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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_540 |
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The purpose of this study is to determine that revaccination of Pneumococcal Vaccine is well tolerated and produces an immune response in older adults.
This study is an extension study (V110-007-10) which met requirements for posting on clinicaltrials.gov. The original study (V110-007-00) was completed in 2004 and did not meet the criteria for registration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1st Revaccination Group | Experimental |
| |
| 2nd Revaccination Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pneumococcal 23v polysaccharide vaccine | Biological | Duration of Treatment: Single vaccination on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 3 | Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B,8, 9V, 12F, 14, 23F) by ELISA. | Day 1 & Day 30 |
| Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 4 | Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA. | Day 1 & Day 30 |
| Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 6B | Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA. | Day 1 & Day 30 |
| Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 8 | Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA. | Day 1 & Day 30 |
| Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 9V | Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA. |
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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 |
|---|---|---|---|
| 21860256 | Result | Musher DM, Manoff SB, McFetridge RD, Liss CL, Marchese RD, Raab J, Rueda AM, Walker ML, Hoover PA. Antibody persistence ten years after first and second doses of 23-valent pneumococcal polysaccharide vaccine, and immunogenicity and safety of second and third doses in older adults. Hum Vaccin. 2011 Sep;7(9):919-28. doi: 10.4161/hv.7.9.15996. Epub 2011 Sep 1. | |
| 20088694 |
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Base trial 4/97-4/98 Prior to results posted Initial: subjects received 1st or 2nd dose of PN23 Persistence: followed immune response 5 yrs; ended 4/03 Extension 7/07-4/08: enrolled 9-10 yrs after base. 1dose of PN23 Blood drawn Days 1&30, immune response to 8 serotypes measured 143 of 400 enrolled: difficulty enrolling eligible/interested subjects
This was a Phase III study. The first patient was enrolled (FPE) on 13-Jul-2007. The last patient last visit (LPLV) was on 30-May-2008. A total of 5 US study centers were involved in the recruitment.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1st Revaccination Group | Received primary vaccination with Pneumovax 23 during the initial phase and 1st revaccination in the extension phase |
| FG001 | 2nd Revaccination Group | Received 1st revaccination with Pneumovax 23 during the initial phase and 2nd revaccination in the extension phase |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1st Revaccination Group | Received primary vaccination with Pneumovax 23 during the initial phase and 1st revaccination in the extension phase |
| BG001 | 2nd Revaccination Group | Received 1st revaccination with Pneumovax 23 during the initial phase and 2nd revaccination in the extension phase |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 3 | Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B,8, 9V, 12F, 14, 23F) by ELISA. | All eligible participants | Posted | Geometric Mean | 95% Confidence Interval | gpELISA units/mL | Day 1 & Day 30 |
|
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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 | 1st Revaccination Group | Received primary vaccination with Pneumovax 23 during the initial phase and 1st revaccination in the extension phase |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 11.0 | Non-systematic Assessment |
Open-label non-randomized group of subjects enrolled in this extension. Subjects recruited from original study which completed five years previously.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
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| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C006045 | 2,4,5,4'-tetrachlorodiphenylsulfoxide |
| D022242 | Pneumococcal Vaccines |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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|
| Day 1 & Day 30 |
| Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 12F | Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA. | Day 1 & Day 30 |
| Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 14 | Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA. | Day 1 & Day 30 |
| Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 23F | Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA. | Day 1 & Day 30 |
| Manoff SB, Liss C, Caulfield MJ, Marchese RD, Silber J, Boslego J, Romero-Steiner S, Rajam G, Glass NE, Whitney CG, Carlone GM. Revaccination with a 23-valent pneumococcal polysaccharide vaccine induces elevated and persistent functional antibody responses in adults aged 65 > or = years. J Infect Dis. 2010 Feb 15;201(4):525-33. doi: 10.1086/651131. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG003 | 2nd Revaccination Group Day 30 |
|
|
| Primary | Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 4 | Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA. | All eligible participants | Posted | Geometric Mean | 95% Confidence Interval | gpELISA units/mL | Day 1 & Day 30 |
|
|
|
| Primary | Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 6B | Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA. | All eligible participants | Posted | Geometric Mean | 95% Confidence Interval | gpELISA units/mL | Day 1 & Day 30 |
|
|
|
| Primary | Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 8 | Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA. | All eligible participants | Posted | Geometric Mean | 95% Confidence Interval | gpELISA units/mL | Day 1 & Day 30 |
|
|
|
| Primary | Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 9V | Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA. | All eligible participants | Posted | Geometric Mean | 95% Confidence Interval | gpELISA units/mL | Day 1 & Day 30 |
|
|
|
| Primary | Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 12F | Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA. | All eligible participants | Posted | Geometric Mean | 95% Confidence Interval | gpELISA units/mL | Day 1 & Day 30 |
|
|
|
| Primary | Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 14 | Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA. | All eligible participants | Posted | Geometric Mean | 95% Confidence Interval | gpELISA units/mL | Day 1 & Day 30 |
|
|
|
| Primary | Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 23F | Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA. | All eligible participants | Posted | Geometric Mean | 95% Confidence Interval | gpELISA units/mL | Day 1 & Day 30 |
|
|
|
| 0 |
| 71 |
| 48 |
| EG001 | 2nd Revaccination Group | Received 1st revaccination with Pneumovax 23 during the initial phase and 2nd revaccination in the extension phase | 0 | 71 | 60 |
| Dry Eye | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Lacrimation Increased | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Macular Degeneration | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Aphthous | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Oral Disorder | Gastrointestinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Anaesthesia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Coldness | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Erythema | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Induration | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Pain (Injection site) | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Paraesthesia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Peripheral Coldness | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Pruritus | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Swelling | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Warmth | General disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Non-systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA 11.0 | Non-systematic Assessment |
|
| Blood Pressure Increased | Investigations | MedDRA 11.0 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Type 2 Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Joint Range of Motion Decreased | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Migrane | Nervous system disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Pruritus Generalised | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Non-systematic Assessment |
|
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.
| D007239 | Infections |
| D045424 |
| Complex Mixtures |