Viewing Study NCT01385566

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Ignite Creation Date: 2025-12-24 @ 4:25 PM
Ignite Modification Date: 2026-01-01 @ 7:29 PM
Study NCT ID: NCT01385566
Status: COMPLETED
Last Update Posted: 2016-06-23
First Post: 2011-06-28
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006562', 'term': 'Herpes Zoster'}], 'ancestors': [{'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053061', 'term': 'Herpes Zoster Vaccine'}, {'id': 'D007279', 'term': 'Injections, Subcutaneous'}], 'ancestors': [{'id': 'D019433', 'term': 'Chickenpox Vaccine'}, {'id': 'D022283', 'term': 'Herpesvirus Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Serious Adverse Events were collected up to 20 months following vaccine administration. Other Adverse Events were collected up to 84 days following vaccine administration.', 'description': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Full Dose Subcutaneous', 'description': '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.', 'otherNumAtRisk': 52, 'otherNumAffected': 30, 'seriousNumAtRisk': 52, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '1/3 Dose Subcutaneous', 'description': '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.', 'otherNumAtRisk': 34, 'otherNumAffected': 10, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Full Dose Intradermal', 'description': '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.', 'otherNumAtRisk': 34, 'otherNumAffected': 27, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '1/3 Dose Intradermal', 'description': '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.', 'otherNumAtRisk': 35, 'otherNumAffected': 23, 'seriousNumAtRisk': 35, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '1/10 Dose Intradermal', 'description': '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.', 'otherNumAtRisk': 34, 'otherNumAffected': 21, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': '1/27 Dose Intradermal', 'description': '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.', 'otherNumAtRisk': 34, 'otherNumAffected': 19, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Placebo', 'description': '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.', 'otherNumAtRisk': 39, 'otherNumAffected': 5, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 25, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 13, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 58, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 39, 'numAffected': 21}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 24, 'numAffected': 18}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 10, 'numAffected': 4}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 17, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 23, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 17, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 23, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 10, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 33, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 10, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 34, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA (15.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '34', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Dose Subcutaneous', 'description': '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.'}, {'id': 'OG001', 'title': '1/3 Dose Subcutaneous', 'description': '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.'}, {'id': 'OG002', 'title': 'Full Dose Intradermal', 'description': '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.'}, {'id': 'OG003', 'title': '1/3 Dose Intradermal', 'description': '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.'}, {'id': 'OG004', 'title': '1/10 Dose Intradermal', 'description': '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.'}, {'id': 'OG005', 'title': '1/27 Dose Intradermal', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.74', 'groupId': 'OG000', 'lowerLimit': '1.48', 'upperLimit': '2.05'}, {'value': '1.64', 'groupId': 'OG001', 'lowerLimit': '1.35', 'upperLimit': '2.00'}, {'value': '3.24', 'groupId': 'OG002', 'lowerLimit': '2.66', 'upperLimit': '3.94'}, {'value': '2.45', 'groupId': 'OG003', 'lowerLimit': '2.02', 'upperLimit': '2.97'}, {'value': '2.21', 'groupId': 'OG004', 'lowerLimit': '1.82', 'upperLimit': '2.69'}, {'value': '1.64', 'groupId': 'OG005', 'lowerLimit': '1.35', 'upperLimit': '2.00'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline and 6 weeks following vaccine administration', 'description': '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.', 'unitOfMeasure': 'Geometric mean fold change', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed included participants who received vaccination and did not have any protocol deviations that may have interfered with the immune response.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reporting an Adverse Experience (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '34', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Dose Subcutaneous', 'description': '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.'}, {'id': 'OG001', 'title': '1/3 Dose Subcutaneous', 'description': '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.'}, {'id': 'OG002', 'title': 'Full Dose Intradermal', 'description': '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.'}, {'id': 'OG003', 'title': '1/3 Dose Intradermal', 'description': '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.'}, {'id': 'OG004', 'title': '1/10 Dose Intradermal', 'description': '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.'}, {'id': 'OG005', 'title': '1/27 Dose Intradermal', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 42 days following vaccine administration', 'description': 'An AE is defined as any unfavorable and unintended change in the\n\nstructure, 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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed was all randomized participants who received study vaccination'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reporting a Serious Adverse Experience (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '34', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Dose Subcutaneous', 'description': '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.'}, {'id': 'OG001', 'title': '1/3 Dose Subcutaneous', 'description': '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.'}, {'id': 'OG002', 'title': 'Full Dose Intradermal', 'description': '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.'}, {'id': 'OG003', 'title': '1/3 Dose Intradermal', 'description': '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.'}, {'id': 'OG004', 'title': '1/10 Dose Intradermal', 'description': '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.'}, {'id': 'OG005', 'title': '1/27 Dose Intradermal', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 42 days following vaccine administration', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed was all randomized participants who received study vaccination'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reporting a Serious Adverse Experience', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Dose Subcutaneous', 'description': '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.'}, {'id': 'OG001', 'title': '1/3 Dose Subcutaneous', 'description': '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.'}, {'id': 'OG002', 'title': 'Full Dose Intradermal', 'description': '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.'}, {'id': 'OG003', 'title': '1/3 Dose Intradermal', 'description': '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.'}, {'id': 'OG004', 'title': '1/10 Dose Intradermal', 'description': '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.'}, {'id': 'OG005', 'title': '1/27 Dose Intradermal', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 5 days after the blood draw at approximately 20 months following vaccine administration', 'description': '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', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed was all randomized participants who received study vaccination and had a Month 20 visit and follow-up'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '34', 'groupId': 'OG005'}, {'value': '39', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Dose Subcutaneous', 'description': '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.'}, {'id': 'OG001', 'title': '1/3 Dose Subcutaneous', 'description': '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.'}, {'id': 'OG002', 'title': 'Full Dose Intradermal', 'description': '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.'}, {'id': 'OG003', 'title': '1/3 Dose Intradermal', 'description': '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.'}, {'id': 'OG004', 'title': '1/10 Dose Intradermal', 'description': '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.'}, {'id': 'OG005', 'title': '1/27 Dose Intradermal', 'description': '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.'}, {'id': 'OG006', 'title': 'Placebo', 'description': '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.'}], 'classes': [{'title': 'Any injection-site AE', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}]}]}, {'title': 'Injection-site anaesthesia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Injection-site erythema', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}]}]}, {'title': 'Injection-site haematoma', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Injection-site induration', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}, {'title': 'Injection-site pain', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Injection-site pruritus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Injection-site rash', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Injection-site scab', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}, {'title': 'Injection-site swelling', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 days following vaccine administration', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed was all randomized participants who received study vaccination'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reporting Systemic Adverse Experiences', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '34', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Dose Subcutaneous', 'description': '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.'}, {'id': 'OG001', 'title': '1/3 Dose Subcutaneous', 'description': '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.'}, {'id': 'OG002', 'title': 'Full Dose Intradermal', 'description': '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.'}, {'id': 'OG003', 'title': '1/3 Dose Intradermal', 'description': '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.'}, {'id': 'OG004', 'title': '1/10 Dose Intradermal', 'description': '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.'}, {'id': 'OG005', 'title': '1/27 Dose Intradermal', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 42 days following vaccine administration', 'description': 'Systemic AEs included all reported AEs except injection-site AEs', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed was all randomized participants who received study vaccination'}, {'type': 'PRIMARY', 'title': 'Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}, {'value': '34', 'groupId': 'OG004'}, {'value': '34', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Full Dose Subcutaneous', 'description': '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.'}, {'id': 'OG001', 'title': '1/3 Dose Subcutaneous', 'description': '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.'}, {'id': 'OG002', 'title': 'Full Dose Intradermal', 'description': '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.'}, {'id': 'OG003', 'title': '1/3 Dose Intradermal', 'description': '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.'}, {'id': 'OG004', 'title': '1/10 Dose Intradermal', 'description': '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.'}, {'id': 'OG005', 'title': '1/27 Dose Intradermal', 'description': '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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 42 days following vaccine administration', 'description': '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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analyzed was all randomized participants who received study vaccination'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Full Dose Subcutaneous', 'description': '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.'}, {'id': 'FG001', 'title': '1/3 Dose Subcutaneous', 'description': '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.'}, {'id': 'FG002', 'title': 'Full Dose Intradermal', 'description': '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.'}, {'id': 'FG003', 'title': '1/3 Dose Intradermal', 'description': '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.'}, {'id': 'FG004', 'title': '1/10 Dose Intradermal', 'description': '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.'}, {'id': 'FG005', 'title': '1/27 Dose Intradermal', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '35'}, {'groupId': 'FG004', 'numSubjects': '34'}, {'groupId': 'FG005', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '34'}, {'groupId': 'FG004', 'numSubjects': '34'}, {'groupId': 'FG005', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}, {'value': '34', 'groupId': 'BG005'}, {'value': '223', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Full Dose Subcutaneous', 'description': '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.'}, {'id': 'BG001', 'title': '1/3 Dose Subcutaneous', 'description': '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.'}, {'id': 'BG002', 'title': 'Full Dose Intradermal', 'description': '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.'}, {'id': 'BG003', 'title': '1/3 Dose Intradermal', 'description': '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.'}, {'id': 'BG004', 'title': '1/10 Dose Intradermal', 'description': '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.'}, {'id': 'BG005', 'title': '1/27 Dose Intradermal', 'description': '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.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.9', 'spread': '7.7', 'groupId': 'BG000'}, {'value': '60.5', 'spread': '7.5', 'groupId': 'BG001'}, {'value': '62.1', 'spread': '8.5', 'groupId': 'BG002'}, {'value': '61.2', 'spread': '8.7', 'groupId': 'BG003'}, {'value': '61.6', 'spread': '8.1', 'groupId': 'BG004'}, {'value': '60.1', 'spread': '7.1', 'groupId': 'BG005'}, {'value': '60.8', 'spread': '7.9', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '125', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '98', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 223}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-19', 'studyFirstSubmitDate': '2011-06-28', 'resultsFirstSubmitDate': '2012-12-11', 'studyFirstSubmitQcDate': '2011-06-28', 'lastUpdatePostDateStruct': {'date': '2016-06-23', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-02-19', 'studyFirstPostDateStruct': {'date': '2011-06-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric Mean Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Antibodies', 'timeFrame': 'Baseline and 6 weeks following vaccine administration', 'description': '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.'}, {'measure': 'Number of Participants Reporting an Adverse Experience (AE)', 'timeFrame': 'Up to 42 days following vaccine administration', 'description': 'An AE is defined as any unfavorable and unintended change in the\n\nstructure, 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.'}, {'measure': 'Number of Participants Reporting a Serious Adverse Experience (SAE)', 'timeFrame': 'Up to 42 days following vaccine administration', 'description': '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.'}, {'measure': 'Number of Participants Reporting a Serious Adverse Experience', 'timeFrame': 'Within 5 days after the blood draw at approximately 20 months following vaccine administration', 'description': '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'}, {'measure': 'Number of Participants Reporting Specific Local Injection-site Adverse Experiences Prompted for on the Vaccine Report Card (VRC)', 'timeFrame': 'Up to 5 days following vaccine administration', 'description': '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.'}, {'measure': 'Number of Participants Reporting Systemic Adverse Experiences', 'timeFrame': 'Up to 42 days following vaccine administration', 'description': 'Systemic AEs included all reported AEs except injection-site AEs'}, {'measure': 'Number of Participants Reporting a Non-injection-site Rash (Varicella, Varicella-like, Herpes Zoster, or Herpes Zoster-like)', 'timeFrame': 'Up to 42 days following vaccine administration', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Herpes Zoster']}, 'referencesModule': {'references': [{'pmid': '27061887', 'type': 'RESULT', 'citation': 'Beals CR, Railkar RA, Schaeffer AK, Levin Y, Kochba E, Meyer BK, Evans RK, Sheldon EA, Lasseter K, Lang N, Weinberg A, Canniff J, Levin MJ. Immune response and reactogenicity of intradermal administration versus subcutaneous administration of varicella-zoster virus vaccine: an exploratory, randomised, partly blinded trial. Lancet Infect Dis. 2016 Aug;16(8):915-22. doi: 10.1016/S1473-3099(16)00133-X. Epub 2016 Apr 6.'}]}, 'descriptionModule': {'briefSummary': 'This study will compare the safety and immunogenicity of ZOSTAVAX™ (V211) administered both intradermally and subcutaneously at various doses.', 'detailedDescription': 'This is an exploratory, randomized, partially blinded, multicenter clinical study designed to compare safety and biomarkers of varicella zoster virus immunogenicity when administering ZOSTAVAX™ (V211) at various doses both intradermally and subcutaneously in healthy male and female participants 50 years of age and older.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prior history of varicella (chickenpox) or residence in a country with endemic varicella zoster virus infection for at least 30 years\n* Temperature less than 100.4 °F on day of vaccination\n* Female participants of reproductive potential must have a negative pregnancy test and agree to remain abstinent or use two acceptable contraceptive methods for 3 months postvaccination\n* In good health\n\nExclusion Criteria:\n\n* History of hypersensitivity reaction to any vaccine component, including gelatin or neomycin\n* Household exposure to pregnant women who have not had chickenpox and have not been vaccinated against varicella or to immunosuppressed/immunodeficient individuals\n* Household or workplace exposure to children 18 months and younger who have not been vaccinated against varicella\n* Prior history of herpes zoster\n* Prior receipt of any varicella or zoster vaccine\n* Received or is expected to receive immune globulin and/or blood products from 5 months prior to randomization through 42 days after vaccination\n* On immunosuppressive therapy\n* Known or suspected immune dysfunction\n* Received a live virus vaccine or is scheduled to receive a live virus vaccine from 4 weeks prior to study vaccination through the completion of all study visits\n* Received any inactivated vaccine or is scheduled to receive any inactivated vaccine from 7 days prior to study vaccination through 7 days postvaccination, except for inactivated influenza vaccine\n* Not ambulatory\n* Pregnant or breastfeeding\n* Use of nontopical antiviral therapy with activity against herpes viruses\n* Active untreated tuberculosis'}, 'identificationModule': {'nctId': 'NCT01385566', 'briefTitle': 'A Study of Intradermal Administration of ZOSTAVAX™ (V211-051 AM2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Partially Blinded Randomized Clinical Trial to Study the Immunogenicity and Safety of Intradermal Administration of ZOSTAVAX™ (V211)', 'orgStudyIdInfo': {'id': 'V211-051'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Full Dose Subcutaneous', 'description': '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.', 'interventionNames': ['Biological: ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous', 'Biological: Intradermal Placebo']}, {'type': 'EXPERIMENTAL', 'label': '1/3 Dose Subcutaneous', 'description': '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.', 'interventionNames': ['Biological: ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneous', 'Biological: Intradermal Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Full Dose Intradermal', 'description': '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.', 'interventionNames': ['Biological: ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Intradermal', 'Biological: Full Dose Intradermal Placebo']}, {'type': 'EXPERIMENTAL', 'label': '1/3 Dose Intradermal', 'description': '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.', 'interventionNames': ['Biological: ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal', 'Biological: Intradermal Placebo']}, {'type': 'EXPERIMENTAL', 'label': '1/10 Dose Intradermal', 'description': '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.', 'interventionNames': ['Biological: ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal', 'Biological: Intradermal Placebo']}, {'type': 'EXPERIMENTAL', 'label': '1/27 Dose Intradermal', 'description': '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.', 'interventionNames': ['Biological: ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal', 'Biological: Intradermal Placebo']}], 'interventions': [{'name': 'ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous', 'type': 'BIOLOGICAL', 'otherNames': ['V211'], 'description': 'One 0.65 mL injection subcutaneously on Day 1', 'armGroupLabels': ['Full Dose Subcutaneous']}, {'name': 'ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneous', 'type': 'BIOLOGICAL', 'otherNames': ['V211'], 'description': 'One approximately 0.22 mL injection subcutaneously on Day 1', 'armGroupLabels': ['1/3 Dose Subcutaneous']}, {'name': 'ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Intradermal', 'type': 'BIOLOGICAL', 'otherNames': ['V211'], 'description': 'Two intradermal injections of approximately 0.15 mL each on Day 1', 'armGroupLabels': ['Full Dose Intradermal']}, {'name': 'ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal', 'type': 'BIOLOGICAL', 'otherNames': ['V211'], 'description': 'One intradermal injection of approximately 0.1 mL on Day 1', 'armGroupLabels': ['1/10 Dose Intradermal', '1/27 Dose Intradermal', '1/3 Dose Intradermal']}, {'name': 'Full Dose Intradermal Placebo', 'type': 'BIOLOGICAL', 'description': 'Two intradermal placebo injections of approximately 0.15 mL each on Day 1', 'armGroupLabels': ['Full Dose Intradermal']}, {'name': 'Intradermal Placebo', 'type': 'BIOLOGICAL', 'description': 'One intradermal placebo injection of approximately 0.1 mL on Day 1', 'armGroupLabels': ['1/10 Dose Intradermal', '1/27 Dose Intradermal', '1/3 Dose Intradermal', '1/3 Dose Subcutaneous', 'Full Dose Subcutaneous']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}