Trial Outcomes & Findings for ZOSTAVAX™ in Patients on Chronic/Maintenance Corticosteroids (V211-017) (COMPLETED) (NCT NCT00546819)

Last Updated: 2017-04-12

Results Overview

A serious adverse event is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

309 participants

Primary outcome timeframe

Up to 182 days postvaccination

Results posted on

2017-04-12

Participant Flow

Participant milestones

Participant milestones
Measure	ZOSTAVAX™ Participants administered ZOSTAVAX™ on Day 1.	Placebo Participants administered Placebo on Day 1.
Overall Study STARTED	207	102
Overall Study VACCINATED	206	100
Overall Study COMPLETED	199	96
Overall Study NOT COMPLETED	8	6

Reasons for withdrawal

Reasons for withdrawal
Measure	ZOSTAVAX™ Participants administered ZOSTAVAX™ on Day 1.	Placebo Participants administered Placebo on Day 1.
Overall Study Adverse Event	2	3
Overall Study Lost to Follow-up	2	1
Overall Study Withdrawal by Subject	4	2

Baseline Characteristics

ZOSTAVAX™ in Patients on Chronic/Maintenance Corticosteroids (V211-017) (COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ZOSTAVAX™ n=207 Participants Participants administered ZOSTAVAX™ on Day 1.	Placebo n=102 Participants Participants administered Placebo on Day 1.	Total n=309 Participants Total of all reporting groups
Age, Continuous	69.8 years STANDARD_DEVIATION 6.9 • n=93 Participants	69.9 years STANDARD_DEVIATION 7.2 • n=4 Participants	69.8 years STANDARD_DEVIATION 7.0 • n=27 Participants
Sex: Female, Male Female	140 Participants n=93 Participants	80 Participants n=4 Participants	220 Participants n=27 Participants
Sex: Female, Male Male	67 Participants n=93 Participants	22 Participants n=4 Participants	89 Participants n=27 Participants
Daily Corticosteroid Dose Stratum 5 to 10 mg of prednisone or equivalent	182 Participants n=93 Participants	88 Participants n=4 Participants	270 Participants n=27 Participants
Daily Corticosteroid Dose Stratum >10 to 20 mg of prednisone or equivalent	25 Participants n=93 Participants	14 Participants n=4 Participants	39 Participants n=27 Participants

PRIMARY outcome

Timeframe: Up to 182 days postvaccination

Population: All participants who were vaccinated and had any safety follow-up were included in the safety analysis.

Outcome measures

Outcome measures
Measure	ZOSTAVAX™ n=204 Participants Participants administered ZOSTAVAX™ on Day 1.	Placebo n=99 Participants Participants administered Placebo on Day 1.
Number of Participants With Serious Adverse Events (SAE)	21 Participants	11 Participants

SECONDARY outcome

Timeframe: 42 days postvaccination

Population: Per-protocol population: All vaccinated participants who had serology results and who had no protocol deviations that would interfere with the evaluation of VZV-specific gpELISA antibody response.

The Geometric Mean Titer (GMT) of VZV antibodies in participants' serum samples was assessed by a glycoprotein enzyme-linked immunosorbent assay (gpELISA).

Outcome measures

Outcome measures
Measure	ZOSTAVAX™ n=167 Participants Participants administered ZOSTAVAX™ on Day 1.	Placebo n=88 Participants Participants administered Placebo on Day 1.
Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibodies at 42 Days Postvaccination	531.1 gpELISA units/mL Interval 453.3 to 622.1	224.3 gpELISA units/mL Interval 169.8 to 296.2

SECONDARY outcome

Timeframe: 42 days postvaccination

The geometric mean fold rise (GMFR) of the VZV antibodies from Day 1 to Week 6 postvaccination.

Outcome measures

Outcome measures
Measure	ZOSTAVAX™ n=167 Participants Participants administered ZOSTAVAX™ on Day 1.	Placebo n=88 Participants Participants administered Placebo on Day 1.
Geometric Mean Fold Rise (GMFR) of the VZV Antibody Response From Day 1 to Day 42 Postvaccination.	2.3 Ratio Interval 2.0 to 2.7	1.1 Ratio Interval 1.0 to 1.2

Adverse Events

ZOSTAVAX™

Serious events: 21 serious events

Other events: 43 other events

Deaths: 0 deaths

Placebo

Serious events: 11 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	ZOSTAVAX™ n=204 participants at risk Participants administered ZOSTAVAX™ on Day 1.	Placebo n=99 participants at risk Participants administered Placebo on Day 1.
General disorders Injection site erythema	17.6% 36/204 • Number of events 39 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	4.0% 4/99 • Number of events 4 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
General disorders Injection site pain	10.8% 22/204 • Number of events 23 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	8.1% 8/99 • Number of events 8 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
General disorders Injection site swelling	11.3% 23/204 • Number of events 24 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	5.1% 5/99 • Number of events 5 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. SPONSOR review can be expedited to meet publication guidelines.
Publication restrictions are in place

Restriction type: OTHER

Measure	ZOSTAVAX™ n=204 participants at risk Participants administered ZOSTAVAX™ on Day 1.	Placebo n=99 participants at risk Participants administered Placebo on Day 1.
Cardiac disorders Acute myocardial infarction	0.49% 1/204 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	0.00% 0/99 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Cardiac disorders Cardiac arrest	0.00% 0/204 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	1.0% 1/99 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Cardiac disorders Hypertensive heart disease	0.00% 0/204 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	1.0% 1/99 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Endocrine disorders Goitre	0.00% 0/204 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	1.0% 1/99 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Gastrointestinal disorders Food poisoning	0.49% 1/204 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	0.00% 0/99 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Gastrointestinal disorders Inguinal hernia, obstructive	0.49% 1/204 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	0.00% 0/99 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Gastrointestinal disorders Large intestine perforation	0.00% 0/204 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	1.0% 1/99 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Gastrointestinal disorders Pancreatitis acute	0.00% 0/204 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	1.0% 1/99 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.49% 1/204 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	0.00% 0/99 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
General disorders Chest pain	0.49% 1/204 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	0.00% 0/99 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Infections and infestations Cellulitis	0.49% 1/204 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	0.00% 0/99 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Infections and infestations Cellulitis of male external genital organ	0.00% 0/204 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	1.0% 1/99 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Infections and infestations Gastritis viral	0.00% 0/204 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	1.0% 1/99 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Infections and infestations Gastroenteritis	0.49% 1/204 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	0.00% 0/99 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Infections and infestations Herpes zoster ophthalmic	0.49% 1/204 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	0.00% 0/99 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Infections and infestations Kidney infection	0.49% 1/204 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	0.00% 0/99 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Infections and infestations Pneumonia	1.5% 3/204 • Number of events 3 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	2.0% 2/99 • Number of events 2 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Infections and infestations Scrotal abscess	0.00% 0/204 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	1.0% 1/99 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Injury, poisoning and procedural complications Comminuted fracture	0.49% 1/204 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	0.00% 0/99 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/204 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	1.0% 1/99 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Musculoskeletal and connective tissue disorders Arthritis	0.49% 1/204 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	0.00% 0/99 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.49% 1/204 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	0.00% 0/99 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/204 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	1.0% 1/99 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Nervous system disorders Cerebrovascular accident	0.49% 1/204 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	1.0% 1/99 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Nervous system disorders Complex regional pain syndrome	0.49% 1/204 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	0.00% 0/99 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Psychiatric disorders Bipolar disorder	0.00% 0/204 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	1.0% 1/99 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Renal and urinary disorders Renal failure	0.00% 0/204 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	1.0% 1/99 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	3.4% 7/204 • Number of events 9 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	2.0% 2/99 • Number of events 2 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.49% 1/204 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	0.00% 0/99 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.49% 1/204 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	0.00% 0/99 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/204 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	1.0% 1/99 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/204 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	1.0% 1/99 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Vascular disorders Deep vein thrombosis	0.98% 2/204 • Number of events 2 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	0.00% 0/99 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.
Vascular disorders Thrombosis	0.49% 1/204 • Number of events 1 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.	0.00% 0/99 • Up to 182 days postvaccination for serious adverse events and 42 days postvaccination for other adverse events.