system disorders Headache	9.8% 4/41 • Number of events 4 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)	0.00% 0/10 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)
Renal and urinary disorders Haematuria	2.4% 1/41 • Number of events 1 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)	0.00% 0/10 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	2.4% 1/41 • Number of events 1 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)	0.00% 0/10 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)
Skin and subcutaneous tissue disorders Dermatitis contact	2.4% 1/41 • Number of events 1 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)	0.00% 0/10 • All clinical adverse experiences (AEs) were followed for 14 days postvaccination, injection-site AEs and oral temperature for 5 days postvaccination, and vaccine-related serious AEs and deaths for 84 days postvaccination (entire duration of the study)