Trial Outcomes & Findings for A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2) (NCT NCT01385566)

NCT ID: NCT01385566

Last Updated: 2016-06-23

Results Overview

VZV antibody titers were measured by glycoprotein enzyme-linked immunosorbent assay at baseline and at 6 weeks after vaccine administration. The geometric mean fold change represents the 6-week value / the baseline value.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

223 participants

Primary outcome timeframe

Baseline and 6 weeks following vaccine administration

Results posted on

2016-06-23

Participant Flow

Participant milestones

Participant milestones
Measure
Full Dose Subcutaneous
Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
1/3 Dose Subcutaneous
Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
Full Dose Intradermal
Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/3 Dose Intradermal
Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/10 Dose Intradermal
Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/27 Dose Intradermal
Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
Overall Study
STARTED
52
34
34
35
34
34
Overall Study
COMPLETED
51
34
34
34
34
34
Overall Study
NOT COMPLETED
1
0
0
1
0
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Full Dose Subcutaneous
Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
1/3 Dose Subcutaneous
Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
Full Dose Intradermal
Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/3 Dose Intradermal
Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/10 Dose Intradermal
Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/27 Dose Intradermal
Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
Overall Study
Lost to Follow-up
1
0
0
0
0
0
Overall Study
Withdrawal by Subject
0
0
0
1
0
0

Baseline Characteristics

A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Full Dose Subcutaneous
n=52 Participants
Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
1/3 Dose Subcutaneous
n=34 Participants
Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
Full Dose Intradermal
n=34 Participants
Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/3 Dose Intradermal
n=35 Participants
Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/10 Dose Intradermal
n=34 Participants
Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/27 Dose Intradermal
n=34 Participants
Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
Total
n=223 Participants
Total of all reporting groups
Age, Continuous
59.9 years
STANDARD_DEVIATION 7.7 • n=5 Participants
60.5 years
STANDARD_DEVIATION 7.5 • n=7 Participants
62.1 years
STANDARD_DEVIATION 8.5 • n=5 Participants
61.2 years
STANDARD_DEVIATION 8.7 • n=4 Participants
61.6 years
STANDARD_DEVIATION 8.1 • n=21 Participants
60.1 years
STANDARD_DEVIATION 7.1 • n=8 Participants
60.8 years
STANDARD_DEVIATION 7.9 • n=8 Participants
Sex: Female, Male
Female
31 Participants
n=5 Participants
20 Participants
n=7 Participants
17 Participants
n=5 Participants
17 Participants
n=4 Participants
16 Participants
n=21 Participants
24 Participants
n=8 Participants
125 Participants
n=8 Participants
Sex: Female, Male
Male
21 Participants
n=5 Participants
14 Participants
n=7 Participants
17 Participants
n=5 Participants
18 Participants
n=4 Participants
18 Participants
n=21 Participants
10 Participants
n=8 Participants
98 Participants
n=8 Participants

PRIMARY outcome

Timeframe: Baseline and 6 weeks following vaccine administration

Population: The population analyzed included participants who received vaccination and did not have any protocol deviations that may have interfered with the immune response.

VZV antibody titers were measured by glycoprotein enzyme-linked immunosorbent assay at baseline and at 6 weeks after vaccine administration. The geometric mean fold change represents the 6-week value / the baseline value.

Outcome measures

Outcome measures
Measure
Full Dose Subcutaneous
n=52 Participants
Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
1/3 Dose Subcutaneous
n=34 Participants
Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
Full Dose Intradermal
n=34 Participants
Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/3 Dose Intradermal
n=35 Participants
Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/10 Dose Intradermal
n=34 Participants
Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/27 Dose Intradermal
n=34 Participants
Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
Placebo
On Day 1 of the study, participants will receive a dose of ZOSTAVAX™ administered in one limb according to their randomized treatment group, and a dose of saline placebo in the alternate limb. Participants in this group were included in the analyses for the V211 treatment groups, and are replicated here specifically to report injection-site adverse experiences reported for the limb receiving a placebo injection.
Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies
1.74 Geometric mean fold change
Interval 1.48 to 2.05
1.64 Geometric mean fold change
Interval 1.35 to 2.0
3.24 Geometric mean fold change
Interval 2.66 to 3.94
2.45 Geometric mean fold change
Interval 2.02 to 2.97
2.21 Geometric mean fold change
Interval 1.82 to 2.69
1.64 Geometric mean fold change
Interval 1.35 to 2.0

PRIMARY outcome

Timeframe: Up to 42 days following vaccine administration

Population: The population analyzed was all randomized participants who received study vaccination

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.

Outcome measures

Outcome measures
Measure
Full Dose Subcutaneous
n=52 Participants
Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
1/3 Dose Subcutaneous
n=34 Participants
Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
Full Dose Intradermal
n=34 Participants
Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/3 Dose Intradermal
n=35 Participants
Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/10 Dose Intradermal
n=34 Participants
Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/27 Dose Intradermal
n=34 Participants
Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
Placebo
On Day 1 of the study, participants will receive a dose of ZOSTAVAX™ administered in one limb according to their randomized treatment group, and a dose of saline placebo in the alternate limb. Participants in this group were included in the analyses for the V211 treatment groups, and are replicated here specifically to report injection-site adverse experiences reported for the limb receiving a placebo injection.
Number of Participants Reporting an Adverse Experience (AE)
30 participants
10 participants
27 participants
23 participants
21 participants
19 participants

PRIMARY outcome

Timeframe: Up to 42 days following vaccine administration

Population: The population analyzed was all randomized participants who received study vaccination

An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention.

Outcome measures

Outcome measures
Measure
Full Dose Subcutaneous
n=52 Participants
Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
1/3 Dose Subcutaneous
n=34 Participants
Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
Full Dose Intradermal
n=34 Participants
Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/3 Dose Intradermal
n=35 Participants
Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/10 Dose Intradermal
n=34 Participants
Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/27 Dose Intradermal
n=34 Participants
Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
Placebo
On Day 1 of the study, participants will receive a dose of ZOSTAVAX™ administered in one limb according to their randomized treatment group, and a dose of saline placebo in the alternate limb. Participants in this group were included in the analyses for the V211 treatment groups, and are replicated here specifically to report injection-site adverse experiences reported for the limb receiving a placebo injection.
Number of Participants Reporting a Serious Adverse Experience (SAE)
0 participants
0 participants
0 participants
0 participants
0 participants
0 participants

PRIMARY outcome

Timeframe: Within 5 days after the blood draw at approximately 20 months following vaccine administration

Population: The population analyzed was all randomized participants who received study vaccination and had a Month 20 visit and follow-up

An SAE is any adverse experience that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in or prolongs an existing inpatient hospitalization, is a congenital anomaly/birth defect in offspring of a study participant, is a cancer, or is another important medical event when, based on appropriate medical judgment, the event may jeopardize the participant and may require medical or surgical intervention

Outcome measures

Outcome measures
Measure
Full Dose Subcutaneous
n=22 Participants
Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
1/3 Dose Subcutaneous
n=16 Participants
Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
Full Dose Intradermal
n=10 Participants
Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/3 Dose Intradermal
n=13 Participants
Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/10 Dose Intradermal
n=15 Participants
Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/27 Dose Intradermal
n=14 Participants
Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
Placebo
On Day 1 of the study, participants will receive a dose of ZOSTAVAX™ administered in one limb according to their randomized treatment group, and a dose of saline placebo in the alternate limb. Participants in this group were included in the analyses for the V211 treatment groups, and are replicated here specifically to report injection-site adverse experiences reported for the limb receiving a placebo injection.
Number of Participants Reporting a Serious Adverse Experience
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: Up to 5 days following vaccine administration

Population: The population analyzed was all randomized participants who received study vaccination

The VRC actively prompts for local injection-site AEs of redness, swelling, and pain/tenderness and for the size of local injection-site reactions of redness and swelling that occur within 5 days of vaccination. The presence of varicella/varicella-like rash and herpes zoster/herpes zoster-like rash is also captured on the VRC. Participants receiving an injection in both limbs will be instructed to complete injection-site reaction information for each limb. All injection-site AEs were reported for the limb in which they occurred: V211 vaccine or placebo.

Outcome measures

Outcome measures
Measure
Full Dose Subcutaneous
n=52 Participants
Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
1/3 Dose Subcutaneous
n=34 Participants
Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
Full Dose Intradermal
n=34 Participants
Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/3 Dose Intradermal
n=35 Participants
Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/10 Dose Intradermal
n=34 Participants
Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/27 Dose Intradermal
n=34 Participants
Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
Placebo
n=39 Participants
On Day 1 of the study, participants will receive a dose of ZOSTAVAX™ administered in one limb according to their randomized treatment group, and a dose of saline placebo in the alternate limb. Participants in this group were included in the analyses for the V211 treatment groups, and are replicated here specifically to report injection-site adverse experiences reported for the limb receiving a placebo injection.
Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC)
Any injection-site AE
27 Participants
7 Participants
27 Participants
22 Participants
19 Participants
19 Participants
5 Participants
Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC)
Injection-site anaesthesia
0 Participants
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC)
Injection-site erythema
16 Participants
5 Participants
26 Participants
20 Participants
16 Participants
18 Participants
4 Participants
Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC)
Injection-site haematoma
2 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC)
Injection-site induration
5 Participants
2 Participants
12 Participants
12 Participants
11 Participants
10 Participants
1 Participants
Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC)
Injection-site pain
15 Participants
5 Participants
8 Participants
9 Participants
5 Participants
6 Participants
0 Participants
Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC)
Injection-site pruritus
1 Participants
2 Participants
3 Participants
3 Participants
1 Participants
1 Participants
0 Participants
Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC)
Injection-site rash
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC)
Injection-site scab
0 Participants
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC)
Injection-site swelling
13 Participants
4 Participants
13 Participants
8 Participants
6 Participants
7 Participants
2 Participants

PRIMARY outcome

Timeframe: Up to 42 days following vaccine administration

Population: The population analyzed was all randomized participants who received study vaccination

Systemic AEs included all reported AEs except injection-site AEs

Outcome measures

Outcome measures
Measure
Full Dose Subcutaneous
n=52 Participants
Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
1/3 Dose Subcutaneous
n=34 Participants
Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
Full Dose Intradermal
n=34 Participants
Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/3 Dose Intradermal
n=35 Participants
Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/10 Dose Intradermal
n=34 Participants
Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/27 Dose Intradermal
n=34 Participants
Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
Placebo
On Day 1 of the study, participants will receive a dose of ZOSTAVAX™ administered in one limb according to their randomized treatment group, and a dose of saline placebo in the alternate limb. Participants in this group were included in the analyses for the V211 treatment groups, and are replicated here specifically to report injection-site adverse experiences reported for the limb receiving a placebo injection.
Number of Participants Reporting Systemic Adverse Experiences
12 participants
6 participants
6 participants
4 participants
5 participants
6 participants

PRIMARY outcome

Timeframe: Up to 42 days following vaccine administration

Population: The population analyzed was all randomized participants who received study vaccination

Non-injection-site rashes were examined by a study physician. Rashes suspected to be varicella/varicella-like or herpes zoster/herpes zoster-like were sampled for verification by polymerase chain reaction.

Outcome measures

Outcome measures
Measure
Full Dose Subcutaneous
n=52 Participants
Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
1/3 Dose Subcutaneous
n=34 Participants
Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
Full Dose Intradermal
n=34 Participants
Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/3 Dose Intradermal
n=35 Participants
Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/10 Dose Intradermal
n=34 Participants
Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/27 Dose Intradermal
n=34 Participants
Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
Placebo
On Day 1 of the study, participants will receive a dose of ZOSTAVAX™ administered in one limb according to their randomized treatment group, and a dose of saline placebo in the alternate limb. Participants in this group were included in the analyses for the V211 treatment groups, and are replicated here specifically to report injection-site adverse experiences reported for the limb receiving a placebo injection.
Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like)
0 participants
0 participants
0 participants
0 participants
0 participants
0 participants

Adverse Events

Full Dose Subcutaneous

Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths

1/3 Dose Subcutaneous

Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths

Full Dose Intradermal

Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths

1/3 Dose Intradermal

Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths

1/10 Dose Intradermal

Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths

1/27 Dose Intradermal

Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Full Dose Subcutaneous
n=52 participants at risk
Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
1/3 Dose Subcutaneous
n=34 participants at risk
Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
Full Dose Intradermal
n=34 participants at risk
Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/3 Dose Intradermal
n=35 participants at risk
Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/10 Dose Intradermal
n=34 participants at risk
Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
1/27 Dose Intradermal
n=34 participants at risk
Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
Placebo
n=39 participants at risk
On Day 1 of the study, participants will receive a dose of ZOSTAVAX™ administered in one limb according to their randomized treatment group, and a dose of saline placebo in the alternate limb. Only injection-site adverse events occurring in the placebo limb are reported; systemic adverse events are reported by V211 treatment group only.
General disorders
Injection site erythema
30.8%
16/52 • Number of events 25 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
14.7%
5/34 • Number of events 13 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
76.5%
26/34 • Number of events 58 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
60.0%
21/35 • Number of events 39 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
47.1%
16/34 • Number of events 20 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
52.9%
18/34 • Number of events 24 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
10.3%
4/39 • Number of events 10 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
General disorders
Injection site induration
9.6%
5/52 • Number of events 9 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
5.9%
2/34 • Number of events 5 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
35.3%
12/34 • Number of events 17 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
34.3%
12/35 • Number of events 23 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
32.4%
11/34 • Number of events 11 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
29.4%
10/34 • Number of events 13 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
2.6%
1/39 • Number of events 1 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
General disorders
Injection site pain
28.8%
15/52 • Number of events 15 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
14.7%
5/34 • Number of events 6 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
23.5%
8/34 • Number of events 17 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
25.7%
9/35 • Number of events 10 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
14.7%
5/34 • Number of events 5 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
17.6%
6/34 • Number of events 8 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
0.00%
0/39 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
General disorders
Injection site pruritus
1.9%
1/52 • Number of events 1 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
5.9%
2/34 • Number of events 4 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
11.8%
4/34 • Number of events 6 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
11.4%
4/35 • Number of events 4 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
2.9%
1/34 • Number of events 1 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
2.9%
1/34 • Number of events 1 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
0.00%
0/39 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
General disorders
Injection site swelling
25.0%
13/52 • Number of events 23 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
11.8%
4/34 • Number of events 10 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
38.2%
13/34 • Number of events 33 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
22.9%
8/35 • Number of events 12 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
17.6%
6/34 • Number of events 6 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
20.6%
7/34 • Number of events 10 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
5.1%
2/39 • Number of events 3 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
Infections and infestations
Nasopharyngitis
1.9%
1/52 • Number of events 1 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
0.00%
0/34 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
2.9%
1/34 • Number of events 1 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
2.9%
1/35 • Number of events 1 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
5.9%
2/34 • Number of events 2 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
5.9%
2/34 • Number of events 2 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
0/0 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
Nervous system disorders
Headache
1.9%
1/52 • Number of events 1 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
5.9%
2/34 • Number of events 4 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
5.9%
2/34 • Number of events 2 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
0.00%
0/35 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
8.8%
3/34 • Number of events 3 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
0.00%
0/34 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
0/0 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
Respiratory, thoracic and mediastinal disorders
Cough
0.00%
0/52 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
0.00%
0/34 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
0.00%
0/34 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
2.9%
1/35 • Number of events 1 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
5.9%
2/34 • Number of events 2 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
0.00%
0/34 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
0/0 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/52 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
0.00%
0/34 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
0.00%
0/34 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
0.00%
0/35 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
5.9%
2/34 • Number of events 2 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
0.00%
0/34 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.
0/0 • Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.
Systemic adverse events are reported by V211 treatment group only. Injection-site adverse events are reported by V211 treatment group and placebo, according to the limb receiving the injection: V211 treatment or placebo.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

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 or presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
  • Publication restrictions are in place

Restriction type: OTHER