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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_592 |
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The purpose of this study is to determine whether Zoster Vaccine Live and Pneumococcal Vaccine, polyvalent are as well tolerated and immunogenic when the vaccines are given together (in different body sites), as when they are given alone, in adults 60 years of age and older.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo Comparator |
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| 2 | Experimental | vaccine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™ | Biological | 0.65 mL injection Zoster Vaccine, Live, (Oka-Merck) over 4 week vaccination period |
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| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination | GMT of the VZV antibody responses at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly. *gpELISA = glycoprotein enzyme-linked immunosorbent assay | 4 weeks postvaccination |
| Geometric Mean Fold Rise (GMFR) of the Varicella-zoster Virus (VZV) Antibody Responses From Day 1 to 4 Weeks Postvaccination. | GMFR of the VZV antibody response from prevaccination to Week 4 postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23. gpELISA = glycoprotein enzyme-linked immunosorbent assay. | Four weeks postvaccination |
| Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 3 Antibody Response at 4 Weeks Postvaccination. | GMT of the PnPs serotype 3 antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly. | Four weeks postvaccination |
| Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 14 Antibody Response at 4 Weeks Postvaccination. | GMT of the PnPs serotype 14 antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly. | Four weeks postvaccination |
| Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 19A Antibody Response at 4 Weeks Postvaccination. | GMT of the PnPs serotype 19A antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of Both Vaccines When Administered Concomitantly. | All adverse events were analyzed including serious adverse events; injection-site adverse events; Vaccination Report Card prompted systemic adverse events, including varicella-like rashes or herpes zoster-like rashes; all other systemic adverse events. | Eight weeks postvaccination |
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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 |
|---|---|---|---|
| 20980796 | Result | MacIntyre CR, Egerton T, McCaughey M, Parrino J, Campbell BV, Su SC, Pagnoni MF, Stek JE, Xu J, Annunziato PW, Chan IS, Silber JL. Concomitant administration of zoster and pneumococcal vaccines in adults >/=60 years old. Hum Vaccin. 2010 Nov;6(11):894-902. doi: 10.4161/hv.6.11.12852. Epub 2010 Nov 1. |
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Phase III
First subject enrolled on 18-Jun-2007.
Last subject enrolled on 05-Dec-2007.
The last subject's last visit was 11-Feb-2008.
The study was conducted at 18 study centers throughout Canada, Australia, and Europe.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nonconcomitant Group | Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4 |
| FG001 | Concomitant Group | Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Comparator: placebo (concomitant-vaccine matched) | Biological | Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL Placebo injection over 4 week vaccination period. |
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| Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23 | Biological | Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL injection over 4 week vaccination period. |
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| Four weeks postvaccination |
| Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 22F Antibody Response at 4 Weeks Postvaccination. | GMT of the PnPs serotype 22F antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly. | Four weeks postvaccination |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nonconcomitant Group | Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4 |
| BG001 | Concomitant Group | Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1 |
| 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 | Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination | GMT of the VZV antibody responses at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly. *gpELISA = glycoprotein enzyme-linked immunosorbent assay | Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window; exposure to herpes zoster (HZ) or VZV. | Posted | Geometric Mean | 95% Confidence Interval | gpELISA units*/mL | 4 weeks postvaccination |
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| Secondary | Safety and Tolerability of Both Vaccines When Administered Concomitantly. | All adverse events were analyzed including serious adverse events; injection-site adverse events; Vaccination Report Card prompted systemic adverse events, including varicella-like rashes or herpes zoster-like rashes; all other systemic adverse events. | All subjects who received at least one vaccination | Posted | Number | Participants | Eight weeks postvaccination |
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| Primary | Geometric Mean Fold Rise (GMFR) of the Varicella-zoster Virus (VZV) Antibody Responses From Day 1 to 4 Weeks Postvaccination. | GMFR of the VZV antibody response from prevaccination to Week 4 postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23. gpELISA = glycoprotein enzyme-linked immunosorbent assay. | Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window; exposure to herpes zoster (HZ) or VZV. | Posted | Geometric Mean | 95% Confidence Interval | gpELISA units/mL | Four weeks postvaccination |
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| Primary | Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 3 Antibody Response at 4 Weeks Postvaccination. | GMT of the PnPs serotype 3 antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly. | Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: prior receipt of a pneumococcal vaccine; receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window. | Posted | Geometric Mean | 95% Confidence Interval | micrograms/mL | Four weeks postvaccination |
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| Primary | Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 14 Antibody Response at 4 Weeks Postvaccination. | GMT of the PnPs serotype 14 antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly. | Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: prior receipt of a pneumococcal vaccine; receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window. | Posted | Geometric Mean | 95% Confidence Interval | micrograms/mL | Four weeks postvaccination |
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| Primary | Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 19A Antibody Response at 4 Weeks Postvaccination. | GMT of the PnPs serotype 19A antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly. | Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: prior receipt of a pneumococcal vaccine; receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window. | Posted | Geometric Mean | 95% Confidence Interval | micrograms/mL | Four weeks postvaccination |
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| Primary | Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 22F Antibody Response at 4 Weeks Postvaccination. | GMT of the PnPs serotype 22F antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly. | Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: prior receipt of a pneumococcal vaccine; receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window. | Posted | Geometric Mean | 95% Confidence Interval | micrograms/mL | Four weeks postvaccination |
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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 | Nonconcomitant Group | Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4 | 4 | 154 | ||||
| EG001 | Concomitant Group | Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1 | 2 | 143 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Non-Hodgkin's Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Non-systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Global amnesia | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Stomach discomfort | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Malaise | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Rash Vesicular | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Erythema (ZOSTAVAX™ injection site) | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Erythema (PNEUMOVAX™ 23 injection site) | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Erythema (Placebo injection site) | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Induration (ZOSTAVAX™ injection site) | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Pain (ZOSTAVAX™ injection site) | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Pain (PNEUMOVAX™ 23 injection site) | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Pain (Placebo injection site) | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Pruritus (ZOSTAVAX™ injection site) | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Swelling (ZOSTAVAX™ injection site) | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Swelling (PNEUMOVAX™ 23 injection site) | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Swelling (Placebo injection site) | General disorders | MedDRA 11.0 | 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 |
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D053061 | Herpes Zoster Vaccine |
| D022242 | Pneumococcal Vaccines |
| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
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| Male |
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| Black or African American |
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| White |
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The power for the noninferiority hypothesis of VZV antibody titers is 92%. The noninferiority margin is the lower bound of the two-sided 95% confidence interval on the VZV antibody GMT ratio[concomitant/nonconcomitant] being >0.67. |
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