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The study evaluated immunogenicity, safety, and tolerability of ZOSTAVAX™ Vaccine (V211) administered concomitantly versus nonconcomitantly with Quadrivalent Influenza Virus vaccine (inactivated) in participants ≥50 years of age. The primary hypotheses tested 1) the noninferiority of concomitant versus nonconcomitant vaccination with regard to Varicella zoster virus (VZV) Geometric Mean Titer (GMT) antibody responses, 2) the acceptability of geometric mean fold rise in VZV antibody response after concomitant vaccination, and 3) the noninferiority of concomitant versus nonconcomitant vaccination with regard to influenza virus strain-specific GMT antibody responses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concomitant Vaccination | Experimental | ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4 |
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| Nonconcomitant Vaccination | Experimental | Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZOSTAVAX™ | Biological | A single blinded administration of 0.65 mL subcutaneous injection on Day 1 (concomitant) or at Week 4 (nonconcomitant) |
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| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody | Anti-VZV antibodies were determined using a Glycoprotein Enzyme-linked Immunosorbent Assay. Baseline was Day 1 for the Concomitant group and Week 4 for the Nonconcomitant group. | Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group) |
| Geometric Mean Fold Rise From Baseline in VZV gpELISA Antibody Titers | Anti-VZV antibodies were determined using a Glycoprotein Enzyme-linked Immunosorbent Assay. Baseline was Day 1 for the Concomitant group and Week 4 for the Nonconcomitant group. | Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group) |
| Geometric Mean Titers of H1N1-specific Influenza Virus Antibody | Antibodies to H1N1-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin. | Baseline and 4 weeks after Influenza vaccination (Week 4) |
| Geometric Mean Titers of H3N2-specific Influenza Virus Antibody | Antibodies to H3N2-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin. | Baseline and 4 weeks after Influenza vaccination (Week 4) |
| Geometric Mean Titers of B-Yamagata-specific Influenza Virus Antibody | Antibodies to B-Yamagata-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28830693 | Result | Levin MJ, Buchwald UK, Gardner J, Martin J, Stek JE, Brown E, Popmihajlov Z. Immunogenicity and safety of zoster vaccine live administered with quadrivalent influenza virus vaccine. Vaccine. 2018 Jan 2;36(1):179-185. doi: 10.1016/j.vaccine.2017.08.029. Epub 2017 Aug 19. |
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A total of 901 participants were screened and 882 were randomized to one of two vaccination groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Concomitant Vaccination | ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4 |
| FG001 | Nonconcomitant Vaccination | Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo to ZOSTAVAX™ | Biological | A single blinded administration of 0.65 mL subcutaneous injection on Day 1 (nonconcomitant) or at Week 4 (concomitant) |
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| Influenza Vaccine | Biological | A single open-label administration of 0.5 mL intramuscular injection on Day 1 |
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| Baseline and 4 weeks after Influenza vaccination (Week 4) |
| Geometric Mean Titers of B-Victoria-specific Influenza Virus Antibody | Antibodies to B-Victoria-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin. | Baseline and 4 weeks after Influenza vaccination (Week 4) |
| Vaccinated on Day 1 |
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| Vaccinated at Week 4 |
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| COMPLETED |
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| NOT COMPLETED |
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Participants are included as randomized
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| ID | Title | Description |
|---|---|---|
| BG000 | Concomitant Vaccination | ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4 |
| BG001 | Nonconcomitant Vaccination | Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody | Anti-VZV antibodies were determined using a Glycoprotein Enzyme-linked Immunosorbent Assay. Baseline was Day 1 for the Concomitant group and Week 4 for the Nonconcomitant group. | Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges. | Posted | Geometric Mean | 95% Confidence Interval | gpELISA units/mL | Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group) |
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| Primary | Geometric Mean Fold Rise From Baseline in VZV gpELISA Antibody Titers | Anti-VZV antibodies were determined using a Glycoprotein Enzyme-linked Immunosorbent Assay. Baseline was Day 1 for the Concomitant group and Week 4 for the Nonconcomitant group. | Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges. | Posted | Geometric Mean | 95% Confidence Interval | Ratio of titers (Week 4 / Baseline) | Baseline and 4 weeks after ZOSTAVAX™ vaccination (Week 4 for Concomitant group and Week 8 for Nonconcomitant group) |
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| Primary | Geometric Mean Titers of H1N1-specific Influenza Virus Antibody | Antibodies to H1N1-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin. | Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Baseline and 4 weeks after Influenza vaccination (Week 4) |
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| Primary | Geometric Mean Titers of H3N2-specific Influenza Virus Antibody | Antibodies to H3N2-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin. | Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Baseline and 4 weeks after Influenza vaccination (Week 4) |
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| Primary | Geometric Mean Titers of B-Yamagata-specific Influenza Virus Antibody | Antibodies to B-Yamagata-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin. | Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Baseline and 4 weeks after Influenza vaccination (Week 4) |
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| Primary | Geometric Mean Titers of B-Victoria-specific Influenza Virus Antibody | Antibodies to B-Victoria-specific influenza virus hemagglutinin were measured using a Hemagglutinin Inhibition (HAI) assay. Antibody titers are the reciprocal of the highest dilution of serum that completely inhibited hemagglutinin. | Participants who met the inclusion criteria, were not protocol violators in a way that could influence the participant's immune response to study vaccine, received the quadrivalent influenza vaccine and ZOSTAVAX™ within the specified day ranges, and had samples for serology obtained within the specified day ranges. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Baseline and 4 weeks after Influenza vaccination (Week 4) |
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Up to 28 days after any vaccination (up to Week 8)
The population analyzed was all randomized participants who received at least one dose of study vaccination and had follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Concomitant Vaccination | ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4 | 4 | 435 | 256 | 435 | ||
| EG001 | Nonconcomitant Vaccination | Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4 | 6 | 438 | 256 | 438 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Coronary artery disease | Cardiac disorders | MedDRA version 19.0 | Systematic Assessment |
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| Gastrointestinal toxicity | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
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| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
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| Oesophagitis | Gastrointestinal disorders | MedDRA version 19.0 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA version 19.0 | Systematic Assessment |
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| Biliary colic | Hepatobiliary disorders | MedDRA version 19.0 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA version 19.0 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.0 | Systematic Assessment |
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| Ureteric cancer local | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.0 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA version 19.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Injection site erythema | General disorders | MedDRA version 19.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA version 19.0 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA version 19.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA version 19.0 | Systematic Assessment |
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The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
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| D053061 | Herpes Zoster Vaccine |
| D007252 | Influenza Vaccines |
| C478242 | vaxigrip |
| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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