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| ID | Type | Description | Link |
|---|---|---|---|
| 2005_036 |
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The purpose of this study is to determine whether the investigational zoster vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile when given concomitantly with another vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concomitant | Experimental | Zostavax concomitantly with influenza vaccine on Day 1, placebo at week 4 |
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| Nonconcomitant | Experimental | Influenza vaccine and Zostavax placebo on Day 1, Zostavax at week 4 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZOSTAVAX™ (concomitant) | Biological | a single administration of 0.65 mL subcutaneous injection of zoster vaccine live on Day 1 and placebo at Week 4 |
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| Measure | Description | Time Frame |
|---|---|---|
| Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody Responses | The Geometric mean titer (GMT) of the VZV glycoprotein enzyme-linked immunosorbent assay (gpELISA) antibody responses at Week 4 postvaccination in participants who received ZOSTAVAX™ concomitantly with influenza vaccine was compared to that in subjects who received influenza vaccine and ZOSTAVAX™ nonconcomitantly. | 4 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Fold Rise (GMFR) in VZV gpELISA Antibody Titers From Prevaccination to 4 Weeks Postvaccination | GMFR of the VZV gpELISA antibody titers from prevaccination to 4 weeks postvaccination when ZOSTAVAX™ is administered concomitantly with influenza vaccine | prevaccination to 4 weeks postvaccination |
| Geometric Mean Titers (GMTs) of H1N1 Strain Antibody Responses at 4 Weeks Postvaccination |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17908055 | Background | Kerzner B, Murray AV, Cheng E, Ifle R, Harvey PR, Tomlinson M, Barben JL, Rarrick K, Stek JE, Chung MO, Schodel FP, Wang WW, Xu J, Chan IS, Silber JL, Schlienger K. Safety and immunogenicity profile of the concomitant administration of ZOSTAVAX and inactivated influenza vaccine in adults aged 50 and older. J Am Geriatr Soc. 2007 Oct;55(10):1499-507. doi: 10.1111/j.1532-5415.2007.01397.x. | |
| 19261769 |
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Participants were recruited at 13 sites in the United States and 7 sites in Europe.
First Patient In (FPI): 23-SEP-2005; Last Patient Last Visit (LPLV): 08-MAR-2006
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| ID | Title | Description |
|---|---|---|
| FG000 | Concomitant Group | ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4 |
| FG001 | Nonconcomitant Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Comparator: Influenza Vaccine | Biological | a single administration of 0.5 mL intramuscular injection of influenza vaccine (inactivated) at Day 1 |
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| ZOSTAVAX™ (Nonconcomitant) | Biological | Placebo injection on Day 1 and a single administration of 0.65 mL subcutaneous injection of zoster vaccine live at Week 4 |
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GMT of the H1N1 strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly |
| 4 weeks postvaccination |
| GMTs of H3N2 Strain Antibody Responses at 4 Weeks Postvaccination | GMT of the H3N2 strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly | 4 weeks postvaccination |
| GMTs of B Strain Antibody Responses at 4 Weeks Postvaccination | GMT of the B strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly | 4 weeks postvaccination |
| Background |
| Sutradhar SC, Wang WW, Schlienger K, Stek JE, Xu J, Chan IS, Silber JL. Comparison of the levels of immunogenicity and safety of Zostavax in adults 50 to 59 years old and in adults 60 years old or older. Clin Vaccine Immunol. 2009 May;16(5):646-52. doi: 10.1128/CVI.00407-08. Epub 2009 Mar 4. |
Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4 |
| Vaccinated at Visit 1 |
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| Vaccinated at Visit 2 |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Concomitant Group | ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4 |
| BG001 | Nonconcomitant Group | Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody Responses | The Geometric mean titer (GMT) of the VZV glycoprotein enzyme-linked immunosorbent assay (gpELISA) antibody responses at Week 4 postvaccination in participants who received ZOSTAVAX™ concomitantly with influenza vaccine was compared to that in subjects who received influenza vaccine and ZOSTAVAX™ nonconcomitantly. | The primary analysis was based on the per protocol population defined as participants who had valid GMT results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the statistical analysis plan (SAP). | Posted | Geometric Mean | 95% Confidence Interval | gpELISA units/mL | 4 weeks |
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| Other Pre-specified | Geometric Mean Fold Rise (GMFR) in VZV gpELISA Antibody Titers From Prevaccination to 4 Weeks Postvaccination | GMFR of the VZV gpELISA antibody titers from prevaccination to 4 weeks postvaccination when ZOSTAVAX™ is administered concomitantly with influenza vaccine | The analysis was based on the per protocol population defined as participants who had valid GMFR results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the statistical analysis plan (SAP) | Posted | Geometric Mean | 95% Confidence Interval | ratio | prevaccination to 4 weeks postvaccination |
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| Other Pre-specified | Geometric Mean Titers (GMTs) of H1N1 Strain Antibody Responses at 4 Weeks Postvaccination | GMT of the H1N1 strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly | The analysis was based on the per protocol population defined as participants who had valid results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the SAP. | Posted | Geometric Mean | 95% Confidence Interval | titers | 4 weeks postvaccination |
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| Other Pre-specified | GMTs of H3N2 Strain Antibody Responses at 4 Weeks Postvaccination | GMT of the H3N2 strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly | The analysis was based on the per protocol population defined as participants who had valid results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the SAP. | Posted | Geometric Mean | 95% Confidence Interval | titers | 4 weeks postvaccination |
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| Other Pre-specified | GMTs of B Strain Antibody Responses at 4 Weeks Postvaccination | GMT of the B strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly | The analysis was based on the per protocol population defined as participants who had valid results from samples obtained within the prespecified day ranges at Day 1, at Week 4, or at Week 8 postvaccination, and who did not meet any of the protocol violations prespecified in the SAP | Posted | Geometric Mean | 95% Confidence Interval | titers | 4 weeks postvaccination |
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Day 1-28 following each vaccination
Injection-site adverse events (AEs), rashes, oral temperatures (if the subject felt febrile), and other AEs were recorded by the participant on a Vaccination Report Card which was reviewed by the study site personnel at the end of each 28-day follow-up period.
4 participants from each group were lost to follow up & not included in the analysis
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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) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Concomitant Group | ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4 | 6 | 378 | 199 | 378 | ||
| EG001 | Nonconcomitant Group | Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4 | 5 | 376 | 181 | 376 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Aortic valve stenosis | Cardiac disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
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| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 9.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Non-systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 9.0 | Non-systematic Assessment |
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| Injection Site Erythema (Influenza vaccine injection site) | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Injection Site Erythema (Placebo injection site) | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Injection Site Erythema (ZOSTAVAX™ injection site) | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Injection Site Pain (Influenza vaccine injection site) | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Injection Site Pain (Placebo injection site) | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Injection Site Pain (ZOSTAVAX™ injection site) | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Injection Site Swelling (Influenza vaccine injection site) | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Injection Site Swelling (ZOSTAVAX™ injection site) | General disorders | MedDRA 9.0 | Systematic Assessment |
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Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| 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 |
|---|---|
| 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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| Asian |
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| Black |
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| Hispanic American |
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| Indian |
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| Multiracial |
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| Native American |
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| White |
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